Montelukast in Seasonal Allergic Rhinitis - Spring 2001 Study (0476-235)

Study Overview
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Brief Summary
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This study will assess the treatment effect of montelukast versus placebo over a 2 week period in patients with seasonal allergic rhinitis. Loratadine is included in the study as an active comparator.

Official Title
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A Multi-Center, Double-blind, Randomized, Parallel-Group Study Investigating the Effect of Montelukast in Patients With Seasonal Allergic Rhinitis-Spring 2001 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 history of season 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 <8 weeks postpartum or is breast-feeding Patient has had major surgery in the past 4 weeks 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 orally once daily at bedtime for 2 weeks.<br>|
| Active Comparator: 2<br>loratadine | Drug: Comparator: loratadine<br>* Loratadine 10-mg tablet orally once daily at bedtime for 2 weeks.<br>|
| Placebo Comparator: 3<br>placebo | Drug: Comparator: Placebo<br>* placebo tablet 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 the 2-week Treatment Period | Mean change from baseline in Daytime Nasal Symptoms. Patients were asked to rate each of the 4 nasal symptoms 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 over the 2-week treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Nighttime Symptoms Score Over the 2-week Treatment Period | Mean change from baseline in Nighttime Symptoms Score. Patients were asked to rate each symptoms of Nasal Congestion Upon Awakening, Difficulty Going to Sleep, and Nighttime Awakenings daily on a 4-point [Scale 0 (best) to 3 (worst)]. The average of the individual symptoms scores was reported as the Nighttime Symptoms Score. | Baseline and over the 2-week treatment period | 
| Mean Change From Baseline in Daytime Eye Symptoms Score Over the 2-week Treatment Period | 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 [0 (best) to 3 (worst)]. The average of the 4 individual eye symptoms scores was reported as the Daytime Eye Symptoms Score. | Baseline and over the 2-week treatment period | 
| Patient's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period | An evaluation by the patient, administered at the last visit (or upon discontinuation) using a 7-point scale [Score 0 (very much better) to 6 (very much worse)], of the change in symptoms as compared to the beginning of the study. | End of the 2-week treatment period | 
| Physician's Global Evaluation of Allergic Rhinitis at the End of the 2-week Treatment Period | An evaluation by the physician, administered at the last visit (or upon discontinuation) using a 7-point scale [Score 0 (very much better) to 6 (very much worse)], of the change in symptoms as compared to the beginning of the study. | End of the 2-week treatment period | 
| Mean Change From Baseline in Rhinoconjunctivitis Quality-of-Life Score After the 2-week Treatment Period | Patients completed a validated, self-administered Rhinoconjunctivitis Quality-of-Life 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 individual domain scores were calculated as the average values of all scores within a domain, then the scores for the 7 domains were averaged for the overall score. | Baseline and at the end of 2-week treatment period |