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

BackgroundCurrent treatments for acute asthma provide inadequate benefit for some patients. Intravenous montelukast may complement existent therapies.ObjectiveTo evaluate efficacy of intravenous montelukast as adjunctive therapy for acute asthma.MethodsA 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 = 291) or placebo (n = 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 60 minutes after drug administration. Secondary endpoints included 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).ResultsMontelukast 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.ConclusionIntravenous 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.