NCT01753739

Bepotastine Besilate Nasal Sprays in the Treatment of Seasonal Allergic Rhinitis (SAR)

A Dose-Ranging Study to Evaluate the Safety and Efficacy of Bepotastine Besilate Nasal Sprays in the Treatment of Seasonal Allergic Rhinitis (SAR) in Subjects With a Demonstrated History of Mountain Cedar Pollen Allergic Sensitivity

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 617 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This study will examine dose ranging characteristics of bepotastine besilate nasal spray compared to placebo nasal spray in 600 male or female subjects 12 years of age and older with active seasonal allergic rhinitis (SAR) and a demonstrated history of allergic sensitivity to Mountain Cedar pollen for at least 2 years prior to the study.

Conditions

• Seasonal Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Bepotastine besilate	Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days
DRUG	Placebo	Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-02-01
• Completion: 2013-05-01
• First posted: 2012-12-20
• Last updated: 2020-10-05
• Results posted: 2020-09-14

Locations

1 site across 1 country: United States