Montelukast Compared With Placebo and Salmeterol in Exercise-Induced Bronchoconstriction

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.

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 - Salmeterol - Placebo
• Experimental: 2
  • Montelukast - Placebo - Salmeterol
• Experimental: 3
  • Salmeterol - Montelukast - Placebo
• Experimental: 4
  • Salmeterol - Placebo - Montelukast
• Experimental: 5
  • Placebo - Montelukast - Salmeterol
• Experimental: 6
  • Placebo - Salmeterol - Montelukast

Primary Measures

• Maximum Percent Fall in Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Post-dose in Patients With Exercise-Induced Bronchoconstriction (EIB)
  • Time Frame: 0-60 minutes after the exercise challenge performed 2 hours after a single oral dose
    Safety Issue?: No

Secondary Measures

• Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 2 Hours Postdose
  • Time Frame: 0-90 minutes after the exercise challenge performed at 2 hours postdose
    Safety Issue?: No
• Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 8.5 Hours Postdose
  • Time Frame: 0-90 minutes after the exercise challenge performed at 8.5 hours postdose
    Safety Issue?: No
• Number of Patients Requiring β-Agonist Rescue Medication After Exercise Challenge at 24 Hours Postdose
  • Time Frame: 0-90 minutes after the exercise challenge performed at 24 hours postdose
    Safety Issue?: No
• Maximum Percent Fall in FEV1 After Exercise Challenge at 8.5 Hours Post-dose in Patients With EIB
  • Time Frame: 0-60 minutes after the exercise challenge performed 8.5 hours after a single oral dose
    Safety Issue?: No
• Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose in Patients With EIB
  • Time Frame: 0-60 minutes after the exercise challenge performed 24 hours after a single oral dose
    Safety Issue?: No
• Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 2 Hours Postdose
  • Time Frame: 0-60 minutes after the exercise challenge at 2 hours postdose
    Safety Issue?: No
• Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 8.5 Hours Postdose
  • Time Frame: 0-60 minutes after the exercise challenge at 8.5 hours postdose
    Safety Issue?: No
• Area Under the Curve for FEV1 Percent Change From Preexercise Baseline During the 60 Minutes Following Exercise Challenge (AUC 0-60 Min) at 24 Hours Postdose
  • Time Frame: 0-60 minutes after the exercise challenge at 24 hours postdose
    Safety Issue?: No
• Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 2 Hours Postdose
  • Time Frame: Exercise challenge at 2 hours postdose
    Safety Issue?: No
• Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 8.5 Hours Postdose
  • Time Frame: Exercise challenge at 8.5 hours postdose
    Safety Issue?: No
• Time to Recovery From Maximum Percentage Decrease in FEV1 After Exercise Challenge at 24 Hours Postdose
  • Time Frame: Exercise challenge at 24 hours postdose
    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 Investigator: Merck Industry

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on February 09, 2012

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

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