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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
47
1 dose montelukast 10 mg tablet given orally in one of three treatment periods
1 dose of 50 ug salmeterol given by inhalation in one of three treatment periods
1 dose matching-image placebo to montelukast tablet in two of three treatment periods
Maximum Percent Fall in Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Post-dose in Patients With Exercise-Induced Bronchoconstriction (EIB)
In patients 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: 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose
Number of Patients Requiring β-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 Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 8.5 Hours Postdose
Time frame: 0-90 minutes after the exercise challenge performed at 8.5 hours postdose
Number of Patients Requiring β-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 8.5 Hours Post-dose 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 (8.5 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: 0-60 minutes after the exercise challenge performed 8.5 hours after a single oral dose
Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose in Patients With EIB
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1 dose matching-image placebo of salmeterol 50 ug inhalation in two of three treatment periods
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.
Time frame: 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
Time frame: 0-60 minutes after the exercise challenge 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 8.5 Hours Postdose
The measure included only the area below the pre-exercise baseline
Time frame: 0-60 minutes after the exercise challenge at 8.5 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 24 Hours Postdose
The measure included only the area below the pre-exercise baseline
Time frame: 0-60 minutes after the exercise challenge 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.
Time frame: Exercise challenge at 2 hours postdose
Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 8.5 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.
Time frame: Exercise challenge at 8.5 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.
Time frame: Exercise challenge at 24 hours postdose