The Clinical Effect of MK0476 With Concomitant Administration of and Removal of Inhaled Beclomethasone in Asthmatic Patients (0476-029)

Study Overview
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Brief Summary
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This study will investigate the additive effect of montelukast (MK0476) taken along with inhaled beclomethasone versus inhaled beclomethasone alone.

Official Title
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A Multicenter, Randomized, Placebo-Controlled, Double-Blind, 2-Period, Parallel-Group Study to Assess the Clinical Effect of MK0476 With Concomitant Administration of and Removal of Inhaled Beclomethasone in Asthmatic Patients

Conditions
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Asthma

Intervention / Treatment
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* Drug: montelukast sodium
* Drug: beclomethasone
* Drug: Placebo inhaler
* Drug: placebo tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients tested negative for pregnancy and agreed to use appropriate contraceptives through out the study Patient was a nonsmoker Patient was in good general health (except for asthma) Exclusion Criteria: Patient was hospitalized Patient was female who was less than 8 weeks postpartum or breast feeding Patient planned to move or vacation away during the study Patient had major surgery within 4 weeks the past 4 weeks Patient has donated blood or participated in a clinical trial within the past 4 weeks Patient was a regular user or recent abuser of alcohol or illicit drugs Patient was 40% over or under normal weight for height

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Montelukast + Beclomethasone | Drug: montelukast sodium<br>* 10 mg tablet taken once daily at bedtime for 16 weeks<br>* Other names: MK0476;Drug: beclomethasone<br>* 200 ug inhaled, taken twice daily for 16 weeks<br>|
| Experimental: 2<br>Montelukast + Placebo inhaler | Drug: montelukast sodium<br>* 10 mg tablet taken once daily at bedtime for 16 weeks<br>* Other names: MK0476;Drug: Placebo inhaler<br>* placebo inhaler taken twice daily for 16 weeks<br>|
| Experimental: 3<br>Placebo tablet + Beclomethasone | Drug: beclomethasone<br>* 200 ug inhaled, taken twice daily for 16 weeks<br>Drug: placebo tablet<br>* placebo tablet taken once daily at bedtime for 16 weeks<br>|
| Placebo Comparator: 4<br>Placebo tablet + Placebo inhaler | Drug: Placebo inhaler<br>* placebo inhaler taken twice daily for 16 weeks<br>Drug: placebo tablet<br>* placebo tablet taken once daily at bedtime for 16 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) in Patients With Chronic Asthma | Mean percent change from baseline in FEV1 in patients with chronic asthma averaged over 16 weeks for the Beclo and MK+ Beclo groups and averaged over last 10 weeks for the Placebo and MK groups | Baseline & over 16 weeks for the Beclomethasone (Beclo) and Montelukast (MK) + Beclo groups and over last 10 weeks for the Placebo and MK groups | 
| Mean Change From Baseline in Daytime Symptom Score on the Daytime Asthma Symptoms Diary in Patients With Chronic Asthma | The daily daytime symptom score was determined by averaging the daily scores (the patient scored his/her symptoms [from 0 (best) to 6 (worst)] on a daily basis.) for the four questions on the Daytime Asthma Symptoms Diary. The average daytime symptom score for the visit was determined by averaging the daily symptom scores over all days between two consecutive visits. | Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent Change From Baseline in Total Daily Beta-agonist Medication Use | Beta-agonist medication use from the daytime and overnight asthma symptoms diaries for each 24-hour period was added to determine the daily total number of puffs used. The average daily number of puffs for the visit was determined as the average daily number of puffs over all days between consecutive visits. | Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups | 
| Mean Change From Baseline in Morning Peak Flow Rate (PEFR) in Patients With Chronic Asthma | Morning PEFR was measured in triplicate immediately upon arising before taking any medication and the best value recorded on the overnight asthma symptoms diary. The mean morning PEFR for the visit was determined by averaging all valid PEFR measurements for the days between consecutive visits. | Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups | 
| Mean Change From Baseline in Nocturnal Asthma Score on the Overnight Asthma Symptoms Diary in Nocturnal Asthmatic Patients Only | Mean change from baseline in Nocturnal asthma score; the patient scored his/her symptoms [from 0 (best) to 3 (worst)] on a daily basis. Responses to the question, Did you wake up with asthma symptoms? (no, once, more than once, awake all night), were assigned numerical values (0, 1, 2, 3, respectively). The average score for the visit was determined by averaging the daily scores over all days between consecutive visits. | Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic asthma