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J Allergy Clin Immunol. 2010 Feb;125(2):374-80. doi: 10.1016/j.jaci.2009.11.015.

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

Author information

1
Department of Emergency Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA. ccamargo@partners.org

Abstract

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 < or = 60-minute screening period. Patients with FEV(1) < or =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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00092989.

PMID:
20159247
DOI:
10.1016/j.jaci.2009.11.015
[Indexed for MEDLINE]

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