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

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01753739
• Collaborator: (none)
• Enrollment: 617
• Location: 1
• Arms: 5
• Duration (Months): 3.9
• Patients Per Site Per Month: 156.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Seasonal Allergic Rhinitis	Drug: Bepotastine besilate; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 617 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: Jan 1, 2013
• Actual Primary Completion Date: Feb 1, 2013
• Actual Study Completion Date: May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bepotastine besilate Concentration 1 Bepotastine besilate nasal spray, BID for 14 days.	Drug: Bepotastine besilate; Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days
Active Comparator: Placebo Placebo nasal spray BID for 14 days	Drug: Placebo; Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days
Experimental: Bepotastine besilate Concentration 2 Bepotastine besilate nasal spray, BID for 14 days.	Drug: Bepotastine besilate; Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days
Experimental: Bepotastine besilate Concentration 3 Bepotastine besilate nasal spray, BID for 14 days.	Drug: Bepotastine besilate; Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days
Experimental: Bepotastine besilate Concentration 4 Bepotastine besilate nasal spray, BID for 14 days.	Drug: Bepotastine besilate; Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days

Outcome Measures

Primary Outcome Measures

1. Mean Change From Baseline (Pre-Dose) Twice Daily Averaged Subject-rated Reflective Total Nasal Symptom Score (TNSS) [14 Days]

   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

1. Mean Change From Baseline (Pre-Dose) in Morning Averaged Subject-rated Reflective (TNSS) [14 Days]

   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.

2. Mean Change From Baseline (Pre-Dose) in Evening Averaged Subject-rated Reflective Total Nasal Symptom Score (TNSS) [14 Days]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bausch & Lomb Incorporated	Irvine	California	United States	92618-2301

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

• Study Director: Jon Williams, Ph.D., Bausch & Lomb Incorporated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT01753739
• Other Study ID Numbers: 823
• First Posted: Dec 20, 2012
• Last Update Posted: Oct 5, 2020
• Last Verified: Oct 1, 2020

• Additional relevant MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Bepotastine besilate

Study Results

Participant Flow

Arm/Group Title	Placebo	Bepotastine Besilate 0.5%	Bepotastine Besilate 1%	Bepotastine Besilate 2%	Bepotastine Besilate 4%
Arm/Group Description	Placebo nasal spray BID for 14 days Placebo: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days	Bepotastine besilate nasal spray, BID for 14 days. Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days	Bepotastine besilate nasal spray, BID for 14 days. Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days	Bepotastine besilate nasal spray, BID for 14 days. Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days	Bepotastine besilate nasal spray, BID for 14 days. Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days
Period Title: Overall Study
STARTED	124	123	123	124	123
COMPLETED	120	118	118	117	120
NOT COMPLETED	4	5	5	7	3

Baseline Characteristics

Arm/Group Title	Placebo	Bepotastine Besilate 0.5%	Bepotastine Besilate 1%	Bepotastine Besilate 2%	Bepotastine Besilate 4%	Total
Arm/Group Description	Placebo nasal spray BID for 14 days Placebo: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days	Bepotastine besilate nasal spray, BID for 14 days. Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days	Bepotastine besilate nasal spray, BID for 14 days. Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days	Bepotastine besilate nasal spray, BID for 14 days. Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days	Bepotastine besilate nasal spray, BID for 14 days. Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days	Total of all reporting groups
Overall Participants	124	123	123	124	123	617
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41.9 (14.7)	41.3 (15.5)	41.3 (14.7)	42.4 (15.1)	39.8 (14.6)	41.3 (14.9)
Sex: Female, Male (Count of Participants)
Female	76 61.3%	74 60.2%	81 65.9%	77 62.1%	73 59.3%	381 61.8%
Male	48 38.7%	49 39.8%	42 34.1%	47 37.9%	50 40.7%	236 38.2%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

The analysis population included randomized participants who had received at least 1 dose of study drug. There was no imputation of missing data at Day 14.

Arm/Group Title	Placebo	Bepotastine Besilate 0.5%	Bepotastine Besilate 1%	Bepotastine Besilate 2%	Bepotastine Besilate 4%
Arm/Group Description	Placebo nasal spray BID for 14 days Placebo: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days	Bepotastine besilate nasal spray, BID for 14 days. Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days	Bepotastine besilate nasal spray, BID for 14 days. Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days	Bepotastine besilate nasal spray, BID for 14 days. Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days	Bepotastine besilate nasal spray, BID for 14 days. Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days
Measure Participants	122	121	122	122	123
Mean (Standard Deviation) [score on a scale]	-1.19 (2.22)	-1.58 (2.28)	-1.68 (2.24)	-1.63 (2.21)	-1.55 (2.23)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

The analysis population included randomized participants who had received at least 1 dose of study drug. There was no imputation of missing data at Day 14.

Arm/Group Title	Placebo	Bepotastine Besilate 0.5%	Bepotastine Besilate 1%	Bepotastine Besilate 2%	Bepotastine Besilate 4%
Arm/Group Description	Placebo nasal spray BID for 14 days Placebo: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days	Bepotastine besilate nasal spray, BID for 14 days. Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days	Bepotastine besilate nasal spray, BID for 14 days. Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days	Bepotastine besilate nasal spray, BID for 14 days. Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days	Bepotastine besilate nasal spray, BID for 14 days. Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days
Measure Participants	122	121	122	122	123
Mean (Standard Deviation) [score on a scale]	-1.29 (2.28)	-1.68 (2.35)	-1.72 (2.22)	-1.71 (2.31)	-1.66 (2.31)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

The analysis population included randomized participants who had received at least 1 dose of study drug. There was no imputation of missing data at Day 14.

Arm/Group Title	Placebo	Bepotastine Besilate 0.5%	Bepotastine Besilate 1%	Bepotastine Besilate 2%	Bepotastine Besilate 4%
Arm/Group Description	Placebo nasal spray BID for 14 days Placebo: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days	Bepotastine besilate nasal spray, BID for 14 days. Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days	Bepotastine besilate nasal spray, BID for 14 days. Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days	Bepotastine besilate nasal spray, BID for 14 days. Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days	Bepotastine besilate nasal spray, BID for 14 days. Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days
Measure Participants	122	121	122	122	123
Mean (Standard Deviation) [score on a scale]	-1.14 (2.24)	-1.55 (2.34)	-1.70 (2.33)	-1.60 (2.23)	-1.50 (2.25)

Adverse Events

Time Frame	14 days
Arm/Group Title	Placebo		Bepotastine Besilate 0.5%		Bepotastine Besilate 1%		Bepotastine Besilate 2%		Bepotastine Besilate 4%
Arm/Group Description	Placebo nasal spray BID for 14 days Placebo: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days		Bepotastine besilate nasal spray, BID for 14 days. Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days		Bepotastine besilate nasal spray, BID for 14 days. Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days		Bepotastine besilate nasal spray, BID for 14 days. Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days		Bepotastine besilate nasal spray, BID for 14 days. Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days
All Cause Mortality
	Placebo		Bepotastine Besilate 0.5%		Bepotastine Besilate 1%		Bepotastine Besilate 2%		Bepotastine Besilate 4%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/124 (0%)		0/123 (0%)		0/123 (0%)		0/124 (0%)		0/123 (0%)
Serious Adverse Events
	Placebo		Bepotastine Besilate 0.5%		Bepotastine Besilate 1%		Bepotastine Besilate 2%		Bepotastine Besilate 4%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/124 (0%)		0/123 (0%)		0/123 (0%)		0/124 (0%)		0/123 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Bepotastine Besilate 0.5%		Bepotastine Besilate 1%		Bepotastine Besilate 2%		Bepotastine Besilate 4%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/124 (0.8%)		8/123 (6.5%)		12/123 (9.8%)		15/124 (12.1%)		18/123 (14.6%)
General disorders
Mild taste following instillation	1/124 (0.8%)		8/123 (6.5%)		12/123 (9.8%)		15/124 (12.1%)		18/123 (14.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Contact sponsor directly for details.