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

Bausch & Lomb Incorporated89 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Seasonal Allergic Rhinitis

Interventions

bepotastine besilate nasal product - low doseDRUG

sterile nasal product

bepotastine besilate nasal product - medium doseDRUG

sterile nasal product

bepotastine besilate nasal product - high doseDRUG

sterile nasal product

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

ISTA Pharmaceuticals, Inc.

Irvine, California, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline, 20 days

Data from ClinicalTrials.gov

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