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Published ahead of print on November 27, 2002, doi:10.1164/rccm.200208-802OC

Am. J. Respir. Crit. Care Med., Volume 167, Number 4, February 2003, 528-533

A more recent version of this article appeared on February 15, 2003
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Submitted on August 6, 2002
Accepted on October 30, 2002

A Randomized Controlled Trial of Intravenous Montelukast in Acute Asthma

Carlos A Camargo1, Howard A Smithline2, Malice Marie-Pierre3, Stuart A Green3*, and Theodore F Reiss3

1 Department of Emergency Medicine, Massachucetts General Hospital(Harvard Medical School), Boston, MA; Department of Medicine, Channing Laboratory, Boston, MA; Brigham and Women's Hospital (Harvard Medical School), Boston, MA, 2 Department of Emergency Medicine, Baystate Medical Center, Springfield, MA, 3 Respiratory and Allergy, Merck Research Laboratories, Rahway, NJ

* To whom correspondence should be addressed. E-mail: stuart_green{at}merck.com.

Many patients with acute asthma do not respond adequately to currently accepted therapy including oxygen, {beta}-agonists, and corticosteroids. Leukotriene receptor antagonists such as montelukast have demonstrated efficacy in chronic asthma, but their efficacy in acute asthma is unknown. In this randomized, double blind, parallel-group pilot study, adults with moderate to severe acute asthma received standard therapy plus either intravenous montelukast (7 or 14 mg) or matching placebo. 201 patients were randomized, and 194 had complete data available for analysis. There was no difference in FEV1 response between the 7- and 14-mg montelukast groups. Montelukast improved FEV1 over the first 20 minutes after intravenous administration (mean percent change from pre-randomization baseline, 14.8 vs. 3.6% for the pooled montelukast and placebo treatment groups, respectively; p = 0.007). This benefit was observed at 10 minutes and over two hours following intravenous therapy. Patients treated with montelukast tended to receive less {beta}-agonists and have fewer treatment failures than patients receiving placebo. The tolerability profile for montelukast was similar to that observed for placebo, and no unexpected adverse experiences were observed. We conclude that intravenous montelukast in addition to standard therapy causes rapid benefit, and is well-tolerated, in adults with acute asthma. Abstract word count: 197.
Key words: Intravenous montelukast; Acute asthma; Asthma exacerbation; Leukotriene antagonists; Intravenous injections




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