Study of MK0476 (Montelukast Sodium) and Effects on Asthma and Nasal Symptoms Upon Exposure to Cats (0476-256)

Organon and Co58 enrolled

Overview

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.

The duration of treatment is 2 weeks.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Asthma, Bronchial Rhinitis, Allergic, Perennial

Interventions

MK0476, montelukast sodiumDRUG

Comparator: placeboDRUG

Eligibility

Sex: ALLMin age: 15 YearsMax age: 55 Years

Medical Language ↔ Plain English

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.

Data from ClinicalTrials.gov

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