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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
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.
Details
| Lead sponsor | Organon and Co |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 364 |
| Start date | 2008-02 |
| Completion | 2010-03 |
Conditions
- Exercise-induced Bronchoconstriction (EIB)
Interventions
- Comparator: montelukast sodium
- Comparator: Comparator: placebo (unspecified)
Primary outcomes
- 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.