Montelukast in Patients With Seasonal Allergic Rhinitis - Spring 2000 Study (MK-0476A-162)(COMPLETED)

Phase 3 Completed 1577 enrolled Organon and Co

RandomizedParallel-groupDouble-blindTreatment

Summary

This study will evaluate the ability of montelukast to improve the signs and symptoms of seasonal allergic rhinitis compared with loratadine and placebo.

Timeline

Start: 2000-03
Primary completion: 2000-05
Completion: 2000-05

Outcome

Met primary endpoint

paper The primary end-point, daytime nasal symptoms score (mean of nasal congestion, rhinorrhea, nasal pruritus, and sneezing scores; 0-3 scale), improved PMID 12100048 ↗

paper in the montelukast, loratadine, and placebo groups, respectively (P < or = 0.001 comparing each active treatment with placebo). PMID 12100048 ↗

Publications

Results Philip G, Malmstrom K, Hampel FC, Weinstein SF, LaForce CF, Ratner PH, Malice MP, Reiss TF; Montelukast Spring Rhinitis Study Group. Montelukast for treating seasonal allergic rhinitis: a randomized, double-blind, placebo-controlled trial performed in the spring. Clin Exp Allergy. 2002 Jul;32(7):1020-8. doi: 10.1046/j.1365-2222.2002.01422.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Loratadine	Small molecule	10 mg	Oral
Subject	Montelukast	Other / unclassified	10 mg	Oral