Safety, Pharmacokinetics, and Efficacy of Bepotastine Besilate Nasal Product After Ragweed Pollen Exposure in an Environmental Chamber
Phase 1
Completed
- Conditions
- Seasonal Allergic Rhinitis
- Interventions
- Registration Number
- NCT01222299
- Lead Sponsor
- Bausch & Lomb Incorporated
- Brief Summary
The purpose of this study is to examine the safety and efficacy of bepotastine besilate nasal product in seasonal allergic rhinitis patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 89
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2 - Medium Dose bepotastine besilate nasal product - medium dose bepotastine besilate nasal product - medium dose Arm 3 - High Dose bepotastine besilate nasal product - high dose bepotastine besilate nasal product - high dose Arm 4 - Placebo placebo comparator nasal product placebo comparator nasal product Arm 1 - Low Dose bepotastine besilate nasal product - low dose bepotastine besilate nasal product - low dose
- Primary Outcome Measures
Name Time Method Mean Change From Baseline (Pre-Dose) in Subject-rated Instantaneous TNSS Baseline, 20 days 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
Name Time Method
Trial Locations
- Locations (1)
ISTA Pharmaceuticals, Inc.
🇺🇸Irvine, California, United States