Montelukast in Exercise-Induced Bronchospasm - 2004 (0476-275)

Study Overview
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Brief Summary
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The purpose of this study is to determine the effect of an approved medication being studied in support of a new approach in the prevention of exercise-induced asthma (a worsening of asthma caused by exercise, also known as exercise-induced bronchospasm), in patients who have a history of worsening asthma after exercise.

Official Title
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A Double-Blind, Randomized, Placebo-Controlled, Multicenter, 2-Period, Crossover Study to Evaluate the Effects of a Single Dose of Montelukast on Exercise-Induced Bronchospasm

Conditions
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Asthma, Exercise-Induced

Intervention / Treatment
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* Drug: Comparator: Montelukast
* Drug: Comparator: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with mild-to-moderate asthma Exclusion Criteria: Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection Patient is, other than asthma, not in good, stable health The Primary Investigator will evaluate whether there are other reasons why the patient may not participate

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 45 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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Montelukast - Placebo | Drug: Comparator: Montelukast<br>* Montelukast 10 mg tablet administered orally as a single witnessed dose before exercise challenge<br>Drug: Comparator: Placebo<br>* Placebo tablet administered orally as a single witnessed dose before exercise challenge<br>|
| Experimental: 2<br>Placebo - Montelukast | Drug: Comparator: Montelukast<br>* Montelukast 10 mg tablet administered orally as a single witnessed dose before exercise challenge<br>Drug: Comparator: Placebo<br>* Placebo tablet administered orally as a single witnessed dose before exercise challenge<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Percent Fall in FEV1 After Exercise Challenge at 2 Hours Post-dose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB) | In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (2 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge. | Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Requiring ß-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose |  | 0-90 minutes after the exercise challenge performed at 2 hours postdose | 
| Number of Patients Requiring ß-Agonist Rescue Medication After Exercise Challenge at 12 Hours Postdose |  | 0-90 minutes after the exercise challenge performed at 12 hours postdose | 
| Number of Patients Requiring ß-Agonist Rescue Medication After Exercise Challenge at 24 Hours Postdose |  | 0-90 minutes after the exercise challenge performed at 24 hours postdose | 
| Maximum Percent Fall in FEV1 After Exercise Challenge at 12 Hours Postdose Compared With Pre-exercise Baseline in Patients With EIB | In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (12 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge. | Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 12 hours after a single oral dose | 
| Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Postdose Compared With Pre-exercise Baseline in Patients With EIB | In patients with EIB, the percent change from pre-exercise baseline FEV, to the lowest FEV1 within 60 minutes after exercise challenge (24 hours post-dose). The FEV1 measurement obtained 5 minutes before the exercise challenge was the baseline, and was specific to each exercise challenge. | Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 24 hours after a single oral dose | 
| Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 2 Hours Postdose | The measure included only the area below the pre-exercise baseline. | Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 2 hours postdose | 
| Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 12 Hours Postdose | The measure included only the area below the pre-exercise baseline. | Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 12 hours postdose | 
| Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60min) at 24 Hours Postdose | The measure included only the area below the pre-exercise baseline. | Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 24 hours postdose | 
| Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 2 Hours Postdose | The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time. | Exercise challenge at 2 hours postdose | 
| Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 12 Hours Postdose | The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time. | Exercise challenge at 12 hours postdose | 
| Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose | The time to recovery from maximum percent fall is the duration between the time at which the maximum percent fall in FEV1 after exercise challenge occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time. | Exercise challenge at 24 hours postdose |