Safety, Pharmacokinetics, and Efficacy of Bepotastine Besilate Nasal Product After Ragweed Pollen Exposure in an Environmental Chamber
1 other identifier
interventional
89
1 country
1
Brief Summary
The purpose of this study is to examine the safety and efficacy of bepotastine besilate nasal product in seasonal allergic rhinitis patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2010
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 14, 2010
CompletedFirst Posted
Study publicly available on registry
October 18, 2010
CompletedResults Posted
Study results publicly available
September 14, 2020
CompletedOctober 5, 2020
October 1, 2020
3 months
October 14, 2010
August 24, 2020
October 1, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (4)
Arm 1 - Low Dose
EXPERIMENTALbepotastine besilate nasal product - low dose
Arm 2 - Medium Dose
EXPERIMENTALbepotastine besilate nasal product - medium dose
Arm 3 - High Dose
EXPERIMENTALbepotastine besilate nasal product - high dose
Arm 4 - Placebo
PLACEBO COMPARATORplacebo comparator nasal product
Interventions
Eligibility Criteria
You may qualify if:
- Subjects 18 to 65 years of age with a positive skin prick test with ragweed allergen
You may not qualify if:
- No active respiratory tract infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ISTA Pharmaceuticals, Inc.
Irvine, California, 92618, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Bausch Health
Study Officials
- STUDY DIRECTOR
Tim McNamara, PharmD
ISTA Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2010
First Posted
October 18, 2010
Study Start
May 1, 2010
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
October 5, 2020
Results First Posted
September 14, 2020
Record last verified: 2020-10