To determine the effect of an approved medication (MK0476) 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...
Date First Received: October 26, 2005
Last Updated: February 14, 2008
Verified by: Merck, February 2008
Clinical Trial Phase: Phase 3 | Start Date: December 2005
Overall Status: Completed
Estimated Enrollment: 42
Brief Summary
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”
Condition Keyword(s):
To determine the effect of an approved medication (MK0476) 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.
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Study Primary Completion Date: July 2006
Intervention(s) in this Clinical Trial
- Drug: MK0476, Montelukast Sodium / Duration of treatment approximately 6 months
- Drug: Comparator: Salmeterol / Duration of treatment approximately 6 months
Outcome Measures for this Clinical Trial
Primary Measures
- Maximum percent-fall (post-exercise change from pre-exercise baseline) in FEV1 after exercise challenge performed at 2 hours post dose.
- Time Frame: 2 hours post dose
Safety Issue?: No
- Time Frame: 2 hours post dose
Secondary Measures
- 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.
- Time Frame: following challenge
Safety Issue?: No
- Time Frame: following challenge
Criteria for Participation in this Clinical Trial
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 Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 15 Years
Maximum Age for this Clinical Trial: 45 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Merck
Overall Clinical Trial Officials and Contacts
Medical Monitor Study Director Merck
Related Publications
References
Philip G, Pearlman DS, Villarán C, Legrand C, Loeys T, Langdon RB, Reiss TF. Single-dose montelukast or salmeterol as protection against exercise-induced bronchoconstriction. Chest. 2007 Sep;132(3):875-83. Epub 2007 Jun 15.
Additional Information
Information obtained from ClinicalTrials.gov on September 04, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00245570
Study ID Number: 2005_043
ClinicalTrials.gov Identifier: NCT00245570
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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