Objective: The purpose of this study was to determine the safety and tolerability profile of montelukast 4-mg oral granules compared with placebo in children aged 6-24 months with asthma.
Methods: This was a randomized, double-blind, placebo-controlled, parallel-group study. Children 6-24 months of age at first visit with a history of at least three episodes of physician-diagnosed asthma or 'asthma-like' symptoms and in need of controller therapy were randomized to either montelukast 4-mg oral granules or placebo once daily in the evening for 6 weeks. The primary variables were the frequency of clinical and laboratory adverse experiences. The exploratory efficacy endpoints included days without beta-agonist use, beta-agonist use per day, unscheduled physician or hospital visits for asthma, oral corticosteroid rescues for asthma, asthma attacks, discontinuation due to worsening of asthma, and total blood peripheral eosinophil counts.
Results: The most common clinical adverse experiences were upper respiratory tract infection, asthma, fever, diarrhea, and vomiting occurring with similar frequencies between treatment groups. There were no clinically meaningful differences between the two treatment groups in clinical or laboratory adverse experiences and no significant differences in frequency of patients with elevated serum transaminases. Differences between the montelukast and placebo treatment groups in the exploratory efficacy endpoints of days without beta-agonist use, oral corticosteroid rescues, emergency care, asthma attacks, and discontinuations due to worsening asthma were not significant.
Conclusions: Montelukast, 4-mg oral granules, was well tolerated over 6 weeks of treatment in children aged 6-24 months with asthma.