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Safety, Pharmacokinetics, and Efficacy of Bepotastine Besilate Nasal Product After Ragweed Pollen Exposure in an Environmental Chamber

Primary Purpose

Seasonal Allergic Rhinitis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
bepotastine besilate nasal product - low dose
bepotastine besilate nasal product - medium dose
bepotastine besilate nasal product - high dose
placebo comparator nasal product
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects 18 to 65 years of age with a positive skin prick test with ragweed allergen

Exclusion Criteria:

  • No active respiratory tract infection

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

Arm 1 - Low Dose

Arm 2 - Medium Dose

Arm 3 - High Dose

Arm 4 - Placebo

Arm Description

bepotastine besilate nasal product - low dose

bepotastine besilate nasal product - medium dose

bepotastine besilate nasal product - high dose

placebo comparator nasal product

Outcomes

Primary Outcome Measures

Mean Change From Baseline (Pre-Dose) in Subject-rated Instantaneous 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 maximum score for increased allergic response of 12 units. The minimum possible total score was 0.

Secondary Outcome Measures

Full Information

First Posted
October 14, 2010
Last Updated
October 1, 2020
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01222299
Brief Title
Safety, Pharmacokinetics, and Efficacy of Bepotastine Besilate Nasal Product After Ragweed Pollen Exposure in an Environmental Chamber
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to examine the safety and efficacy of bepotastine besilate nasal product in seasonal allergic rhinitis patients.

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 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 - Low Dose
Arm Type
Experimental
Arm Description
bepotastine besilate nasal product - low dose
Arm Title
Arm 2 - Medium Dose
Arm Type
Experimental
Arm Description
bepotastine besilate nasal product - medium dose
Arm Title
Arm 3 - High Dose
Arm Type
Experimental
Arm Description
bepotastine besilate nasal product - high dose
Arm Title
Arm 4 - Placebo
Arm Type
Placebo Comparator
Arm Description
placebo comparator nasal product
Intervention Type
Drug
Intervention Name(s)
bepotastine besilate nasal product - low dose
Intervention Description
sterile nasal product
Intervention Type
Drug
Intervention Name(s)
bepotastine besilate nasal product - medium dose
Intervention Description
sterile nasal product
Intervention Type
Drug
Intervention Name(s)
bepotastine besilate nasal product - high dose
Intervention Description
sterile nasal product
Intervention Type
Drug
Intervention Name(s)
placebo comparator nasal product
Intervention Description
sterile nasal product
Primary Outcome Measure Information:
Title
Mean Change From Baseline (Pre-Dose) in Subject-rated Instantaneous 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 maximum score for increased allergic response of 12 units. The minimum possible total score was 0.
Time Frame
Baseline, 20 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects 18 to 65 years of age with a positive skin prick test with ragweed allergen Exclusion Criteria: No active respiratory tract infection
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

Safety, Pharmacokinetics, and Efficacy of Bepotastine Besilate Nasal Product After Ragweed Pollen Exposure in an Environmental Chamber

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