Investigation of Intravenous (IV) Administration of an Approved Drug (MK-0476, Montelukast Sodium) for Acute Asthma (MK-0476-288)

Phase 3 Completed 650 enrolled Organon and Co

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate improved results of treatment for patients entering an emergency department with asthma attacks when given an investigational IV administration of an approved drug (MK-0476, montelukast sodium) in addition to approved standard treatment.

Timeline

Start: 2004-07
Primary completion: 2007-03
Completion: 2007-03

Outcome

Met primary endpoint

paper Montelukast significantly increased FEV(1) at 60 minutes postdose; PMID 20159247 ↗

paper montelukast (0.32 L; 95% CI, 0.27, 0.37) was 0.10 L (95% CI, 0.04, 0.16). PMID 20159247 ↗

Publications

Camargo CA Jr, Gurner DM, Smithline HA, Chapela R, Fabbri LM, Green SA, Malice MP, Legrand C, Dass SB, Knorr BA, Reiss TF. A randomized placebo-controlled study of intravenous montelukast for the treatment of acute asthma. J Allergy Clin Immunol. 2010 Feb;125(2):374-80. doi: 10.1016/j.jaci.2009.11.015.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Montelukast	Other / unclassified	7 mg	Intravenous