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

Organon

Status and phase: Completed; Phase 3

Conditions: Asthma, Bronchial; Rhinitis, Allergic, Seasonal

Treatments: Drug: Comparator: placebo; Drug: MK0476, montelukast sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00092885

2004_025

0476-269

Details and patient eligibility

About

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.

Full description

The duration of treatment is 2 weeks.

Enrollment: 831 patients

Sex: All

Ages: 15 to 85 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind