Montelukast Compared With Placebo and Salmeterol in Exercise-Induced Bronchoconstriction | RxWiki

Montelukast Compared With Placebo and Salmeterol in Exercise-Induced Bronchoconstriction

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Asthma, Exercise-Induced
Intervention	Drug: Comparator: Montelukast Drug: Comparator: Salmeterol Drug: Comparator: Placebo (montelukast) Drug: Comparator: Placebo (salmeterol)
Phase	Phase 3
Sponsor	Merck Sharp & Dohme Corp.
Responsible Party	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier	NCT00245570
First Received	October 26, 2005
Last Updated	May 27, 2010
Last verified	May 2010

Tracking Information[ + expand ][ + ]

First Received Date	October 26, 2005
Last Updated Date	May 27, 2010
Start Date	December 2005
Estimated Primary Completion Date	August 2006
Current Primary Outcome Measures	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] [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 (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 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] [Designated as safety issue: No] 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] [Designated as safety issue: No] 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] [Designated as safety issue: No] 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] [Designated as safety issue: No]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] [Designated as safety issue: No]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] [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 0-60 Min) at 8.5 Hours Postdose [Time Frame: 0-60 minutes after the exercise challenge at 8.5 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 0-60 Min) at 24 Hours Postdose [Time Frame: 0-60 minutes after the exercise challenge 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 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] [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 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] [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 after exercise challenge occurs and the time when FEV1 returns to within 5% of the preexercise baseline for the first time.

Descriptive Information[ + expand ][ + ]

Brief Title	Montelukast Compared With Placebo and Salmeterol in Exercise-Induced Bronchoconstriction
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 Description	Not Provided
Study Type	Interventional
Study Phase	Phase 3
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Condition	Asthma, Exercise-Induced
Intervention	Drug: Comparator: Montelukast 1 dose montelukast 10 mg tablet given orally in one of three treatment periods Drug: Comparator: Salmeterol 1 dose of 50 ug salmeterol given by inhalation in one of three treatment periods Drug: Comparator: Placebo (montelukast) 1 dose matching-image placebo to montelukast tablet in two of three treatment periods Drug: Comparator: Placebo (salmeterol) 1 dose matching-image placebo of salmeterol 50 ug inhalation in two of three treatment periods
Study Arm (s)	Experimental: 1 Montelukast - Salmeterol - Placebo Experimental: 2 Montelukast - Placebo - Salmeterol Experimental: 3 Salmeterol - Montelukast - Placebo Experimental: 4 Salmeterol - Placebo - Montelukast Experimental: 5 Placebo - Montelukast - Salmeterol Experimental: 6 Placebo - Salmeterol - Montelukast

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	47
Estimated Completion Date	August 2006
Estimated Primary Completion Date	July 2006
Eligibility Criteria	Inclusion Criteria: - Physician-diagnosed exercise-induced bronchospasm Exclusion Criteria: - Patient is, other than asthma, not in good, stable health. The Primary Investigator will evaluate whether there are other reasons why the patient may not participate.
Gender	Both
Ages	15 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Not Provided

Administrative Information[ + expand ][ + ]

NCT Number	NCT00245570
Other Study ID Numbers	2005_043
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	May 2010