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

NCT ID: NCT00092885

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 831 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-03-31
• Study Completion Date: 2003-10-31

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.

Conditions

Rhinitis, Allergic, Seasonal; Asthma, Bronchial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

MK0476, montelukast sodium

Intervention Type: DRUG

Comparator: placebo

Intervention Type: DRUG

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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. doi: 10.1185/030079904x3348.

Reference Type: BACKGROUND

PMID: 15462688 (View on PubMed)

Other Identifiers

2004_025

Identifier Type: -

Identifier Source: secondary_id

0476-269

Identifier Type: -

Identifier Source: org_study_id