Montelukast in Exercise-Induced Bronchospasm - 2003

• 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 ] [ Designated as safety issue: No ]
• 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 ] [ Designated as safety issue: No ]
• 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 ] [ Designated as safety issue: No ]
• Maximum Percent Fall in FEV1 After Exercise Challenge at 12 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB) [ Time Frame: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 12 hours after a single oral dose ] [ Designated as safety issue: No ]
  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.
• Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Postdose Compared With Pre-exercise Baseline in Patients With Exercise-induced Bronchospasm (EIB) [ Time Frame: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed 24 hours after a single oral dose ] [ Designated as safety issue: No ]
  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.
• 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 [ Time Frame: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 2 hours postdose ] [ Designated as safety issue: No ]
  The measure included only the area below the pre-exercise baseline.
• 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 [ Time Frame: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 12 hours postdose ] [ Designated as safety issue: No ]
  The measure included only the area below the pre-exercise baseline.
• 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 [ Time Frame: Pre-exercise baseline measurement and 0-60 minutes after the exercise challenge performed at 24 hours postdose ] [ Designated as safety issue: No ]
  The measure included only the area below the pre-exercise baseline.
• Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 2 Hours Postdose [ Time Frame: Exercise challenge at 2 hours postdose ] [ Designated as safety issue: No ]
  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 to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 12 Hours Postdose [ Time Frame: Exercise challenge at 12 hours postdose ] [ Designated as safety issue: No ]
  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 to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose [ Time Frame: Exercise challenge at 24 hours postdose ] [ Designated as safety issue: No ]
  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.

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.

• Drug: Comparator: Montelukast
  Montelukast 10 mg tablet administered orally as a single witnessed dose before exercise challenge
• Drug: Comparator: Placebo
  Placebo tablet administered orally as a single witnessed dose before exercise challenge

• Experimental: 1
  Montelukast - Placebo
  Interventions:

  • Drug: Comparator: Montelukast
  • Drug: Comparator: Placebo
• Experimental: 2
  Placebo - Montelukast
  Interventions:

  • Drug: Comparator: Montelukast
  • Drug: Comparator: Placebo

Inclusion Criteria:

• Participants with mild-to-moderate asthma

Exclusion Criteria:

• Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection