Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study (0476-246)

Phase 3 Completed 1365 enrolled Organon and Co

RandomizedParallel-groupDouble-blindTreatment

Summary

This study will assess the ability of montelukast to improve the signs and symptoms of perennial allergic rhinitis compared to placebo. Cetirizine is included in the study as an active control.

Timeline

Start: 2001-11
Primary completion: 2002-05
Completion: 2002-05

Outcome

Missed primary endpoint

paper Over 4 weeks, montelukast showed numerical improvement over placebo in DNSS (least-squares mean difference of -0.04 [95% confidence interval (CI}, -0.09, 0.01]); PMID 17619558 ↗

paper However, when averaged over 6 weeks, neither active treatment was significantly different from placebo. PMID 17619558 ↗

Publications

Results Philip G, Williams-Herman D, Patel P, Weinstein SF, Alon A, Gilles L, Tozzi CA, Dass SB, Reiss TF. Efficacy of montelukast for treating perennial allergic rhinitis. Allergy Asthma Proc. 2007 May-Jun;28(3):296-304. doi: 10.2500/aap.2007.28.3000.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Cetirizine	Other / unclassified	10 mg	Oral
Subject	Montelukast	Other / unclassified	10 mg	Oral