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 participants who have a history of worsening asthma after exercise.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
51
Montelukast 10 mg tablet administered orally as a single witnessed dose before exercise challenge
Placebo tablet administered orally as a single witnessed dose before exercise challenge
Maximum Percent Fall in FEV1 After Exercise Challenge at 2 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB)
In Participants with EIB, the percent change from pre-exercise baseline FEV1 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.
Time frame: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose
Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose
Time frame: 0-90 minutes after the exercise challenge performed at 2 hours postdose
Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 12 Hours Postdose
Time frame: 0-90 minutes after the exercise challenge performed at 12 hours postdose
Number of Participants Requiring ß-Agonist Rescue Medication After Exercise Challenge at 24 Hours Postdose
Time frame: 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 Exercise-induced Bronchospasm (EIB)
In patients with EIB, the percent change from pre-exercise baseline FEV1 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.
Time frame: 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 Exercise-induced Bronchospasm (EIB)
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In patients with EIB, the percent change from pre-exercise baseline FEV1 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.
Time frame: 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 0-60min) at 2 Hours Postdose
The measure included only the area below the pre-exercise baseline.
Time frame: 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 0-60min) at 12 Hours Postdose
The measure included only the area below the pre-exercise baseline.
Time frame: 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.
Time frame: 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 occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.
Time frame: 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 occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.
Time frame: 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 occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.
Time frame: Exercise challenge at 24 hours postdose