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

Bausch + Lomb

Status and phase: Completed; Phase 2

Conditions: Seasonal Allergic Rhinitis

Treatments: Drug: Placebo Comparator; Drug: Bepotastine besilate formulation; Drug: Fluticasone propionate; Drug: Bepotastine besilate-fluticasone propionate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01578278

S00186

Details and patient eligibility

About

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.

Enrollment: 606 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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606 participants in 4 patient groups, including a placebo group

Bepotastine besilate formulation

Experimental group

Description:

Nasal Spray

Treatment:

Drug: Bepotastine besilate formulation

Fluticasone propionate

Experimental group

Description:

Nasal Spray

Treatment:

Drug: Fluticasone propionate

Bepotastine besilate-fluticasone propionate

Experimental group

Description:

Nasal Spray

Treatment:

Drug: Bepotastine besilate-fluticasone propionate

Placebo Comparator

Placebo Comparator group

Description:

Nasal Spray

Treatment:

Drug: Placebo Comparator