A Multicenter, Double-Blind, Randomized, Crossover Study Investigating the Clinical Effect of Montelukast in Patients With Concomitant Asthma and Allergic Rhinitis Upon Controlled Exposure to Cat Allergen

Organon and Co0 sites58 target enrollmentApril 1, 2002

ConditionsAsthma, Bronchial Rhinitis, Allergic, Perennial

DrugsMK0476, montelukast sodium Comparator: placebo

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Asthma, Bronchial
Sponsor: Organon and Co
Enrollment: 58
Primary Endpoint: Co-Primary endpoints: (1) Area Under the Curve (AUC) for the percent fall from prechallenge FEV1 during allergen challenge; (2) Area Under the Curve for the increase from prechallenge Nasal Symptoms score during allergen challenge
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to determine the protective effect of an approved medication on asthma and allergic rhinitis (inflammation of the mucous membrane of the nose) upon exposure to cats.

Detailed Description

The duration of treatment is 2 weeks.

Registry

clinicaltrials.gov

Start Date

April 1, 2002

End Date

January 28, 2003

Last Updated

last year

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Organon and Co

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Increased sensitivity to cat allergen proven by positive allergy testing, and by decreased lung function and increased symptoms of allergic rhinitis (runny nose) upon exposure to cats.

Exclusion Criteria

•Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection.

Outcomes

Primary Outcomes

Co-Primary endpoints: (1) Area Under the Curve (AUC) for the percent fall from prechallenge FEV1 during allergen challenge; (2) Area Under the Curve for the increase from prechallenge Nasal Symptoms score during allergen challenge

Secondary Outcomes

(1) Maximum percent fall from prechallenge FEV1; (2) AUC for the increase from prechallenge Chest Symptoms score (3) AUC for the increase from prechallenge Nasal Symptoms score collected over 60 minutes after terminating the challenge.