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
Sponsored by
About this trial
This is an interventional treatment trial for Seasonal Allergic Rhinitis
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
Sites / Locations
- ISTA Pharmaceuticals, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Bepotastine besilate formulation
Fluticasone propionate
Bepotastine besilate-fluticasone propionate
Placebo Comparator
Arm Description
Nasal Spray
Nasal Spray
Nasal Spray
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
No
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
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.
Time Frame
Baseline, 14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Learn more about this trial
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
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