Phase 2
Completed N=601
Safety and Efficacy of Bepotastine Besilate Nasal Spray in the Treatment of Seasonal Allergic Rhinitis
Source: ClinicalTrials.gov NCT01277341 ↗Enrolled (actual)
601
Serious AEs
0.2%
Results posted
Sep 2020
Primary outcomePrimary: Mean Change From Baseline (Pre-Dose) in Subject-rated Reflective TNSS — -1.84; -1.71; -1.47; -0.99 score on a scale
Summary
This is an efficacy study of bepotastine besilate nasal spray in seasonal allergic rhinitis.
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 | — |
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. Informational only — not medical advice.