Study of MK0476 (Montelukast Sodium) and Effects on Asthma and Nasal Symptoms Upon Exposure to Cats (0476-256)
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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
Actual Study Start Date
April 1, 2002
Actual Primary Completion Date
January 1, 2003
Actual Study Completion Date
January 28, 2003
Resource links provided by the National Library of Medicine
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 Outcome Measures
(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.
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Ages Eligible for Study:
15 Years to 55 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection.