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

NCT01753739 | Completed Phase 2 Results

• 1 other identifier: 823
• Study Type: interventional
• Target: 617
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline (Pre-Dose) Twice Daily Averaged Subject-rated Reflective Total Nasal Symptom Score (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.

  14 Days

Secondary Outcomes (2)

• Mean Change From Baseline (Pre-Dose) in Morning Averaged Subject-rated Reflective (TNSS)

  14 Days

• Mean Change From Baseline (Pre-Dose) in Evening Averaged Subject-rated Reflective Total Nasal Symptom Score (TNSS)

  14 Days

Study Arms (5)

Bepotastine besilate Concentration 1

EXPERIMENTAL

Bepotastine besilate nasal spray, BID for 14 days.

Drug: Bepotastine besilate

Placebo

ACTIVE COMPARATOR

Placebo nasal spray BID for 14 days

Drug: Placebo

Bepotastine besilate Concentration 2

EXPERIMENTAL

Bepotastine besilate nasal spray, BID for 14 days.

Drug: Bepotastine besilate

Bepotastine besilate Concentration 3

EXPERIMENTAL

Bepotastine besilate nasal spray, BID for 14 days.

Drug: Bepotastine besilate

Bepotastine besilate Concentration 4

EXPERIMENTAL

Bepotastine besilate nasal spray, BID for 14 days.

Drug: Bepotastine besilate

Interventions

Bepotastine besilate DRUG

Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days

Bepotastine besilate Concentration 1; Bepotastine besilate Concentration 2; Bepotastine besilate Concentration 3; Bepotastine besilate Concentration 4

Placebo DRUG

Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days

Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is a male or female 12 years of age or older.
• Have a documented history of SAR resulting from exposure to Mountain Cedar pollen for a minimum of 2 years immediately preceding Screening Visit 1.
• Have demonstrated sensitivity to Mountain Cedar pollen through a standard skin prick test.
• Have a minimum rTNSS of at least 6 units for the morning (AM) assessment on the day of Visit 2 and Visit 3.
• Have a minimum average rTNSS score of at least 6 units for 3 of the worst 4 days prior to Visit 3 plus the AM assessment on the day of Visit 3.
• Have a minimum stuffy nose score of at least 2 units on the day of Visit 3.
• Have a minimum average stuffy nose score of at least 2 units for 3 of the worst 4 days prior to Visit 3 plus the AM assessment on the day of Visit 3.
• Have at least one score ≥ 2 units at Visit 3 of any of the RQLQ(S) questions #4-#6 regarding sleep.

You may not qualify if:

• Have a nasal condition which, in the opinion of the Investigator, interferes with successful nasal drug administration or absorption (in either nostril) within the last 60 days prior to Screening Visit 2.
• Have asthma requiring medication other than intermittent use of an inhaled short-acting β-agonist.
• Is participating or have participated in any investigational drug or device study within 30 days preceding Visit 2.
• Have had nasal or sinus surgery within 12 weeks of Visit 2.
• Have a known sensitivity to bepotastine besilate or any excipient component of the investigational product (IP).

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Bausch & Lomb Incorporated

Irvine, California, 92618-2301, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

bepotastine besilate

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Bausch Health

susan.harris@bauschhealth.com

908-300-9920

Study Officials

• Jon Williams, Ph.D.

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2012
• First Posted: December 20, 2012
• Study Start: January 1, 2013
• Primary Completion: February 1, 2013
• Study Completion: May 1, 2013
• Last Updated: October 5, 2020
• Results First Posted: September 14, 2020

Record last verified: 2020-10

Locations

US (1)