Conditions: Exercise-induced Bronchoconstriction (EIB)
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 364
Healthy volunteers: no

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:

Arms:
arm 1: Participants 4-5 years: A single dose of 4 mg Montelukast chewable tablet daily, crossing over to matching placebo (Pbo) after a 3- to 7-day washout period (no participants 4-5 years were enrolled)

Participants 6-14 years: A single dose of 5 mg Montelukast chewable tablet daily, crossing over to matching Pbo after a 3- to 7-day washout period arm 2: Participants 4-5 years: A single dose of 4 mg Pbo chewable tablet daily, crossing over to Montelukast 4 mg chewable tablet after a 3- to 7-day washout period (no participants 4-5 years of age were enrolled)

Participants 6-14 years: A single dose of 5 mg Pbo chewable tablet daily, crossing over to Montelukast 5 mg chewable tablet after a 3- to 7-day washout period

Interventions: intervention 1: Comparator: montelukast sodium intervention 2: Comparator: Comparator: placebo (unspecified)
Intervention descriptions: intervention 1: Patients 4-5 years: 4 mg Montelukast chewable tablet daily

Patients 6-14 years: 5 mg chewable tablet daily intervention 2: Patients 4-5 years: 4 mg Pbo chewable tablet daily

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

Protocol document: