NCT01578278

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 606 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Bepotastine besilate formulation	Nasal Spray
DRUG	Fluticasone propionate	Nasal Spray
DRUG	Bepotastine besilate-fluticasone propionate	Nasal Spray
DRUG	Placebo Comparator	Nasal Spray

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2012-04-16
• Last updated: 2020-10-05
• Results posted: 2020-09-14

Locations

1 site across 1 country: United States