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Impact of Montelukast on

Symptoms of Mild-to-Moderate

Persistent Asthma and

Exercise-Induced Asthma:

The ASTHMA Survey

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Background: Using Montelukast with an ICSImproved Asthma Control in Clinical Studies

Improved asthma control compared with adding placebo to beclomethasone 400 g/day

– Fewer days with asthma exacerbations (CASIOPEA study: Vaquerizo MJ et al Thorax 2003;58:204-210)

Was as effective as doubling the dose of budesonide from 800 g/day to 1600 g/day

– With a faster onset of action, shown by a greater increase in morning PEF and reduced beta-agonist use compared with baseline over days 1-3

– Similar reduction in inflammatory cells (eosinophils)(COMPACT study: Price DB et al Thorax 2003;58:211-216)

Was as effective as adding a long-acting beta-agonist (LABA), salmeterol 100 g/day, to fluticasone 200 g/day

– With a greater reduction in inflammatory cells (eosinophils)(IMPACT study: Bjermer L et al BMJ 2003;327:891-895)

In clinical studies involving symptomatic asthma patients on inhaled corticosteroids (ICS), adding montelukast:

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Why Conduct the ASTHMA Survey?

For many patients, asthma symptoms persist despite controller therapy

– Limitation of daily activities

– Sleep disturbance

– Frequent use of reliever medication

Contributing factors may include:

– Compliance – Low adherence to inhaled therapy and incorrect inhaler technique

– Concomitant conditions – Up to 80% of patients with asthma suffer from comorbid allergic rhinitis

Rabe KF et al Eur Respir J 2000;16:802-807; Price D et al Asthma J 1999;4:74-78; Milgrom H et al J Allergy Clin Immunol 1996;98:1051-1057; Cochrane MG et al Chest 2000;117:542-550;

Leynaert B et al J Allergy Clin Immunol 2000;106(Suppl 5):S201-S205.

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ASTHMA Survey: Patients and Methods

A large-scale Belgian survey conducted among > 11,000 GP-treated symptomatic patients with mild-to-moderate persistent asthma despite treatment with ICS or with exercise-induced asthma (EIA)

Questionnaire given before and at least 4 weeks after starting treatment with montelukast once daily at bedtime

– Montelukast 5 mg for patients aged 6–14 years

– Montelukast 10 mg for patients aged 15 years

Malonne H et al Curr Med Res Opin 2002;18:512-519.

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Assessments

Symptoms

– Difficulty with sleep

– Early morning awakening

– Limitation of activities

– Short-acting beta-agonist use (SABA) twice per week

Satisfaction

– Willingness to continue montelukast treatment

Global evaluation of well being

– Patient (or parent of young children)

– PhysicianMalonne H et al Curr Med Res Opin 2002;18:512-519.

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Patient Demographics and Characteristics

Malonne H et al Curr Med Res Opin 2002;18:512-519.

1360 GP participants (~10% of Belgian GPs)

Patients

– 11,054 patients recruited

– 9082 patients included in analysis (after exclusion of incorrectly completed questionnaires and those already on LTRAs)

– 51% male, 45% female (4% sex not mentioned)

– 13% aged 6–14 years, 87% aged 15 years

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Pre-study MedicationsLABA

(+ Other, No ICS)4%

No Medicationmentioned

4% Other

8%

ICS (+ Other, No LABA)

24% ICS + LABA (+ Other)

60%

Other = anticholinergics, theophylline, antihistamine, cromoglycate, oral corticosteroids, ketotifen

Malonne H et al Curr Med Res Opin 2002;18:512-519.

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Pre-study Medications by Age

Other = anticholinergics, theophylline, antihistamine, cromoglycate, oral corticosteroids, ketotifen

Malonne H et al Curr Med Res Opin 2002;18:512-519.

40%

3%

33%

15%8%

22%

4%

64%

6% 4%

0

15

30

45

60

75

ICS (+ other,

no LABA)

LABA(+ other,no ICS)

ICS + LABA (+ other)

Other Nonementioned

6–14 years (n = 1184)

15 years (n = 7898)

Patients(%)

• Children were more likely to be using medications other than ICS or LABA

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‘Other’ Pre-study Medications by Age

Other therapies

Anticholinergics

Theophylline

Oral corticosteroids

Antihistamine

Cromoglycate

Ketotifen

Bromhexine HCl, acetylcysteine

Totaln = 9082

14.0

6.2

2.1

2.0

2.0

1.4

0.4

6–14 yearsn = 1184

8.8

0.4

0.4

5.0

6.3

4.5

0.2

15 yearsn = 7898

14.8

7.1

2.3

1.6

1.5

1.0

0.4Malonne H et al Curr Med Res Opin 2002;18:512-519.

Percentage of patients

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Pre-study Symptoms (Total Study Group)

• Most patients suffered asthma-related limitations

Malonne H et al Curr Med Res Opin 2002;18:512-519.

78%

92%

48%

Patients(%)

0

20

40

60

80

100

Difficulty withsleep

Limitation ofactivities

SABA use twice a week

45%

Early morningawakening

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Pre-study Symptoms by Age

• More adults and adolescents reported symptoms compared with children

Malonne H et al Curr Med Res Opin 2002;18:512-519.

Difficulty withsleep

Limitation ofactivities

SABA use twice a week

Aged 6–14 years Aged 15 years

p<0.001

p<0.05

p<0.001Patients(%)

0

20

40

60

80

100

Early morningawakening

p<0.001

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Asthma Symptoms Persisted Despite Treatment• Patients using ICS + LABA reported more symptoms than those using other treatments (*p<0.001 vs. all other subgroups)

Malonne H et al Curr Med Res Opin 2002;18:512-519.

*

**

Other (n=1056)

ICS + LABA (+ other) (n=5472)

LABA (+ other) (n=341)

ICS (+ other) (n=2213)

Patients(%)

0

20

40

60

80

100

Difficulty withsleep

Limitation ofactivities

SABA use twice a week

Early morningawakening

*

Other = anticholinergics, theophylline, antihistamine, cromoglycate, oral corticosteroids, ketotifen

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Results: Montelukast Improved Symptoms and Activities• Treatment with montelukast afforded patients less symptoms, better sleep and less limitation of activities

Malonne H et al Curr Med Res Opin 2002;18:512-519.

87% 85%

77%

12% 14%21%

0.5% 0.6% 0.8%

Less

Unchanged

More

Patients(%)

0

20

40

60

80

100

80%

19%

0.6%

Difficulty withsleep

(n=4403)

Limitation ofactivities(n=8363)

SABA use twice a week

(n=7117)

Early morningawakening

(n=4096)

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Results: Treatment Effect Was Even More Pronounced in Children

6–14 years

• More children compared with adults showed improvement with montelukast

Malonne H et al Curr Med Res Opin 2002;18:512-519.

Less difficulty with sleep

Less limitation of activities

Decrease inSABA use

p<0.001 p<0.001p<0.001

15 years

0

20

40

60

80

100Patients(%)

p<0.001

Less earlyawakening

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Results: Symptom Improvements Were Greatest When Adding Montelukast to ICS• Among patients using ICS, symptom improvement was slightly, but significantly, less pronounced in patients using concomitant LABA

Malonne H et al Curr Med Res Opin 2002;18:512-519.

87% 88%

83%

90%88%

81%

87%84%

76%

60

70

80

90

100

No ICSICS (+ other)ICS+LABA (+ other)p<0.05 p<0.05

p<0.05

Patients(%)

82%83%

80%

p <0.05

Less difficulty with sleep

Less limitation of activities

Decrease inSABA use

Less earlyawakening

Other = anticholinergics, theophylline, antihistamine, cromoglycate, oral corticosteroids, ketotifen

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Results: Global Evaluations of Well Being Were Favourable After Treatment with Montelukast

Patient(n=8672)

Parent (if child)

(n=972)

1 2 3 4 5 6

4.53

4.88

4.57Doctor

(n=8592)

Very Bad Very Good

• After treatment with montelukast, patient well being was rated as high by patients, parents and doctors

Malonne H et al Curr Med Res Opin 2002;18:512-519.

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• Most patients were willing to continue montelukast, regardless of age

Malonne H et al Curr Med Res Opin 2002;18:512-519.

Yes90%

No8%

No answer2%

Results: 90% of Patients Were Willing to Continue Montelukast

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Results: 92% of Children Were Willing to Continue Montelukast

• Most children aged 6–14 years were willing to continue montelukast therapy

Malonne H et al Curr Med Res Opin 2002;18:512-519.

Yes92%

No6%

No answer2%

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The ASTHMA Survey: Summary

At enrollment, asthma symptoms persisted, despite the use of daily controller medication (60% of patients were using ICS + LABA)

Montelukast reduced asthma symptoms and improved activities for most patients

90% of patients were willing to continue montelukast therapy, regardless of age

Malonne H et al Curr Med Res Opin 2002;18:512-519.

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The ASTHMA Survey: Conclusions

In previous studies, montelukast added to ICS provided additional clinical benefits

Complementary benefit of montelukast may be due to blockade of the leukotriene pathway – key mediators in asthmatic inflammation not blocked by steroids

In this survey of 9082 patients with persistent asthma symptoms despite ICS, better control of asthmatic inflammation with montelukast led to better patient outcomes and willingness to continue therapy

90% of patients wished to continue taking montelukast

Laviolette M et al Am J Respir Crit Care Med 1999;160:1862-1868; Phipatanakul W et al Ann Allergy Asthma Immunol 2002;91:49-54; Vaquerizo MJ et al Thorax 2003;58:204-210; Price DB et al Thorax 2003;58:211-216; Bjermer L et al BMJ 2003;327:891-895;

Malonne H et al Curr Med Res Opin 2002;18:512-519.

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References

See notes page for references.

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Before prescribing, please consult the manufacturers’ prescribing information.

Merck does not recommend the use of any product in any different manner than as described in the

prescribing information.

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