Official Title: “A Double-Blind, Placebo-Controlled, Multicenter, Crossover Study to Evaluate the Effects of a Single Oral Dose of Montelukast, Compared With Placebo, on Exercise-Induced Bronchoconstriction (EIB) in Pediatric Patients Aged 4 to 14 Years”

This study will see if there is a change in breathing after exercising when the child receives study drug ( montelukast or placebo). Breathing will be measured by a spirometer before exercising and measured again several times after exercising.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2009

Intervention(s) in this Clinical Trial

• Drug: montelukast sodium
  • Patients 4-5 yrs: 4mg chewable tablet qd, Patients 6-14 yrs: 5mg chewable tablet qd.
• Drug: Comparator: placebo (unspecified)
  • Patients 4-5 yrs: 4mg Pbo chewable tablet qd, Patients 6-14 yrs: 5mg Pbo chewable tablet qd.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Patients 4-5 yrs: 4mg chewable tablet qd, crossing over to Pbo. Patients 6-14 yrs: 5mg chewable tablet qd, crossing over to Pbo.
• Placebo Comparator: 2
  • Patients 4-5 yrs: 4mg Pbo chewable tablet qd, crossing over to montelukast 4mg chewable tablet. Patients 6-14 yrs: 5mg Pbo chewable tablet qd, crossing over to montelukast 5mg chewable tablet.

Primary Measures

• The change from pre-exercise baseline spirometry reading to the maximum fall in the spirometry reading (FEV1) during one exercise challenge with montelukast compared to another challenge with placebo
  • Time Frame: 1 Day
    Safety Issue?: No

Secondary Measures

• The time the maximum fall in the spirometry reading (FEV1) takes to return to the baseline measurement
  • Time Frame: 1 Day
    Safety Issue?: No

Inclusion Criteria:

• The child is 4 years to 14 years of age
• The child is a non smoker
• The child has exercise-induced bronchoconstriction (EIB)

Exclusion Criteria:

• The child has active or chronic breathing disease, other than asthma
• The child has required insertion of a breathing tube for asthma
• The child had major surgery within the last 4 weeks
• The child is currently in the hospital
• The child has or had an upper respiratory tract infection within the last 2 weeks
• The child has been hospitalized or visited the emergency room or had a change in their medication for asthma within the last 4 weeks
• The child has been in a research study in the last 4 weeks
• The child has stomach, brain, heart, kidney or liver disease
• The child drinks more that 4 caffeinated drinks a day

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 4 Years

Maximum Age for this Clinical Trial: 14 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Overall Contact: Toll Free Number 1-888-577-8839 

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00534976

Study ID Number: 2007_586

ClinicalTrials.gov Identifier: NCT00534976

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