NCT00092885CompletedPhase 3
A Multicenter, Double-Blind, Randomized Study Investigating the Clinical Effect of Montelukast on Allergic Rhinitis in Patients With Seasonal Allergic Rhinitis and Chronic Asthma
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Organon and Co
- Enrollment
- 831
- Primary Endpoint
- Daily Rhinitis Symptoms score; the Daytime Nasal Symptoms score and Nighttime Symptoms score
Study Overview
Brief Summary
The purpose of this study is to determine the effect of an approved medication on the symptoms of seasonal allergic rhinitis (a seasonal variety of inflammation of the mucous membrane of the nose) in patients who are experiencing symptoms of seasonal allergic rhinitis and asthma.
Detailed Description
The duration of treatment is 2 weeks.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 15 Years to 85 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Non-smoker
- •A 2-year documented history of seasonal allergic rhinitis
- •A 1-year documented history of chronic asthma
- •Positive allergy testing
Exclusion Criteria
- •Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection.
Outcomes
Primary Outcomes
Daily Rhinitis Symptoms score; the Daytime Nasal Symptoms score and Nighttime Symptoms score
Secondary Outcomes
- (1) Rhinoconjunctivitis Quality-of-Life Questionnaire overall score; (2) Global Evaluation of Allergic Rhinitis by Patient; (3) Global Evaluation of Allergic Rhinitis by Physician
Investigators
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