Study of Inhaled Corticosteroid Plus Montelukast Compared With Inhaled Corticosteroid Therapy Alone in Patients With Chronic Asthma (0476-386)

Study Overview
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Brief Summary
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This study assesses inhaled corticosteroid plus montelukast compared with inhaled corticosteroid therapy alone for treatment of patients with chronic asthma.

Detailed Description
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During this study, all patients will receive mometasone (powder, 220 mcg once-daily, for approximately 6 weeks). In a crossover manner, eligible patients will also receive montelukast (powder, 1 mg once-daily, for approximately 2 weeks) followed by placebo; or will receive placebo followed by montelukast. The order of when each of these 2 treatments are added to the mometasone will be randomized.

Official Title
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Randomized, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of Inhaled Corticosteroid Plus Montelukast Compared With Inhaled Corticosteroid Therapy Alone in Patients With Chronic Asthma

Conditions
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Asthma

Intervention / Treatment
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* Drug: Comparator: mometasone
* Drug: Comparator: montelukast
* Drug: Comparator: placebo (unspecified)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has decreased breathing capacity (when not taking asthma medicine) that improves after taking a fast-acting asthma inhaler Within one month of the first study visit, patient has been treated with a fast-acting asthma inhaler, and may be treated with a corticosteroid inhaler or an inhaler that combines a corticosteroid plus a bronchodilator Exclusion Criteria: Patient is hypersensitive to inhaled beta-agonists, corticosteroids, leukotriene antagonists, or any of their components Has required an oral corticosteroid rescue for worsening asthma during the screening period

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>mometasone | Drug: Comparator: mometasone<br>* mometasone (inhalation powder, 220 mcg once-daily, for approximately 6 weeks)<br>|
| Placebo Comparator: 2<br>montelukast followed by placebo; or placebo followed by montelukast. | Drug: Comparator: montelukast<br>* montelukast (inhalation powder, 1 mg once-daily, for approximately 2 weeks)<br>Drug: Comparator: placebo (unspecified)<br>* Placebo (Placebo once-daily, for approximately 2 weeks)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in FEV1 (Forced Expiratory Volume; Volume of Air That is Exhaled During the First Second of a Forced Exhalation) | To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on bronchodilation assessed by average change from baseline in FEV1 over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average. | Baseline and 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Daytime Asthma Symptom Score | To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on asthma symptoms assessed by average change from baseline in daytime asthma symptom score (which could range from 0 [best] to 6 [worst]) over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average. | Baseline and 2 weeks | 
| Change From Baseline in Nighttime Asthma Symptom Score | To determine the effect of 2 weeks of treatment with inhaled montelukast plus mometasone and mometasone alone on asthma symptoms assessed by average change from baseline in nighttime asthma symptom score (which could range from 0 [best] to 3 [worst]) over the 2 week treatment period; measurements taken at 1 and 2 weeks contributed to the average. | Baseline and 2 weeks |