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Medline ® Abstract for Reference 81

of 'Management of acute exacerbations of asthma in adults'

81
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A randomized placebo-controlled study of intravenous montelukast for the treatment of acute asthma.
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Camargo CA Jr, Gurner DM, Smithline HA, Chapela R, Fabbri LM, Green SA, Malice MP, Legrand C, Dass SB, Knorr BA, Reiss TF
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J Allergy Clin Immunol. 2010;125(2):374.
 
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.
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Department of Emergency Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA. ccamargo@partners.org
PMID