The Safety and Effectiveness of MK0476 (Montelukast) in Patients With Chronic Asthma (0476-388)

Summary

This study will test the safety and effectiveness of a range of doses of MK0476 (montelukast) compared to placebo on improved lung function in patients with chronic asthma.

Timeline

Start

2008-07

Primary completion

2008-12

Completion

2008-12

Outcome

Met primary endpoint

registry Placebo vs 100 mcg Montelukast; Difference in Least-Squares Means 0.10 (95% CI 0.04 to 0.15) NCT00739297 ↗

paper 100 μg (0.13 L; p ≤ .001), 250 μg (0.10 L; p < .01), and 1000 μg (0.12 L; p ≤ .001) had significantly greater ΔFEV₁ PMID 20936994 ↗

Publications

• Philip G, Pedinoff A, Vandormael K, Tymofyeyev Y, Smugar SS, Reiss TF, Korenblat PE. A phase I randomized, placebo-controlled, dose-exploration study of single-dose inhaled montelukast in patients with chronic asthma. J Asthma. 2010 Dec;47(10):1078-84. doi: 10.3109/02770903.2010.520100. Epub 2010 Nov 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Montelukast	Other / unclassified	25 ug	Inhaled
Subject	Montelukast	Other / unclassified	50 ug	Inhaled
Subject	Montelukast	Other / unclassified	100 ug	Inhaled
Subject	Montelukast	Other / unclassified	250 ug	Inhaled
Subject	Montelukast	Other / unclassified	500 ug	Inhaled
Subject	Montelukast	Other / unclassified	1000 ug	Inhaled

Indications