Montelukast in Patients With Seasonal Allergic Rhinitis - Spring 2000 Study (MK-0476A-162)(COMPLETED)

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

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

Conditions
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Seasonal Allergic Rhinitis

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


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 and has been a nonsmoker for at least 1 year 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

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: Comparator: montelukast<br>* 10 mg montelukast tablet given once daily at bedtime for 2 weeks<br>|
| Experimental: 2<br>loratadine | Drug: Comparator: loratadine<br>* 10 mg loratadine tablet given once daily at bedtime for 2 weeks<br>|
| Placebo Comparator: 3<br>placebo | Drug: Comparator: placebo<br>* placebo tablet given once daily at bedtime for 2 weeks<br>|
| Experimental: 4<br>montelukast/loratadine | Drug: Comparator: montelukast/loratadine<br>* montelukast 10-mg/loratadine 10-mg combination tablet taken orally once daily at bedtime 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 Over 2 Weeks | 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. The average of the 4 individual nasal symptoms scores was reported as the Daytime Nasal Symptoms Score. Scores were measured as 0 (best) to 3 (worst). | Baseline and Week 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Nighttime Symptoms Score Over 2 Weeks | Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptom daily on a 4-point scale, and the combined score of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings was reported as the Nighttime Symptoms Score. Scores were measured as 0 (best) to 3 (worst). | Baseline and Week 2 | 
| Mean Change From Baseline in Daytime Eye Symptoms Score Over 2 Weeks | Mean change from baseline in Daytime Eye Symptoms scores. Patients were asked to rate each of the 4 eye symptoms of tearing, itchy, red, and puffy eyes daily on a 4-point scale. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score. Scores were measured as 0 (best) to 3 (worst). | Baseline and Week 2 | 
| Patient's Global Evaluation of Allergic Rhinitis at Week 2 | 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. Scores were measured as 0 (best) to 6 (worst). | Week 2 | 
| Physician's Global Evaluation of Allergic Rhinitis at Week 2 | 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. Scores were measured as 0 (best) to 6 (worst). | Week 2 | 
| Mean Change From Baseline in Rhinoconjunctivitis Quality-of-life Questionnaire (RQLQ) Overall Score at Week 2 | Patients completed the validated, self-administered RQLQ, which included 28 items on a 7-point scale across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. Scores for each domain were averaged, then scores for the 7 domains were averaged for the overall score. Scores were measured as 0 (best) to 6 (worst). | Week 2 |