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

Organon and Co1,992 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,992

Conditions

Rhinitis, Allergic, Perennial

Interventions

MontelukastDRUG

one 10 mg tablet, taken once daily at bed time for 6 weeks

Comparator: PlaceboDRUG

one placebo tablet, taken once daily at bed time for 6 weeks

Eligibility

Sex: ALLMin age: 15 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Mean Change From Baseline in Daytime Nasal Symptoms Score Averaged Over the 6-week Treatment Period in Patients With Perennial Allergic Rhinitis

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 \[Score 0 (best) to 3 (worst)\].

Time frame: 6 week treatment period (from baseline though the end of week 6)

Secondary Outcomes

Patient's Global Evaluation of Allergic Rhinitis 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.

Time frame: At the end of the 6 week treatment period

Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score After the 6 Week Treatment Period

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.

Time frame: Baseline and Week 6

Data from ClinicalTrials.gov

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