A Study of MK0476 to Prevent Exercise-Induced Bronchospasm
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma, Exercise-Induced
Intervention: MK0476, Montelukast Sodium / Duration of treatment approximately 6 months (Drug); Comparator: Salmeterol / Duration of treatment approximately 6 months (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
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.
Clinical Details
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
Study design: Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: Maximum percent-fall (post-exercise change from pre-exercise baseline) in FEV1 after exercise challenge performed at 2 hours post dose.
Secondary outcome: 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.
Eligibility
Minimum age: 15 Years.
Maximum age: 45 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Related publications: 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.
Starting date: December 2005
Last updated: February 14, 2008
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