Montelukast in Exercise-Induced Bronchospasm - 2003 | RxWiki

Montelukast in Exercise-Induced Bronchospasm - 2003

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Asthma, Exercise-Induced
Intervention	Drug: Comparator: Montelukast Drug: Comparator: Placebo
Phase	Phase 3
Sponsor	Merck Sharp & Dohme Corp.
Responsible Party	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier	NCT00092131
First Received	September 21, 2004
Last Updated	June 29, 2010
Last verified	June 2010

Tracking Information[ + expand ][ + ]

First Received Date	September 21, 2004
Last Updated Date	June 29, 2010
Start Date	July 2003
Estimated Primary Completion Date	December 2003
Current Primary Outcome Measures	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.
Current Secondary Outcome Measures	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.

Descriptive Information[ + expand ][ + ]

Brief Title	Montelukast in Exercise-Induced Bronchospasm - 2003
Official Title	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
Brief Summary	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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 3
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Condition	Asthma, Exercise-Induced
Intervention	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
Study Arm (s)	Experimental: 1 Montelukast - Placebo Experimental: 2 Placebo - Montelukast

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	51
Estimated Completion Date	December 2003
Estimated Primary Completion Date	November 2003
Eligibility Criteria	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
Gender	Both
Ages	15 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Not Provided

Administrative Information[ + expand ][ + ]

NCT Number	NCT00092131
Other Study ID Numbers	2004_026
Has Data Monitoring Committee	No
Information Provided By	Merck Sharp & Dohme Corp.
Study Sponsor	Merck Sharp & Dohme Corp.
Collaborators	Not Provided
Investigators	Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Verification Date	June 2010