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

Primary Purpose

Seasonal Allergic Rhinitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bepotastine besilate
Placebo
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
  • For female subjects 12 years of age or older (other than those who have been menopausal for at least 24 months or those who are surgically sterile), are pregnant, planning to become pregnant, or nursing/lactating, or refuses to abide by the contraception stipulations in the inclusion criteria.

Sites / Locations

  • Bausch & Lomb Incorporated

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Bepotastine besilate Concentration 1

Placebo

Bepotastine besilate Concentration 2

Bepotastine besilate Concentration 3

Bepotastine besilate Concentration 4

Arm Description

Bepotastine besilate nasal spray, BID for 14 days.

Placebo nasal spray BID for 14 days

Bepotastine besilate nasal spray, BID for 14 days.

Bepotastine besilate nasal spray, BID for 14 days.

Bepotastine besilate nasal spray, BID for 14 days.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mean Change From Baseline (Pre-Dose) in Morning Averaged 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.
Mean Change From Baseline (Pre-Dose) in Evening 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.

Full Information

First Posted
December 18, 2012
Last Updated
October 1, 2020
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01753739
Brief Title
Bepotastine Besilate Nasal Sprays in the Treatment of Seasonal Allergic Rhinitis (SAR)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
617 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bepotastine besilate Concentration 1
Arm Type
Experimental
Arm Description
Bepotastine besilate nasal spray, BID for 14 days.
Arm Title
Placebo
Arm Type
Active Comparator
Arm Description
Placebo nasal spray BID for 14 days
Arm Title
Bepotastine besilate Concentration 2
Arm Type
Experimental
Arm Description
Bepotastine besilate nasal spray, BID for 14 days.
Arm Title
Bepotastine besilate Concentration 3
Arm Type
Experimental
Arm Description
Bepotastine besilate nasal spray, BID for 14 days.
Arm Title
Bepotastine besilate Concentration 4
Arm Type
Experimental
Arm Description
Bepotastine besilate nasal spray, BID for 14 days.
Intervention Type
Drug
Intervention Name(s)
Bepotastine besilate
Intervention Description
Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days
Primary Outcome Measure Information:
Title
Mean Change From Baseline (Pre-Dose) Twice Daily Averaged Subject-rated Reflective Total Nasal Symptom Score (TNSS)
Description
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.
Time Frame
14 Days
Secondary Outcome Measure Information:
Title
Mean Change From Baseline (Pre-Dose) in Morning Averaged Subject-rated Reflective (TNSS)
Description
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.
Time Frame
14 Days
Title
Mean Change From Baseline (Pre-Dose) in Evening Averaged Subject-rated Reflective Total Nasal Symptom Score (TNSS)
Description
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.
Time Frame
14 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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). For female subjects 12 years of age or older (other than those who have been menopausal for at least 24 months or those who are surgically sterile), are pregnant, planning to become pregnant, or nursing/lactating, or refuses to abide by the contraception stipulations in the inclusion criteria.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jon Williams, Ph.D.
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Bausch & Lomb Incorporated
City
Irvine
State/Province
California
ZIP/Postal Code
92618-2301
Country
United States

12. IPD Sharing Statement

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

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