A Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis (MK-0476-192)(COMPLETED)

Study Overview
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Brief Summary
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A study of the ability of montelukast to improve signs and symptoms of seasonal allergic rhinitis compared with placebo. Loratadine is included in the study as an active control.

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

Conditions
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Seasonal Allergic Rhinitis

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has a documented clinical history of seasonal allergic rhinitis symptoms that become worse during the study season Patient is a non-smoker Patient is in good mental and physical health Exclusion Criteria: Patient is hospitalized Patient is a woman who is <8 weeks postpartum or is breast feeding Patient intends to move or vacation away during the study 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, taken orally once daily at bed time for 2 weeks<br>|
| Active Comparator: 2<br>loratadine | Drug: Comparator: loratadine<br>* loratadine 10 mg tablet, taken orally once daily at bed time for 2 weeks<br>|
| Placebo Comparator: 3<br>placebo | Drug: Comparator: placebo<br>* placebo tablet, taken orally 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 on a 4-point scale [0(best) to 3(worst)]. The average of the 4 individual nasal symptoms scores (Congestion, Rhinorrhea, Itching, and Sneezing) 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 on a 4-point scale [0(best) to 3(worst)]. The average of 3 scores (Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings) was reported as the Nighttime Symptoms Score. | Baseline and Week 2 | 
| Mean Change From Baseline in Daytime Eye Symptoms Score | Mean change from baseline in Daytime Eye Symptoms scores on a 4-point scale [0(best) to 3(worst)]. The average of the 4 individual eye symptoms scores (tearing, itchy, red, and puffy eyes) was reported as the Daytime Eye Symptoms Score. | 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, in answer to a single question regarding 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 (or upon discontinuation) | 
| 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 validated, self-administered questionnaire, which included 28 questions on a 7-point scale [score 0 (best) to 6 (worst)] across 7 domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. The scores for each domain were averaged, then the scores for the 7 domains were averaged for the overall score. | Baseline and Week 2 |