Objective: To examine whether outpatient post-stabilization therapy with montelukast produces more treatment failures than prednisolone.
Study design: In this randomized, double-blind, double-dummy non-inferiority trial, 130 children 2 to 17 years of age with mild to moderate acute asthma stabilized with prednisolone in the emergency department received 5 daily treatments with either prednisolone or montelukast after discharge. The primary outcome was treatment failure within 8 days (ie, an asthma-related unscheduled visit, hospitalization, or additional systemic corticosteroids).
Results: The rates of treatment failure were 7.9% in the prednisolone group and 22.4% in the montelukast group (95% CI, 26.5%-2.4%). Treatment was more likely to fail in younger patients (odds ratio, 4.9). In the montelukast group, more patients received additional pharmacotherapy than in patients receiving prednisolone (23.9% versus 9.5%, P = .03). The differences in the daily salbutamol treatments, asymptomatic days, and changes in the Pediatric Respiratory Assessment Measure score were not significant (P = .85, .75, and .26, respectively).
Conclusion: Montelukast does not represent an adequate alternative to corticosteroids after outpatient stabilization in mild to moderate acute asthma. This population should receive oral corticosteroids after discharge.
Trial registration: ClinicalTrials.gov NCT00213252.