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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00092885

Enrollment

831

Registered

2004-09-28

Start date

2003-03-31

Completion date

2003-10-31

Last updated

2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Bronchial, Rhinitis, Allergic, Seasonal

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.

Interventions

DRUGMK0476, montelukast sodium

DRUGComparator: placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

15 Years to 85 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Daily Rhinitis Symptoms score; the Daytime Nasal Symptoms score and Nighttime Symptoms score	—

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026