Safety and Efficacy of Bepotastine Besilate Nasal Spray in the Treatment of Seasonal Allergic Rhinitis

This is an efficacy study of bepotastine besilate nasal spray in seasonal allergic rhinitis.

Study Overview

• Status: Completed
• Conditions: Seasonal Allergic Rhinitis
• Intervention / Treatment: Drug: Bepotastine Besilate Nasal Spray 2% Twice a day; Drug: Bepotastine Besilate Nasal Spray 3% Twice a day; Drug: Bepotastine Besilate Nasal Spray 4% Twice a day; Drug: Placebo Nasal Spray

• Study Type: Interventional
• Enrollment (Actual): 601
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92618
      • ISTA Pharmaceuticals, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo nasal spray	Drug: Placebo Nasal Spray; nasal spray
Experimental: 2% Twice a day; Bepotastine Besilate Nasal Spray 2% Twice a day	Drug: Bepotastine Besilate Nasal Spray 2% Twice a day; nasal spray
Experimental: 3% Twice a day; Bepotastine Besilate Nasal Spray 3% Twice a day	Drug: Bepotastine Besilate Nasal Spray 3% Twice a day; nasal spray
Experimental: 4% Twice a day; Bepotastine Besilate Nasal Spray 4% Twice a day	Drug: Bepotastine Besilate Nasal Spray 4% Twice a day; nasal spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline (Pre-Dose) in Subject-rated Reflective TNSS	Total nasal symptom score (TNSS) was the summed scores for nasal pruritus [itching], rhinorrhea [runny nose], nasal congestion, and sneezing. Individual nasal symptoms were each rated on a 4-point scale from 0-3 (0=Absent, 1=Mild, 2=Moderate, 3=Severe), with no half-unit assessments. TNSS was the sum score of 4 nasal symptoms with a minimum score of 0 units and a maximum score of 12 units, with higher score corresponding to increased nasal allergy symptoms. Morning and evening scores were averaged.	Baseline, 14 days

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: January 7, 2011
• First Submitted That Met QC Criteria: January 13, 2011
• First Posted (Estimate): January 14, 2011

Study Record Updates

• Last Update Posted (Actual): October 5, 2020
• Last Update Submitted That Met QC Criteria: October 1, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Anti-Allergic Agents; Bepotastine besilate
• Other Study ID Numbers: S00082