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

Phase 3

Completed

• Conditions: Rhinitis, Allergic, Seasonal; Asthma, Bronchial

• Registration Number: NCT00092885
• Lead Sponsor: Organon and Co

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.

Study Timeline

• Study Start: 2003-03
• Primary Completion: 2003-10
• Study Completion: 2003-10
• Study First Submitted: 2004-09-23
• Study First Submitted QC: 2004-09-27
• Study First Posted: 2004-09-28
• Status Verified: 2022-02
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 831

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Daily Rhinitis Symptoms score; the Daytime Nasal Symptoms score and Nighttime Symptoms score

Secondary Outcome Measures

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