asthma (chest 2012)
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STEPPING DOWN APPROACH
OF ASTHMA BRONCHIALE(GINA 2011)
C. Martin Rumende
Divisi Pulmonologi Departemen Ilmu
Penyakit Dalam FKUI/RSCM
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G
IN
A
lobal
itiative for
sthma
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Definition of Asthma
A chronic inflammatory disorder of the airways
Many cells and cellular elements play a role
Chronic inflammation is associated with airwayhyperresponsiveness that leads to recurrentepisodes of wheezing, breathlessness, chest
tightness, and coughing Widespread, variable, and often reversible
airflow limitation
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GINA Program Objectives
Increase appreciation of asthma as a global public
health problem
Present key recommendations for diagnosis andmanagement of asthma
Provide strategies to adapt recommendations to
varying health needs, services, and resources
Identify areas for future investigation of particular
significance to the global community
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Levels of Asthma Control(Preferably over 4 weeks)
Characterist icControlled
(All of the following)
Partly controlled(Any present in any week)
Uncontrolled
Daytime symptomsNone (2 or less /
week)
More than
twice / week
3 or more
features of
partly
controlled
asthma
present inany week
Limitations ofactivities
None Any
Nocturnal
symptoms /
awakening
None Any
Need for rescue /reliever
treatment
None (2 or less /
week)
More than
twice / week
Lung function
(PEF or FEV1)Normal
< 80% predicted or
personal best (if
known) on any day
Exacerbation None One or more / ear 1 in an week
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1.Develop Patient/DoctorPartnership
2. Identify and Reduce Exposureto Risk Factors
3.Assess, Treat and Monitor
Asthma4. Manage Asthma Exacerbations
Asthma Management and PreventionProgram: Five Components
Revised 2011
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Asthma Management and Prevention Program
Component 3: Assess, Treatand Monitor Asthma
The goal of asthma treatment, toachieve and maintain clinical
control, can be achieved in amajority of patients with apharmacologic intervention strategy
developed in partnership betweenthe patient/family and the healthcare professional
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Asthma Management and Prevention Program
Component 3: Assess, Treatand Monitor Asthma
Depending on level of asthma control,the patient is assigned to one of fivetreatment steps
Treatment is adjusted in a continuouscycle driven by changes in asthmacontrol status. The cycle involves:
- Assessing Asthma Control
- Treating to Achieve Control
- Monitoring to Maintain Control
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A stepwise approach to pharmacologicaltherapy is recommended
The aim is to accomplish the goals oftherapy with the least possible medication
Although in many countries traditionalmethods of healing are used, their efficacyhas not yet been established and their usecan therefore not be recommended
Asthma Management and Prevention Program
Component 3: Assess, Treatand Monitor Asthma
A th M t d P ti P
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The choice of treatment should be guided by:
Level of asthma control
Current treatment
Pharmacological properties and availabilityof the various forms of asthma treatment
Economic considerations
Cultural preferences and differing health caresystems need to be considered
Asthma Management and Prevention Program
Component 3: Assess, Treatand Monitor Asthma
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Component 4: Asthma Management and Prevention Program
Controller Medications
Inhaled glucocorticosteroids
Leukotriene modifiers
Long-acting inhaled 2-agonists Systemic glucocorticosteroids
Theophylline
Cromones
Long-acting oral 2-agonists
Anti-IgE
Systemic glucocorticosteroids
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Estimate Comparative Daily Dosages of Inhaled
Glucocorticosteroids for Adults and Children > 5 years
Drug Low Daily Dose (g) Medium Daily Dose (g) High Daily Dose (g)
Beclomethasone 200-500 >500-1000 >1000
Budesonide 200-400 400-800 800 - 1600
Budesonide-Neb
Inhalation Suspension
250-500 >500-1000 >1000
Ciclesonide 80 160 >160-320 >320-1280
Flunisolide 500-1000 >1000-2000 >2000
Fluticasone 100-250 >250-500 >500
Mometasone furoate 200-400 > 400-800 >800-1200
Triamcinolone acetonide 400-1000 >1000-2000 >2000
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Component 4: Asthma Management and Prevention Program
Reliever Medications
Rapid-acting inhaled 2-agonists
Anticholinergics
Theophylline
Short-acting oral 2-agonists
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Global Strategy for Asthma
Management and Prevention
Evidence Category Sources of Evidence
A Randomized clinical trials
Rich body of data
B Randomized clinical trialsLimited body of data
C Non-randomized trialsObservational studies
D Panel judgment consensus
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controlled
partly controlled
uncontrolled
exacerbation
LEVEL OF CONTROL
maintain and find lowest
controlling step
consider stepping up to
gain control
step up until controlled
treat as exacerbation
TREATMENT OF ACTION
TREATMENT STEPSREDUCE INCREASE
STEP
1
STEP
2
STEP
3
STEP
4
STEP
5
REDUCE
INCREASE
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Step 1 As-needed reliever medication
Patients with occasional daytime symptoms of
short duration
A rapid-acting inhaled 2-agonist is the
recommended reliever treatment (Evidence A)
When symptoms are more frequent, and/or
worsen periodically, patients require regular
controller treatment (step 2or higher)
Treating to Achieve Asthma Control
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Step 2 Reliever medication plus a singlecontroller
A low-dose inhaled glucocorticosteroid isrecommended as the initial controller
treatment for patients of all ages (Evidence A)
Alternative controller medications includeleukotriene modifiers (Evidence A)
appropriate for patients unable/unwilling to
use inhaled glucocorticosteroids
Treating to Achieve Asthma Control
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Step 3
Reliever medication plus one or twocontrollers
For adults and adolescents, combine a low-dose
inhaled glucocorticosteroid with an inhaled long-acting 2-agonist either in a combination inhaler
device or as separate components (Evidence A)
Inhaled long-acting 2-agonist must not be usedas monotherapy
For children, increase to a medium-dose inhaled
glucocorticosteroid (Evidence A)
Treating to Achieve Asthma Control
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Additional Step 3 Options for Adolescents and Adults
Increase to medium-dose inhaled
glucocorticosteroid (Evidence A) Low-dose inhaled glucocorticosteroid
combined with leukotriene modifiers
(Evidence A)
Low-dose sustained-release theophylline
(Evidence B)
Treating to Achieve Asthma Control
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Step 4
Reliever medication plus two or morecontrollers
Selection of treatment at Step 4depends
on prior selections at Steps 2 and 3
Where possible, patients not controlled on
Step 3treatments should be referred to a
health professional with expertise in the
management of asthma
Treating to Achieve Asthma Control
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Step 4
Reliever medication plus two or more controllers
Medium- or high-dose inhaled glucocorticosteroid
combined with a long-acting inhaled 2-agonist
(Evidence A)
Medium- or high-dose inhaled glucocorticosteroid
combined with leukotriene modifiers (Evidence A)
Low-dose sustained-release theophylline addedto medium- or high-dose inhaled
glucocorticosteroid combined with a long-acting
inhaled 2-agonist (Evidence B)
Treating to Achieve Asthma Control
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Treating to Achieve Asthma Control
Step 5
Reliever medication plus additional controller options
Addition of oral glucocorticosteroids to other
controller medications may be effective
(Evidence D) but is associated with severe
side effects (Evidence A)
Addition of anti-IgE treatment to othercontroller medications improves control of
allergic asthma when control has not been
achieved on other medications (Evidence A)
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Treating to Maintain Asthma Control
Stepping down treatment when asthma is controlled
When controlled on medium- to high-dose
inhaled glucocorticosteroids: 50% dosereduction at 3 month intervals (Evidence
B)
When controlled on low-dose inhaled
glucocorticosteroids: switch to once-daily
dosing (Evidence A)
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Treating to Maintain Asthma Control
Stepping down treatment when asthma is controlled
When controlled on combination inhaled
glucocorticosteroids and long-actinginhaled 2-agonist, reduce dose of inhaledglucocorticosteroid by 50% whilecontinuing the long-acting 2-agonist
(Evidence B) If control is maintained, reduce to low-
dose inhaled glucocorticosteroids and
stop long-acting 2-agonist (Evidence D)
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Treating to Maintain Asthma Control
Stepping up treatment in response to loss of control
Rapid-onset, short-acting or long-
acting inhaled 2-agonistbronchodilators provide temporaryrelief.
Need for repeated dosing over morethan one/two days signals need forpossible increase in controller therapy
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Treating to Maintain Asthma Control
Stepping up treatment in response to loss of control
Use of a combination rapid and long-actinginhaled
2
-agonist (e.g.,formoterol) and aninhaled glucocorticosteroid (e.g.,budesonide)in a single inhaler both as a controller andreliever is effecting in maintaining a high levelof asthma control and reduces exacerbations(Evidence A)
Doubling the dose of inhaled glucocortico-steroids is not effective, and is not
recommended (Evidence A)
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Asthma management - a continuous process
is needed to ensure that controlis maintained
Adapted from GINA 2011 (www.ginasthma.org)
RESCUE USE
> 2 /WEEK
Party
Controlled
Uncontrolled
NOConsider
Step-upmaintenance
treatment
Initiate
treatment
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GINA 2009
When should you step down?
When control is maintained for at least 3
months, treatment can be stepped downwith the aim of establishing the lowest step
and dose of treatment that maintains
control
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ss
ICS/LABA 50/250g bd
n=660
ICS/LABA 50/100g bd
n=208
ICS 250g bd
n=188
12 16 20 24
ScreeningEnd of
treatment
SABA
only
2 0 4 8
Run-in period Double-blind treatment period
Weeks
Stepping-down Bateman study
Randomisation
Primary endpoint: mean morning PEF
Secondary endpoints:Asthma control, symptoms, and rescue albuterol usage
Bateman et al. J Allergy Clin Immunol 2006
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M i t f th t l
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Maintenance of asthma control
during step down
14 16 18 20 22 24
ICS 250 bid0
20
40
60
80
100
2 4 6 8 10 12
%o
fwell-controlle
dsubjects
Weeks
Open-label period
ICS/LABA 50/250
Run-in
Double-blind period
4 wks
Well
controlled
ICS/LABA 50/250 bid
(two lines show groups that were
randomised during blinded phase)
ICS/LABA 50/100 bid
Bateman et al. J Allergy Clin Immunol 2006
Conclusion: Stepping down to a lower dose of
ICS/LABA is more effective than switching to an ICS
alone
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THANK YOU
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