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Phase 2 Completed N=89 Randomized Double-blind Treatment

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

Source: ClinicalTrials.gov NCT01222299 ↗
Enrolled (actual)
89
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcomePrimary: Mean Change From Baseline (Pre-Dose) in Subject-rated Instantaneous TNSS — -1.17; -0.69; -2.43; -1.65 units on a scale

Summary

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

Outcome Measures

OutcomeResultp-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

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. Informational only — not medical advice.

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