Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study (0476-246)

Study Overview
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Brief Summary
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This study will assess the ability of montelukast to improve the signs and symptoms of perennial allergic rhinitis compared to placebo. Cetirizine is included in the study as an active control.

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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Perennial Allergic Rhinitis

Intervention / Treatment
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* Drug: montelukast sodium
* Drug: Comparator: cetirizine
* Drug: Comparator: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has a documented clinical history of perennial allergic rhinitis Patient is a nonsmoker Patient is in good general health Exclusion Criteria: Patient is hospitalized Patient is a woman who is <8 weeks postpartum or is breast-feeding Patient is a current or past abuser of alcohol or illicit drugs

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 sodium<br>* montelukast 10 mg tablet orally once daily at bedtime for 6 weeks<br>|
| Active Comparator: 2<br>cetirizine | Drug: Comparator: cetirizine<br>* cetirizine 10 mg tablet orally once daily at bedtime for 6 weeks<br>|
| Placebo Comparator: 3<br>placebo | Drug: Comparator: placebo<br>* placebo tablet orally once daily at bedtime 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 | Mean change from baseline in Daytime Nasal Symptoms score. Patients were asked to rate each nasal symptom of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale [Score 0 (best) to 3 (worst)]. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score. | Baseline and first 4 weeks of a 6-week treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Nighttime Symptoms Score | Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptom daily on a 4-point scale [Score 0 (best) to 3 (worst)], and the average score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score. | Baseline and first 4 weeks in 6-week treatment period | 
| Mean Change From Baseline in Composite Symptoms Score | Composite Symptoms Scores were computed as the average of the Daytime Nasal Symptoms Scores [Score 0 (best) to 3 (worst)]. and Nighttime Symptoms Scores collected [Score 0 (best) to 3 (worst)]. | Baseline and first 4 weeks in 6-week treatment period | 
| Patient's Global Evaluation of Allergic Rhinitis | An evaluation by the patient, administered at week 4 of the study (or upon discontinuation) using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study. | End of the first 4 weeks in 6-week treatment period | 
| Physician's Global Evaluation of Allergic Rhinitis | An evaluation by the physician, administered at week 4 of the study (or upon discontinuation) using a 7-point scale [Score 0 (best) to 6 (worst)], of the change in symptoms as compared to the beginning of the study. | End of the first 4 weeks in 6-week treatment period |