Montelukast Asthmatic Smoker Study (0476-332)(COMPLETED)

Study Overview
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Brief Summary
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This is a multicenter study to evaluate the efficacy and safety of MK0476 versus placebo in participants with chronic asthma who actively smoke cigarettes.

Official Title
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A Multicenter, Randomized, Double-Blind, Parallel-Group 6-Month Study to Evaluate the Efficacy and Safety of Oral Montelukast Sodium, Fluticasone Propionate and Placebo in Patients With Chronic Asthma Who Smoke Cigarettes

Conditions
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Asthma

Intervention / Treatment
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* Drug: montelukast sodium
* Drug: Comparator: Placebo
* Drug: Comparator: fluticasone
* Drug: Comparator: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with chronic asthma who actively smoke at least 0.5 to no more than 2 packs of cigarettes a day Exclusion Criteria: Participant cannot have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or emphysema.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Arm 1: Montelukast | Drug: montelukast sodium<br>* montelukast 10 mg tablet once daily, 6 month treatment period<br>Drug: Comparator: Placebo<br>* fluticasone propionate 250 mcg Placebo (Pbo) twice daily, 6 month treatment period<br>|
| Active Comparator: 2<br>Arm 2: Fluticasone | Drug: Comparator: fluticasone<br>* fluticasone propionate 250 mcg twice daily, 6 month treatment period<br>Drug: Comparator: Placebo<br>* montelukast 10 mg Pbo tablet once daily, 6 month treatment period<br>|
| Placebo Comparator: 3<br>Arm 3: Placebo | Drug: Comparator: Placebo<br>* fluticasone propionate 250 mcg Placebo (Pbo) twice daily, 6 month treatment period<br>Drug: Comparator: Placebo<br>* montelukast 10 mg Pbo tablet once daily, 6 month treatment period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Asthma-control Days Over the 6-month Treatment Period | An asthma-control day, computed from daily diaries, was any day with no unscheduled visit for asthma care, no use of > than 2 puffs of β-agonist, no use of other asthma rescue medication, and no nocturnal awakening. The percentage of asthma-control days was the number of days with asthma-control divided by the total number of days with non-missing values for this endpoint. The patient diary had questions concerning daytime and nighttime symptoms, morning (AM) and evening (PM) peak expiratory flow rate (PEFR), β-agonist use, asthma attacks and smoking activity. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean Daytime Symptom Score Over a 6-month Treatment Period | 4 daytime symptoms were evaluated daily on a 7-point scale from 0 (best)- 6 (worst). The on-treatment daytime symptom score was computed by averaging over Period II the mean of the 4 daily symptom scores recorded daily in the diary while the baseline daytime symptom score was obtained by averaging the mean of the 4 daily symptom scores across the daily diary entries of the Baseline period (Period I). The change from baseline in mean daytime symptom score is computed as the difference between the mean on-treatment daytime symptom score & the mean baseline daytime symptom score. | Baseline and 6 months | 
| Change From Baseline in Average Morning (AM) PEFR (Peak Expiratory Flow Rate) Over a 6-month Treatment Period | PEFR measurements were performed daily, in the morning before using any medication. The on-treatment AM PEFR was computed by averaging over Period II (treatment period) the AM PEFR recorded daily in the diary, while the baseline AM PEFR was obtained by averaging the AM PEFR across the daily diary entries of the Baseline Period or Period I (placebo run-in period). The change from baseline in average AM PEFR is computed as the difference between mean on-treatment AM PEFR and mean baseline AM PEFR. | Baseline and 6 months |