Conditions: Exercise Induced Asthma
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 154
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Period I - Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II - Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study. arm 2: Period I - Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II - Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.

Interventions: intervention 1: Montelukast sodium intervention 2: Salmeterol xinafoate intervention 3: Fluticasone propionate intervention 4: Montelukast matching placebo intervention 5: Salmeterol matching placebo
Intervention descriptions: intervention 1: Montelukast 5 mg chewable tablet once daily intervention 2: Salmeterol 50 mcg dry powder per actuation inhaled twice daily intervention 3: Fluticasone (50 mcg per actuation) 100 mcg inhaled twice daily intervention 4: Matching placebo to montelukast oral tablet administered once daily. intervention 5: Matching placebo to salmeterol dry powder for inhalation administered twice daily

Protocol document: