MK0524 Asthma POC Study (0524-008)(COMPLETED)

Study Overview
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Brief Summary
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The purpose of the study is to demonstrate the benefit of MK0524 compared to placebo in patients with chronic asthma.

Official Title
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A Multicenter, Randomized, Double Blind, Crossover Study Comparing the Effect of MK0524 With Placebo and Concomitant Administration of MK0524 Plus Montelukast in Adult Patients With Chronic Asthma

Conditions
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Asthma

Intervention / Treatment
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* Drug: Comparator: MK0524 + placebo
* Drug: Comparator: MK0524 + montelukast
* Drug: Comparator: placebo + montelukast
* Drug: Comparator: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has symptoms of chronic asthma (shortness of breath, wheezing, chest tightness, etc.) for at least 1 year Nonsmoker for at least 1 year with a smoking history of no more than 7 pack-years (i.e., 1 pack per day for 7 years) Exclusion Criteria: Any clinically significant disease of heart, intestinal, kidney, liver, lung or uncontrolled blood pressure Any surgery within 4 weeks prior to Visit 1 Patient is intending to move or vacation for more than 5 days during the study Patient is pregnant or breast-feeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Experimental: 1<br>Treatment Sequence 1: MK0524 + placebo, MK0524 + montelukast, placebo, placebo, placebo + montelukast | Drug: Comparator: MK0524 + placebo<br>* Two 150 mg MK0524 tablets + one placebo tablet in the matching image of montelukast 10 mg once daily for 3 weeks<br>Drug: Comparator: MK0524 + montelukast<br>* Two 150 mg MK0524 tablets and one 10 mg montelukast tablet once daily for 2 weeks<br>Drug: Comparator: placebo + montelukast<br>* Two placebo tablets in the matching image of MK0524 150 mg and one 10 mg tablet montelukast once daily for 2 weeks<br>Drug: Comparator: Placebo<br>* During the double-blind treatment periods, patients receive either two placebo tablets in the matching image of MK0524 150 mg or one placebo tablet in the matching image of montelukast 10 mg in a crossover manner. During the washout period before the crossover to the opposite treatment sequence, patients receive two placebo tablets in the matching image of MK0524 150 mg and one placebo tablet in the matching image of montelukast 10 mg once daily for two weeks.<br>|
| Experimental: 2<br>Treatment sequence 2: Placebo, montelukast, placebo, MK0524, MK0524 + montelukast | Drug: Comparator: MK0524 + placebo<br>* Two 150 mg MK0524 tablets + one placebo tablet in the matching image of montelukast 10 mg once daily for 3 weeks<br>Drug: Comparator: MK0524 + montelukast<br>* Two 150 mg MK0524 tablets and one 10 mg montelukast tablet once daily for 2 weeks<br>Drug: Comparator: placebo + montelukast<br>* Two placebo tablets in the matching image of MK0524 150 mg and one 10 mg tablet montelukast once daily for 2 weeks<br>Drug: Comparator: Placebo<br>* During the double-blind treatment periods, patients receive either two placebo tablets in the matching image of MK0524 150 mg or one placebo tablet in the matching image of montelukast 10 mg in a crossover manner. During the washout period before the crossover to the opposite treatment sequence, patients receive two placebo tablets in the matching image of MK0524 150 mg and one placebo tablet in the matching image of montelukast 10 mg once daily for two weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate benefits of MK0524 compared with placebo on Forced Expiratory Volume in 1 second (FEV1) |  | Last 2 weeks of each treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the benefits of MK0524 as compared with placebo on the key secondary endpoints (Daytime & Nighttime Asthma Symptoms scores |  | Last 2 weeks of each treatment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Asthma