Phase 2
N=601
Safety and Efficacy of Bepotastine Besilate Nasal Spray in the Treatment of Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT01277341 ↗Enrolled (actual)
601
Serious AEs
0.2%
Results posted
Sep 2020
Primary outcome: Primary: Mean Change From Baseline (Pre-Dose) in Subject-rated Reflective TNSS — -1.84; -1.71; -1.47; -0.99 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bepotastine Besilate Nasal Spray 2% Twice a day (Drug); Bepotastine Besilate Nasal Spray 3% Twice a day (Drug); Bepotastine Besilate Nasal Spray 4% Twice a day (Drug); Placebo Nasal Spray (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline (Pre-Dose) in Subject-rated Reflective TNSS |
-1.84; -1.71; -1.47; -0.99 | — |
Summary
This is an efficacy study of bepotastine besilate nasal spray in seasonal allergic rhinitis.
Eligibility Criteria
Inclusion Criteria
- Male or female at least 12 years of age with a history of mountain cedar allergy
Exclusion Criteria
- No active nasal infection or nasal abnormality that would affect subject safety or symptom assessments
Data sourced from ClinicalTrials.gov (NCT01277341). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.