The Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis (0476-265)

Phase 3

Completed

• Conditions: Rhinitis, Allergic, Perennial
• Interventions: Drug: Montelukast

• Registration Number: NCT00092118
• Lead Sponsor: Organon and Co

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 available

Study Timeline

• Study Start: 2003-10
• Primary Completion: 2004-05
• Study Completion: 2004-05
• Study First Submitted: 2004-09-21
• Study First Submitted QC: 2004-09-23
• Study First Posted: 2004-09-24
• Results First Submitted: 2009-09-10
• Results First Submitted QC: 2010-06-29
• Results First Posted: 2010-07-23
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-01
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1992

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Montelukast	Montelukast

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Daytime Nasal Symptoms Score Averaged Over the 6-week Treatment Period in Patients With Perennial Allergic Rhinitis	6 week treatment period (from baseline though the end of week 6)	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 \[Score 0 (best) to 3 (worst)\].

Secondary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score After the 6 Week Treatment Period	Baseline and Week 6	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.
Patient's Global Evaluation of Allergic Rhinitis at the End of the 6 Week Treatment Period	At the end of the 6 week treatment period	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.