Phase 2
N=606
Bepotastine Besilate-corticosteroid Nasal Spray Combination Compared to Placebo, Bepotastine Besilate Nasal Spray, and Corticosteroid Nasal Spray in the Treatment of Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT01578278 ↗Enrolled (actual)
606
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Mean Change From Baseline (Pre-Dose) in Morning and Evening Averaged Subject-rated Reflective TNSS — -3.57; -2.31; -2.96; -1.48 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bepotastine besilate formulation (Drug); Fluticasone propionate (Drug); Bepotastine besilate-fluticasone propionate (Drug); Placebo Comparator (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline (Pre-Dose) in Morning and Evening Averaged Subject-rated Reflective TNSS |
-3.57; -2.31; -2.96; -1.48 | — |
Summary
This is a clinical study to evaluate the safety and efficacy of a bepotastine besilate-corticosteroid combination nasal spray for the treatment of seasonal allergic rhinitis (SAR) in an open exposure study with subjects who have a demonstrated history of Mountain Cedar pollen allergy. The primary study objective is to assess the reduction from baseline in averaged morning (AM) and evening (PM) values of reflective total nasal symptom scores for each of 3 nasal sprays (bepotastine besilate-fluticasone propionate combination nasal spray, bepotastine besilate nasal spray, fluticasone propionate nasal spray) compared to placebo nasal spray. For enrolled subjects, the study will involve a 7-10 day run-in screening period dosing with placebo nasal spray and then a 14-day treatment period where subjects will dose twice a day with 1 of the 4 test agent nasal sprays and record reflective and instantaneous scores for both nasal and ocular symptoms prior to each dosing.
Eligibility Criteria
Inclusion Criteria
- Male or female at least 12 years of age with a demonstrated history of Mountain Cedar pollen allergy
Exclusion Criteria
- No active nasal infection or nasal abnormality that would affect subject safety or symptom assessments
Data sourced from ClinicalTrials.gov (NCT01578278). 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.