Phase 2 N=89 Randomized Double-blind Treatment

Safety, Pharmacokinetics, and Efficacy of Bepotastine Besilate Nasal Product After Ragweed Pollen Exposure in an Environmental Chamber

Seasonal Allergic Rhinitis

Bottom Line

View on ClinicalTrials.gov: NCT01222299 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2020

Primary outcome: Primary: Mean Change From Baseline (Pre-Dose) in Subject-rated Instantaneous TNSS — -1.17; -0.69; -2.43; -1.65 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: bepotastine besilate nasal product - low dose (Drug); bepotastine besilate nasal product - medium dose (Drug); bepotastine besilate nasal product - high dose (Drug); placebo comparator nasal product (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bausch & Lomb Incorporated
Primary completion: Aug 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change From Baseline (Pre-Dose) in Subject-rated Instantaneous TNSS	-1.17; -0.69; -2.43; -1.65; -1.63; -0.64	—

Summary

The purpose of this study is to examine the safety and efficacy of bepotastine besilate nasal product in seasonal allergic rhinitis patients.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01222299). 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.