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

Phase 2

Completed

• Conditions: Seasonal Allergic Rhinitis
• Interventions: Drug: Bepotastine besilate formulation; Drug: Fluticasone propionate; Drug: Bepotastine besilate-fluticasone propionate; Drug: Placebo Comparator

• Registration Number: NCT01578278
• Lead Sponsor: Bausch & Lomb Incorporated

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

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-01-18
• Study First Submitted QC: 2012-04-13
• Study First Posted: 2012-04-16
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Disposition First Submitted: 2013-08-23
• Disposition First Submitted QC: 2014-04-04
• Disposition First Posted: 2014-05-01
• Results First Submitted: 2020-08-24
• Results First Submitted QC: 2020-08-24
• Results First Posted: 2020-09-14
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-01
• Last Update Posted: 2020-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 606

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bepotastine besilate formulation	Bepotastine besilate formulation	Nasal Spray
Fluticasone propionate	Fluticasone propionate	Nasal Spray
Bepotastine besilate-fluticasone propionate	Bepotastine besilate-fluticasone propionate	Nasal Spray
Placebo Comparator	Placebo Comparator	Nasal Spray

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline (Pre-Dose) in Morning and Evening Averaged Subject-rated Reflective TNSS	Baseline, 14 days	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.

Trial Locations

Locations (1)

ISTA Pharmaceuticals, Inc.; 🇺🇸 Irvine, California, United States