Montelukast in Seasonal Allergic Rhinitis - Fall 1999 Study (0476A-117)

Study Overview
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Brief Summary
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This study will evaluate the ability of oral montelukast/loratadine to improve the signs and symptoms of seasonal allergic rhinitis compared with loratadine alone, montelukast alone and placebo.

Official Title
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A Multicenter, Double-Blind, Randomized, Parallel-Group Study Investigating the Clinical Effect of Combination Montelukast/Loratadine in Patients With Seasonal Allergic Rhinitis-Fall Study

Conditions
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Seasonal Allergic Rhinitis

Intervention / Treatment
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* Drug: Comparator: montelukast/loratadine
* Drug: Comparator: montelukast
* Drug: Comparator: loratadine
* Drug: Comparator: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has a documented history of seasonal allergic rhinitis symptoms that flare up during the study season Patient is a nonsmoker Patient is in good general health Exclusion Criteria: Patient is hospitalized Patient is a woman who is less than 8 weeks postpartum or is breast-feeding Patient intends to move or vacation away during the study Patient has had any major surgery within 4 weeks of study start Patient is a current or past abuser of alcohol or illicit drugs Patient has been treated in an emergency room for asthma in the past month Patient had an upper respiratory infection with in 3 weeks prior to study start Patient has any active pulmonary disorder other than asthma

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/loratadine | Drug: Comparator: montelukast/loratadine<br>* montelukast 10 mg/loratadine 10 mg tablet taken once daily at bed time for 2 weeks<br>|
| Experimental: 2<br>loratadine | Drug: Comparator: loratadine<br>* loratadine 10 mg tablet taken once daily at bed time for 2 weeks<br>|
| Experimental: 3<br>montelukast | Drug: Comparator: montelukast<br>* montelukast 10 mg tablet taken once daily at bed time for 2 weeks<br>|
| Placebo Comparator: 4<br>placebo | Drug: Comparator: placebo<br>* placebo tablet taken once daily at bed time for 2 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 of the 4 nasal symptoms of Congestion, Rhinorrhea, Itching, and Sneezing daily on a 4-point scale (0 (best) to 3 (worst)). The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score. | Baseline and Week 2 | 

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 (0 (best) to 3 (worst)), and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score. | Baseline and Week 2 | 
| Change From Baseline in Composite Symptoms Score (Daytime Nasal and Nighttime Symptoms) | Composite Symptoms scores were computed as the average of the Daytime Nasal Symptoms scores and Nighttime Symptoms scores collected on a 4 point scale (0 (best) to 3 (worst)). | Baseline and Week 2 | 
| Mean Change From Baseline in Daytime Eye Symptoms Score | Mean change from baseline in Daytime Eye Symptoms scores. Patients were asked to rate each of the 4 eye symptom of tearing, itchy, red, and puffy eyes daily on a 4-point scale (0 (best) to 3 (worst)). The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score. | Baseline and Week 2 | 
| Mean Change From Baseline in Daytime Nasal Congestion Score | Patients were asked to rate the nasal symptom of Congestion daily on a 4-point scale (0 (best) to 3 (worst)). | Baseline and Week 2 | 
| Mean Change From Baseline in Daytime Rhinorrhea Score | Patients were asked to rate the nasal symptom of Rhinorrhea daily on a 4-point scale (0 (best) to 3 (worst)). | Baseline and Week 2 | 
| Mean Change From Baseline in Daytime Nasal Itching Score | Patients were asked to rate the nasal symptom of Nasal Itching daily on a 4-point scale (0 (best) to 3 (worst)). | Baseline and Week 2 | 
| Mean Change From Baseline in Daytime Sneezing Score | Patients were asked to rate the nasal symptom of Sneezing daily on a 4-point scale (0 (best) to 3 (worst)). | Baseline and Week 2 | 
| Mean Change From Baseline in Nasal Congestion Upon Awakening | Patients were asked to rate the symptom of Nasal Congestion Upon Awakening daily on a 4-point scale (0 (best) to 3 (worst)). | Baseline and Week 2 | 
| Patient's Global Evaluation of Allergic Rhinitis | An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the study. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse). | Week 2 | 
| Physician's Global Evaluation of Allergic Rhinitis | An evaluation by the physician, administered at the last visit (or upon discontinuation) using a 7-point scale, of the change in symptoms as compared to the beginning of the study. Responses were assigned numerical values from 0 (very much better) to 6 (very much worse). | Week 2 | 
| Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score | Patients completed a Rhinoconjunctivitis Quality-of-Life Questionnaire, 28 questions on a 7-point scale [0(best) to 6(worst)] across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, emotional. Scores per domain were averaged, then scores for the 7 domains were averaged for an overall score. | Week 2 |