A Multicenter, Double-Blind, Randomized Study Investigating the Clinical Effect of Montelukast on Allergic Rhinitis in Patients With Seasonal Allergic Rhinitis and Chronic Asthma

Organon and Co0 sites831 target enrollmentMarch 2003

ConditionsRhinitis, Allergic, Seasonal Asthma, Bronchial

DrugsMK0476, montelukast sodium Comparator: placebo

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Rhinitis, Allergic, Seasonal
Sponsor: Organon and Co
Enrollment: 831
Primary Endpoint: Daily Rhinitis Symptoms score; the Daytime Nasal Symptoms score and Nighttime Symptoms score
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to determine the effect of an approved medication on the symptoms of seasonal allergic rhinitis (a seasonal variety of inflammation of the mucous membrane of the nose) in patients who are experiencing symptoms of seasonal allergic rhinitis and asthma.

Detailed Description

The duration of treatment is 2 weeks.

Registry

clinicaltrials.gov

Start Date

March 2003

End Date

October 2003

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Organon and Co

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Non-smoker
•A 2-year documented history of seasonal allergic rhinitis
•A 1-year documented history of chronic asthma
•Positive allergy testing

Exclusion Criteria

•Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection.

Outcomes

Primary Outcomes

Daily Rhinitis Symptoms score; the Daytime Nasal Symptoms score and Nighttime Symptoms score

Secondary Outcomes

(1) Rhinoconjunctivitis Quality-of-Life Questionnaire overall score; (2) Global Evaluation of Allergic Rhinitis by Patient; (3) Global Evaluation of Allergic Rhinitis by Physician