Back to resultsAn Approved Drug to Study a New Indication for Seasonal Allergic Rhinitis in Patients With Asthma (0476-269)
Primary Purpose
Rhinitis, Allergic, Seasonal, Asthma, Bronchial
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0476, montelukast sodium
Comparator: placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rhinitis, Allergic, Seasonal
Eligibility Criteria
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Daily Rhinitis Symptoms score; the Daytime Nasal Symptoms score and Nighttime Symptoms score
Secondary Outcome Measures
(1) Rhinoconjunctivitis Quality-of-Life Questionnaire overall score; (2) Global Evaluation of Allergic Rhinitis by Patient; (3) Global Evaluation of Allergic Rhinitis by Physician
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00092885
Brief Title
An Approved Drug to Study a New Indication for Seasonal Allergic Rhinitis in Patients With Asthma (0476-269)
Official Title
A Multicenter, Double-Blind, Randomized Study Investigating the Clinical Effect of Montelukast on Allergic Rhinitis in Patients With Seasonal Allergic Rhinitis and Chronic Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
October 2003 (Actual)
Study Completion Date
October 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Seasonal, Asthma, Bronchial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
831 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0476, montelukast sodium
Intervention Type
Drug
Intervention Name(s)
Comparator: placebo
Primary Outcome Measure Information:
Title
Daily Rhinitis Symptoms score; the Daytime Nasal Symptoms score and Nighttime Symptoms score
Secondary Outcome Measure Information:
Title
(1) Rhinoconjunctivitis Quality-of-Life Questionnaire overall score; (2) Global Evaluation of Allergic Rhinitis by Patient; (3) Global Evaluation of Allergic Rhinitis by Physician
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
15462688
Citation
Philip G, Nayak AS, Berger WE, Leynadier F, Vrijens F, Dass SB, Reiss TF. The effect of montelukast on rhinitis symptoms in patients with asthma and seasonal allergic rhinitis. Curr Med Res Opin. 2004 Oct;20(10):1549-58. doi: 10.1185/030079904x3348.
Results Reference
background
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
An Approved Drug to Study a New Indication for Seasonal Allergic Rhinitis in Patients With Asthma (0476-269)
We'll reach out to this number within 24 hrs