At a glance
ClinicalIndex Comparison Record- ✓Age 6-14 years
- ✓History of asthma for at least 12 months
- ✓Documented exercise-induced airway constriction
- ✕Taking medications not permitted by the study protocol
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Double-Blind, Randomized, Crossover Design Study to Evaluate the Effect of Montelukast Vs. Salmeterol on the Inhibition of Exercise-Induced Bronchoconstriction in Asthmatic Patients Aged 6-14 Years
In Brief
A Phase 3 clinical trial evaluating Montelukast sodium, Salmeterol xinafoate, and 3 other interventions for Exercise Induced Asthma. Completed, enrolled 154 participants.
Detailed Summary
The purpose of this study is to determine the effect of four weeks of treatment with two investigational drugs (oral versus inhaled administration) plus an inhaled medication in the treatment of airway constriction brought on by exercise in participants with asthma.
Study Details
Timeline
Interventions
Montelukast 5 mg chewable tablet once daily
Salmeterol 50 mcg dry powder per actuation inhaled twice daily
Fluticasone (50 mcg per actuation) 100 mcg inhaled twice daily
Matching placebo to montelukast oral tablet administered once daily.
Matching placebo to salmeterol dry powder for inhalation administered twice daily