Montelukast Asthmatic Smoker Study (0476-332)(COMPLETED)

Phase 3 Completed 1640 enrolled Organon and Co

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a multicenter study to evaluate the efficacy and safety of MK0476 versus placebo in participants with chronic asthma who actively smoke cigarettes.

Timeline

Start: 2006-05
Primary completion: 2010-04
Completion: 2010-04

Outcome

Met primary endpoint

registry analysis (unspecified test); Montelukast vs Placebo; Least Squares Mean Difference 5.92 (95% CI 0.28 to 11.56) NCT00284856 ↗

paper montelukast, P < .05 vs placebo PMID 23380218 ↗

Publications

Results Price D, Popov TA, Bjermer L, Lu S, Petrovic R, Vandormael K, Mehta A, Strus JD, Polos PG, Philip G. Effect of montelukast for treatment of asthma in cigarette smokers. J Allergy Clin Immunol. 2013 Mar;131(3):763-71. doi: 10.1016/j.jaci.2012.12.673. Epub 2013 Feb 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Fluticasone propionate	Other / unclassified	250 ug	—
Subject	Montelukast	Other / unclassified	10 mg	Oral