MK0476 Study in Adult Patients With Acute Asthma (0476-322)

NCT00229970 ↗

Phase 3 Completed 225 enrolled Organon and Co

RandomizedParallel-groupDouble-blindTreatment

Summary

This study evaluates the efficacy and safety of MK0476 intravenous administration in adult patients with acute asthma.

Timeline

Start: 2005-09
Primary completion: 2006-10
Completion: 2007-06

Outcome

Met primary endpoint

registry analysis (unspecified test); Montelukast 7 mg vs Placebo; p = 0.022; Mean Difference (Final Values) 0.09 (95% CI 0.01 to 0.16); ANCOVA NCT00229970 ↗

registry analysis (unspecified test); Montelukast 14 mg vs Placebo; p <0.001; Mean Difference (Final Values) 0.17 (95% CI 0.09 to 0.24); ANCOVA NCT00229970 ↗

Publications

Adachi M, Taniguchi H, Tohda Y, Sano Y, Ishine T, Smugar SS, Hisada S. The efficacy and tolerability of intravenous montelukast in acute asthma exacerbations in Japanese patients. J Asthma. 2012 Aug;49(6):649-56. doi: 10.3109/02770903.2012.690479. Epub 2012 Jun 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Montelukast	Other / unclassified	7 mg	Intravenous
Subject	Montelukast	Other / unclassified	14 mg	Intravenous