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 ICS
Improved Asthma Control in Clinical Studies
In clinical studies involving symptomatic asthma patients on inhaled
corticosteroids (ICS), adding montelukast:
 Improved asthma control compared with adding placebo to
beclomethasone 400 mg/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 mg/day to
1600 mg/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 mg/day, to fluticasone 200 mg/day
– With a greater reduction in inflammatory cells (eosinophils)
(IMPACT study: Bjermer L et al BMJ 2003;327:891-895)
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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)
– Physician
Malonne H et al Curr Med Res Opin 2002;18:512-519.
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Patient Demographics and Characteristics
 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
Malonne H et al Curr Med Res Opin 2002;18:512-519.
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Pre-study Medications
LABA
(+ Other, No ICS)
4%
No Medication
mentioned
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
• Children were more likely to be using medications other than ICS or LABA
Patients 75
(%)
64%
6–14 years (n = 1184)
 15 years (n = 7898)
60
45
40%
33%
30
22%
15%
15
6%
3% 4%
8%
4%
0
ICS
(+ other,
no LABA)
LABA
(+ other,
no ICS)
ICS + LABA
(+ other)
Other
None
mentioned
Other = anticholinergics, theophylline, antihistamine, cromoglycate, oral
corticosteroids, ketotifen
Malonne H et al Curr Med Res Opin 2002;18:512-519.
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‘Other’ Pre-study Medications by Age
Percentage of patients
Other therapies
Total
n = 9082
6–14 years
n = 1184
 15 years
n = 7898
Anticholinergics
14.0
8.8
14.8
Theophylline
6.2
0.4
7.1
Oral corticosteroids
2.1
0.4
2.3
Antihistamine
2.0
5.0
1.6
Cromoglycate
2.0
6.3
1.5
Ketotifen
1.4
4.5
1.0
Bromhexine HCl, acetylcysteine
0.4
0.2
0.4
Malonne H et al Curr Med Res Opin 2002;18:512-519.
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Pre-study Symptoms (Total Study Group)
• Most patients suffered asthma-related limitations
Patients 100
(%)
92%
78%
80
60
48%
45%
40
20
0
Difficulty with
sleep
Early morning
awakening
Limitation of
activities
SABA use
 twice a week
Malonne H et al Curr Med Res Opin 2002;18:512-519.
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Pre-study Symptoms by Age
• More adults and adolescents reported symptoms compared with children
Patients 100
(%)
p<0.05
Aged 6–14 years
p<0.001
Aged  15 years
80
60
p<0.001
p<0.001
40
20
0
Difficulty with Early morning Limitation of
SABA use
sleep
awakening
activities
 twice a week
Malonne H et al Curr Med Res Opin 2002;18:512-519.
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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)
Patients 100
(%)
ICS + LABA (+ other) (n=5472)
*
LABA (+ other) (n=341)
80
*
ICS (+ other) (n=2213)
Other (n=1056)
60
*
*
40
20
0
Difficulty with Early morning Limitation of
sleep
awakening
activities
Other = anticholinergics, theophylline, antihistamine,
cromoglycate, oral corticosteroids, ketotifen
SABA use
 twice a week
Malonne H et al Curr Med Res Opin 2002;18:512-519.
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Results: Montelukast Improved Symptoms
and Activities
• Treatment with montelukast afforded patients less symptoms, better sleep
and less limitation of activities
Patients 100
(%)
Less
87%
85%
80%
80
Unchanged
77%
More
60
40
20
14%
12%
0.5%
0
21%
19%
0.6%
0.6%
0.8%
Difficulty with Early morning Limitation of
SABA use
sleep
awakening
activities
 twice a week
(n=4403)
(n=4096)
(n=8363)
(n=7117)
Malonne H et al Curr Med Res Opin 2002;18:512-519.
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Results: Treatment Effect Was Even More
Pronounced in Children
• More children compared with adults showed improvement with montelukast
6–14 years
Patients 100
(%)
p<0.001
p<0.001
p<0.001
Less early
awakening
Less limitation
of activities
 15 years
p<0.001
80
60
40
20
0
Less difficulty
with sleep
Decrease in
SABA use
Malonne H et al Curr Med Res Opin 2002;18:512-519.
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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
No ICS
p<0.05
Patients 100
(%)
90
87%
90%
p<0.05
p<0.05
p <0.05
88% 88%
87%
82%
80
ICS (+ other)
ICS+LABA (+ other)
84%
83%
80%
83%
81%
76%
70
60
Less difficulty
with sleep
Less early
awakening
Other = anticholinergics, theophylline, antihistamine,
cromoglycate, oral corticosteroids, ketotifen
Less limitation
of activities
Decrease in
SABA use
Malonne H et al Curr Med Res Opin 2002;18:512-519.
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Results: Global Evaluations of Well Being Were
Favourable After Treatment with Montelukast
• After treatment with montelukast, patient well being was rated as high
by patients, parents and doctors
Very Bad
Very Good
1
Patient
(n=8672)
2
3
4
5
6
4.53
Parent
(if child)
4.88
(n=972)
Doctor
(n=8592)
4.57
Malonne H et al Curr Med Res Opin 2002;18:512-519.
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Results: 90% of Patients Were Willing to
Continue Montelukast
• Most patients were willing to continue montelukast, regardless of age
No answer
2%
No
8%
Yes
90%
Malonne H et al Curr Med Res Opin 2002;18:512-519.
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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
No answer
2%
No
6%
Yes
92%
Malonne H et al Curr Med Res Opin 2002;18:512-519.
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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.
Copyright © 2003 Merck & Co., Inc., Whitehouse Station, NJ, USA.
All rights reserved.
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Printed in USA
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