Montelukast in Pediatric Patients Aged 6 to 24 Months With Asthma--Safety Study (0476-176)

A Multicenter, Double-Blind, Randomized, Parallel-Group Study Comparing Montelukast With Placebo in Pediatric Patients Aged 6 to 24 Months With Asthma

A study of Montelukast compared to placebo in asthmatic children aged 6-24 months.

Inclusion Criteria:

• Patient is in good, stable health
• Patient has been fed solid foods for at least 1 month
• Patients had at least 3 episodes of asthma or asthma-like symptoms, all occurring after 8 weeks of age; at least one within 6 months of the Prestudy Visit
• Patients had to be in need of a controller therapy according to criteria established in the Global Initiative for Asthma (GINA) guidelines

Exclusion Criteria:

• Patient was hospitalized at the start of the study or required a visit to the emergency room due to asthma with in past 2 weeks