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

Organon and Co831 enrolled

Overview

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.

The duration of treatment is 2 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

831

Conditions

Rhinitis, Allergic, Seasonal Asthma, Bronchial

Interventions

MK0476, montelukast sodiumDRUG

Comparator: placeboDRUG

Eligibility

Sex: ALLMin age: 15 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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