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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Exercise-induced Bronchoconstriction (EIB)

Intervention / Treatment
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* Drug: Comparator: montelukast sodium
* Drug: Comparator: Comparator: placebo (unspecified)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Montelukast Sodium<br>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 | Drug: Comparator: montelukast sodium<br>* Patients 4-5 years: 4 mg Montelukast chewable tablet daily Patients 6-14 years: 5 mg chewable tablet daily<br>|
| Experimental: Placebo<br>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 | Drug: Comparator: Comparator: placebo (unspecified)<br>* Patients 4-5 years: 4 mg Pbo chewable tablet daily Patients 6-14 years: 5 mg Pbo chewable tablet daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Percent Fall in Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Postdose | Maximum Percent Fall in FEV1 was defined as the % change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 mins (minutes) after exercise. Spirometry measurements were taken 5 mins prior to each exercise challenge and immediately, 5, 10, 15, 30, 45, & 60 mins after each exercise challenge. The 2-hour exercise challenges occurred 2 hours after the witnessed dose of study medication. The calculation used to produce the results was [100*(1-(X/Y))] where X= the lowest FEV1 within 60 mins after exercise & Y= pre-exercise baseline FEV1. Smaller values mean greater response to therapy. | Pre-exercise baseline and 0-60 minutes after the exercise challenge performed 2 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose | Maximum Percent Fall in FEV1 was defined as the % change from pre-exercise baseline FEV1 to the lowest FEV1 within 60 mins after exercise. Spirometry measurements were taken 5 mins prior to each exercise challenge and immediately, 5, 10, 15, 30, 45, & 60 mins after each exercise challenge. The 24-hour exercise challenges occurred 20-24 hours after the witnessed dose of study medication. The calculation used to produce the resulted results was [100*(1-(X/Y))] where X= the lowest FEV1 within 60 mins after exercise & Y= pre-exercise baseline FEV1. Smaller values mean greater response to therapy. | Pre-exercise baseline and 0-60 minutes after the exercise challenge performed 24 hours post-dose | 
| 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 | AUC0-60min was defined as the Area Under the Curve for FEV1 percent change from pre-exercise baseline to the 60 mins following exercise challenge. The area was computed by applying the trapezoidal rule, and including only the area below the pre-exercise baseline. If a participant received β-agonist during the 60 mins after the exercise challenge, the FEV1 measurements obtained after β-agonist administration were excluded and the last pre-rescue FEV1 measurement was carried forward to the 60 mins time point in the calculation of the AUC0-60 min. Smaller values mean greater response to therapy. | Pre-exercise baseline to 60 minutes after the exercise challenge performed 2 hours post-dose | 
| 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 | AUC0-60min was defined as the Area Under the Curve for FEV1 percent change from pre-exercise baseline to the 60 mins following exercise challenge. The area was computed by applying the trapezoidal rule, and including only the area below the pre-exercise baseline. If a participant received β-agonist during the 60 mins after the exercise challenge, the FEV1 measurements obtained after β-agonist administration were excluded and the last pre-rescue FEV1 measurement was carried forward to the 60 mins time point in the calculation of the AUC0-60 min. Smaller values mean greater response to therapy. | Pre-exercise baseline to 60 minutes after the exercise challenge performed 24 hours post-dose | 
| Time to Recovery From Maximum Percent Fall in FEV1 at 2 Hours Post-dose | This endpoint was defined as the duration between the time at which the maximum percent fall in FEV1 occurred & the time when the percent fall in FEV1 returned to within 5% of the pre-exercise baseline for the first time. Spirometry measurements were taken 5 mins prior to each exercise challenge & immediately, 5, 10, 15, 30, 45, & 60 mins after each exercise challenge. If participant had not returned to within 5% of the pre-exercise FEV1 value by 60 mins, then measurements were obtained at 75 & 90 mins. The 2-hour exercise challenges occurred 2 hours after the witnessed dose of medication. | 0-60 minutes and 0-90 minutes after the exercise challenge at 2 hours postdose | 
| Time to Recovery From Maximum Percent Fall in FEV1 at 24 Hours Post-dose | This endpoint was defined as the duration between the time at which the maximum percent fall in FEV1 occurred & the time when the percent fall in FEV1 returned to within 5% of the pre-exercise baseline for the first time. Spirometry measurements were taken 5 mins prior to each exercise challenge & immediately, 5, 10, 15, 30, 45 & 60 mins after each exercise challenge. If participant had not returned to within 5% of the pre-exercise FEV1 value by 60 mins, then measurements were obtained at 75 & 90 mins. The 24-hour exercise challenges occurred 20-24 hours after the witnessed dose of medication. | 0-60 minutes and 0-90 minutes after the exercise challenge at 24 hours postdose | 
| Number of Participants Requiring Rescue Medication at 2 Hours Postdose | This endpoint was defined as the number of participants requiring rescue medication with β-agonist within the 90 mins following exercise challenge. The 2-hour exercise challenges occurred 2 hours after the witnessed dose of study medication. | 0-90 minutes after the exercise challenge at 2 hours postdose | 
| Number of Participants Requiring Rescue Medication at 24 Hours Postdose | This endpoint was defined as the number of participants requiring rescue medication with β-agonist within the 90 mins following exercise challenge. The 24-hour exercise challenges occurred 20-24 hours after the witnessed dose of study medication. | 0-90 minutes after the exercise challenge at 24 hours postdose |