The Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis | RxWiki

The Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis

Overview[ - collapse ][ - ]

Purpose	The purpose of this study is to determine the effect of an approved medication on the symptoms of perennial allergic rhinitis (an inflammation of the mucous membrane of the nose similar to that found in hay fever except that symptoms persist throughout the year), in patients who have a history of perennial allergic rhinitis.
Condition	Rhinitis, Allergic, Perennial
Intervention	Drug: Montelukast Drug: Comparator: Placebo
Phase	Phase 3
Sponsor	Merck Sharp & Dohme Corp.
Responsible Party	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier	NCT00092118
First Received	September 21, 2004
Last Updated	June 29, 2010
Last verified	June 2010

Tracking Information[ + expand ][ + ]

First Received Date	September 21, 2004
Last Updated Date	June 29, 2010
Start Date	October 2003
Estimated Primary Completion Date	May 2004
Current Primary Outcome Measures	Mean Change From Baseline in Daytime Nasal Symptoms Score Averaged Over the 6-week Treatment Period in Patients With Perennial Allergic Rhinitis [Time Frame: 6 week treatment period (from baseline though the end of week 6)] [Designated as safety issue: No]Mean change from baseline in Daytime Nasal Symptoms score averaged over the 6-week treatment period. The Daytime Nasal Symptoms score was calculated as the average of the 3 individual scores for Congestion, Rhinorrhea, and Sneezing, each rated by patients daily on a 4-point scale [Score 0 (best) to 3 (worst)].
Current Secondary Outcome Measures	Patient's Global Evaluation of Allergic Rhinitis at the End of the 6 Week Treatment Period [Time Frame: At the end of the 6 week treatment period] [Designated as safety issue: No]An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale [Score 0 (best) to 6 (worst)], in answer to a single question regarding the change in symptoms as compared to the beginning of the study. Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score After the 6 Week Treatment Period [Time Frame: Baseline and Week 6] [Designated as safety issue: No]Patients completed the validated, self-administered RQLQ which included 28 items on a 7-point scale [Score 0 (best) to 6 (worst)] across 7 domains: activities, sleep, nonnose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. The scores for each domain were averaged, then scores for the 7 domains were averaged to obtain the overall score.

Descriptive Information[ + expand ][ + ]

Brief Title	The Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis
Official Title	A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Investigating the Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis
Brief Summary	The purpose of this study is to determine the effect of an approved medication on the symptoms of perennial allergic rhinitis (an inflammation of the mucous membrane of the nose similar to that found in hay fever except that symptoms persist throughout the year), in patients who have a history of perennial allergic rhinitis.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 3
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Condition	Rhinitis, Allergic, Perennial
Intervention	Drug: Montelukast one 10 mg tablet, taken once daily at bed time for 6 weeks Drug: Comparator: Placebo one placebo tablet, taken once daily at bed time for 6 weeks
Study Arm (s)	Experimental: 1 Montelukast Placebo Comparator: 2 Placebo

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	1992
Estimated Completion Date	May 2004
Estimated Primary Completion Date	May 2004
Eligibility Criteria	Inclusion Criteria: - Non-smoker with a 2-year documented history of perennial allergic (symptoms that persist throughout the year) rhinitis symptoms and positive allergy testing Exclusion Criteria: - Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection
Gender	Both
Ages	15 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Not Provided

Administrative Information[ + expand ][ + ]

NCT Number	NCT00092118
Other Study ID Numbers	2004_018
Has Data Monitoring Committee	No
Information Provided By	Merck Sharp & Dohme Corp.
Study Sponsor	Merck Sharp & Dohme Corp.
Collaborators	Not Provided
Investigators	Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Verification Date	June 2010