Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Participants With Asthma (0476-911)

Phase 3 Completed 154 enrolled Organon and Co

RandomizedCrossoverDouble-blindTreatment

Summary

The purpose of this study is to determine the effect of four weeks of treatment with two investigational drugs (oral versus inhaled administration) plus an inhaled medication in the treatment of airway constriction brought on by exercise in participants with asthma.

Timeline

Start: 2005-12
Primary completion: 2008-11
Completion: 2008-11

Outcome

Met primary endpoint

paper Montelukast, compared with salmeterol, significantly reduced the mean maximum percentage decrease in FEV1 (10.6% vs 13.8%; P = .009) PMID 20568384 ↗

Publications

Fogel RB, Rosario N, Aristizabal G, Loeys T, Noonan G, Gaile S, Smugar SS, Polos PG. Effect of montelukast or salmeterol added to inhaled fluticasone on exercise-induced bronchoconstriction in children. Ann Allergy Asthma Immunol. 2010 Jun;104(6):511-7. doi: 10.1016/j.anai.2009.12.011.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Montelukast	Other / unclassified	5 mg	Oral
Subject	Salmeterol	Other / unclassified	50 ug	Inhaled
Background	Fluticasone	Other / unclassified	100 ug	Inhaled