Conditions: Asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 190
Healthy volunteers: no

Brief summary:
Patients were treated with either montelukast 4 mg oral granules or usual care. Patients who completed Protocol MK0476-176-01 (NCT00943683) had the option to enroll in this study. Additionally, patients with asthma who were 6 to 11 months of age and who had not participated in Protocol MK0476-176-01, could also enroll.

Detailed description:

Arms:
arm 1: Montelukast arm 2: Usual Care

Interventions: intervention 1: montelukast sodium intervention 2: Comparator: Usual Care
Intervention descriptions: intervention 1: Montelukast 4 mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks intervention 2: Usual care defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator's usual clinical practice for 52 weeks

Protocol document: