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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

Primary Purpose

Seasonal Allergic Rhinitis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Bepotastine besilate formulation

Fluticasone propionate

Bepotastine besilate-fluticasone propionate

Placebo Comparator

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

ISTA Pharmaceuticals, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Bepotastine besilate formulation

Fluticasone propionate

Bepotastine besilate-fluticasone propionate

Placebo Comparator

Arm Description

Nasal Spray

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01578278

First Posted

January 18, 2012

Last Updated

October 1, 2020

Sponsor

Bausch & Lomb Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT01578278

Brief Title

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 Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

December 2011 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Seasonal Allergic Rhinitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

606 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bepotastine besilate formulation

Arm Type

Experimental

Arm Description

Nasal Spray

Arm Title

Fluticasone propionate

Arm Type

Experimental

Arm Description

Nasal Spray

Arm Title

Bepotastine besilate-fluticasone propionate

Arm Type

Experimental

Arm Description

Nasal Spray

Arm Title

Placebo Comparator

Arm Type

Placebo Comparator

Arm Description

Nasal Spray

Intervention Type

Drug

Intervention Name(s)

Bepotastine besilate formulation

Intervention Description

Nasal Spray

Intervention Type

Drug

Intervention Name(s)

Fluticasone propionate

Intervention Description

Nasal Spray

Intervention Type

Drug

Intervention Name(s)

Bepotastine besilate-fluticasone propionate

Intervention Description

Nasal Spray

Intervention Type

Drug

Intervention Name(s)

Placebo Comparator

Intervention Description

Nasal Spray

Primary Outcome Measure Information:

Title

Mean Change From Baseline (Pre-Dose) in Morning and Evening Averaged Subject-rated Reflective TNSS

Description

Time Frame

Baseline, 14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tim McNamara, PharmD

Organizational Affiliation

ISTA Pharmaceuticals, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

ISTA Pharmaceuticals, Inc.

City

Irvine

State/Province

California

ZIP/Postal Code

92618

Country

United States

12. IPD Sharing Statement

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