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”

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

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

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

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

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

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

Merck: Patient & Caregiver U.S. Product Web Site