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

作者：Camargo Carlos A Jr^*; Gurner Deborah M; Smithline Howard A; Chapela Rocio; Fabbri Leonardo M; Green Stuart A; Malice Marie Pierre; Legrand Catherine; Dass S Balachandra; Knorr Barbara A; Reiss Theodore F

来源：Journal of Allergy and Clinical Immunology, 2010, 125(2): 374-380.

DOI：10.1016/j.jaci.2009.11.015

• Intravenous montelukast
• acute asthma
• asthma exacerbation
• FEV(1)
• hospitalization
• leukotriene receptor antagonist
• randomized trial

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 FEV(1) <= 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 FEV(1) during 60 minutes after drug administration. Secondary endpoints included the time-weighted average change in FEV(1) 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 FEV(1) 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 FEV(1)-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. (J Allergy Clin Immunol 2010;125:374-80.)

• 出版日期2010-2