Safety and Efficacy of Bepotastine Besilate Nasal Spray in the Treatment of Seasonal Allergic Rhinitis
1 other identifier
interventional
601
1 country
1
Brief Summary
This is an efficacy study of bepotastine besilate nasal spray in seasonal allergic rhinitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2010
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 7, 2011
CompletedFirst Posted
Study publicly available on registry
January 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedResults Posted
Study results publicly available
September 14, 2020
CompletedOctober 5, 2020
October 1, 2020
2 months
January 7, 2011
August 24, 2020
October 1, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Mean Change From Baseline (Pre-Dose) in Subject-rated Reflective TNSS
Total nasal symptom score (TNSS) was the summed scores for nasal pruritus \[itching\], rhinorrhea \[runny nose\], nasal congestion, and sneezing. Individual nasal symptoms were each 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 minimum score of 0 units and a maximum score of 12 units, with higher score corresponding to increased nasal allergy symptoms. Morning and evening scores were averaged.
Baseline, 14 days
Study Arms (4)
2% Twice a day
EXPERIMENTALBepotastine Besilate Nasal Spray 2% Twice a day
3% Twice a day
EXPERIMENTALBepotastine Besilate Nasal Spray 3% Twice a day
4% Twice a day
EXPERIMENTALBepotastine Besilate Nasal Spray 4% Twice a day
Placebo
PLACEBO COMPARATORPlacebo nasal spray
Interventions
Eligibility Criteria
You may qualify if:
- Male or female at least 12 years of age with a history of mountain cedar allergy
You may not qualify if:
- No active nasal infection or nasal abnormality that would affect subject safety or symptom assessments
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 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2011
First Posted
January 14, 2011
Study Start
December 1, 2010
Primary Completion
February 1, 2011
Study Completion
May 1, 2011
Last Updated
October 5, 2020
Results First Posted
September 14, 2020
Record last verified: 2020-10