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NCT00092885 Clinical Trial

An Approved Drug to Study a New Indication for Seasonal Allergic Rhinitis in Patients With Asthma (0476-269)

Rhinitis, Allergic, Seasonal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00092885
Other study ID # 0476-269
Secondary ID 2004_025
Status Completed
Phase Phase 3
First received
Last updated
Start date March 2003
Est. completion date October 2003

Study information
Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

The duration of treatment is 2 weeks.

Recruitment information / eligibility
Status Completed
Enrollment 831
Est. completion date October 2003
Est. primary completion date October 2003
Accepts healthy volunteers No
Gender All
Age group 15 Years to 85 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MK0476, montelukast sodium

• Comparator: placebo

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

References & Publications (1)

Philip G, Nayak AS, Berger WE, Leynadier F, Vrijens F, Dass SB, Reiss TF. The effect of montelukast on rhinitis symptoms in patients with asthma and seasonal allergic rhinitis. Curr Med Res Opin. 2004 Oct;20(10):1549-58. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Daily Rhinitis Symptoms score; the Daytime Nasal Symptoms score and Nighttime Symptoms score
Secondary (1) Rhinoconjunctivitis Quality-of-Life Questionnaire overall score; (2) Global Evaluation of Allergic Rhinitis by Patient; (3) Global Evaluation of Allergic Rhinitis by Physician
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