Study of MK0476 (Montelukast Sodium) and Effects on Asthma and Nasal Symptoms Upon Exposure to Cats (0476-256)(COMPLETED)
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.
Rhinitis, Allergic, Perennial
Drug: MK0476, montelukast sodium
Drug: Comparator: placebo
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||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|
- 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
- (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.
|Study Start Date:||April 2002|
|Primary Completion Date:||January 2003 (Final data collection date for primary outcome measure)|
The duration of treatment is 2 weeks.