fluticasone furoate/vilanterol (ff/vi; gw685698+gw642444)€¦ · final protocol approved 04 jan...

HEALTH OUTCOMES PROTOCOL

UNIQUE IDENTIFIER HO-15-15503 / 204888ABBREVIATED TITLE Patients’ Experiences of Relvar Ellipta TreatmentFINAL PROTOCOL APPROVED

04 Jan 2016 (Date of last approval signature)

FULL TITLE Evaluating the Impact, Benefits and Preferences of Relvar Ellipta® in Patients with COPD and asthma

SPONSORSHIP SponsoredDIVISION PharmaBUSINESS UNIT Research & Development / Respiratory FranchiseDEPARTMENT VEOHO STUDY ACCOUNTABLE PERSON(S)CONTRIBUTING AUTHORS

RETENTION CATEGORYINFORMATION TYPE Health Outcomes Observational (Non-Interventional) ProtocolKEY WORDS / MESH HEADINGS / META DATA

Qualitative Interviews; Survey; Patient Preferences; Asthma; COPD; Patient-reported

ASSET ID Fluticasone furoate/Vilanterol (FF/VI; GW685698+GW642444)

GSK ASSET Relvar Ellipta

INDICATION COPD and asthma

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PROTOCOL SYNOPSIS

Unique Identifier HO-15-15503 / 204888

Abbreviated Title Patients’ Experiences of Relvar Ellipta Treatment

GSK Product Relvar Ellipta

Rationale Existing treatments for asthma and COPD are typically twice daily (BID) inhaled corticosteroid/long acting beta agonist (ICS/LABA) treatments (e.g. BID Fluticasone Propionate/Salmeterol). Fluticasone Furoate + Vilanterol (FF + VI, or Relvar) has been recently launched by GSK as a new, combined medicine in the maintenance treatment of COPD and asthma. One of the main features of FF/VI is 24-hour continuous efficacy and, as such, it is the first and only Once-Daily (QD) inhaled ICS/LABA combination available. FF/VI is delivered via an easy to use and patient preferred inhaler device, ElliptaTM (Svedsater et al., 2013).

The current study does not aim to test a hypothesis, rather the study aims to collect data on patients’ experiences with Relvar and how this compares to previous treatments (where appropriate/relevant). Previous research has demonstrated that patients find Ellipta™ easy to use (Svedsater et al., 2013), and as a once daily medication, this is likely to result in greater convenience on behalf of the patients (Svedsater et al., 2013). A 24-hour continuous efficacy profile may also lead to fewer nocturnal symptoms, consequently improve sleep quality and reduce fatigue, with potential benefits of greater productivity and ability to conduct various activities. However, other treatment impacts may arise during the course of this research that are unknown or difficult to predict at this stage. Other treatment impacts,benefits/disadvantages, preferences and satisfaction/dissatisfaction of using Relvar Ellipta will be investigated during qualitative patient interviews but may include greater frequency of rescue and symptom-free 24-hour periods and lower levels of anxiety. In addition, any unanticipated adverse effects of this once daily medication may also be identified.

Data from the semi-structured patient interviews will be used to inform and develop a quantitative survey which will be used to measure the extent to which Relvar Ellipta patients are satisfied with their treatment based on the impacts of Relvar Ellipta highlighted in the qualitative interviews.

Objectives The main purpose of this study is to identify and evaluate treatment

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(Primary, Secondary &Exploratory)

satisfaction including treatment impact, benefits/disadvantages, preferences and satisfaction/dissatisfaction of using Relvar Ellipta by patients who are currently being prescribed this medicine for their asthma or COPD.

This will be investigated by utilising a mixed methods approach. A sample of patients will participate in semi-structured interviews in order to provide detailed thematic qualitative data. Another sample will complete a structured questionnaire (administered online, by pen and paper or by phone) that will target related, more detailed quantitative data to answer specific research questions developed from the qualitative data.

The objectives of the study are thus:

1) To conduct semi-structured qualitative interviews with asthma and COPD patients currently being prescribed Relvar Ellipta to evaluate benefits, preferences and satisfaction of Relvar Ellipta in comparison with other treatments they have taken.

2) To design and conduct a structured quantitative survey with asthma and COPD patients who are currently being prescribed Relvar Ellipta in order to obtain evaluative quantitative data on specific aspects of treatment satisfaction, including benefits/disadvantages, preferences and satisfaction/dissatisfaction.

Study Design A mixed-methods design involving two stages:

Stage I will involve semi-structured and open-ended qualitative interviews with asthma and COPD patients receiving Relvar Ellipta treatment.

Stage II will comprise of a quantitative survey for the same population; the survey will be developed from the results of Stage I.

Study Population and Sampling Methods

Inclusion criteria:A self-reported diagnosis of asthma/COPD from a physicianOR has Asthma, COPD and Asthma-COPD Overlap Syndrome (ACOS)Has had asthma, COPD or co-Are currently prescribed Relvar Ellipta for asthma or COPD

ageCurrently resident in the UK Adequate written and oral fluency in English as judged by the investigator

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Willing and able to provide informed consent Able to complete an interview (for qualitative stages)Access to the internet (for participants completing the quantitative survey online)

Exclusion criteria:

An acute illness or cognitive impairment that in the opinion of the investigator would interfere with the study requirements.Any co-morbidity that would inhibit the ability to provide informed consent or allow participation in a telephone or face-to-face interview.Taken part in any other stage or phase of this study.

Data Source Individual qualitative interviews to inform development of the quantitative survey.

Data Analysis Methods Stage I-Semi-structured InterviewsThe findings of the interviews will be analysed using MAXQDA. The qualitative data will be coded into themes and sub-themes. Results will be presented as narratives representing common themes and/or viewpoints, and descriptive analyses will be conducted on key selected themes and outcomes. The results will inform the development of the quantitative survey.

Stage II - Structured SurveyThe current study does not aim to test hypotheses. The objectives of quantitative data analysis are first to summarise the responses of participants to the survey questions using appropriate descriptive statistics (e.g., means with standard deviations, medians with interquartile ranges, response frequencies with percentages).

Quantitative data will be analysed using SPSS v19.0. Analyses will largely be confined to descriptive statistics, although consideration will be given where appropriate to univariate and regression analysis. Primary and secondary research questions, including pre-specified study hypotheses, will be analysed as appropriate using inferential statistics, with type I error set at the 5% level (p<0.05). Hypothesis tests will be conducted as appropriate and 95% confidence intervals used to capture the uncertainty in the data.

The ACT and CAT will be scored according to developer instructions.

Sample Size and Power All sample sizes will be recruited on a best effort basis.

Stage I - Semi-structured Interviews

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Up to 50 Relvar Ellipta patients (asthma, n=25; COPD, n=25).

Data saturation will be assessed; saturation is expected to be reached after approximately 15-20 interviews.

Stage II - Structured SurveyPhase I: Cognitive debrief interviewsUp to 6 Relvar Ellipta patients (asthma, n=3; COPD, n=3).

The aim of cognitive debrief interviews is to evaluate general readability of the quantitative survey and individual item comprehension. This sample size has been used in previous studies and has provided enough data to finalise surveys.

Phase II: Quantitative SurveyUp to 200 Relvar Ellipta patients (asthma, n=100; COPD, n=100).

This size of sample would allow comparisons to be made both across conditions in terms of a precision threshold of ±10%.

Limitations 1) As participants are recruited by an agency, participants will be asked to self-report their diagnosis; this information will not be verified via a clinician diagnosis. In order to control for any misrepresentation, a detailed screening script has been developed.

2) Some participants will be recruited through a database of patients who have previously volunteered, or expressed interest, in participating in research, which could create selection bias. In order to recruit as broad a sample as possible, the recruitment agency will recruit through several methods including HCPs, support groups, and consumer networks.

3) It will not be possible to guarantee representativeness of the study participants. In all stages of the study, however, particular focus will be placed on obtaining a broad sample of patient participants in terms of age, ethnicity, gender and disease control (asthma) or disease impact (COPD). Participants will complete a socio-demographic form and either the asthma Control Test (ACT) or the COPD Assessment Test (CAT), both of which will be monitored and used to recruit patients across the socio-demographic and disease control/impact spectrum.

4) The quantitative survey (Stage II) will be hosted online, in paper version or conducted via telephone interview. This would enable participants to take part in either format and thus will minimise any limitation of requiring participants to have access to the internet. As in Phase I, disease control (asthma)/impact (COPD) and demographics will be monitored with the aim of achieving as broad patient sample as

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possible and minimize the limitation of having a non-representative sample.

5) As Relvar Ellipta is a relatively new treatment, it may be difficult to recruit the required number of patients through a patient recruitment agency, particularly the relatively large number required for the quantitative survey. If necessary, to achieve the target patient numbers, the recruitment agency will recruit directly thought NHS sites. In this instance this protocol will be submitted for NHS ethical review.

6) Stage I and II of the project will be questioning patients on their disease history, previous treatments and experiences and is therefore reliant on self-reported data that is subject to recall bias. In order to minimize this bias, methodological approaches to the development of study materials will be undertaken to ensure that materials are well developed and where possible use standardized well-structured questionnaires.

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TABLE OF CONTENTS

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ABBREVIATIONS

ACOS Asthma-COPD Overlap SyndromeACT Asthma Control TestAE Adverse EventsBID Twice DailyCAT COPD Assessment TestCI Confidence IntervalCOPD Chronic Obstructive Pulmonary DiseaseFF Fluticasone FuroateHCPs Health Care ProfessionalsICD Informed Consent Document

ICS Inhaled corticosteroidsIRB Institutional Review BoardLABA Long-Acting Beta AgonistsQD Once DailyURL Uniform Resource LocatorVI Vilanterol

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1. INTRODUCTION/BACKGROUND Asthma and Chronic Obstructive Pulmonary Disease (COPD) are two of the most common respiratory conditions in the UK (Mukherjee et al 2014; NHS Choices 2014), with 1 in 12 adults currently receiving treatment for asthma (Asthma UK) and more than 3 million people living with COPD.

Existing treatments for asthma and COPD are typically twice daily (BID) inhaled corticosteroid/long acting beta agonist (ICS/LABA) treatments (e.g. BID Fluticasone Propionate/Salmeterol). Fluticasone Furoate + Vilanterol (FF + VI, or Relvar) has been recently launched by GSK as a new, combined medicine in the maintenance treatment of COPD and asthma. One of the main features of FF/VI is 24-hour continuous efficacy and, as such, it is the first and only Once-Daily (QD) inhaled ICS/LABA combination available. FF/VI is delivered via an easy to use and patient preferred inhaler device, ElliptaTM (Svedsater et al., 2013).

It is hypothesized that Relvar Ellipta will result in patient benefits over the existing available ICS/LABA treatments. Previous research has demonstrated that patients find Ellipta™ easy to use (Svedsater et al., 2013), and as a once daily medication, this is likely to result in greater convenience on behalf of the patients (Svedsater et al., 2013). A 24-hour continuous efficacy profile may also lead to fewer nocturnal symptoms, consequently improve sleep quality and reduce fatigue, with potential benefits of greater productivity and ability to conduct various activities. However, other treatment impacts may arise during the course of this research that are unknown or difficult to predict at this stage. Other treatment impacts, benefits/disadvantages, preferences and satisfaction/dissatisfaction of using Relvar Ellipta will be investigated during qualitative patient interviews but may include greater frequency of rescue and symptom-free 24-hour periods and lower levels of anxiety. In addition, any unanticipated adverse effects of this once daily medication may also be identified.

Following semi-structured patient interviews, a structured survey will be developed to measure extent to which Relvar Ellipta patients are satisfied with their treatment based on the impacts of Relvar Ellipta highlighted in the semi-structured interviews.

2. OBJECTIVES The overall aim of this mixed-methods study (project phase 4) is to elicit the benefits/disadvantages, preferences and satisfaction/dissatisfaction relating to Relvar Ellipta asthma and COPD treatment, and to quantify those benefits and preferences in a structuredpatient satisfaction survey.

2.1. Primary1) To conduct in depth, qualitative interviews with asthma and COPD patients currently

treated with Relvar Ellipta to evaluate benefits, preferences and satisfaction of Relvar

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Ellipta in comparison with other treatments they have taken.

2) To design, evaluate, and conduct a structured survey with asthma and COPD patients who are currently being prescribed Relvar Ellipta in order to obtain quantitative data on specific aspects of treatment satisfaction including benefits/disadvantages, preferences and satisfaction/dissatisfaction.

Other exploratory questions are:

How is a 24-hour/once-daily medication viewed by asthma/COPD patients using Relvar Ellipta?To what extent does Relvar Ellipta affect impact and quality of life, such as;

o Day-time symptoms o Sleep qualityo Physical activityo Social activityo Sensitivity to triggerso Emotional functioningo Ease and ability to take medication

To what extent are asthma/COPD patients prescribed Relvar Ellipta overall satisfied or dissatisfied with the treatment?

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1. RESEARCH METHODOLOGY

a. STUDY DESIGN

The purpose of this phase of the project is to identify and evaluate treatment impact, benefits/disadvantages, preferences and satisfaction/dissatisfaction of Relvar Ellipta directly from patients who are currently prescribed Relvar Ellipta for their asthma and/or COPD. Treatment impacts will be investigated using a mixed-methods design. Asthma and COPD patients will participate in individual interviews to provide detailed qualitative data. The majority of these interviews will be semi-structured, with the final set of interviews being an open-ended discussion of the main themes identified from the initial semi-structured interviews. These qualitative results will then be used to inform the development of the survey (stage two) to collect quantitative data on specific aspects of the effects and impact of Relvar Ellipta including benefits/disadvantages, preferences and satisfaction/dissatisfaction. Appropriate attention will be given to each stage to ensure that the study minimises bias and produces robust and valid results.

In the first stage of the study, qualitative interviews will be conducted with participants with asthma and COPD to explore the effects and impact of Relvar Ellipta.

In the second stage of the project, a draft quantitative survey will be developed and explored with participants in cognitive debrief interviews. Up to 6 participants in the UK will be asked to complete the survey for the patient group to which they belong (asthma and/or COPD) and then comment on its accuracy. The survey will be modified and finalized according to the participant feedback obtained.

Following the cognitive debrief task, approximately 200 participants in the UK (100 per condition) will complete the finalised quantitative survey designed to elicit quantitative dataon the benefits and preferences associated with Relvar Ellipta.

Sample size for the quantitative survey is determined in terms of the precision of study estimates. Implications for varying sample sizes in terms of estimates of proportion are shown in Table 1. Sample size requirements are highest when the estimated proportion is 0.50, becoming progressively smaller as the proportion approaches 0 or 1. The implications are shown in terms of precision of the 95% confidence interval (CI) around estimates of proportion of 0.50 and 0.25. It can be seen that a sample size of 100 individual patients (per condition or overall) would give at minimum a precision of ±0.099, with a resulting CI width of at most 0.20 (0.40 to 0.60 around an estimate of 0.50). If the sample size increased to 250 individuals (125 per condition) the precision would increase to a minimum of ±0.062, with a resulting CI width of at most 0.12 (0.44 to 0.56 around an estimate of 0.50). Conversely, if the sample size falls to 50 (25 per condition), the precision would decrease to a minimum of ± 0.14, with a resulting CI width of at most .28 (.36 to .64 around an estimate of 0.50).

Sample size: 25 50 100 250 500

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Estimated proportion = 0.50Precision± .196 .139 .099 .062 .04495% CI .30-.70 .36-.64 .40-.60 .44-.56 .45-.55Width of 95%CI .40 .28 .20 .12 .10


We would aim to recruit up to 100 per condition for the quantitative phase of the study (200 patients overall). This size of sample would allow comparisons to be made both across conditions in terms of a precision threshold of ±10%.

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b. STUDY POPULATION

1.b.1. ELIGIBILITY CRITERIA

1.b.1.1. Inclusion CriteriaA self-reported diagnosis of asthma/COPD from a physician OR Asthma-COPD Overlap Syndrome (ACOS)Has had asthma, COPD or co-Are currently prescribed Relvar Ellipta for asthma or COPD

Currently resident in the UK Adequate written and oral fluency in English as judged by the investigator Willing and able to provide informed consent Able to complete an interview (for qualitative stages)Access to the internet (for participants completing the quantitative survey online)

1.b.1.2. Exclusion CriteriaAn acute illness or cognitive impairment that in the opinion of the investigator would interfere with the study requirements.Any co-morbidity that would inhibit the ability to provide informed consent or allow participation in a telephone or face-to-face interview.Taken part in any other stage or phase of this study.

1.b.2. SAMPLINGStage I - Qualitative InterviewsThe recruitment agency will identify and recruit up to 25 people diagnosed with asthma and 25 people diagnosed with COPD (N=50); patients with co-morbid asthma/COPD will be assigned to the COPD condition. The recruitment agency will make contact with patients in the UK who are diagnosed with asthma and/or COPD, being prescribed Relvar Ellipta, and who match the eligibility criteria using the screening form (Appendix A), and will provide them an invitation to participate (Appendix B) and the IRB-approved informed consent document (ICD). A broad patient sample for each condition will be recruited based on age, gender and disease control/impact as assessed by the asthma Control Test (ACT, Appendix G) and COPD Assessment Test (CAT, Appendix H). Interested patients will then be invited to participate in an individual 60-minute interview. We aim to conduct up to 40 individual telephone interviews (asthma, n=20, COPD, n=20) and up to 10 face-to-face interviews (asthma, n=5, COPD, n=5). Participants will be reimbursed for their time for completing the interview (£45).

Stage II - Quantitative surveyThe results of the qualitative interviews will be used to develop a quantitative survey to gather detailed quantitative data relating to patients’ experiences and treatment impactsincluding benefits/disadvantages, preferences and satisfaction/dissatisfaction with Relvar

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Ellipta as a treatment for their asthma/COPD.

Cognitive Debriefing: The recruitment agency will identify three patients per condition (overall N=6). Participants will be asked to complete screening questions over the phone. The first six who are eligible and interested will be asked to review a study invitation letter and ICD. An interview date/time will then be scheduled. Patients will be invited to complete a paper version of the draft quantitative survey (taking up to 45 minutes to complete) prior to the telephone cognitive debriefing interview (lasting up to 60 minutes) (Appendix N). Participants will be asked to return the signed ICD before the cognitive debrief interview. Participants will be reimbursed for their time (£TBD).

Questionnaire completion: The recruitment agency will identify from their UK user database patients who match the eligibility criteria, and email or post them a study invitation (Appendix C) including an IRB-approved informed consent form (Appendix E) and, if completing the survey online, a URL for the online access to the survey. A broad patient sample for each condition will be recruited based on age, gender, ethnicity, and disease control/impact as assessed by the ACT(ACT, Appendix G) and CAT(CAT, Appendix H). Patients will be invited to complete a quantitative survey either online, by pen and paper or telephone interview (taking up to 45 minutes). If they wish to participate, they will be asked to provide consent online before completing the survey. Participants will review an ICD at home and post or email the consent form to before the interview. Participants will also be able to provide consent electronically by reviewing the ICD online via URL. Participants will be reimbursed for their time (£TBD).

In all stages of the study particular focus will be placed on obtaining a broad sample of patient participants in terms of age, ethnicity, gender and disease control (asthma) or disease impact (COPD). Participants will complete a socio-demographic form and either the asthma Control Test (ACT) or the COPD Assessment Test (CAT), both of which will be monitored and used to recruit patients across the socio-demographic and disease control/impact spectrum.

Institutional Review Board (IRB) approval will be obtained for all phases of the study.

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c. DATA SOURCE / DATA COLLECTIONStage I-Qualitative InterviewsPatients will be screened for eligibility (Appendix A) and asked to review the study invitation letter (Appendix B) and ICD. Patients will be asked to complete either a paper version of the ICD and send it to or provide consent electronically by reviewing the ICD online via aURL before their individual interview. The ICD will also ask for the participant’s consent to follow up on adverse events (AEs) related to any medicine manufactured by the study sponsor that may be identified during the interviews, as well as the reporting of these to the study sponsor (Appendix O).

Prior to individual interviews, participants will be asked socio-demographic questions and either the ACT or CAT will be administered depending on disease (Appendices F, G and H,respectively); patients with co-morbid asthma/COPD will be assigned to the COPD group and will this be interviewed about COPD and complete the CAT and clinical background questions. Demographic and CAT/ACT data may be collected electronically via URL from participants consenting electronically. Up to 20 semi-structured individual interviews will be conducted over the telephone by experienced trained interviewers from

Up to 10 open-ended individual interviews will be conducted in-person at a suitable research facility, or at the participant’s home, by experienced interviewers from The interviews will be conducted according to the approved individual interview guides (Appendix I-L), with the flexibility of allowing the interviewer to adapt the questioning and probe for additional information for each individual participant.

The individual interviews will be audio-recorded and transcribed verbatim. Following the completion of each interview, participants will be reimbursed (£45 for the individual interviews, to include travel expenses as appropriate).

Stage II-Cognitive DebriefingThe quantitative survey will be administered first in a cognitive debrief interview format with individuals being prescribed Relvar Ellipta for asthma/COPD in the UK. Cognitive debriefing interviews will be conducted in the UK (N=6) to evaluate general readability of the survey and item comprehension using a cognitive debrief interview guide (Appendix N). Participants will be requested to complete a paper version of the survey as well as socio-demographic questions and either the ACT or CAT before participating in the interviews;patients with co-morbid asthma/COPD will be assigned to COPD. The interviews will be conducted over the telephone by trained interviewers from The interviews will be conducted according to the approved cognitive interview guide, with the flexibility of allowing the interviewer to adapt the questioning and probe for further information for each individual participant. The interviews will be analysed using an interview grid to evaluate the information gathered and whether revisions to the survey are required. Any necessary modifications will be made to the survey for use in any subsequent cognitive debrief interviews. Following the completion of each interview, participants will be reimbursed (£TBD).

Stage II - Quantitative Survey

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Data collection: Quantitative data collection will be via an online survey, posted pen and paper survey or a telephone interview. Participants who opt to complete the pen and paper survey or telephone interview will be posted or emailed an ICD to review at home and will post or email the signed consent form to before completing the survey/interview. Participants completing the survey online will provide consent electronically by reviewing the ICD online via URL. The URL will also provide a link to the study website where they will complete the online survey. The data collected in the quantitative survey will include a socio-demographic form and either the ACT or CAT (Appendix G and H). Upon completion of these forms participants will next complete the main survey, relevant to either asthma or COPD as appropriate. Following the completion of the quantitative survey, participants will be reimbursed (£TBD).

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1.c.1. ENDPOINTS

1.c.1.1. Primary Endpoint Qualitative data on benefits, preferences and satisfaction of Relvar Ellipta in comparison with other treatments will be collected through the semi-structured patient interviews (Stage I).

1.c.1.2. Secondary Endpoint(s)The qualitative data from the semi-structured patient interviews will inform the developmentof questions to be included in the structured survey. Quantitative data on specific aspects of treatment satisfaction including benefits/ disadvantages, preferences and satisfaction/dissatisfaction will then be collected through the structured patient survey (Stage II).

1.c.1.3. Exploratory Endpoint(s)Views of 24-hour/once-daily medication by asthma/COPD patients using Relvar Ellipta.Effect of Relvar Ellipta on daily functioning and quality of life (Stage I):

o Day-time symptoms o Sleep qualityo Physical activityo Social activityo Sensitivity to triggerso Emotional functioningo Ease and ability to take medication

Satisfaction/dissatisfaction of asthma/COPD patients prescribed Relvar Ellipta overall (Stage II).

d. SAMPLE SIZE / POWER CALCULATIONSAll sample sizes will be recruited on a best effort basis.

Stage I-Qualitative InterviewsUp to 50 Relvar Ellipta patients (asthma, n=25; COPD, n=25).

Data saturation will be assessed; saturation is expected to be reached after approximately 15-20 interviews.

Stage II - Quantitative SurveyPhase I: Cognitive debrief interviewsUp to 6 Relvar Ellipta patients (asthma, n=3; COPD, n=3).

The aim of cognitive debrief interviews is to evaluate general readability of the quantitativesurvey and individual item comprehension. This sample size has been used in previous studies and been provided enough data to finalise surveys.

Phase II: Data CollectionUp to 200 Relvar Ellipta patients (asthma, n=100; COPD, n=100).Sample size for the quantitative survey is determined in terms of the precision of study estimates. Implications for varying sample sizes in terms of estimates of proportion are

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shown in Table 1. Sample size requirements are highest when the estimated proportion is 0.50, becoming progressively smaller as the proportion approaches 0 or 1. The implications are shown in terms of precision of the 95% confidence interval (CI) around estimates of proportion of 0.50 and 0.25. It can be seen that a sample size of 100 individual patients (per condition or overall) would give at minimum a precision of ±0.099, with a resulting CI width of at most 0.20 (0.40 to 0.60 around an estimate of 0.50). If the sample size increased to 250 individuals (125 per condition) the precision would increase to a minimum of ±0.062, with a resulting CI width of at most 0.12 (0.44 to 0.56 around an estimate of 0.50). Conversely, if the sample size falls to 50 (25 per condition), the precision would decrease to a minimum of ± 0.14, with a resulting CI width of at most .28 (.36 to .64 around an estimate of 0.50).

Sample size: 25 50 100 250 500Estimated proportion = 0.50

Precision± .196 .139 .099 .062 .04495% CI .30-.70 .36-.64 .40-.60 .44-.56 .45-.55Width of 95%CI .40 .28 .20 .12 .10


We would aim to recruit up to 100 per condition for the quantitative phase of the study (200 patients overall). This size of sample would allow comparisons to be made both across conditions in terms of a precision threshold of ±10%.

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e. HYPOTHESESThe current study does not aim to test a hypothesis, rather the study aims to collect data on

patients’ experiences with Relvar and how this compares to previous treatments (where appropriate/relevant). This will be achieved by conducting semi-structured interviews and a quantitative survey with asthma/COPD patients.

2. DATA ANALYSIS CONSIDERATIONS

Hypothesis testing is not being carried out. All data analysis will be for descriptive purposesonly.

Demographic Background QuestionnaireDemographic data will be summarised using descriptive statistics (e.g. means, standard deviations and frequencies, as appropriate).

ACT/CATACT/CAT scores will be summarised using descriptive statistics (e.g. means, standard deviations and frequencies, as appropriate).

Asthma Control Test (ACT)The ACT is a five-item patient-completed instrument that captures how well their asthma has been controlled during the past four weeks (Quality Metric, 2002). Across the five items, responses are scored from one to five with a minimum score of 5 and a maximum score of

weeks; a total score of 20-24 indicates that asthma has been reasonably well controlled during the past four weeks; and a total score of 25 indicates that asthma has been under control during the past four weeks (Quality Metric, 2002).

COPD Assessment Test (CAT)The CAT is an eight-item patient-completed instrument that quantifies the impact of COPD on the patient’s health (CAT Test Online, 2012). Across the eight items, responses are scored from zero to five with a minimum score of 0 and a maximum score of 40. A total score of <10 indicates a low impact level; a total score of 10-20 indicates a medium level impact; a total score of >20 indicates high level impact and a total score >30 indicates a very high impact level (CAT Test Online, 2012).

Stage I - Qualitative Interview DataAfter completion of the interviews, the audio-recordings will be transcribed verbatim and the data analysed using a qualitative software tool, MAXQDA (VERBI GmbH 2015).

The analysis phase will begin with a careful review of the interview transcripts by members of the project team. This initial review of the transcripts will ensure comprehensiveness and accuracy of the transcripts. It will also enable any missing or incorrect information to be identified and corrected, participant names and identifying information to be removed, and themes to begin to be identified.

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The interview transcripts will be analysed using thematic analysis. Thematic analysis will be conducted according to the methodology described by Braun and Clarke (2006). This is a rigorous and transparent qualitative analysis approach, which is well suited to qualitative patient reported outcomes research (Kerr et al 2011). Up to 25 asthma patients and up to 25 COPD patients will be interviewed until data saturation has been reached. Data saturation is expected to be reached after approximately 15-20 interviews per condition and will be accessed using a documented codebook approach and saturation tables (Kerr et al 2010) providing important documentary evidence of the rigor of the qualitative methods. The analysis will explore themes that emerge from the open-ended data that relate to the effect Relvar Ellipta has on quality of life, patient experiences using Relvar Ellipta and satisfaction/dissatisfaction with the medication for treating asthma and COPD. The analysis will be conducted by experienced qualitative researchers.

Stage II - Cognitive Debrief Interview DataThe cognitive debrief interviews will be analysed using an interview grid to evaluate the information gathered and whether revisions to the quantitative survey are required. Respondent burden will also be evaluated.

Stage II - Quantitative Survey DataA statistical analysis plan (SAP) will be written to guide the quantitative data analysis. The objectives of the data analysis will be to summarise, using appropriate statistics, the responses of the participants using appropriate descriptive statistics (means with standard deviations, medians with interquartile ranges, response frequencies with percentages).

Primary and secondary research questions, including pre-specified study hypotheses, will be analysed as appropriate using inferential statistics, with type I error set at the 5% level (p<0.05). Data on responses to individual questions in the survey will be described as appropriate for the data distribution: mean with standard deviation (SD) or standard error (SE) for normally distributed continuous data; median with range and/or interquartile range for non-normally distributed continuous data; count/frequency with percentages (of all respondents and/or of those responding to the question – valid percent) for categorical data. The uncertainty in the data will be taken into account with the use of 95% confidence intervals (CI) around the sample estimates. Data will also be presented diagrammatically where appropriate, using figures such as histograms and bar charts.

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3. LIMITATIONS1) As participants are recruited by an agency, participants will be asked to self-report their diagnosis, this information will not be verified via a clinician diagnosis. In order to control for any misrepresentation, a detailed screening script has been developed.

2) Some participants will be recruited through a database of patients who have previously volunteered, or expressed interest, in participating in research, which could create selection bias. In order to recruit as broad a sample as possible, the recruitment agency will recruitthrough several methods including HCPs, support groups, and consumer networks. 3) The quantitative survey (Stage II) will be hosted online, in paper version, or conducted via telephone interview. This would enable participants to take part in either format and thus will minimize any limitation of requiring participants to have access to the internet. As in Phase I, disease control (asthma)/impact (COPD) and demographics will be monitored with the aim of achieving as broad patient sample as possible and minimize the limitation of having a non-representative sample.

4) As Relvar Ellipta is a relatively new treatment, it may be difficult to recruit the required number of patients through a patient recruitment agency, particularly the relatively large number required for the quantitative survey. If necessary, to achieve the target patient numbers, the recruitment agency will recruit directly thought NHS sites. In this instance this protocol will be submitted for NHS ethical review.

5) Stage I and II of the project will be questioning patients on their disease history, previous treatments and experiences and is therefore reliant on self-reported data that is subject to recall bias. In order to minimize this bias, methodological approaches to the development of study materials will be undertaken to ensure that materials are well developed and where possible utilise standardized well-structured questionnaires.

4. STUDY CONDUCT, MANAGEMENT & ETHICSAll subjects are free to withdraw from participation in this study at any time, for any reason, specified or unspecified, and without penalty or loss of benefits to which the subject is otherwise entitled. It is not necessary for withdrawn subjects to complete any additional documentation.

a. ETHICS/IRB APPROVAL The study protocol and all study materials will be submitted for review by Salus Institutional Review Board (IRB) in Texas, USA.

b. INFORMED CONSENTInformed consent will be obtained from all participants prior to study initiation. Written information will be given to the participants explaining the details of the study (including the purpose of the interview, the types of questions that will be asked and who will have access to the data collected). Participants will be required to indicate they have read and understood

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the terms of the study and wish to participate, before any data will be collected.

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c. DATA PRIVACYAll data collected in this study will be strictly confidential in accordance with all appropriate legislation. Access to the participant files will not be permitted to anyone other than the study staff and auditors. Only the study staff involved in data collection will know the identity of the participants. Study staff will be instructed to maintain complete confidentiality of all collected data. Patient files will be kept on secure servers (or any physical copies in a locked file cabinet). The study report will not contain any patient identifying information. Participants will be assigned a unique participant number to ensure confidentiality and anonymity. Interview transcripts will be identified by this unique participant number and will not have any identifiers associated with the individual.

d. PERSONALLY IDENTIFIABLE INFORMATION (PII)Any PII will be removed from data. PII will be kept separately from data, linked only by a study ID. Electronically stored PII will be protected by a password known only by those directly involved with the study or helping with recruitment. Hardcopies of PPI and data will be kept in a separate locked cupboards.

e. AE REPORTINGThis study is non-interventional and has no direct clinical site involvement. As such the study presents minimal risk. However, if during the recruitment or study participation an adverse event (AE) is reported and suspected to be associated with the use of one of the study Sponsor’s products this will be reported by the interviewer/moderator to the study Sponsor within one working day (but no later than three calendar days after date of receipt if information is received, e.g. during a weekend or on public holidays) (Appendix O). All members of the project research team at involved in data collection and all third parties involvement in recruitment have completed AE training required by the study Sponsor prior to commencing the study.

f. DATA STORAGE/ARCHIVALAll data will be stored according to GSK policy.

5. EXTERNAL INVOLVEMENT

a. Third Party Supplier (Company Name, Address & Staff Names/Email/Phone)

24

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Tel: Fax: Email:

b. External Expert/Health Care Professionals (Consultants & Research PIs) Conduct ABAC due diligence. Include HCP CID number; indicate if EE/HCP is a government employee. Indicate if EE/HCP is a Consultant or Researcher

25

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MILESTONES

MILESTONE GUIDANCE OR POLICY

REQUIREMENT

FORECAST DATE

MM-YYYYForecast Final Protocol Approval Forecast GSK CSR Protocol Summary

FPA Actual + 30 days

Forecast Statistical Analysis Plan Approved Forecast Statistical Analysis Complete Forecast Final Study Report Complete

SAC Actual + 6 months

Forecast GSK CSR Results Summary Posting


Forecast Manuscript Submission


26

DISCLOSURE PLAN

FORECAST GSK CSR PROTOCOL SUMMARY (FPA + 30 DAYS)

GSK CSR RESULTS SUMMARY (SAC + 8 MONTHS)

FULL PROTOCOL POSTING DATE (Manuscript submission actual + 30 days)

27

Evaluating the Impact, Benefits and Preferences of Relvar® Ellipta® in

Patients with COPD and Asthma

Study Protocol

GlaxoSmithKline Study number: 0018-0681

18 January 2017

Version 10.0

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0018-0681 Phase IV Study Protocol_V10_18JAN17

2

CONFIDENTIAL

Authors:

Tel: Fax:

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3

Table of Contents

PROTOCOL SYNOPSIS ...................................................................................................... 5

INTRODUCTION ................................................................................................................ 10

PURPOSE ...................................................................................................................... 11

METHODS ...................................................................................................................... 12

1.1 Study Design .................................................................................................................. 12

1.2 Eligibility Criteria ............................................................................................................. 13

1.3 Participant Recruitment, Eligibility Screening and Consent ............................................. 14

1.3.1 Stage I – Qualitative Interviews ...................................................................... 14

1.3.2 Stage II – Quantitative Survey ....................................................................... 15

1.4 Study Procedures ........................................................................................................... 16



1.5 Analysis .......................................................................................................................... 17



1.5.3 Adverse Event Reporting ............................................................................... 19

1.6 Limitations of the Study .................................................................................................. 20

STAGE II – QUANTITATIVE SURVEY ............................................................................... 21

PROTECTION OF HUMAN SUBJECTS ............................................................................ 22

1.7 Ethical review ................................................................................................................. 22

1.8 Informed Consent ........................................................................................................... 22

1.9 Potential Risks and Benefits ........................................................................................... 22

1.10 Confidentiality ................................................................................................................. 22

1.11 Personally Identifiable Information (PII) .......................................................................... 22

1.12 Subject Withdrawal from Study ....................................................................................... 22

1.13 Adverse Events .............................................................................................................. 23

1.13.1 Definition of AEs ............................................................................................ 23

1.13.2 Definition of Serious Adverse Event (SAEs) ................................................... 23

1.13.3 Definition of Adverse Drug Reaction (ADR) ................................................... 23

1.13.4 Safety Reporting Requirements ..................................................................... 23

REFERENCES ................................................................................................................... 24

APPENDIX A: INTERVIEW PATIENT SCREENING FORM ............................................... 25

APPENDIX B: INTERVIEW STUDY INVITATION LETTER ............................................... 28

APPENDIX C: QUANTITATIVE SURVEY STUDY INVITATION LETTER.......................... 29


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APPENDIX D: QUALITATIVE INTERVIEW INFORMED CONSENT DOCUMENT ............ 30

APPENDIX E: QUANTITATIVE SURVEY INFORMED CONSENT DOCUMENT ............... 35

APPENDIX F: QUALITATIVE INTERVIEW SOCIODEMOGRAPHIC FORM ..................... 40

APPENDIX G: ASTHMA CONTROL TEST (ACT) ............................................................. 45

APPENDIX H: COPD ASSESSMENT TEST (CAT) ............................................................ 46

APPENDIX I: SEMI-STRUCTURED ASTHMA PATIENT INTERVIEW GUIDE .................. 47

APPENDIX J: SEMI-STRUCTURED COPD PATIENT INTERVIEW GUIDE ...................... 55

APPENDIX K: QUANTITATIVE SURVEY SOCIODEMOGRAPHIC FORM ........................ 63

APPENDIX L: QUANTITATIVE SURVEY .......................................................................... 65

APPENDIX M: QUANTITATIVE SURVEY PRE-SCREENING FORM ................................ 80

APPENDIX N: ADVERSE EVENT REPORTING FORM ..................................................... 83

APPENDIX O: ABOUT ............................................................................................. 85

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PROTOCOL SYNOPSIS Characteristic Description

Rationale Existing treatments for asthma and COPD are typically twice daily (BID) inhaled corticosteroid/long acting beta agonist (ICS/LABA) treatments (e.g. BID Fluticasone Propionate/Salmeterol). Fluticasone Furoate + Vilanterol (FF + VI, or Relvar) has been recently launched by GSK as a new, combined medicine in the maintenance treatment of COPD and asthma. One of the main features of FF/VI is 24-hour continuous efficacy and, as such, it is the first and only Once-Daily (QD) inhaled ICS/LABA combination available. FF/VI is delivered via an easy to use and patient preferred inhaler device, Ellipta® (Svedsater et al., 2013).

The current study does not aim to test a hypothesis, rather the study aims to collect data on patients’ experiences with Relvar and how this compares with previous treatments (where appropriate/relevant). Previous research has demonstrated that patients find Ellipta™ easy to use (Svedsater et al., 2013), and as a once daily medication, this is likely to result in greater convenience on behalf of the patients (Svedsater et al., 2013). A 24-hour continuous efficacy profile may also lead to fewer nocturnal symptoms, consequently improve sleep quality and reduce fatigue, with potential benefits of greater productivity and ability to conduct various activities. However, other treatment impacts may arise during the course of this research that are unknown or difficult to predict at this stage. Other treatment impacts, benefits/disadvantages, preferences and satisfaction/dissatisfaction of using Relvar® Ellipta® will be investigated during qualitative patient interviews; these may include greater frequency of rescue, symptom-free 24-hour periods and lower levels of anxiety. In addition, any unanticipated adverse effects of this once daily medication may also be identified.

Data from the semi-structured patient interviews will be used to inform and develop a quantitative survey, which will be used to measure the extent to which Relvar® Ellipta® patients are satisfied with their treatment.

Aim and Objectives

The main purpose of this study is to identify and evaluate treatment satisfaction including treatment impact, benefits/disadvantages, preferences and satisfaction/dissatisfaction of using Relvar® Ellipta® by patients who are currently being prescribed this medicine for their asthma or COPD.

This will be investigated by utilising a mixed methods approach. A sample of patients will participate in semi-structured interviews in order to provide detailed thematic qualitative data. Another sample will complete a structured questionnaire (administered online, or by phone (pen and paper) that will target related, more detailed quantitative data to answer specific research questions developed from the qualitative data.


6

The objectives of the study are thus:

1) To conduct semi-structured qualitative interviews with asthma and COPD patients currently being prescribed Relvar® Ellipta® to evaluate perceived benefits/disadvantages, preferences and satisfaction/dissatisfaction of Relvar® Ellipta® in comparison with other treatments they have taken.

2) To design and conduct a structured quantitative survey with asthma and COPD patients who are currently being prescribed Relvar® Ellipta® in order to obtain evaluative quantitative data on specific aspects of treatment satisfaction, including benefits/disadvantages, preferences and satisfaction/dissatisfaction.

Study design A mixed-methods design involving two stages:

Stage I will involve semi-structured qualitative interviews with asthma and COPD patients receiving Relvar® Ellipta® treatment.

Stage II will comprise a quantitative survey for the same population with the survey being developed from the results of Stage I.

Procedures Stage I

Qualitative Interviews

Participants will review an informed consent document (ICD) in person with a healthcare professional (HCP) before the interview. Socio-demographic data will be collected prior to the interview and either the Asthma Control Test (ACT) or COPD Assessment Test (CAT) will be administered before the interview depending on disease; patients with Asthma-COPD Overlap Syndrome (ACOS) will be assigned to the COPD group and will thus be interviewed about COPD and complete the CAT. Interviews will be conducted to explore how Relvar® Ellipta® has impacted asthma/COPD patients and their everyday life. Participants will be reimbursed for their time (£50 each). Participants will be asked open-ended, qualitative questions. Up to 50 semi-structured interviews (25 in each condition) will be conducted over the phone. All interviews will be audio recorded and transcribed verbatim.

Stage II

Quantitative Survey

Phase I: Cognitive Debrief Interviews

Participants will review an ICD before the interview. Up to 6 (asthma n=3, COPD n=3) patients will be invited to complete an online version or paper version of the draft survey (taking up to 30 minutes) prior to the telephone cognitive debriefing interview of the survey (lasting up to 60 minutes). Participants will be reimbursed for their time (£75 each).


7

Phase II: Data Collection

Data collection will be primarily via an online survey. The option to complete the survey on paper at the Primary Care site will also be made available for those who are unable to get online, or should there be any technical issues with the online survey. Participants completing the survey online will provide consent electronically; those completing by paper will provide written consent. Following consent, participants will either complete the full survey (including socio-demographic questions, ACT/CAT, and questions about satisfaction with Relvar® Ellipta® and another recent medication, as appropriate), or just the ACT/CAT for screening purposes given that there are target participant numbers per ACT/CAT grouping. Participants completing the full survey will be reimbursed £25 for their time. Participants completing just the ACT/CAT will be reimbursed £10 for their time.

Inclusion Criteria

The study will aim to recruit a broad sample of asthma and COPD patients in the UK with varying degrees of control in terms of the ACT (<15 uncontrolled, 15-19 not well or partly controlled, ≥20 controlled asthma) and impact in terms of the CAT (>20 high impact, 10-20 medium impact, <10 low impact), respectively. Each participant must meet the following inclusion criteria before entry to the study:

1. A diagnosis of asthma, COPD or asthma-COPD Overlap Syndrome (ACOS) from a physician.

2. Has had asthma, COPD or ACOS diagnosis for ≥1 year.

3. Are currently prescribed Relvar® Ellipta® for asthma or COPD (Stage I, and Stage II: Phase II only).

4. Have been using Relvar® Ellipta® for ≥3 months (Stage I, and Stage II: Phase II only).

5. ≥ 18 years of age.

6. Currently resident in the UK.

7. Adequate written and oral fluency in English as judged by the investigator screening.

8. Willing and able to provide informed consent.

9. Able to complete a telephone interview (for qualitative stages).

10. Access to the internet (for participants completing the quantitative survey online).

Exclusion Criteria

Individuals meeting the following criteria will not be eligible for this study:

1. An acute illness or cognitive impairment that in the opinion of the investigator would interfere with the study requirements.

2. Any co-morbidity that would inhibit the ability to provide informed consent or allow participation in a telephone or face-to-face interview.


8

3. Taken part in any other stage or phase of this study.

Sample Stage I

Qualitative Interviews

Up to 50 Relvar® Ellipta® participants (asthma, n=25; COPD, n=25) interested in providing feedback regarding Relvar® Ellipta® treatment.

Stage II

Quantitative Survey


Up to 6 participants (asthma, n=3; COPD, n=3) diagnosed with asthma/COPD.


Up to 200 participants (asthma, n=100; COPD, n=100) diagnosed with asthma/COPD and currently prescribed Relvar® Ellipta®; patients with ACOS will be assigned to the COPD condition. The aim is to recruit 26-40 patients in each ACT (<15 uncontrolled, 15-19 not well or partly controlled, ≥20 controlled asthma) and CAT (>20 high impact, 10-20 medium impact, <10 low impact) group. Once a group has been fully recruited it will be closed to new recruits. The aim to recruit 5-15% non-white participants.

Recruitment Participants (adults with asthma and COPD) will be identified and recruited through a specialist recruitment agency (Global Perspectives, GP). The agency will work with up to 15 NHS Primary Care sites to identify participants using referrals of eligible participants from HCPs. Participants may also be identified and recruited using a combination of support groups, consumer networks and GP’s own database of patients.

Stage I

Potential participants will be initially asked to complete screening questions in person with a HCP. If participants meet the eligibility criteria they will be invited to take part in an individual interview or to complete the quantitative survey and review the ICD.

Stage II: Phase I

Participants will be recruited through non-clinical methods and screened by telephone. Participants will review and completed either an electronic or paper ICD in their own time.

Stage II: Phase II

NHS Primary Care sites (General Practitioners) will pre-screen patients using their existing patient records to generate a list of potentially suitable participants, based on in/exclusion criteria. Potential participants will be approached regarding the study via telephone, email or invitation letter.


9

All approaches will be made from the NHS Primary Care sites and no contact information will be removed or transferred from the sites. If initially interested, potential participants will then be asked to review and complete the ICD. Once consented, participants may be asked to either complete the full survey or, if one of the ACT/CAT groups is near full or full, just the ACT/CAT.

Study Materials • Interview Patient Screening form • Interview study invitation letter • Quantitative survey study invitation letter • Qualitative Interview informed consent document (ICD) • Quantitative survey informed consent document (ICD) • Qualitative Interview Socio-demographic form • Asthma Control Test/COPD Assessment Test • Semi-structured Asthma/COPD interview guide • Full Quantitative survey comprising:

o Quantitative Socio-demographic Form o Asthma Control Test/COPD Assessment Test o Quantitative Survey

• Quantitative Survey Pre-Screening Form • Adverse event reporting form

Analysis The objectives of the qualitative data analysis are to evaluate treatment impact, benefits/disadvantages, preferences and satisfaction/ dissatisfaction of Relvar® Ellipta® in patients diagnosed with COPD and/or asthma who are currently being prescribed the medication.

The findings of the interviews will be analysed using MAXQDA (v 11.0.4 or above). The qualitative data will be coded into themes and sub-themes. Results will be presented as narratives representing common themes and/or viewpoints, and descriptive analyses will be conducted on key selected themes and outcomes. The results will inform the development of the quantitative survey.

The objectives of quantitative data analysis are first to summarise the responses of participants to the survey questions using appropriate descriptive statistics (e.g., means with standard deviations, medians with interquartile ranges, response frequencies with percentages).

Quantitative data will be analysed using SPSS v19.0. Analyses will largely be confined to descriptive statistics, although consideration will be given where appropriate to univariate and regression analysis. Primary and exploratory research questions will be analysed as appropriate using inferential statistics, with type I error set at the 5% level (p<0.05). Hypothesis tests will be conducted as appropriate and 95% confidence intervals used to capture the uncertainty in the data.

The ACT and CAT will be scored according to developer instructions.


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INTRODUCTION

Asthma and Chronic Obstructive Pulmonary Disease (COPD) are two of the most common

respiratory conditions in the UK (Mukherjee et al., 2014; NHS Choices 2014), with 1 in 12

adults currently receiving treatment for asthma (Asthma UK) and more than 3 million people

living with COPD.

Existing treatments for asthma and COPD are typically twice daily (BID) inhaled

corticosteroid/long acting beta agonist (ICS/LABA) treatments (e.g., BID Fluticasone

Propionate/Salmeterol). Fluticasone Furoate + Vilanterol (FF + VI, or Relvar) has been

recently launched by GSK as a new, combined medicine in the maintenance treatment of

COPD and asthma. One of the main features of FF/VI is 24-hour continuous efficacy and, as

such, it is the first and only Once-Daily (QD) inhaled ICS/LABA combination available. FF/VI

is delivered via an easy to use and patient preferred inhaler device, Ellipta® (Svedsater et al.,

2013).

The current study does not aim to test a hypothesis, rather the study aims to collect data on

patients’ experiences with Relvar® and how this compares with previous treatments (where

appropriate/relevant). Previous research has demonstrated that patients find Ellipta™ easy

to use (Svedsater et al., 2013), and as a once daily medication, this is likely to result in

greater convenience on behalf of the patients (Svedsater et al., 2013). A 24-hour continuous

efficacy profile may also lead to fewer nocturnal symptoms, consequently improve sleep

quality and reduce fatigue, with potential benefits of greater productivity and ability to

conduct various activities. However, other treatment impacts may arise during the course of

this research that are unknown or difficult to predict at this stage. Other treatment impacts,

benefits/disadvantages, preferences and satisfaction/dissatisfaction of using Relvar®

Ellipta® will be investigated during qualitative patient interviews; these may include greater

frequency of rescue and symptom-free 24-hour periods and lower levels of anxiety. In

addition, any unanticipated adverse effects of this once daily medication may also be

identified.

The aim was then for data from the semi-structured patient interviews and cognitive

debriefing interviews to be used to inform and develop a quantitative survey. This

amendment relates to Stage II: Phase II in which the quantitative survey will be used to

measure the extent to which Relvar® Ellipta® patients are satisfied with their treatment

based on the impacts of Relvar® Ellipta® highlighted in the qualitative interviews.


11

PURPOSE

The overall aim of this study (project Phase IV) is to elicit the benefits/disadvantages,

preferences and satisfaction/dissatisfaction relating to Relvar® Ellipta® asthma and COPD

treatment, and to quantify those benefits and preferences in a patient satisfaction survey.

The specific objectives of this project phase are:

1. To conduct in depth, qualitative interviews with asthma and COPD patients currently

treated with Relvar® Ellipta® to evaluate benefits/disadvantages, preferences and

satisfaction/disadvantages of Relvar® Ellipta® compared with other treatments they

have taken.

2. To design, evaluate, and conduct a quantitative survey with asthma and COPD

patients who are currently being prescribed Relvar® Ellipta® in order to obtain

quantitative data on specific aspects of treatment satisfaction including

benefits/disadvantages, preferences and satisfaction/dissatisfaction.

Other exploratory questions are:

• How is a 24-hour/once-daily medication viewed by asthma/COPD patients using

Relvar® Ellipta®?

• To what extent does Relvar® Ellipta® affect impact and quality of life, such as;

o Day-time symptoms

o Sleep quality

o Physical activity

o Social activity

o Sensitivity to triggers

o Emotional functioning

o Ease and ability to take medication

• To what extent are asthma/COPD patients prescribed Relvar® Ellipta® overall

satisfied or dissatisfied with the treatment?


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METHODS

1.1 Study Design

The purpose of this phase of the project is to identify and evaluate treatment impact,

benefits/disadvantages, preferences and satisfaction/dissatisfaction of Relvar® Ellipta®

directly from patients who are currently prescribed Relvar® Ellipta® for their asthma and/or

COPD. Treatment impacts will be investigated using a mixed-methods design. Asthma and

COPD patients will participate in semi-structured individual interviews to provide detailed

qualitative data (Stage I). These qualitative results will then be used to inform the

development of the survey (Stage II) to collect quantitative data on specific aspects of the

effects and impact of Relvar® Ellipta® including benefits/disadvantages, preferences and

satisfaction/dissatisfaction. Appropriate attention will be given to each stage to ensure that

the study minimises bias and produces robust and valid results.

In Stage I of the study, qualitative interviews will be conducted with up to 50 participants with

asthma and COPD (25 per condition) to explore the effects and impact of Relvar® Ellipta®.

In the second stage of the project, a draft quantitative survey will be developed and explored

with participants in cognitive debrief interviews. Up to 6 participants in the UK will be asked

to complete the survey for the patient group to which they belong (asthma and/or COPD)

and then comment on its appropriateness. The survey will be modified and finalized

according to the participant feedback obtained.

Following the cognitive debrief task, approximately 200 participants in the UK (100 per

condition) will complete the finalised quantitative survey designed to elicit quantitative data

on the benefits and preferences associated with Relvar® Ellipta®.

Sample size for the quantitative survey is determined in terms of the precision of study

estimates. Implications for varying sample sizes in terms of estimates of proportion are

shown in Table 1. Sample size requirements are highest when the estimated proportion is

0.50, becoming progressively smaller as the proportion approaches 0 or 1. The implications

are shown in terms of precision of the 95% confidence interval (CI) around estimates of

proportion of 0.50 and 0.25. It can be seen that a sample size of 100 individual patients (per

condition or overall) would give at minimum a precision of ±0.099, with a resulting CI width of

at most 0.20 (0.40 to 0.60 around an estimate of 0.50). If the sample size increased to 250

individuals (125 per condition) the precision would increase to a minimum of ±0.062, with a

resulting CI width of at most 0.12 (0.44 to 0.56 around an estimate of 0.50). Conversely, if

the sample size falls to 50 (25 per condition), the precision would decrease to a minimum of

± 0.14, with a resulting CI width of at most 0.28 (0.36 to 0.64 around an estimate of 0.50).


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Table 1: Sample Size Calculations

Sample size:

25

50

100

250

500

Estimated proportion = 0.50

Precision±

.196

.139

.099

.062

.044

95% CI

.30-

.36-

.40-

.44-

.45-

Width of 95%

.40

.28

.20

.12

.10

Estimated proportion = 0.25

Precision±

.170

.120

.085

.056

.038

95% CI

.08-

.13-

.17-

.20-

.21-

Width of 95%

.34

.24

.17

.11

.08

We would aim to recruit up to 100 per condition for the quantitative phase of the study (200

patients overall). This size of sample would allow comparisons to be made across conditions

in terms of a precision threshold of ±10%.

In all stages of the study particular focus will be placed on obtaining a broad sample of

patient participants in terms of age, ethnicity, gender and disease control (asthma) or

disease impact (COPD). Disease control in asthma patients will be measured using Asthma

Control Test (ACT) score, and COPD impact will be measured using COPD Assessment

Test (CAT) score. In Stage II: Phase II, patients will be grouped according to the scores in

Table 2. The aim is to recruit 26-40 patients per group. Once a group has reached the

maximum number of participants, it will be closed to new recruits. Both pre-screening data

and ACT/CAT data will be monitored and used to recruit patients across the socio-

demographic and disease control/impact spectrum.

Table 2: Asthma ACT groups and COPD CAT groups

ACT groups CAT groups

<15 uncontrolled >20 high impact

15-19 not well or partly controlled 10-20 medium impact

≥20 controlled <10 low impact

NHS Health Research Authority (HRA) approval will be obtained for all phases of the study

where participants are recruited through NHS clinical sites (Stage I, and Stage II: Phase II).

1.2 Eligibility Criteria

Patient inclusion criteria:

Each participant must meet the following inclusion criteria before entry to the study:


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1. A diagnosis of asthma/COPD or Asthma-COPD Overlap Syndrome (ACOS) from a

physician.

2. Has had asthma, COPD or ACOS diagnosis for ≥1 year.

3. Are currently prescribed Relvar® Ellipta® for asthma or COPD (Stage I, and Stage II: Phase II only).

4. Have been using Relvar® Ellipta® for ≥ 3 months (Stage I, and Stage II: Phase II only).

5. ≥ 18 years of age.

6. Currently resident in the UK.

7. Adequate written and oral fluency in English as judged by the investigator screening.

8. Willing and able to provide informed consent.

9. Able to complete a telephone interview (for qualitative stages).

10. Access to the internet (for participants completing the quantitative survey online).

Patient exclusion criteria:

Individuals meeting the following criteria will not be eligible for this study:

1. Has an acute illness or cognitive impairment that in the opinion of the screening

investigator would interfere with the study requirements.

2. Any co-morbidity that would inhibit the ability to provide informed consent or allow

participation in a telephone interview.

3. Has taken part in any other stage of phase of this study.

1.3 Participant Recruitment, Eligibility Screening and Consent

A specialist recruitment agency will be used to recruit participants at all stages using a

combination of HCPs, support groups, consumer networks and their own database of

patients. The agency will work with up to 15 NHS Primary Care sites to identify participants

using referrals of eligible participants from HCPs. Participants will only be asked to take part

in either stage I or II of the study. For example, participants taking part in the qualitative

interview will not be eligible to complete the quantitative survey.

1.3.1 Stage I – Qualitative Interviews

The recruitment agency will identify and recruit up to 25 people diagnosed with asthma and

25 people diagnosed with COPD (n=50); patients with ACOS will be assigned to the COPD

condition. Potential participants will be initially asked to complete screening questions in

person with a HCP (Appendix A). If participants meet the eligibility criteria they will be invited

to take part in an individual interview and review the ICD (Appendix D). A broad patient


15

sample for each condition will be recruited based on age, gender and disease control/impact

as assessed by the Asthma Control Test (ACT, Appendix G) and COPD Assessment Test

(CAT, Appendix H). Interested patients will then be invited to participate in an individual 60-

minute interview. We aim to conduct up to 50 semi-structured individual telephone interviews

(asthma; n=25, COPD; n=25). Participants will be reimbursed for their time after completing

the interview (£50).

1.3.2 Stage II – Quantitative Survey

The results of the qualitative interviews will be used to develop a quantitative survey to

gather detailed quantitative data relating to patients’ experiences and treatment impact

including benefits/disadvantages, preferences and satisfaction/dissatisfaction with Relvar®

Ellipta® as a treatment for their asthma/COPD.


The recruitment agency will identify three patients per condition (overall n=6) using non-

clinical recruitment methods. Participants will be asked to complete screening questions over

the phone (Appendix A). The first six who are eligible and interested will be asked to review

a study invitation letter and ICD (either online or paper) in their own time. An interview

date/time will then be scheduled. Patients will be invited to complete a paper or electronic

version of the draft quantitative survey (taking up to 30 minutes to complete) prior to the

telephone cognitive debriefing interview (lasting up to 60 minutes). Participants will be asked

to return the signed paper ICD before the cognitive debrief interview. Participants will be

reimbursed for their time (£75).


The recruitment agency will identify through HCPs asthma (n=100) and COPD (n=100)

patients who match the eligibility criteria; patients with ACOS will be assigned to the COPD

condition. NHS Primary Care sites (General Practitioners) will use their existing patient

records to generate a list of potentially suitable participants, based on in/exclusion criteria

(Pre-screening form; Appendix M). Potential participants will be approached regarding the

study via telephone, in person at the site, or by invitation letter (sent via email or post;

Appendix C). All approaches to the patients will be made by the NHS Primary Care sites

and no contact information will be removed or transferred from the sites. Patients will be

invited to complete the quantitative survey online, or in person (completion electronically by

tablet, or pen and paper). Patients who wish to participate will be asked to provide consent

before completing the survey (Appendix E). Consent may be collected online or on paper,

depending on the mode of survey completion. As the aim is to recruit 26-40 patients per ACT


16

(<15 uncontrolled, 15-19 not well or partly controlled, ≥20 controlled asthma) and CAT (>20

high impact, 10-20 medium impact, <10 low impact) group, patients may be screened initially

to determine their ACT/CAT score prior to survey completion if any of the groups are close to

being fully recruited or are fully recruited.

1.4 Study Procedures


Qualitative Interviews: Patients will be screened for eligibility (Appendix A) and asked to

review the study invitation letter (Appendix B) and ICD (Appendix D). Patients will be asked

to complete a paper version of the ICD in person before their individual interview. The ICD

will also ask for the participant’s consent to follow up on adverse events (AEs) related to any

medicine manufactured by the study sponsor that may be identified during the interviews, as

well as the reporting of these to the study sponsor (Appendix N).

Prior to individual interviews, participants will be asked socio-demographic questions and

either the ACT or CAT will be administered depending on disease (Appendix F, G and H);

patients with ACOS will be interviewed about COPD and will complete the CAT. Up to 25

semi-structured individual interviews per condition will be conducted over the telephone by

experienced trained interviewers from

The interviews will be conducted according to the approved individual interview guides

(Appendices I and J), with the flexibility of allowing the interviewer to adapt the questioning

and probe for additional information for each individual participant.

The individual interviews will be audio-recorded and transcribed verbatim. Following the

completion of each interview, participants will be reimbursed (£50 each).



The quantitative survey will be administered first in a cognitive debrief interview format with

asthma/COPD patients in the UK. Cognitive debriefing interviews will be conducted in the

UK (n=6) to evaluate general readability of the survey and item comprehension using a

cognitive debrief interview guide (Appendix L). Participants will be requested to complete a

paper or electronic version of the survey as well as socio-demographic questions (Appendix

F) before participating in the interviews; patients with ACOS will be assigned to COPD. The

interviews will be conducted over the telephone by trained interviewers from The

interviews will be conducted according to the approved cognitive interview guide, with the

flexibility of allowing the interviewer to adapt the questioning and probe for further

PPD

PPD


17

information for each individual participant. The interviews will be analysed using an interview

grid to evaluate the information gathered and whether revisions to the survey are required.

Following the completion of each interview, participants will be reimbursed (£75). Any

necessary modifications will be made to the survey after all interviews have been completed.


Quantitative data collection will primarily be via an online survey, with pen and paper

completion made available for those who are unable to get online, or should there be any

technical issues with the online survey. Participants completing the survey online may either

be given a unique URL by which they can complete the survey away from the Primary Care

site, at a time and place convenient for them, or they will complete the survey via tablet at

the Primary Care site. Participants completing the survey online will provide consent

electronically via tick boxes (Appendix E1). Participants completing the survey by pen and

paper will provide written consent (Appendix E2). The quantitative survey will first include a

socio-demographic form (Appendix K), including questions about employment, marital

status, smoking status and pet ownership. Next, participants will complete either the ACT

(asthma patients; Appendix G) or CAT (ACOS/COPD patients; Appendix H). Finally, the

main survey (Appendix L) will be completed, which includes questions about ease-of-use,

satisfaction, and impact of both Relvar® Ellipta® and the treatment take before Relvar®

Ellipta®. Following the completion of the full quantitative survey, participants will be

reimbursed (£25) within two weeks of completing the survey.

If any of the ACT (<15 uncontrolled, 15-19 not well or partly controlled, ≥20 controlled

asthma) or CAT (>20 high impact, 10-20 medium impact, <10 low impact) groups are

nearing full recruitment or are fully recruited, patients may be screened initially according to

their ACT/CAT score. Patients will be asked to complete just the ACT/CAT. Patients whose

score falls within one of the closed groups will be informed that they are not eligible to take

part in the full study, and screened out. Participants who are screened out, and just complete

the ACT/CAT will be reimbursed £10 for their time within two weeks of completing the

survey. Patients whose score falls within one of the open groups will be asked to complete

the full quantitative survey as above.

1.5 Analysis


1.5.1.1 Demographic Background Questionnaire

Demographic data will be summarised using descriptive statistics (e.g., means, standard

deviations and frequencies, as appropriate).


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1.5.1.2 ACT/CAT

ACT/CAT scores will be summarised using descriptive statistics (e.g., means, standard

deviations and frequencies, as appropriate).

Asthma Control Test (ACT)

The ACT is a five-item patient-completed instrument that captures how well the patient’s

asthma has been controlled during the past four weeks (Quality Metric, 2002). Across the

five items, responses are scored from one to five with a minimum score of 5 and a maximum

score of 25. A total score ≤ 20 indicates that asthma has not been controlled during the past

four weeks; a total score of 20-24 indicates that asthma has been reasonably well controlled

during the past four weeks; and a total score of 25 indicates that asthma has been under

control during the past four weeks (Quality Metric, 2002).

COPD Assessment Test (CAT)

The CAT is an eight-item patient-completed instrument that quantifies the impact of COPD

on the patient’s health (CAT Test Online, 2012). Across the eight items, responses are

scored from zero to five with a minimum score of 0 and a maximum score of 40. A total

score of <10 indicates a low level impact; a total score of 10-20 indicates a medium level

impact; a total score of >20 indicates high level impact; and a total score >30 indicates a

very high level impact (CAT Test Online, 2012).

1.5.1.3 Interview Data

After completion of the interviews, the audio-recordings will be transcribed verbatim and the

data analysed using a qualitative software tool, MaxQDA (v 11.0.4 or above, VERBI GmbH

2015).

The analysis phase will begin with a careful review of the interview transcripts by members

of the project team. This initial review of the transcripts will ensure comprehensiveness and

accuracy of the transcripts. It will also enable any missing or incorrect information to be

identified and corrected, participant names and identifying information to be removed, and

themes to begin to be identified.

The interview transcripts will be analysed using thematic analysis. Thematic analysis will be

conducted according to the methodology described by Braun and Clarke (2006). This is a

rigorous and transparent qualitative analysis approach, which is well suited to qualitative

patient reported outcomes research (Kerr et al., 2011). Up to 25 asthma patients and up to

25 COPD patients will be interviewed until data saturation has been reached. Data

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will be accessed using a documented codebook approach and saturation tables (Kerr et al.,

2010) providing important documentary evidence of the rigor of the qualitative methods. The

analysis will explore themes that emerge from the open-ended data that relate to the effect

Relvar® Ellipta® has on quality of life, patient experiences using Relvar® Ellipta® and

satisfaction/dissatisfaction with the medication for treating asthma and COPD. The analysis

will be conducted by experienced qualitative researchers.



The cognitive debrief interviews will be analysed using an interview grid to evaluate the

information gathered and whether revisions to the quantitative survey are required.

Respondent burden will also be evaluated. Descriptive statistics will be used to summarise

the socio-demographic information as in Stage I.


A statistical analysis plan (SAP) will be written to guide the quantitative data analysis. The

objectives of the data analysis will be to summarise, using appropriate statistics, the

responses of the participants using appropriate descriptive statistics (means with standard

deviations, medians with interquartile ranges, response frequencies with percentages).

Primary and exploratory research questions will be analysed as appropriate using inferential

statistics, with type I error set at the 5% level (p<0.05). Data on responses to individual

questions in the survey will be described as appropriate for the data distribution: mean with

standard deviation (SD) or standard error (SE) for normally distributed continuous data;

median with range and/or interquartile range for non-normally distributed continuous data;

count/frequency with percentages (of all respondents and/or of those responding to the

question – valid percent) for categorical data. The uncertainty in the data will be taken into

account with the use of 95% confidence intervals (CI) around the sample estimates. Data will

also be presented diagrammatically where appropriate, using figures such as histograms

and bar charts.

1.5.3 Adverse Event Reporting

This study is non-interventional and has no direct clinical site involvement. As such the study

presents minimal risk. However, if during the recruitment or study participation a reported

adverse event (AE) is suspected to be associated with the use of one of the study Sponsor’s

products this will be reported by the interviewer/moderator to the study Sponsor within one

working day (but no later than three calendar days after date of receipt if information is


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received during a weekend or on public holidays) (Appendix N). All members of the project

research team at involved in data collection and all third parties involvement in

recruitment have completed AE training required by the study Sponsor prior to commencing

the study.

1.6 Limitations of the Study

Some limitations of the study, and plans to minimize their potential impact, are as follows:

1) The quantitative survey (Stage II) will be hosted online, or conducted via telephone

interview (completion by pen and paper). This would enable participants to take part

in either format and thus will minimize any limitation of requiring participants to have

access to the internet.

2) As in Stage I, disease control (asthma), impact (COPD) and demographics will be

monitored with the aim of achieving as broad patient sample as possible and to

minimize any non-representativeness of the sample.

3) As Relvar® Ellipta® is a relatively new treatment; it may be difficult to recruit the

required number of patients through a patient recruitment agency, particularly the

relatively large number required for the quantitative survey. To achieve the target

patient numbers, the recruitment agency will recruit directly through NHS sites.

4) Stage I and II of the project will involve questioning patients on their disease history,

previous treatments and experiences; these stages are therefore reliant on self-

reported data subject to recall bias. In order to minimize this bias, methodological

approaches to the development of study materials will be undertaken to ensure that

materials are well developed and, where possible, utilise standardised well-structured

questionnaires.

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STAGE II – QUANTITATIVE SURVEY

The findings from the qualitative stage were used to inform development of the quantitative

survey for completion by a larger sample of people with asthma and COPD (Stage II: Phase

II of the study).

A draft version of the survey was developed and tested in cognitive debrief interviews with

asthma and COPD patients as outlined in this protocol (Stage II: Phase I). NHS REC/HRA

approval was not sought for Stage II: Phase I as non-clinical recruitment methods were

used. Instead, a separate protocol was developed and ethics approval was obtained from an

Institutional Review Board (SalusIRB; ref: GlaxoSmithKline/0018-0681).

This amended protocol, and additional study documents and informed consent forms are

being submitted for NHS Health Research Authority (HRA) approval of Stage II: Phase II.


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PROTECTION OF HUMAN SUBJECTS

1.7 Ethical review The study protocol and all study materials will be submitted for review by the NHS Health

Research Authority (HRA) in the UK where participants are recruited through NHS clinical

sites (Stage I, and Stage II: Phase II).

1.8 Informed Consent Informed consent will be obtained from all participants prior to study initiation. Written

information will be given to the participants explaining the details of the study (including the

purpose of the interview, the types of questions that will be asked and who will have access

to the data collected). Participants will be required to indicate they have read and understood

the terms of the study and wish to participate before any data will be collected.

1.9 Potential Risks and Benefits There are no known risks to participants. If participants have any questions or concerns

during the interviews they will be free to share them with the interviewer.

There are no known direct benefits to the participants.

1.10 Confidentiality

All data collected in this study will be strictly confidential in accordance with all appropriate

legislation. Access to the participant files will not be permitted to anyone other than the study

staff and auditors. Only the study staff involved in data collection will know the identity of the

participants. Study staff will be instructed to maintain complete confidentiality of all collected

data. Patient files will be kept on secure servers (or any physical copies in a locked file

cabinet). The study report will not contain any patient identifying information. Participants will

be assigned a unique participant number to ensure confidentiality and anonymity. Interview

transcripts will be identified by this unique participant number and will not have any

identifiers associated with the individual.

1.11 Personally Identifiable Information (PII) Any PII will be removed from data. PII will be kept separately from data, linked only by a

study ID. Electronically stored PII will be protected by a password known only by those

directly involved with the study or helping with recruitment. Hardcopies of PII and data will be

kept in separate locked cupboards.

1.12 Subject Withdrawal from Study All subjects are free to withdraw from participation in this study at any time, for any reason,

specified or unspecified, and without penalty or loss of benefits to which the subject is


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otherwise entitled. It is not necessary for withdrawn subjects to complete any additional

documentation.

1.13 Adverse Events

1.13.1 Definition of AEs

An Adverse Event (AE) is any untoward medical occurrence in a patient administered a

pharmaceutical product and which does not necessarily have a causal relationship with this

treatment(s). An AE can therefore be any unfavourable and unintended sign (including an

abnormal laboratory finding), symptom or disease temporally associated with the use of a

medicinal product whether or not related to the medicinal product.

1.13.2 Definition of Serious Adverse Event (SAEs)

An SAE is any untoward medical occurrence that at any dose:

• Results in death.

• In life-threatening (note: the term “life-threatening” refers to an event in which the

subject was at immediate risk of death at the time of the event; it does not refer to an

event which could hypothetically have caused a death had it been more severe).

• Requires a new in-patient hospitalisation of prolongation of existing hospitalisation.

• Results in persistent or significant disability/incapacity.

• Is a congenital anomaly/birth defect.

• Is medically significant or requires intervention to prevent one of other of the

outcomes listed above.

Note: all cases of suspected transmission of an infectious agent via medicinal product and

all pregnancy reports should be handles as “serious” with regard to documentation and

reporting time lines (expedited reporting).

1.13.3 Definition of Adverse Drug Reaction (ADR)

An ADR is an AE suspected to be causally related to the product.

1.13.4 Safety Reporting Requirements

In the conduct of the Study, only de-identified participant information is exported for analysis.

GSK requests the recruitment agency report any adverse events identified during the course

of this study that have been experienced by a study participant while receiving a GSK

medicine to the GSK Drug Safety department within 24 hours of awareness using the study

specific AE reporting form (Appendix N).


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REFERENCES

Asthma UK. Asthma facts and FAQs. http://www.asthma.org.uk/asthma-facts-and-statistics (visited 25 Feb 2015)

Braun V and Clark V (2006). Using thematic analysis in psychology. Qualitative Research in Psychology 3:77-101.

COPD Assessment Test: Healthcare Professional User Guide. (2012). http://www.catestonline.org/images/UserGuides/CATHCPUser%20guideEn.pdf

Johnson FR, Lancsar E, Marshall D, et al. (2013) Constructing experimental designs for discrete-choice experiments: report of the ISPOR Conjoint Analysis Experimental Design Good Research Practices Task Force. Value in Health 16:3-13.

Kerr C, Nixon A, Acaster S, Flood E (2011). Fit for purpose, rigorous methodology for qualitative research supporting patient reported outcome (PRO) selection and development: The way forward. Poster Presentation (1049/376) ISOQOL 18th Annual Conference. October 26-29.

Kerr C, Nixon A, Wild D (2010). Assessing and demonstrating data saturation in qualitative inquiry supporting patient-reported outcomes research. Expert Review of Pharmacoecononmics and Outcomes Research 10(3):269-281.

King MT, Hall J, Lancsar E, et al. (2007) Patient Preferences for Managing Asthma: Results from a Discrete Choice Experiment. Health Economics 16:703-717.

VERBI GmbH (2015) MAXQDA [Computer program] http://www.maxqda.com

Mukherjee M, Gupta R, Farr A et al. (2014). Estimating the incidence, prevalence and true cost of Asthma in the UK: secondary analysis of national stand-alone and linked databases in England, Northern Ireland, Scotland and Wales – a study protocol. British Medical Journal Open, 4, e006647.

NHS Choices (2014).Chronic obstructive pulmonary disease. http://www.nhs.uk/Conditions/Chronic-obstructive-pulmonary-disease/Pages/Introduction.aspx (visited 25 Feb 2015).

Rabe-Hesketh S, Skrondal A (2012) Dichotomous or binary responses. Multilevel and longitudinal modelling using Stata, 3rd Edition. Stata Press, Texas, pp 557–559.

Svedsater H, Dale P, Garrill K, Walker R, Woepse MW (2013). Qualitative assessment of attributes and ease of use of the ELLIPTA TM dry powder inhaler for delivery of maintenance therapy for asthma and COPD. BMC Pulmonary Medicine 13(72).

Quality Metric (2002). Asthma Control Test. http://www.asthma.org.uk/Handlers/Download.ashx%3FIDMF%3D8384ca5b-80a1-44d3-aca3-ced0c643286c&rct=j&frm=1&q=&esrc=s&sa=U&ved=0CBMQFjAAahUKEwjJ-ebrsvvHAhXHodsKHUsvCeQ&usg=AFQjCNHPHEXdyWJmj0Ia__PGmNAuj3UauA


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APPENDIX A: INTERVIEW PATIENT SCREENING FORM

Participant Screening Form Identifier: ___________________________________________

Date of screening (day/month/year): ________________________________

Screener: Please complete the following questions to determine patient eligibility for the

study. Refer to asthma or COPD as appropriate.

Introductory script:

Would you be interested in taking part in a study looking into your experience of using

Relvar® Ellipta® for your asthma/COPD? The study is being carried out on behalf of

GlaxoSmithKline (a pharmaceutical company) by The

study would involve you taking part in a telephone interview that would last around 60

minutes and you would be compensated £50 for your time. We are interested in your views

of being treated with Relvar® Ellipta® for your asthma/COPD, which together with others’

views would provide valuable information on how Relvar® Ellipta® affects everyday lives of

patients.

If you are interested in taking part, I would like to ask you some questions to see if you are

eligible. Answering these questions does not commit you to taking part. If you are eligible for

the study and are interested in taking part, I will send you some further information about the

study.

Do you have a few minutes to answer some questions about this today? Your answers will

be kept confidential to (name of association) and only.

[If ‘no’, ask if there is another time. If ‘yes’ proceed to the next question’]

1. Are you currently living in the UK?

Yes

No [End of screening]

2. Are you aged 18 or over?

Yes


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3. Have you been diagnosed with asthma or COPD by a Doctor?

Asthma

COPD [if patient does not understand the term COPD prompt with

chronic bronchitis or emphysema]

Both asthma and COPD


4. When were you diagnosed with asthma/COPD?

Month: Year:

5. Are you currently receiving Relvar® Ellipta® treatment for asthma/COPD?

Yes


6. Please list other asthma/COPD medications you are currently receiving.

7. [In the opinion of the investigator, not to be read out] Does the patient have

adequate oral fluency in English?

Yes


If you are interested, this study will involve a telephone interview in the next couple of

weeks, this will take up to 60 minutes and you will be reimbursed £50 for your time.


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8. Do you agree to us sending you more information about the study and the

information you have provided today to the study team at ?

If yes, continue

If no, offer the following telephone number at if they wish to discuss

further:

Contact Details:

Title (Mr/Ms/Mrs/Miss/Dr/etc.): _____________________________________

Name: ________________________________________________________

Primary telephone number: ________________________________________

Secondary telephone number:______________________________________

Address:_______________________________________________________

______________________________________________________________

______________________________________________________________

Email address:__________________________________________________

Any notes about availability/preferences for contact or interview time:

______________________________________________________________

______________________________________________________________

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APPENDIX B: INTERVIEW STUDY INVITATION LETTER

Study Invitation

Dear [insert name]

Re: Patients’ experience with Relvar® Ellipta® treatment for asthma or chronic obstructive pulmonary disease (COPD) (a study funded by GlaxoSmithKline)

Thank you for your interest in the above study. Please find enclosed a copy of the Informed Consent Document (ICD).

The ICD gives further information about the study. If you have questions about the study please do not hesitate to contact us at If you are willing to take part, please read the ICD.

A member of the research or recruitment team will call you in the next couple of days to check that you have received the information and to answer any questions you have. No pressure will be placed on you to take part. If you are interested in taking part we would then also discuss the ICD with you and make the interview arrangements.

Yours sincerely,

[Contact details to go here]

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APPENDIX C: QUANTITATIVE SURVEY STUDY INVITATION LETTER

Dear [insert name]

Invitation to take part in a research study!

We are contacting you because our records indicate that you are a patient with asthma or chronic obstructive pulmonary disease (COPD), and are currently being prescribed Relvar® Ellipta®. We are supporting recruitment of patients for a survey that is being run to find about preferences, impact, satisfaction and dissatisfaction with asthma and COPD treatment. As one of our patients, we thought you may value the opportunity to share your views and experience.

The survey should take no longer than 30 minutes to complete and is being run on a first-come, first-served basis. If you complete the full survey, you will receive £25 by cheque or Amazon voucher to thank you for your time. However, we may first need to ask you some additional questions to check you are eligible to take part.

This survey will ask you to provide some basic information about yourself (e.g., occupation, marital status), and complete either the Asthma Control Test or the COPD Assessment Test. The survey also includes questions about Relvar® Ellipta® and another recent inhaler treatment. This includes questions about how often you use the treatment, how easy or difficult you find using the inhaler, and how satisfied or dissatisfied you are with various attributes of the inhaler (such as how your symptoms are controlled, your ability to do various activities).

[If including link for participant to access survey online: If you are interested in taking part in the survey, please use the following web address for more information and to access the survey: INSERT URL HERE]

Thank you for taking the time to read this letter. Research is a vital part in understanding conditions and experiences such as yours. We may contact you by telephone to discuss this study, or discuss it with you at your next appointment. However, please do not hesitate to contact us if you would like to take part or have any further questions.

Kind regards,

[Include contact details in email signature and/or print on headed paper]


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APPENDIX D: QUALITATIVE INTERVIEW INFORMED CONSENT DOCUMENT

AN AGREEMENT TO BE IN A RESEARCH STUDY INFORMED CONSENT DOCUMENT – PATIENT

Sponsor: GlaxoSmithKline

City and State: London, UK

Protocol Number and Title: 0018-0681: Evaluating the Impact, Benefits and Preferences of Relvar® Ellipta®® in Patients with COPD and Asthma

Principal Investigator: DPhil

Project Manager: MSc

Study Research Associates: MSc BSc

Address of Study Site(s):

Contact Telephone Number: (09:00 - 17:30 GMT Monday-Friday)

Project Manager’s email address:

INVITATION AND BRIEF SUMMARY

You are being invited to take part in an interview study. Before you decide to take part in this study, you should read this document. This document, called an Informed Consent Document, explains the study. Please ask as many questions as needed so that you can decide if you want to be in the study. Participation is voluntary, and you are free to choose whether or not you would like to participate.

has been commissioned by the sponsor to conduct this research study.

PURPOSE OF THE STUDY AND WHAT IS INVOLVED

You have been asked to take part in this study to discuss your experience of using Relvar® Ellipta®. The aim of the study is to identify and evaluate patient treatment satisfaction, including treatment impact, benefits/disadvantages, preferences and satisfaction/dissatisfaction, of using Relvar® Ellipta® by patients who are currently being prescribed this medicine for asthma or chronic obstructive pulmonary disease (COPD).

is a research company working for GlaxoSmithKline (GSK), a medicines company. We are conducting this research to find out the effects of Relvar® Ellipta® and your satisfaction with the treatment.

This study is for GlaxoSmithKline (GSK) to collect information from patients that have already been prescribed Relvar Ellipta and no further clinical advice or diagnosis will be given.

WHAT WOULD TAKING PART INVOLVE

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If you choose to participate in this study a telephone interview will be scheduled at a time that is convenient for you.

Prior to the interview you will be asked to provide some basic information about yourself (e.g., age, gender and occupation) and asked questions about your asthma/COPD. These questions allow us to describe the sample of participants who are taking. If you agree to take part in this study, the screening questions you have already answered (such as when you were diagnosed) that helped determine if you were eligible to take part in this study may also be used in this way. The information you have already given will only be used if you consent to taking part in this study.

The interview questions will be about how your life is affected by asthma/COPD, the symptoms you experience, how you perceive your quality of life, your current treatment and your experience of Relvar® Ellipta®.

All interviews will be audio recorded and you will be told in advance of when the audio recording is started. The interviews will be transcribed (written out) for analysis. Any information that is likely to identify you will be removed from the transcripts before we analyse the data and we will not include any information that is likely to identify you when we report the results of this study. If you do not want the interview to be recorded, you should not take part in this research study.

Your interview will last for up to 60 minutes and you will be given the opportunity to take a break approximately halfway through.

You must be honest with the study staff in order to participate in this study.

SCOPE OF THE STUDY AND NUMBER OF PARTICIPANTS

Up to 50 patients (25 with asthma and 25 with COPD) are expected to take part in telephone interviews over the next few weeks.

The information provided from all participants will be combined together and used to develop a survey. The survey will be used in a larger study to further explore Relvar® Ellipta® treatment effects and satisfaction with asthma and COPD patients who are similar to you. The study will be completed by the end of October 2016.

POSSIBLE BENEFITS OF TAKING PART IN THE STUDY

The information you provide will help us learn about the experiences and preferences of people with asthma/COPD who are currently being prescribed Relvar® Ellipta®. As there is no treatment provided during the study there is no direct benefit to you, however, you may value the opportunity to share your experiences with others.

PAYMENT FOR BEING IN THE STUDY

You will receive £50 by cheque or Amazon voucher (this should be within 2 weeks of the interview). If you leave the study once the interview has begun but before it has finished you will still be paid for your time.

ADDITIONAL COSTS

There are no costs to you associated with participating in this study.

POSSIBLE DISADVANTAGES AND RISKS OF TAKING PART


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As this study does not involve medication in any way, there are no risks of side effects. It is possible that you may find it difficult, or feel emotional, when talking about your asthma/COPD and how it affects your life. However, you do not have to answer any questions that you do not want to answer. You are also free to end the interview at any time without giving a reason. Please let the interviewer know if you do not want to answer a question or want to stop the interview. If you become tired or out of breath during the interview, please let the interviewer know and you will be able to take a break.

NEW FINDINGS

You will be contacted if there is a change to the way the research will be performed that might influence your willingness to continue participating in this study.

IN CASE OF RESEARCH-RELATED INJURY

You must tell the study staff if you feel you have been injured as a result of participating in this study. No form of compensation is offered for a research-related injury.

LEAVING THE STUDY

Taking part in this study is your choice. You may choose either to take part or not to take part in the study. You have the right to leave this study at any time. If you do not want to be in the study, there will be no penalty to you, and you will not lose any benefits to which you are otherwise entitled.

If you wish to leave this study, please contact at

If you withdraw from the study, no new data about you will be collected for study purposes. The Project Manager will inform you whether they intend to either: (1) retain and analyse any data relating to you that has already been collected up to the time of your withdrawal; or (2) honour your request that the investigator destroy the your data or that the investigator exclude your data from any analysis.

Your part in this study may be stopped at any time and for any reason without you being asked. The following people can stop your participation and/or the study itself:

• (Study coordinators)

• GSK (Study sponsor)

• Recruitment agency

• Other country or local regulatory agencies

If you do not follow the study procedures or there are any conditions or circumstances that may jeopardise your welfare or the integrity of the study then you may be taken out of the study.

ALTERNATIVES TO PARTICIPATION

Because this study is for research only, you can choose not to take part in this research study.

RELEASE OF RESULTS AND PRIVACY

Records of you being in this study will be kept private. Contact details that you have provided and signed consent forms will be kept securely and separate from the study data you provide (linked by a study number only). If information from this study is published

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or presented at scientific meetings, your name and other personal information will not be used. Information relating to your personal details, such as name, address, and telephone number, will only be seen by staff or those helping with recruitment. The company we use to transcribe the audio recordings of your interview may hear the personal details discussed during the interview (such as your name or name of your Doctor) but will not have access to any other personal information we have collected (such as your contact details). The following people will have access to the anonymised interview data collected:

• GSK (Study sponsor)

• Recruitment agency

You may, by written notice to the principal investigator, cancel your authorisation to use or disclose your personal information at any time.

If you withdraw your authorisation, the information collected up to that time may still be used to preserve the scientific integrity of the study. By signing this consent form, you authorise these uses and disclosures of your personal information. If you do not authorise these uses and disclosures, you will not be able to participate in the study.

During the study should any adverse events be reported in relation to the study Sponsors products, are required to report this to the study Sponsor using their official reporting documents.

LEGAL RIGHTS

You do not lose any legal rights by signing this consent document.

WHOM TO CONTACT

You may contact the Project Manager using the contact details on the first page of this consent document for:

• answers to questions, concerns, or complaints about this research study

• information about study procedures

If you have any questions or concerns about your health please contact your personal Doctor.

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(Form to be on headed paper)

Centre number:

Study number:

Unique participant number:

CONSENT FORM

Title of Project: Evaluating the Impact, Benefits and Preferences of Relvar® Ellipta®® in Patients with COPD and Asthma

Name of Researcher: (insert name of doctor)

This consent document contains important information to help you decide if you want to be in this study. If you have any questions that are not answered in this consent document, please ask the person explaining this document or one of the study staff.

I confirm that I have been given and read a copy of all pages of information sheet dated 5th April 2016 (version 7.0) I have had an opportunity to consider the information, ask questions and have received satisfactory answers to all of my questions about this study. I understand that my participation is voluntary and that I am free to leave the study at any time without having to give a reason and without affecting my medical care. I understand that information relating to my personal details, such as name, address, and telephone number; will only be seen by staff or those helping with recruitment. The transcription company will hear any personal details discussed during the interview but will not have any access to other personal details I have given. Information may be seen by regulatory authorities or my general practitioner where it is relevant to taking part in this project. I give permission for these individuals to have access to my records. I understand that the information collected about me will be used to support other research in the future, and may be shared anonymously with other researchers. I understand and agree to the following statement:

I understand that the agency is required to pass on to their client, who is a manufacturer of medicines, details of any side effects related to their own products that are mentioned during the course of this Health Outcomes research activity. Although what is mentioned in the research study will, of course, be treated in confidence, should I raise a side effect; the agency will need to report this, so that they can learn more about the safety of their medicines. I understand what I say will, of course, be treated in confidence.

IF YOU DO NOT AGREE WITH THE STATEMENT ABOVE, YOU SHOULD NOT SIGN THIS INFORMED CONSENT DOCUMENT.

I agree to take part in the above study

Name of Participant (print) Date Signature

Name of person taking Date Signature

consent (print)

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APPENDIX E: QUANTITATIVE SURVEY INFORMED CONSENT DOCUMENT INFORMATION SHEET – version 10, 18 January 2017

Sponsor: GlaxoSmithKline

City and State: London, UK

Protocol Number and Title: 0018-0681: Evaluating the Impact, Benefits and Preferences of Relvar® Ellipta® in Patients with COPD and Asthma

Principal Investigator: DPhil

Study Contact: MSc Address of Study Site(s):

Contact Telephone Number:

(09:00 - 17:30 GMT Monday-Friday)

Contact email address:

INVITATION AND BRIEF SUMMARY

You are being invited to take part in a survey study. Before you decide to take part in this study, you should read this document. This document, called an Informed Consent Document, explains the study. Please ask as many questions as needed so that you can decide if you want to be in the study. Participation is voluntary, and you are free to choose whether or not you would like to participate.

is a research company working for GlaxoSmithKline (GSK), a medicines company.

PURPOSE OF THE STUDY AND WHAT IS INVOLVED

The aim of the study is to identify and evaluate satisfaction and dissatisfaction, impact, and preferences of asthma and chronic obstructive pulmonary disease (COPD) treatment. You have been asked to take part in this study because our records indicated that you are a patient with asthma or COPD, and are currently being prescribed Relvar® Ellipta®.

WHAT WOULD TAKING PART INVOLVE

This study involves completing a survey. In the survey you will be asked to provide some basic information about yourself (e.g., occupation, marital status), and complete either the Asthma Control Test or the COPD Assessment Test. These questions, along with information identified in your medical records (age, gender, ethnicity, date of asthma/COPD diagnosis, date prescribed Relvar® Ellipta®) will allow us to describe the sample of participants who take part in this study.

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The main survey includes questions about Relvar® Ellipta® and another recent treatment. Questions include how often you use the treatment, how easy or difficult you find using the inhaler, and how satisfied or dissatisfied you are with various attributes of the inhaler (such as how your symptoms are controlled, your ability to do various activities).

LENGTH OF THE SURVEY AND NUMBER OF PARTICIPANTS EXPECTED TO TAKE PART

The survey should take no longer than 30 minutes to complete. Up to 200 patients (100 with asthma and 100 with COPD) are expected to complete the survey over the next few months. If you complete the full survey, you will receive £25 by cheque or Amazon voucher (this should be within 2 weeks of completing the survey).

We would like to capture the experiences and views of patients with different levels of asthma and COPD severity. To do this we will monitor ACT and CAT scores. For example, we would like include a maximum of 40 patients with uncontrolled asthma, and up to 40 patients with low impact COPD. Therefore, we may ask you to complete either the ACT or CAT to check you can take part in the survey according to your level of severity. If your level of severity is not in line with our recruitment targets you will not be eligible to take part in the full survey. If this is the case and you complete just the ACT or CAT, you will receive £10 by cheque or Amazon voucher for your time (this should be within 2 weeks of completing the survey).

POSSIBLE BENEFITS OF THE SURVEY

As this is a survey, there is no direct medical benefit to you as a result of taking part in this survey. However, information learned from the study may help other patients in the future.

ADDITIONAL COSTS

There are no costs to you associated with participating in this study.

POSSIBLE DISADVANTAGES AND RISKS OF TAKING PART

As this survey does not involve medication in any way, there are no risks of side effects. However, it is possible that you may find it difficult, or feel emotional, when considering and answering questions about your experiences. If you would like to speak to someone about your feelings, please contact your usual support group or healthcare professional.

LEAVING THE STUDY

Taking part in this study is your choice. You may choose either to take part or not to take part in the Survey. If you do not want to be in the study, there will be no penalty to you.

If you do decide to take part, you are free to withdraw from the study or revoke your consent for any reason, specified or unspecified, and without penalty or loss of benefits to which you are otherwise entitled.

If you withdraw from the study prior to completing the survey, no new data about you will be collected. Any data you have provided may still be used in the analysis of the survey and the results of the study.

If you revoke your consent, all data collected before analysis will be excluded from the analysis and will not be used in the results of the study.


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If you wish to leave this survey, please contact at

Your part in this study may be stopped at any time and for any reason without you being asked. The following people can stop your participation and/or the study itself:

• (Study coordinators) • GSK (Study sponsor) • Recruitment agency • NHS Research Ethic Committee or your hospital or clinical site • Other country or local regulatory agencies

If you do not follow the study procedures or there are any conditions or circumstances that may jeopardise your welfare or the integrity of the study then you may be taken out of the study.

ALTERNATIVES TO PARTICIPATION

You can choose not to take part in this survey.

RELEASE OF RESULTS AND PRIVACY

Records of you being in this study will be kept private. Contact details that you have provided and signed consent forms will be kept securely and separate from the study data you provide (linked by a study number only). If information from this study is published or presented at scientific meetings, your name and other personal information will not be used. Information relating to your personal details, such as name, address, and telephone number, will only be seen by staff or those helping with recruitment. The following people will have access to the anonymised survey data collected:

• GSK (Study sponsor) • Recruitment agency • NHS Research Ethics Comittee

The use of the results obtained will be governed by the UK Data Protection Act. The sponsoring company will have no access personal information, or be able to identify individuals who agree to participate.

LEGAL RIGHTS

You do not lose any legal rights by consenting to participate in this survey.

WHOM TO CONTACT

You may contact using the contact details on the first page of this consent document for:

• answers to questions, concerns, or complaints about this research study • information about study procedures

If you have any questions or concerns about your health please contact your personal Doctor.

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[For paper survey completion – print on headed paper]

CONSENT FORM

Centre number: Study number:

Unique participant number:

Title of Project: Evaluating the Impact, Benefits and Preferences of Relvar® Ellipta® in Patients with COPD and Asthma

Name of Researcher/Doctor:


I confirm that I have been given and read a copy of all pages of the information sheet dated 18 January 2017 (version 10). I have had an opportunity to consider the information, ask questions and have received satisfactory answers to all of my questions about this study.

☐

I understand that I am free to leave the study at any time without having to give a reason and without affecting my medical care.

☐

I understand that information relating to my personal details, such as name, address, and telephone number will only be seen by staff or those helping with recruitment. Information may be seen by regulatory authorities or my general practitioner where it is relevant to taking part in this project. I give permission for these individuals to have access to my records.

☐

I understand that the information collected about me will be used to support other research in the future, and may be shared anonymously with other researchers.

☐


☐

IF YOU DO NOT AGREE WITH THE STATEMENT ABOVE, YOU SHOULD NOT SIGN THIS INFORMED CONSENT DOCUMENT. I agree to take part in this study ☐ Name of Participant Date Signature Name of Person Taking Consent Date Signature

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[For online survey completion]

CONSENT FORM

Title of Project: Evaluating the Impact, Benefits and Preferences of Relvar® Ellipta® in Patients with COPD and Asthma


I confirm that I have been given and read a copy of all pages of the information sheet dated 18 January 2017 (version 10). I have had an opportunity to consider the information, ask questions and have received satisfactory answers to all of my questions about this study.

☐

I understand that I am free to leave the study at any time without having to give a reason and without affecting my medical care.

☐

I understand that information relating to my personal details, such as name, address, and telephone number will only be seen by staff or those helping with recruitment. Information may be seen by regulatory authorities or my general practitioner where it is relevant to taking part in this project. I give permission for these individuals to have access to my records.

☐

I understand that the information collected about me will be used to support other research in the future, and may be shared anonymously with other researchers.

☐


☐

SELECT ‘YES’ BELOW IF YOU AGREE TO PARTICIPATE IN THE SURVEY. BY SELECTING THIS OPTION YOU DO NOT WAIVE ANY OF YOUR LEGAL RIGHTS. Yes, I agree to take part in this study ☐ No, I do not agree to take part in this study ☐ Please click the ‘Click to Print This Page’ button to print or save a copy of this screen for your own records

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APPENDIX F: QUALITATIVE INTERVIEW SOCIODEMOGRAPHIC FORM

Patient Sociodemographic Form Participant ID:_________________ Date of screening: _______________________

This form asks you to provide some background information about yourself. These questions

help us to describe the group of people who take part in the study.

Please answer the following questions:

1. What is your age?

__________________ Years

2. What is your gender?

Male

Female

3. What is your racial/ethnic background?

White

British Any other white background (please provide details)

_________________________________________

Mixed/multiple ethnic groups

White and Black Caribbean White and Black African White and Asian Any other mixed/multiple ethnic background (please provide details)

_________________________________________

Asian/Asian British

Indian Pakistani Bangladeshi Any other Asian background (please provide details)

_________________________________________

African/Caribbean/Black British

African Caribbean Any other Black background (please provide details)

_________________________________________


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Chinese or Chinese British

Chinese Any other Chinese background (please provide details)

_________________________________________

Other ethnic group

Middle Eastern Any other ethnic background (please provide details)

_________________________________________

4. Which of the following best describes your main activity?

Employed full time Employed part time Student Seeking work Unemployed Retired Self-employed Stay at home Long term sickness Unpaid carer

Other:

5. What is your highest level of education?

No formal qualifications GCSE/Secondary school A Levels/College/Apprenticeship Undergraduate degree (e.g. BSc, BA) Postgraduate degree (e.g. Masters, PhD) Other ___________________________

6. What is your current marital status?

Single Partnership/Civil Partnership Married Divorced/ separated Widowed Other ______________________________

7. Are you a smoker?

Yes Former smoker No

8. Are you a pet-owner?

Yes Formerly owned a pet No


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9. What medications are you currently taking for asthma and/or COPD? This could be

both maintenance and reliever medication(s) and tablets (E.g., montelukast,

theophylines, prednisolone, azithromycin etc.).

Medication Name Date began medication

(month & year)

__________ /________

__________ /________

__________ /________

__________ /________

__________ /________

__________ /________

__________ /________

__________ /________

__________ /________

__________ /________

__________ /________

__________ /________


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10. What medications were you previously taking for asthma and/or COPD before your Doctor or Nurse prescribed Relvar® Ellipta®? This could be both maintenance

and reliever medication(s) and tablets (E.g., montelukast, theophylines, prednisolone,

azithromycin etc.).


(month & year)

Date stopped medication

(month & year)

______ /______

______ /______

______ /______

______ /______

______ /______

______ /______

______ /______

______ /______

______ /______

______ /______

______ /______

______ /______

______ /______

______ /______

______ /______

______ /______

______ /______

______ /______

______ /______

______ /______

______ /______

______ /______

______ /______

______ /______


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11. What other medications are you currently taking (not relating to asthma and/or

COPD)?


(month & year)

__________ /________

__________ /________

__________ /________

__________ /________

__________ /________

__________ /________

__________ /________

__________ /________

__________ /________

__________ /________

__________ /________

__________ /________

__________ /________


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APPENDIX G: ASTHMA CONTROL TEST (ACT)

CCI - This section contained Clinical Outcome Assessment data collection questionnaires or indices, which are protected by third party copyright laws and therefore have been excluded.


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APPENDIX H: COPD ASSESSMENT TEST (CAT) Note: the electronic version of the CAT will be administered to participants completing the

Stage II: Phase II survey online.


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APPENDIX I: SEMI-STRUCTURED ASTHMA PATIENT INTERVIEW GUIDE

Instructions to the patient [Interviewer instructions are in italicised square brackets. Please

have the participant’s sociodemographic form to hand to refer to previous/other medications,

if this is not available please ask the participant which medications they are describing].

• Thank you for your interest in this study and agreeing to take part in the interview

today.

• My name is ______. I am a researcher from a

health research company.

• The purpose of this study is to understand how you perceive asthma and how it affects

your everyday life. We are interested in the kind of compromises and changes you

have to make to your lifestyle because of your asthma. We also want to learn about

your experiences of the Relvar® Ellipta® asthma treatment you take at the moment,

the benefits it provides, how you feel about it, whether you have any needs, that are

not being met by your current treatment and how Relvar® Ellipta® compares to other

treatments you may have taken in the past.

• We will be conducting approximately 25 interviews with other asthma patients. The

results of these interviews will be used to develop a survey investigating Relvar®

Ellipta® treatment effects and satisfaction with patients who are similar to you.

• All the information you provide today will be used for the purpose of this research

project only. We will publish the results of these interviews in a journal but all the

information you provide will be anonymous. This means that we will not mention you

by name or include any information that is likely to identify you, such as the town you

live in, names of hospitals or clinicians or the work that you do.

• There are no right or wrong answers and you do not have to answer any questions you

don’t want to. We are interested in your thoughts and opinions.

• I am not a medical expert and my role here is to ask questions and fully understand

your answers.

• This interview will last approximately 1 hour. If needed I will give you the opportunity to

take a break approximately halfway through but please let me know if you need a

break at any other point.

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• As mentioned on the consent form, I will be recording this interview for reference

purposes. Please speak clearly so that we can hear all of your comments. I will let you

know as soon as I switch the recorders on.

• Before we begin, do you have any questions about the study or about the consent

form? [Interviewer: Allow time for response]

• When I start the recording, I will need to give a couple of study reference numbers.

• I will now start the recorders.

[Begin recording] • This is study number 0018-0681.

• This is interview number _____.

• Today’s date is _____.

• The time is _____.

Opening

1. How is your asthma at the moment?

2. When were you formally diagnosed with asthma?

HRQL

3. Could you talk me through how asthma affects your everyday life since you were

diagnosed? [If patient struggles to remember or summarise since diagnosis, ask about

the last few years. Allow patient to answer before using probes: reasons patient

can/cannot do things due to their experience of their condition or because they are

worried or embarrassed about having asthma, taking medication, their

moods/emotions, for each point and how this has changed over time and how

treatment impacts/changes this.]

a. Ability to work – having to take time off and impact of this, such as financial

implications. Is/was your asthma worse at work, any workplace dusts, gases,

fumes or vapours, or extreme temperatures that make your breathing worse?

b. Physical activities – ability to exercise, going up stairs, walking up hills or inclines,

walkable distance.

c. Social life - ability to visit family and socialise with friends, join social clubs.

d. Hobbies – ability to do things you want to do

e. Sleep – ability to have an uninterrupted night’s sleep

4. Do you ever experience severe attacks due to asthma? If yes, please describe how you


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feel when this happens.

a. Which symptoms do you experience? How long do you experience them for?

b. How do these severe attacks impact you? [Probe around ability to work, physical

activities, social life, and hobbies].

c. Do you require more than one treatment for your asthma? If yes, please

describe. (E.g. has he/she needed more than one inhaler as a result?)

d. Has an attack ever led to a change of treatment?

e. How confident are you in your treatment when you experience a severe

attack? Have you ever worried before that your medication won’t work? In

what way?

Current Treatment – Rescue Medication

We are now going to talk about the treatments that you currently take for your asthma. First,

I would like to briefly discuss short-term rescue/relief treatments which you take when your

symptoms may have become particularly bad, such as an attack, flare or an exacerbation of

symptoms.

5. Do you use a rescue medication?

6. How do you use your rescue medication?

a. Could you describe the kind of situations when you typically need rescue

medication?

• How does this make you feel? Why?

b. How often has your Doctor said you can take it?

c. How often do you need it? [E.g. number of times daily, weekly, monthly, every 3

months.]

d. How well/not well does your treatment work to relieve your symptoms?

e. How quickly does your treatment take effect, i.e. you have relief of symptoms?

f. Does this vary? If so, how?

g. How would you feel if you did not need reliever/rescue medication?


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Current Treatment – Relvar® Ellipta®

Now we will discuss your maintenance or preventer inhaler. Specifically, Relvar® Ellipta®,

the long-term treatment you take primarily to prevent a recurrence of your symptoms.

7. Please can you describe your thoughts and experience of using Relvar® Ellipta®?

8. Do you know why your Doctor or Nurse prescribed you Relvar® Ellipta®?

a. How did you feel about this at the time?

• How do you feel about the medication now?

b. Were you taking any other treatments before using Relvar® Ellipta®? [Use

sociodemographic form for reference and ask about each medication listed. Probe for

oral tablet, inhaler, other.]

• How does Relvar® Ellipta® compare to these other treatments? Why is

this?

9. Since you have been using Relvar® Ellipta®, has there been any change in your

asthma? Can you describe any affect this has had on your daily life?

a. Ability to work – task that can/cannot be done, having to take time off and impact

of this, financial impact.

b. Physical activities – ability to exercise, going up stairs, walking up hills or

inclines, walkable distance (probe for how much physical activity they are able to

do, that they would like to do and whether this has changed since they started

using Relvar® Ellipta®).

c. Social life - ability to visit family and socialise with friends, join social clubs (probe

for how much social activity they are able to do that they would like to do and

whether this has changed since they started using Relvar® Ellipta®).

d. Hobbies – ability to do things you want to do Relvar® Ellipta®

e. Sleep – ability to have an uninterrupted night’s sleep (probe for how often they

wake up each night on average each week and whether this has changed since

they started using Relvar® Ellipta®).


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I would now like to talk about some of the different aspects or factors of Relvar® Ellipta®.

10. How do you feel about the way you use Relvar® Ellipta®?

a. What makes you feel this way?

b. How long does it take to use every time? How do you feel about this?

c. How easy or difficult is Relvar® Ellipta® to use?

d. How does this compare to other inhalers you have used? [Use

sociodemographic form for reference and ask about each medication listed].

e. Do you think there can be anything improved?

11. How often do you use Relvar® Ellipta®? [Probe: number of times daily/weekly].

a. How do you feel about this?

b. At what times of the day do you use Relvar® Ellipta®? Why?

c. Is this the same as how often your Doctor or Nurse has told you that you should

use Relvar® Ellipta®? Why/why not? [Use the following questions as probes

where necessary]

• Effect on daily routine? Is there a difference between weekdays and

weekends? Holidays?

• Are there times or situations when you are more or less likely to take

Relvar® Ellipta®? Why does this happen?

• What happens if you miss a dose?

• Are there any physical aspects of your medication that you feel affect

this? E.g. taste, side effects you experience, ease of use.

• Are there instances when activities/duties interfere with taking your

medication? When? Why?


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12. Do you feel you are symptom free when you take a dose of Relvar® Ellipta®?[If yes,

proceed to Q13]

a. Why do you feel your symptoms are not controlled?

b. Do you feel the same every time you take a dose of Relvar® Ellipta®? If not,

please describe.

• Does this vary depending on the situation or attack trigger? If so, how?

c. How does this impact your life?

d. Are there times during the day/week that your asthma symptoms seem better

controlled (e.g., mornings vs evenings, weekdays vs weekends)?

e. In general, how well controlled do you think your symptoms are? Are your symptoms stable and well controlled all day or just some of the day?

f. How does this compare to other medications you have taken? [Use


13. How do you feel about the length of time that you are controlled after taking a dose of

Relvar® Ellipta®?

a. How long are your symptoms controlled for after you have taken a dose of

Relvar® Ellipta®? (Probe for hours, days).

b. Do you always have relief for the same periods of time? If not, please describe.

c. How fast can you feel Relvar® Ellipta® take effect? i.e. until you have relief of

symptoms (15-mins, 30-mins, 1-hour).

d. Does this vary depending on the situation or attack trigger? If so, how?

e. How does this impact your life?

f. Are there times during the day/week that your asthma symptoms seem better


g. In general, how well controlled do you think your symptoms are? Are your

symptoms stable and well controlled all day or just some of the day?

h. How does this compare to other medications you have taken? [Use



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14. Relvar® Ellipta® is a once daily medication. How did you feel about taking medication

once per day when your Doctor or Nurse first prescribed it?

a. How do you feel about it now?

b. How do you feel once daily medication compares to medication you need to

take more frequently? [Use sociodemographic form for reference and ask about

each medication listed. Probe for positives and negatives].

15. Can you describe any ways in which asthma disturbs your sleep or wakes you during

the night?

a. How have you been sleeping since you have been taking Relvar® Ellipta®? How

does this affect your life?

b. Do you ever wake up in the night needing your medication? If yes, please

describe. [Probe for how many times each night and over a week].

c. What medication do you take when you wake up? Please describe the effect of

taking this medication. [Probe: length of time until relief and/or getting back to

sleep; sleep for the rest of the night?]

16. Have you experienced any treatment side effects while using Relvar® Ellipta®? [e.g.,

Dry mouth, hoarseness, sore throat/tongue, thrush, nausea, headache].

a. How do these side effects impact your daily life? [Ask for each side effect].

b. How do you manage these side effects?

c. How do these compare to other treatments you have used? [Use


d. How important is it for you to avoid this side effect if possible?

e. How much do treatment side effects concern you day-to-day?


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17. How confident would you say you are you in Relvar® Ellipta®? Can you tell me any

more about this? Why do you feel this way?

a. When you are comparing Relvar to other treatments you have taken, which

inhalers do you mean?

b. Why have you chosen to compare Relvar® Ellipta® to this treatment? [Probe for

main reason: e.g., symptom relief, frequency of dosage, ease of use, sleep

disturbance, frequency of attacks/exacerbations, ability to do desired physical or

social activities].

18. We have been discussing different aspects of Relvar® Ellipta®. Do you have any other

thoughts or comments about this treatment that we haven’t discussed?

19. That’s all of my questions. Is there anything else you would like to talk about in relation

to your asthma treatment and lifestyle or do you have any other questions or

concluding remarks?

Thank you for taking the time to participate in this study. Everything you have said, along

with the background questionnaire which you have already completed, will help us to

understand how asthma and Relvar® Ellipta® treatment is affecting you and will be very

useful. I am now going to stop the recorder.

[Turn off recorder]


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APPENDIX J: SEMI-STRUCTURED COPD PATIENT INTERVIEW GUIDE

Instructions to the patient [Interviewer instructions are in italicised square brackets. Please

have the participant’s sociodemographic form to hand to refer to previous/other medications,

if this is not available please ask the participant which medications they are describing.]

• Thank you for your interest in this study and agreeing to take part in the interview

today.

• My name is ______. I am a researcher from a

health research company.

• The purpose of this study is to understand how you perceive COPD and how it affects

your everyday life. We are interested in the kind of compromises and changes you

have to make to your lifestyle because of your COPD. We also want to learn about

your experiences of the Relvar® Ellipta® COPD treatment you take at the moment, the

benefits it provides, how you feel about it, whether you have any needs, that are not

being met by your current treatment and how Relvar® Ellipta® compares to other

treatments you may have taken in the past.

• We will be conducting approximately 25 interviews with other COPD patients. The

results of these interviews will be used to develop a survey investigating Relvar®

Ellipta® treatment effects and satisfaction with patients who are similar to you.

• All the information you provide today will be used for the purpose of this research

project only. We may publish the results of these interviews in a journal but all the

information you provide will be anonymous. This means that we will not mention you

by name or include any information that is likely to identify you, such as the town you

live in, names of hospitals or clinicians or the work that you do.

• There are no right or wrong answers and you do not have to answer any questions you

don’t want to. We are interested in your thoughts and opinions.

• I am not a medical expert and my role here is to ask questions and fully understand

your answers.

• This interview will last approximately 1 hour. If needed I will give you the opportunity to

take a break approximately halfway through but please let me know if you need a

break at any other point.

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• As mentioned on the consent form, I will be recording this interview for reference

purposes. Please speak clearly so that we can hear all of your comments. I will let you

know as soon as I switch the recorders on.

• Before we begin, do you have any questions about the study or about the consent

form? [Interviewer: Allow time for response.]

• When I start the recording, I will need to give a couple of study reference numbers.

• I will now start the recorders.

[Begin recording] • This is study number 0018-0681.

• This is interview number _____.

• Today’s date is _____.

• The time is _____.

Opening

1. How is your COPD at the moment?

2. When were you formally diagnosed with COPD?

HRQL

3. Could you talk me through how COPD affects your everyday life since you were

diagnosed? [If patient struggles to remember or summaries since diagnosis, ask about

the last few years. Allow patient to answer before using probes: reasons patient

can/cannot do things due to their experience of their condition or because they are

worried or embarrassed about having COPD, taking medication, their moods/emotions,

for each point and how this has changed over time and how treatment impacts/changes

this.]

a. Ability to work – having to take time off and impact of this, such as financial

implications. Is/was your COPD worse at work, any workplace dusts, gases,

fumes or vapours, or extreme temperatures that make your breathing worse?


inclines, walkable distance.

c. Social life - ability to visit family and socialise with friends, join social clubs.

d. Hobbies – ability to do things you want to do.

e. Sleep – ability to have an uninterrupted night’s sleep.


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4. Do you ever experience severe exacerbations due to COPD? If yes, please describe

how you feel when this happens.

a. Which symptoms do you experience? How long do you experience them for?

b. How do these exacerbations impact you? [Probe around ability to work, physical

activities, social life, hobbies.]

c. Do you require more than one treatment for your COPD? If yes, please describe.

(E.g., has he/she needed more than one inhaler as a result?)

d. Has a severe exacerbation ever led to a change of treatment?

e. How confident are you in your treatment when you experience an exacerbation?

Have you ever worried before that your medication won’t work? In what way?

Current Treatment – Rescue Medication

We are now going to talk about the treatments that you currently take for your COPD. I

would like to briefly discuss short-term rescue/relief treatments which you take when your

symptoms may have become particularly bad, such as an attack, flare or an exacerbation of

symptoms.

5. Do you use a rescue medication?

6. How do you use your rescue medication?

a. Could you describe the kind of situations when you typically need rescue

medication?

• How does this make you feel? Why?

b. How often has your Doctor said you can take it?

c. How often do you need it? [E.g., number of times daily, weekly, monthly, every 3

months.]

d. How well/not well does your treatment work to relieve your symptoms?

e. How quickly does your treatment take effect, i.e. you have relief of symptoms?

f. Does this vary? If so, how?

g. How would you feel if you did not need reliever/rescue medication?

Current Treatment – Relvar® Ellipta®

Now we will discuss Relvar® Ellipta® specifically, the long-term treatment you take primarily

to prevent your symptoms reoccurring.


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7. Please can you describe your thoughts and experience of using Relvar® Ellipta®?

8. Do you know why your Doctor or Nurse prescribed you Relvar® Ellipta®?

a. How did you feel about this at the time?

• How do you feel about the medication now?

b. Were you taking any other treatments before using Relvar® Ellipta®? [Use

sociodemographic form for reference and ask about each medication listed. Probe for

oral tablet, inhaler, other.]

• How does Relvar® Ellipta® compare to these other treatments? Why is

this?

9. Since you have been using Relvar® Ellipta®, have you noticed any change in your

COPD? Could you describe any affect this has had on your daily life?

a. Ability to work – task that can/cannot be done, having to take time off and impact

of this, financial impact.


inclines, walkable distance (probe for how much physical activity they are able to

do that they would like to do and whether this has changed since they started

using Relvar® Ellipta®).

c. Social life - ability to visit family and socialise with friends, join social clubs (probe

for how much social activities they are able to do that they would like to do and

whether this has changed since they started using Relvar® Ellipta®).

d. Hobbies – ability to do things you want to do whilst using Relvar® Ellipta®

e. Sleep – ability to have an uninterrupted night’s sleep (probe for how often

they wake up on average each night each week and whether this has

changed since they started using Relvar® Ellipta®)


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I would now like to talk about some of the different aspects or factors of Relvar® Ellipta®.

10. How do you feel about the way you use Relvar® Ellipta®?

a. What makes you feel this way?

b. How long does it take to use every time? How do you feel about this?

c. How easy or difficult is Relvar® Ellipta® to use?

d. How does this compare to other inhalers you have used? [Use


e. Do you think there can be anything improved?

11. How often do you use Relvar® Ellipta®? [Probe: number of times daily/weekly].

a. How do you feel about this?

b. At what times of the day so you use Relvar® Ellipta®? Why?

c. Is this the same as how often your Doctor or Nurse has told you that you should

use Relvar® Ellipta®? Why/why not? [Use the following questions as probes

where necessary].

• Effect on daily routine? Is there a difference between weekdays and

weekends? Holidays?

• Are there times or situations when you are more or less likely to take

Relvar® Ellipta®? Why does this happen?

• What happens if you miss a dose?

• Are there any physical aspects of your medication that you feel affect

this? E.g., taste, side effects you experience, ease of use.

• Are there instances when activities/duties interfere with taking your

medication? When? Why?


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12. Do you feel your symptoms are controlled when you take a dose of Relvar® Ellipta®?

[If yes, proceed to Q13].

a. Why do you feel your symptoms are not controlled?

b. Do you feel the same every time you take a dose of Relvar® Ellipta®? If not,

please describe.

• Does this vary depending on the situation or activity you are doing? If so,

how?

c. How does this impact your life?

d. Are there times during the day/week that your COPD symptoms seem better


e. In general, how well controlled do you think your symptoms are? Are your


f. How does this compare to other medications you have taken? [Use


13. How do you feel about the length of time that your symptoms are controlled for after

taking a dose of Relvar® Ellipta®?

a. How long are your symptoms controlled for after you have taken a dose of

Relvar® Ellipta®? (Probe for hours, days)

b. Are your symptoms controlled for the same periods of time? If not, please

describe.

c. How fast can you feel Relvar® Ellipta® take effect? i.e. until you have control of

symptoms (15-mins, 30-mins, 1-hour)

d. Does this vary depending on the activity you are doing at the time? If so, how?

e. How does this impact your life?

f. Are there times during the day/week that your COPD symptoms seem better


g. In general, how well controlled do you think your symptoms are? Are your


h. How does this compare to other medications you have taken? [Use



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a. Relvar® Ellipta® is a once daily medication. How did you feel about taking

medication once per day when your Doctor or Nurse first prescribed it? How do

you feel about it now?

b. How do you feel once daily medication compares to medication you need to take

more frequently? [Use sociodemographic form for reference and ask about each

medication listed. Probe for positives and negatives].

14. Can you describe any ways in which COPD disturbs your sleep or wakes you during

the night?

a. How have you been sleeping since you have been taking Relvar® Ellipta®? How

does this affect your life?

b. Do you ever wake up in the night needing your medication? If yes, please

describe. [Probe for how many times each night and over a week].

c. What medication do you take when you wake up? Please describe the effect of

taking this medication. [Probe: length of time until relief and/or getting back to

sleep, for the rest of the night?]

15. Have you experienced any treatment side effects while using Relvar® Ellipta®? [e.g.,

Dry mouth, hoarseness, sore throat/tongue, thrush, nausea, headache].

a. How do these side effects impact your daily life? [Ask for each side effect].

b. How do you manage these side effects?

c. How do these compare to other treatments you have used? [Use


d. How important is it for you to avoid this side effect if possible?

e. How much do treatment side effects concern you day-to-day?

16. How confident would you say you are you in Relvar® Ellipta®? Can you tell me any

more about this? Why do you feel this way?

a. When you are comparing Relvar to other treatments you have taken, which inhalers do you mean?

b. Why have you chosen to compare Relvar® Ellipta® to this treatment? [Probe for

main reason: e.g., symptom relief, frequency of dosage, ease of use, sleep

disturbance, frequency of attacks/exacerbations, ability to do desired physical or

social activities]


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17. We have been discussing different aspects of Relvar® Ellipta®. Do you have any other

thoughts or comments about this treatment that we haven’t discussed?

18. That’s all of my questions. Is there anything else you would like to talk about in relation

to your COPD treatment and lifestyle or do you have any other questions or concluding

remarks?

Thank you for taking the time to participate in this study. Everything you have said, along

with the background questionnaire which you have already completed, will help us to

understand how COPD and Relvar® Ellipta® treatment is affecting you and will be very

useful. I am now going to stop the recorder.

[Turn off recorder]


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APPENDIX K: QUANTITATIVE SURVEY SOCIODEMOGRAPHIC FORM

This first section asks you to provide some background information about yourself. These

questions help us to describe the group of people who take part in the study.

1. What is your age?

__________________ Years

2. What is your gender?

Male Female Other (please provide details): ________________________________

3. What is your racial/ethnic background?

White - British/European (or other White background) Mixed/multiple ethnic group (White and Black Caribbean, White and Black African,

White and Asian, or other mixed/multiple ethnic background) Asian/Asian British (Indian, Pakistani, Bangladeshi or other Asian background) African/Caribbean/Black British (or other Black background) Chinese or Chinese British (or other Chinese background) Other ethnic background (please provide details):

_____________________________

4. Which of the following best describes your main activity?

Employed full time Employed part time Student Seeking work Unemployed Retired Self-employed Stay at home Long term sickness Unpaid carer Other (please provide details):

5. What is your highest level of education?

No formal qualifications GCSE/Secondary school A Levels/College/Apprenticeship Undergraduate degree (e.g. BSc, BA) Postgraduate degree (e.g. Masters, PhD) Other (please provide details):


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6. What is your current marital status?

Single Partnership/Civil Partnership Married Divorced/ separated Widowed Other (please provide details):

7. Are you a smoker?

Yes Former smoker No

8. Are you a pet-owner?

Yes Formerly owned a pet No

9. Are you currently taking rescue / reliever medication for you condition? Rescue / reliever medication is designed to give immediate, short-term relief and should be

taken when your symptoms are worse and have not been controlled by the

maintenance medication you take on a regular basis. Rescue / reliever medications

most usually are blue inhalers (e.g., Ventolin or Salbutamol).

Yes No


65

APPENDIX L: QUANTITATIVE SURVEY Note: Order of Relvar® Ellipta® and Recent Medications sections may be randomised.

Relvar® Ellipta®

In this section you will be asked questions about various aspects of taking Relvar® Ellipta®.

Relvar® Ellipta® is a long-term treatment that you will be taking to prevent and relieve asthma symptoms.

Please give one answer to each question.

1. For how long have you been taking Relvar® Ellipta®? ____________ Years ____________ Months

2. How often do you take Relvar® Ellipta®? Less than once a day Once a day Twice a day More than twice a day

3. When do you usually take Relvar® Ellipta®? As part of my morning routine Around lunch time (your mid-day meal) In the afternoon Around dinner time (your evening meal) In the evening (after your evening meal) Just before bedtime During the night

4. How easy or difficult is it to use your Relvar® Ellipta® inhaler? Very difficult Difficult Neutral Easy Very easy


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5. How easy or difficult is it to fit taking your Relvar® Ellipta® medication into your daily routine? Very difficult Difficult Neutral Easy Very easy

6. How convenient or inconvenient is it to take your Relvar® Ellipta® medication as instructed? Very inconvenient Inconvenient Neither inconvenient or convenient Convenient Very convenient

7. Do you ever forget to take Relvar® Ellipta®? Always Most of the time Sometimes Rarely Never

8. How satisfied or dissatisfied are you with the frequency you need to take Relvar® Ellipta®? Very dissatisfied Dissatisfied Neutral Satisfied Very satisfied

9. How satisfied or dissatisfied are you with the ability of Relvar® Ellipta® to control your symptoms? Very dissatisfied Dissatisfied Neutral Satisfied Very satisfied

10. How satisfied or dissatisfied are you with the length of time your symptoms are controlled after taking a dose of Relvar® Ellipta®? Very dissatisfied Dissatisfied Neutral Satisfied Very satisfied


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11. How confident or unconfident are you that Relvar® Ellipta® will relieve your symptoms all day? Very unconfident Unconfident Neutral Confident Very confident

12. How satisfied or dissatisfied are you with the amount of time it takes Relvar® Ellipta® to start working? Very dissatisfied Dissatisfied Neutral Satisfied Very satisfied

13. How satisfied or dissatisfied are you with the impact Relvar® Ellipta® has on your quality of sleep? Very dissatisfied Dissatisfied Neutral Satisfied Very satisfied

14. How satisfied or dissatisfied are you with your ability to sleep through the night while taking Relvar® Ellipta®? Very dissatisfied Dissatisfied Neutral Satisfied Very satisfied

15. How satisfied or dissatisfied are you with the impact Relvar® Ellipta® has on your ability to do your normal daily activities (e.g., household chores, shopping, driving)? Very dissatisfied Dissatisfied Neutral Satisfied Very satisfied


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16. How satisfied or dissatisfied are you with the impact Relvar® Ellipta® has on your ability to work (e.g., needing to take time off work because of your condition)? Very dissatisfied Dissatisfied Neutral Satisfied Very satisfied Not applicable, I do not work

17. How satisfied or dissatisfied are you with the impact Relvar® Ellipta® has on your ability to do physical activities (e.g., ability to exercise, going up and down stairs, walking up hills or inclines)? Very dissatisfied Dissatisfied Neutral Satisfied Very satisfied

18. How satisfied or dissatisfied are you with the impact Relvar® Ellipta® has on your ability to do social activities (e.g., ability to visit family, socialise with friends, joining social clubs)? Very dissatisfied Dissatisfied Neutral Satisfied Very satisfied

19. How satisfied or dissatisfied are you with the impact Relvar® Ellipta® has on your hobbies (the things you like doing or want to do outside or your normal daily or social activities)? Very dissatisfied Dissatisfied Neutral Satisfied Very satisfied

20. How satisfied or dissatisfied are you with any side effects you may experience as a consequence of taking Relvar® Ellipta®? Very dissatisfied Dissatisfied Neutral Satisfied Very satisfied


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21. How satisfied or dissatisfied are you with how Relvar® Ellipta® protects you against

allergens and other triggers which may lead to exacerbations/flare-ups (a worsening of your symptoms, or occasionally an attack)? Very dissatisfied Dissatisfied Neutral Satisfied Very satisfied

22. How satisfied or dissatisfied are you with how often you need to use your rescue medication while taking Relvar® Ellipta®? Very dissatisfied Dissatisfied Neutral Satisfied Very satisfied

23. How satisfied or dissatisfied are you with your ability to plan ahead and commit to activities/events while taking Relvar® Ellipta®? Very dissatisfied Dissatisfied Neutral Satisfied Very satisfied

24. While taking Relvar® Ellipta® do you feel anxious, worried or depressed about your condition? Much more anxious, worried or depressed Somewhat more anxious, worried or depressed About the same Somewhat less anxious, worried or depressed Much less anxious, worried or depressed

25. How satisfied or dissatisfied are you with how often you have to use Relvar® Ellipta® in public? Very dissatisfied Dissatisfied Neutral Satisfied Very satisfied Not applicable/I don’t use Relvar® Ellipta® in public


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26. How satisfied or dissatisfied are you with the extent to which Relvar® Ellipta® reduces any embarrassment of taking an inhaler in public? Very dissatisfied Dissatisfied Neutral Satisfied Very satisfied Not applicable/I don’t use Relvar® Ellipta® in public

27. How satisfied or dissatisfied are you with your overall experience of using Relvar® Ellipta®? Very dissatisfied Dissatisfied Neutral Satisfied Very satisfied

28. Is there anything else positive, not covered in the previous questions, you would like to tell us regarding your experience of using Relvar® Ellipta®? Yes No [Move on to next question]

[If yes] Please tell us about your experiences.

_________________________________________________________________________

_________________________________________________________________________

_______________________________________________________________________________

29. Is there anything else negative, not covered in the previous questions, you would like to tell us regarding your experience of using Relvar® Ellipta®? Yes No [Move on to next question]

[If yes] Please tell us about your experiences.

_________________________________________________________________________

_________________________________________________________________________

_________________________________________________________________________


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30. Would you like to continue taking Relvar® Ellipta®? Yes No, I would like to switch back to the medication I was previously taking No, I would like to try a new or different medication that I have not previously taken

Please tell us why?

_________________________________________________________________________

_________________________________________________________________________

_______________________________________________________________________________


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Recent Medication In this section we would like you to consider your experience of taking a maintenance / preventer treatment other than Relvar® Ellipta®. These medications may have been brown, purple, or yellow inhalers that you took daily to prevent and relieve asthma symptoms. You may still be using this medication(s) alongside or in addition to Relvar® Ellipta®. Examples are shown below:


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1. Have you ever taken any maintenance / preventer inhalers other than Relvar® Ellipta®? Yes No (End survey or display Relvar Ellipta Questions) If yes, please tell us which other maintenance / preventer inhalers you have taken and if you stopped taking them?

Medication Year stopped taking Currently taking

Atimos modulate (formoterol)

Atrovent (ipratropium bromide)

Becotide

Bricanyl (terbutaline)

Clenil

DuoResp

Flixotide (fluticasone propionate)

Flutiform

Fostair

Seebri (Glycopyrronium)

Onbrez (Indacaterol)

Pulmicort (budesonide)

QVAR

Seretide

Severent

Spiriva (tiotropium bromide)

Symbicort

Ultibro

Other (please provide details): _____________________________




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2. Which of your maintenance / preventer medications listed above did you use most recently before taking Relvar® Ellipta®? Please state as written above: _____________________________

[For online survey: display list of medications selected above]

The next questions refer to your most recent medication [Paper survey: you selected in Q2 Online survey: display medication chosen in Q2]. When answering these questions please think about this medication not Revlar® Ellipta®.

3. For how long were you taking your most recent medication?

____________ Years ____________ Months

4. How often did you take your most recent medication? Less often than once a day Once a day Twice a day More often than twice a day

5. When did you take your most recent medication? (tick all that apply) As part of my morning routine Around lunch time (your midday meal) In the afternoon Around dinner time (your evening meal) In the evening Just before bedtime During the night

6. How easy or difficult was it to use your most recent inhaler? Very difficult Difficult Neutral Easy Very easy

7. How easy or difficult was it to fit taking your most recent medication in to your daily

routine? Very difficult Difficult Neutral Easy Very easy


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8. How convenient or inconvenient was it to take your most recent medication as instructed? Very inconvenient Inconvenient Neither inconvenient or convenient Convenient Very convenient

9. Did you ever forget to take your most recent medication? Always Most of the time Sometimes Rarely Never

10. How satisfied or dissatisfied were you with the frequency with which you used to take your most recent medication? Very dissatisfied Dissatisfied Neutral Satisfied Very satisfied

11. How satisfied or dissatisfied were you with the ability of your most recent medication to control your symptoms? Very dissatisfied Dissatisfied Neutral Satisfied Very satisfied

12. How satisfied or dissatisfied were you with the length of time your symptoms were controlled after taking a dose of your most recent medication? Very dissatisfied Dissatisfied Neutral Satisfied Very satisfied

13. How confident or unconfident were you that your most recent medication would relieve your symptoms all day? Very unconfident Unconfident Neutral Confident Very confident


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14. How satisfied or dissatisfied were you with the amount of time your most recent medication took to start working? Very dissatisfied Dissatisfied Neutral Satisfied Very satisfied

15. How satisfied or dissatisfied were you with the impact your most recent medication had on your quality of sleep? Very dissatisfied Dissatisfied Neutral Satisfied Very satisfied

16. How satisfied or dissatisfied were you with your ability to sleep through the night when taking your most recent medication? Very dissatisfied Dissatisfied Neutral Satisfied Very satisfied

17. How satisfied or dissatisfied were you with the impact your most recent medication had on your ability to do your normal daily activities (e.g., household chores, shopping, driving)? Very dissatisfied Dissatisfied Neutral Satisfied Very satisfied

18. How satisfied or dissatisfied were you with the impact your most recent medication had on your ability to work (e.g., needing to take time off work because of your condition)? Very dissatisfied Dissatisfied Neutral Satisfied Very satisfied Not applicable, I do not work


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19. How satisfied or dissatisfied were you with the impact your most recent medication had on your ability to do physical activities (e.g., ability to exercise, going up and down stairs, walking up hills or inclines)? Very dissatisfied Dissatisfied Neutral Satisfied Very satisfied

20. How satisfied or dissatisfied were you with the impact your most recent medication had on your ability to do social activities (e.g., ability to visit family, socialise with friends, joining social clubs)? Very dissatisfied Dissatisfied Neutral Satisfied Very satisfied

21. How satisfied or dissatisfied were you with the impact your most recent medication had on your hobbies (the things you like doing or want to do outside or your normal daily or social activities)? Very dissatisfied Dissatisfied Neutral Satisfied Very satisfied

22. How satisfied or dissatisfied were you with any side effects you may have experienced as a consequence of taking your most recent medication? Very dissatisfied Dissatisfied Neutral Satisfied Very satisfied

23. How satisfied or dissatisfied are you with how your most recent medication protected you against allergens and other triggers which may lead to exacerbations/flare-ups (a worsening of your symptoms, or occasionally an attack)? Very dissatisfied Dissatisfied Neutral Satisfied Very satisfied


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24. How satisfied or dissatisfied were you with how often you needed to use your rescue medication when taking your most recent medication? Very dissatisfied Dissatisfied Neutral Satisfied Very satisfied

25. How satisfied or dissatisfied were you with your ability to plan ahead and commit to activities/events when taking your most recent medication? Very dissatisfied Dissatisfied Neutral Satisfied Very satisfied

26. When taking your most recent medication did you feel anxious, worried or depressed about your condition? Much more anxious, worried or depressed Somewhat more anxious, worried or depressed About the same Somewhat less anxious, worried or depressed Much less anxious, worried or depressed

27. How satisfied or dissatisfied were you with how often you had to use your most recent medication in public? Very dissatisfied Dissatisfied Neutral Satisfied Very satisfied Not applicable/I didn’t use my most recent medication in public

28. How satisfied or dissatisfied were you with the extent to which your most recent medication reduced any embarrassment of taking an inhaler in public? Very dissatisfied Dissatisfied Neutral Satisfied Very satisfied Not applicable/I didn’t use my most recent medication in public


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29. How satisfied or dissatisfied were you with your overall experience of using your most recent medication? Very dissatisfied Dissatisfied Neutral Satisfied Very satisfied

THANK YOU FOR TAKING PART IN THIS SURVEY!


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APPENDIX M: QUANTITATIVE SURVEY PRE-SCREENING FORM

Participant Pre-Screening Form Patient ID: _________________ Site: _________________

Date of screening (day/month/year): ___________________________

Completed by: _____________________________________________

Please use medical records/database to perform a pre-screen of potential participants.

1. Currently living in the UK?

Yes

No [Not eligible, end of screening]

2. Aged 18 or over?

Yes, state age: _____________


3. Diagnosis of asthma, COPD or ACOS?

Asthma

COPD

ACOS (both asthma and COPD)


4. Had asthma/COPD/ACOS diagnosis for ≥1 year?

Yes, state date of diagnosis (month/year): ________________


5. Currently prescribed Relvar® Ellipta® treatment for ≥ 3 months?

Yes, state date began prescription (month/year): ________________



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7. Any known illness, cognitive impairment, or co-morbidity that would interfere with the

study requirements, or inhibit the patient’s ability to provide informed and/or complete

the survey?

Yes [Not eligible, end of screening]

No

8. Has the patient taken part in any other stage or phase of this study?

Yes [Not eligible, end of screening]

No

If eligible according to the above, please complete the following so the sample can be

monitored.

9. Gender?

Male

Female

Other (please provide details): ______________________________

10. Ethnicity? (if known)

White - British/European (or other White background)

Mixed/multiple ethnic group (White and Black Caribbean, White and

Black African, White and Asian, or other mixed/multiple ethnic

background)

Asian/Asian British (Indian, Pakistani, Bangladeshi or other Asian

background)

African/Caribbean/Black British (or other Black background)

Chinese or Chinese British (or other Chinese background)

Other ethnic background (please provide details):

_____________________________


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Please complete the patient’s contact details below. This is for internal site use only, contact

details should not be removed or transferred outside of the site.

Patient Contact Details:

Title (Mr/Ms/Mrs/Miss/Dr/etc.): _____________________________________

Name: ________________________________________________________

Primary telephone number: ________________________________________

Secondary telephone number: ______________________________________

Address: _______________________________________________________

______________________________________________________________

______________________________________________________________

Email address: __________________________________________________


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APPENDIX N: ADVERSE EVENT REPORTING FORM

Agency/Project details

Activity type:

Project no./Activity ID: Project title:

Agency name: Contact name:

Address:

Country:

Tel. no: Fax no: E-mail:

Safety information

Event no: Respondent ID:

When did the agency identify the safety information (day:month:year)?

What GSK product is the safety information about?

What indication (condition) was the product used for?

Dose used: Lot/Batch no: Expiry date:

Describe the safety information disclosed during the research (include any verbatim text):

GSK Global Adverse Event Reporting Form for Health Outcomes research activities utilizing interview and/or elicitation methods (e.g. HO Surveys; PRO Development; Preference Studies; Utility

Elicitation; WTP etc.)

To be completed in English Please send completed form to GSK within 24 hours of identifying the safety information via fax or e-mail to:

For POM & OTC products CMG GCSP Reports from Americas:

Reports outside of Americas:

PPD

PPD

mailto:[email protected]

mailto:[email protected]


84

Information about the reporter (respondent) who disclosed the safety information

Reporter:Consumer Doctor Nurse Pharmacist Other (specify):______________

Which country does the reporter live in?

Did the reporter consider the event was possibly related to the product use?Yes No Unknown

Is the reporter willing for GSK’s safety team to contact them to discuss further?Yes No If No, please complete just the reporter fields above. If Yes, please provide contact details below. For an HCP it is their contact details; for a patient it is their Doctor’s contact details:

Name:

Address:

Tel. no / E-mail:

Information about the patient (person) or groups who used the product (may be the reporter or someone else)

Gender: Male Female DK Individual/Multiple Patients: Individual Multiple

Age: If Multiple state no. if known:

Initials: Other (date/year of birth, patient ID, etc.):

Was the patient pregnant when using the product?Yes No Unknown

Agency signature and date:


85

APPENDIX O: ABOUT

is one of the world’s leading providers of outsourced development services to the

pharmaceutical, biotechnology and medical device industries. Several years ago,

formed the Late Phase & Outcomes Research group to address an expanding customer

need for peri/post-approval study execution and consultative commercialisation support.

Along the way, we combined the scientific expertise from our acquisitions, Oxford Outcomes

and PriceSpective, with that from existing ‘late phase’ operational teams to create an

organisation that aligns well with our client’s product commercialisation goals to support and

expand brands in the market place.

The combined strengths in our scientific practices and operational delivery teams offer

tremendous opportunity to harness expertise and capabilities from multiple practices at

once, or in sequence, creating a stronger and more persistent focus on product value and

commercial success than the constituencies alone; we've had a very positive response from

the clients we've served to date in this way.

By completing the integration of our acquisition of Oxford Outcomes and PriceSpective,

has cemented its position as one of the most highly regarded, widely recognised,

broadly geographically represented, and most comprehensive CROs in the world today to

support pharmaceutical and biomedical customers taking powerful products to market.

To reflect the evolution of our offerings, we are changing the name of late phase group and

its legacy sub-brands, Oxford Outcomes and PriceSpective to one new consolidated brand

Commercialization and Outcomes (ICO).

We have changed our name, but our commitment to providing the very best in product

research, development, and commercialization strategy is stronger than ever. What that

means for you is that we now offer a broader and more coordinated range of expertise and

services, all delivered with the same level of excellence and commitment to customer

service that you have always known.

Mission

The ICO mission is:

• To provide market-leading clinical research, real-world studies, health economics and

patient reported outcomes research to support late phase product development.

• To begin planning for later phases at an early phase so as to create a service cluster

that integrates clinical research and health technology assessment with market

access strategy through the entire product lifecycle in order that we maximise return

on investment for our clients.

PPD

PPD

PPD

PPD

PPD


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• To face the challenge, with our clients, of truly integrating global market access and

reimbursement strategies and supporting these processes with powerful and credible

evidence.

• To break new ground by bringing together this market leading package of expertise

and experience under one roof.

The end goal is to provide a single-source, end-to-end solution to get products to market

quickly and cost effectively and then to extend their productive life cycle with appropriate and

effective applied late phase research models. In fact, in its current configuration, ICO

addresses scientific, commercialization and research interests across the full product

lifecycle.

suite of commercialization and outcomes practices are designed to maximize new

products’ success and benefits to patients’ health. We work with clients to determine and

execute the best strategies for long-term value—through customized engagements that fit

the compound, the company, and the market. Now with the practices fully integrated within

the result is best-in-class clinical development integrated with best-in-class

commercial development.

Clinical Outcomes Assessment (COA)

Our Clinical Outcomes Assessment (COA) group brings together a team of over 50

scientists and consultants with expertise in the selection, development, validation and

analysis of patient reported outcomes (PROs) and other COAs. Senior members of the

team, based in offices in (UK), (US), and (US), have

more than 20 years’ experience in COA research, and broad experience of working with

industry, and a track record of publication. We help decision-makers to understand the value

of patient endpoints and to estimate the impact of new health technologies. COA services

include:

• Conceptual and endpoint models

• Discrete choice experiments

• Market research

• COA evidence dossiers

• Scientific dissemination and medical writing

• COA instrument development and validation

• COA selection

• COA statistical analysis

• Strategic COA advice

• Systematic and focused literature reviews

PPD

PPD

PPD PPD PPD


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• Training

• Translation and linguistic validation of COA measures

• Utility and patient preference studies

• Treatment adherence and satisfaction

fluticasone furoate/vilanterol (ff/vi; gw685698+gw642444)€¦ · final protocol approved 04 jan...

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