Study of MK0476 (Montelukast Sodium) and Effects on Asthma and Nasal Symptoms Upon Exposure to Cats
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma, Bronchial; Rhinitis, Allergic, Perennial
Intervention: MK0476, montelukast sodium (Drug); Comparator: placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck
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.
Clinical Details
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
Study design: Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: 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: (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.
Detailed description:
The duration of treatment is 2 weeks.
Eligibility
Minimum age: 15 Years.
Maximum age: 55 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Related publications: Perry TT, Corren J, Philip G, Kim EH, Conover-Walker MK, Malice MP, Massaad R, Dass SB, Reiss TF, Wood RA. Protective effect of montelukast on lower and upper respiratory tract responses to short-term cat allergen exposure. Ann Allergy Asthma Immunol. 2004 Nov;93(5):431-8.
Starting date: April 2002
Last updated: November 21, 2006
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