A randomized placebo-controlled study of intravenous montelukast for the treatment of acute asthma.

Background: Current treatments for acute asthma provide inadequate benefit for some patients. Intravenous montelukast may complement existent therapies.Objective: To evaluate efficacy of intravenous montelukast as adjunctive therapy for acute asthma.Methods: A total of 583 adults with acute asthma were treated with standard care during a #60-minute screening period.Patients with FEV1 #50% predicted were randomly allocated to intravenous montelukast 7 mg (n 5 291) or placebo (n 5 292) in addition to standard care. This double-blind treatment period lasted until a decision for discharge, hospital admission, or discontinuation from the study. The primary efficacy endpoint was the time-weighted average change in FEV1 during 60minutes after drug administration. Secondary endpointsincluded the time-weighted average change in FEV1 at various intervals (10-120 minutes) and percentage of patients with treatment failure (defined as hospitalization or lack of decision to discharge by 3 hours postadministration).Results: Montelukast significantly increased FEV1 at 60 minutes postdose; the difference between change from baseline for placebo (least-squares mean of 0.22 L; 95% CI, 0.17, 0.27) and montelukast (0.32 L; 95% CI, 0.27, 0.37) was 0.10 L (95% CI, 0.04, 0.16). Similar improvements in FEV1-related variables were seen at all time points (all P <.05). Although treatment failure did not differ between groups (OR 0.92; 95% CI, 0.63,1.34), a prespecified subgroup analysis suggests likely benefit for intravenous montelukast at US sites.Conclusion: Intravenous montelukast added to standard care in adults with acute asthma produced significant relief of airway obstruction throughout the 2 hours after administration, with an onset of action as early as 10 minutes.