Montelukast in Exercise-Induced Bronchospasm - 2003
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00092131
First received: September 21, 2004
Last updated: June 29, 2010
Last verified: June 2010
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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 | Intervention | Phase |
|---|---|---|
|
Asthma, Exercise-Induced |
Drug: Comparator: Montelukast Drug: Comparator: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Further study details as provided by Merck:
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.
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.
| Enrollment: | 51 |
| Study Start Date: | July 2003 |
| Study Completion Date: | December 2003 |
| Primary Completion Date: | November 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Montelukast - Placebo
|
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: 2
Placebo - Montelukast
|
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
|
Eligibility| Ages Eligible for Study: | 15 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00092131 History of Changes |
| Other Study ID Numbers: | 2004_026, MK0476-270 |
| Study First Received: | September 21, 2004 |
| Results First Received: | September 24, 2009 |
| Last Updated: | June 29, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Asthma, Exercise-Induced Bronchial Spasm Asthma Bronchial Diseases Respiratory Tract Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
Montelukast Leukotriene Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013