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NCT01222299 Clinical Trial

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

Seasonal Allergic Rhinitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01222299
Other study ID # S00032
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date May 2010
Est. completion date August 2010

Study information
Verified date October 2020
Source Bausch & Lomb Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 89
Est. completion date August 2010
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• bepotastine besilate nasal product - low dose
sterile nasal product
• bepotastine besilate nasal product - medium dose
sterile nasal product
• bepotastine besilate nasal product - high dose
sterile nasal product
• placebo comparator nasal product
sterile nasal product

Locations
Country Name City State
United States ISTA Pharmaceuticals, Inc. Irvine California

Sponsors (1)
Lead Sponsor Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Baseline, 20 days
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