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.