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

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Investigating the Clinical Effects of Montelukast in Patients With Perennial Allergic Rhinitis

Conditions
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Rhinitis, Allergic, Perennial

Intervention / Treatment
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* Drug: Montelukast
* Drug: Comparator: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Montelukast | Drug: Montelukast<br>* one 10 mg tablet, taken once daily at bed time for 6 weeks<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Comparator: Placebo<br>* one placebo tablet, taken once daily at bed time for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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)]. | 6 week treatment period (from baseline though the end of week 6) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline and Week 6 |