Bepotastine Besilate-corticosteroid Nasal Spray Combination Compared to Placebo, Bepotastine Besilate Nasal Spray, and Corticosteroid Nasal Spray in the Treatment of Patients With Seasonal Allergic Rhinitis

Study Overview
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Brief Summary
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This is a clinical study to evaluate the safety and efficacy of a bepotastine besilate-corticosteroid combination nasal spray for the treatment of seasonal allergic rhinitis (SAR) in an open exposure study with subjects who have a demonstrated history of Mountain Cedar pollen allergy. The primary study objective is to assess the reduction from baseline in averaged morning (AM) and evening (PM) values of reflective total nasal symptom scores for each of 3 nasal sprays (bepotastine besilate-fluticasone propionate combination nasal spray, bepotastine besilate nasal spray, fluticasone propionate nasal spray) compared to placebo nasal spray. For enrolled subjects, the study will involve a 7-10 day run-in screening period dosing with placebo nasal spray and then a 14-day treatment period where subjects will dose twice a day with 1 of the 4 test agent nasal sprays and record reflective and instantaneous scores for both nasal and ocular symptoms prior to each dosing.

Conditions
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Seasonal Allergic Rhinitis

Intervention / Treatment
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* Drug: Bepotastine besilate formulation
* Drug: Fluticasone propionate
* Drug: Bepotastine besilate-fluticasone propionate
* Drug: Placebo Comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female at least 12 years of age with a demonstrated history of Mountain Cedar pollen allergy Exclusion Criteria: No active nasal infection or nasal abnormality that would affect subject safety or symptom assessments

Ages Eligible for Study
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Minimum Age: 12 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bepotastine besilate formulation<br>Nasal Spray | Drug: Bepotastine besilate formulation<br>* Nasal Spray<br>|
| Experimental: Fluticasone propionate<br>Nasal Spray | Drug: Fluticasone propionate<br>* Nasal Spray<br>|
| Experimental: Bepotastine besilate-fluticasone propionate<br>Nasal Spray | Drug: Bepotastine besilate-fluticasone propionate<br>* Nasal Spray<br>|
| Placebo Comparator: Placebo Comparator<br>Nasal Spray | Drug: Placebo Comparator<br>* Nasal Spray<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline (Pre-Dose) in Morning and Evening Averaged Subject-rated Reflective TNSS | Total nasal symptom scores (TNSS) was the summed scores for nasal pruritus [itching], rhinorrhea [runny nose], nasal congestion, and sneezing. Individual nasal symptoms were rated on a 4-point scale from 0-3 (0=Absent, 1=Mild, 2=Moderate, 3=Severe), with no half-unit assessments. TNSS was the sum score of 4 nasal symptoms with a minimum score of 0 and a maximum score of 12 units, with higher score corresponding to increased severity of nasal allergy symptoms. The morning and evening scores were averaged. | Baseline, 14 days |