Background: Up to 30% of patients require hospitalization for acute asthma despite standard therapy in the emergency department. In adults, intravenous montelukast added to standard therapy significantly improved forced expiratory volume in 1 second (FEV1) and reduced hospital admissions compared with standard therapy alone.
Objective: To evaluate the efficacy of intravenous montelukast added to standard therapy in children with acute asthma.
Methods: This was a randomized, double-blind, placebo-controlled, multicenter study of children aged 6 to 14 years conducted from August 25, 2005 to March 17, 2008. Patients with an FEV1 of 75% or less of the predicted value after up to 120 minutes of standard therapy (e.g., oxygen, albuterol, inhaled anticholinergics, and systemic oral corticosteroids) were randomized to intravenous montelukast, 5.25 mg (n=145), or placebo (n=131) added to standard therapy. The primary end point was the time-weighted average change in FEV1 during 60 minutes (deltaFEV1[0-60 min]). Secondary end points included the percentage of patients in whom treatment failed (patients who required hospitalization or for whom a decision to discharge was not reached within 2 hours after drug administration) and the change from baseline in modified pulmonary index score after 60 minutes of treatment.
Results: Montelukast was not significantly more effective than placebo for deltaFEV1[0-60 min] when added to standard therapy (0.08 vs. 0.07 L; least squares mean, 0.01; 95% confidence interval, -0.06 to 0.08; P = .78). No significant differences were found in the percentages of patients in whom treatment failed or the modified pulmonary index score after 60 minutes. Both treatments were well tolerated.
Conclusions: In this study of children with acute asthma, intravenous montelukast was not significantly better than placebo in improving FEV1, symptoms, or overall hospital course.
Trial registration: ClinicalTrials.gov NCT00117338.