A randomized, placebo-controlled study of intravenous montelukast in children with acute asthma

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 (eg, 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 (ΔFEV 1[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 ΔFEV 1[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.