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Montelukast in Exercise-Induced Bronchospasm - 2003 (0476-270)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092131
First received: September 21, 2004
Last updated: May 9, 2014
Last verified: May 2014

September 21, 2004
May 9, 2014
July 2003
November 2003   (final data collection date for primary outcome measure)
Maximum Percent Fall in FEV1 After Exercise Challenge at 2 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 2 hours after a single oral dose ] [ Designated as safety issue: No ]
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.
Not Provided
Complete list of historical versions of study NCT00092131 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
Not Provided
 
Montelukast in Exercise-Induced Bronchospasm - 2003 (0476-270)
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Asthma, Exercise-Induced
  • 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
Pearlman DS, van Adelsberg J, Philip G, Tilles SA, Busse W, Hendeles L, Loeys T, Dass SB, Reiss TF. Onset and duration of protection against exercise-induced bronchoconstriction by a single oral dose of montelukast. Ann Allergy Asthma Immunol. 2006 Jul;97(1):98-104.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
December 2003
November 2003   (final data collection date for primary outcome measure)

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
Both
15 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00092131
0476-270, MK0476-270, 2004_026
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP