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

Organon and Co364 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

364

Conditions

Exercise-induced Bronchoconstriction (EIB)

Interventions

Comparator: montelukast sodiumDRUG

Patients 4-5 years: 4 mg Montelukast chewable tablet daily Patients 6-14 years: 5 mg chewable tablet daily

Comparator: Comparator: placebo (unspecified)DRUG

Patients 4-5 years: 4 mg Pbo chewable tablet daily Patients 6-14 years: 5 mg Pbo chewable tablet daily

Eligibility

Sex: ALLMin age: 4 YearsMax age: 14 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Pre-exercise baseline and 0-60 minutes after the exercise challenge performed 2 hours post-dose

Secondary Outcomes

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.

Time frame: 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.

Data from ClinicalTrials.gov

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Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 0-90 minutes after the exercise challenge at 24 hours postdose