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

Phase 4

Completed

• Conditions: Exercise-induced Bronchoconstriction (EIB)

• Registration Number: NCT00534976
• Lead Sponsor: Organon and Co

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-09-21
• Study First Submitted QC: 2007-09-25
• Study First Posted: 2007-09-26
• Study Start: 2008-02
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Results First Submitted: 2011-03-11
• Results First Submitted QC: 2011-03-11
• Results First Posted: 2011-04-07
• Status Verified: 2022-01
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 364

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Maximum Percent Fall in Forced Expiratory Volume in 1 Second (FEV1) After Exercise Challenge at 2 Hours Postdose	Pre-exercise baseline and 0-60 minutes after the exercise challenge performed 2 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 (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.

Secondary Outcome Measures

Name	Time	Method
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	Pre-exercise baseline to 60 minutes after the exercise challenge performed 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.
Number of Participants Requiring Rescue Medication at 2 Hours Postdose	0-90 minutes after the exercise challenge 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.
Number of Participants Requiring Rescue Medication at 24 Hours Postdose	0-90 minutes after the exercise challenge 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.
Maximum Percent Fall in FEV1 After Exercise Challenge at 24 Hours Post-dose	Pre-exercise baseline and 0-60 minutes after the exercise challenge performed 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.
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	Pre-exercise baseline to 60 minutes after the exercise challenge performed 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.
Time to Recovery From Maximum Percent Fall in FEV1 at 2 Hours Post-dose	0-60 minutes and 0-90 minutes after the exercise challenge at 2 hours postdose	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 to Recovery From Maximum Percent Fall in FEV1 at 24 Hours Post-dose	0-60 minutes and 0-90 minutes after the exercise challenge at 24 hours postdose	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.