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...
Date First Received: October 26, 2005
Last Updated: January 26, 2009
Verified by: Merck, January 2009
Clinical Trial Phase: Phase 3 | Start Date: December 2005
Overall Status: Completed
Estimated Enrollment: 47
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 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 (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Study Primary Completion Date: July 2006
Intervention(s) in this Clinical Trial
- 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
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Montelukast + Placebo
- Experimental: 2
- Placebo + Placebo
- Experimental: 3
- Salmeterol + Placebo
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, 8.5, and 24 hours post drug administration
Safety Issue?: No
- Time Frame: 2, 8.5, and 24 hours post drug administration
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: 90 minutes post drug administration
Safety Issue?: No
- Time Frame: 90 minutes post drug administration
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, VillarĂ¡n 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 July 02, 2009
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
MedWatch - FDA maintained medical product safety Information
PhRMA Clinical Study Results Database - web-based repository for clinical study results
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