Conditions: Asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1771
Healthy volunteers: no

Brief summary:
This is a year-long study evaluating the efficacy of both daily and intermittent treatment of asthma in children who experience symptoms episodically (i.e., seasonally, usually in the context of upper respiratory tract infection).

Detailed description:

Arms:
arm 1: Montelukast once a day (qd) + episode driven supplemental placebo qd for 12 days for a 52-wk treatment period arm 2: Placebo qd + episode driven supplemental Montelukast qd for 12 days for a 52-wk treatment period arm 3: Placebo qd + episode driven supplemental placebo qd for 12 days for a 52-wk treatment period

Interventions: intervention 1: montelukast sodium intervention 2: Comparator: Placebo (unspecified) intervention 3: montelukast sodium
Intervention descriptions: intervention 1: Montelukast 4 mg (or 5 mg, depending on age of patient) qd + episode driven supplemental Pbo qd for 12 days for a 52-wk treatment period. intervention 2: Placebo (Pbo) qd + episode driven supplemental Pbo for 12 days for a 52-wk treatment period. intervention 3: Pbo qd + episode driven supplemental Montelukast 4 mg (or 5 mg, depending on age of patient) qd for 12 days for a 52-wk treatment period.

Protocol document: