The Effect of Montelukast on Difficulty in Breathing After Exercise in Pediatric Patients (MK0476-377)(COMPLETED)

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.

Intervention(s) in this Clinical Trial

• Drug: Comparator: montelukast sodium
  • Patients 4-5 years: 4 mg Montelukast chewable tablet daily Patients 6-14 years: 5 mg chewable tablet daily
• Drug: Comparator: Comparator: placebo (unspecified)
  • Patients 4-5 years: 4 mg Pbo chewable tablet daily Patients 6-14 years: 5 mg Pbo chewable tablet daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Montelukast Sodium
  • Participants 4-5 years: A single dose of 4 mg Montelukast chewable tablet daily, crossing over to matching placebo (Pbo) after a 3- to 7-day washout period (no participants 4-5 years were enrolled) Participants 6-14 years: A single dose of 5 mg Montelukast chewable tablet daily, crossing over to matching Pbo after a 3- to 7-day washout period
• Experimental: Placebo
  • Participants 4-5 years: A single dose of 4 mg Pbo chewable tablet daily, crossing over to Montelukast 4 mg chewable tablet after a 3- to 7-day washout period (no participants 4-5 years of age were enrolled) Participants 6-14 years: A single dose of 5 mg Pbo chewable tablet daily, crossing over to Montelukast 5 mg chewable tablet after a 3- to 7-day washout period

Primary Measures

• Maximum Percent Fall in Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Postdose
  • Time Frame: Pre-exercise baseline and 0-60 minutes after the exercise challenge performed 2 hours post-dose
    Safety Issue?: No

Secondary Measures

• Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose
  • Time Frame: Pre-exercise baseline and 0-60 minutes after the exercise challenge performed 24 hours post-dose
    Safety Issue?: No
• Area Under the Curve for FEV1 Percent Fall From Pre-exercise Baseline to 60 Minutes Following Exercise Challenge (AUC0-60 Min) at 2 Hours Post-dose
  • Time Frame: Pre-exercise baseline to 60 minutes after the exercise challenge performed 2 hours post-dose
    Safety Issue?: No
• Area Under the Curve for FEV1 Percent Fall From Pre-exercise Baseline to 60 Minutes Following Exercise Challenge (AUC0-60 Min) at 24 Hours Post-dose
  • Time Frame: Pre-exercise baseline to 60 minutes after the exercise challenge performed 24 hours post-dose
    Safety Issue?: No
• Time to Recovery From Maximum Percent Fall in FEV1 at 2 Hours Post-dose
  • Time Frame: 0-60 minutes and 0-90 minutes after the exercise challenge at 2 hours postdose
    Safety Issue?: No
• Time to Recovery From Maximum Percent Fall in FEV1 at 24 Hours Post-dose
  • Time Frame: 0-60 minutes and 0-90 minutes after the exercise challenge at 24 hours postdose
    Safety Issue?: No
• Number of Participants Requiring Rescue Medication at 2 Hours Postdose
  • Time Frame: 0-90 minutes after the exercise challenge at 2 hours postdose
    Safety Issue?: No
• Number of Participants Requiring Rescue Medication at 24 Hours Postdose
  • Time Frame: 0-90 minutes after the exercise challenge at 24 hours postdose
    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?: 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/NCT00534976

Study ID Number: MK-0476-377

ClinicalTrials.gov Identifier: NCT00534976

Health Authority: United States: Food and Drug Administration

MedWatch - FDA maintained medical product safety Information

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