Clinical Trial: Montelukast Compared With Placebo and Salmeterol in Exercise-Induced Bronchoconstriction (0476-316)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Double-Blind, Randomized Multicenter, 3-Period, Crossover Study to Evaluate the Effects of a Single Dose of Montelukast Compared With Placebo and Salmeterol on Exercise-Induced Bronchoconstriction

Brief Summary: 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.

Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome: 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) [ Time Frame: 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose ]

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.


Original Primary Outcome: Maximum percent-fall (post-exercise change from pre-exercise baseline) in FEV1 after exercise challenge performed at 2 hours postdose.

Current Secondary Outcome:

  • 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 [ Time Frame: 0-60 minutes after the exercise challenge performed 8.5 hours after a single oral dose ]
    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.
  • Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose in Patients With EIB [ Time Frame: 0-60 minutes after the exercise challenge performed 24 hours after a single oral dose ]
    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.
  • 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 [ Time Frame: 0-60 minutes after the exercise challenge at 2 hours postdose ]

    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 0-60 Min) at 8.5 Hours Postdose [ Time Frame: 0-60 minutes after the exercise challenge at 8.5 hours postdose ]
    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 0-60 Min) at 24 Hours Postdose [ Time Frame: 0-60 minutes after the exercise challenge at 24 hours postdose ]
    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 ]
    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 to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 8.5 Hours Postdose [ Time Frame: 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 to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose [ Time Frame: 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.



Original Secondary Outcome: Area under the curve for percent-fall from pre-exercise FEV1 over time, Time to recovery of FEV1 to within 5% or pre-exercise baseline, and Use of inhaled short-acting B-agonist (as "rescue" medication) following challenge.

Information By: Merck Sharp & Dohme Corp.

Dates:
Date Received: October 26, 2005
Date Started: December 2005
Date Completion:
Last Updated: June 22, 2015
Last Verified: June 2015