Conditions: Seasonal Allergic Rhinitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 606
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: Nasal Spray arm 2: Nasal Spray arm 3: Nasal Spray arm 4: Nasal Spray

Interventions: intervention 1: Bepotastine besilate formulation intervention 2: Fluticasone propionate intervention 3: Bepotastine besilate-fluticasone propionate intervention 4: Placebo Comparator
Intervention descriptions: intervention 1: Nasal Spray intervention 2: Nasal Spray intervention 3: Nasal Spray intervention 4: Nasal Spray

Protocol document: