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

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01277341
• Collaborator: (none)
• Enrollment: 601
• Location: 1
• Arms: 4
• Duration (Months): 5
• Patients Per Site Per Month: 121.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Seasonal Allergic Rhinitis	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	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 601 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Dec 1, 2010
• Actual Primary Completion Date: Feb 1, 2011
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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
Placebo Comparator: Placebo Placebo nasal spray	Drug: Placebo Nasal Spray; nasal spray

Outcome Measures

Primary Outcome Measures

1. Mean Change From Baseline (Pre-Dose) in Subject-rated Reflective TNSS [Baseline, 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.

Eligibility Criteria

Criteria

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ISTA Pharmaceuticals, Inc.	Irvine	California	United States	92618

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

• Study Director: Tim McNamara, PharmD, ISTA Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT01277341
• Other Study ID Numbers: S00082
• First Posted: Jan 14, 2011
• 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	2% Twice a Day	3% Twice a Day	4% Twice a Day	Placebo
Arm/Group Description	Bepotastine Besilate Nasal Spray 2% Twice a day Bepotastine Besilate Nasal Spray 2% Twice a day: nasal spray	Bepotastine Besilate Nasal Spray 3% Twice a day Bepotastine Besilate Nasal Spray 3% Twice a day: nasal spray	Bepotastine Besilate Nasal Spray 4% Twice a day Bepotastine Besilate Nasal Spray 4% Twice a day: nasal spray	Placebo nasal spray Placebo Nasal Spray: nasal spray
Period Title: Overall Study
STARTED	150	150	149	152
COMPLETED	146	145	145	146
NOT COMPLETED	4	5	4	6

Baseline Characteristics

Arm/Group Title	2% Twice a Day	3% Twice a Day	4% Twice a Day	Placebo	Total
Arm/Group Description	Bepotastine Besilate Nasal Spray 2% Twice a day Bepotastine Besilate Nasal Spray 2% Twice a day: nasal spray	Bepotastine Besilate Nasal Spray 3% Twice a day Bepotastine Besilate Nasal Spray 3% Twice a day: nasal spray	Bepotastine Besilate Nasal Spray 4% Twice a day Bepotastine Besilate Nasal Spray 4% Twice a day: nasal spray	Placebo nasal spray Placebo Nasal Spray: nasal spray	Total of all reporting groups
Overall Participants	150	150	149	152	601
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.0 (15.2)	40.9 (15.6)	41.6 (15.9)	39.5 (14.9)	40.5 (15.4)
Sex: Female, Male (Count of Participants)
Female	92 61.3%	94 62.7%	87 58.4%	90 59.2%	363 60.4%
Male	58 38.7%	56 37.3%	62 41.6%	62 40.8%	238 39.6%

Outcome Measures

1. Primary Outcome

Title	Mean Change From Baseline (Pre-Dose) in 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. Morning and evening scores were averaged.
Time Frame	Baseline, 14 days

Outcome Measure Data

Analysis Population Description

All randomized participants were included in the analysis population, with no imputation of missing data at 14 days.

Arm/Group Title	2% Twice a Day	3% Twice a Day	4% Twice a Day	Placebo
Arm/Group Description	Bepotastine Besilate Nasal Spray 2% Twice a day Bepotastine Besilate Nasal Spray 2% Twice a day: nasal spray	Bepotastine Besilate Nasal Spray 3% Twice a day Bepotastine Besilate Nasal Spray 3% Twice a day: nasal spray	Bepotastine Besilate Nasal Spray 4% Twice a day Bepotastine Besilate Nasal Spray 4% Twice a day: nasal spray	Placebo nasal spray Placebo Nasal Spray: nasal spray
Measure Participants	135	134	128	130
Mean (Standard Deviation) [score on a scale]	-1.84 (1.80)	-1.71 (1.97)	-1.47 (1.88)	-0.99 (1.69)

Adverse Events

Time Frame	14 days
Arm/Group Title	2% Twice a Day		3% Twice a Day		4% Twice a Day		Placebo
Arm/Group Description	Bepotastine Besilate Nasal Spray 2% Twice a day Bepotastine Besilate Nasal Spray 2% Twice a day: nasal spray		Bepotastine Besilate Nasal Spray 3% Twice a day Bepotastine Besilate Nasal Spray 3% Twice a day: nasal spray		Bepotastine Besilate Nasal Spray 4% Twice a day Bepotastine Besilate Nasal Spray 4% Twice a day: nasal spray		Placebo nasal spray Placebo Nasal Spray: nasal spray
All Cause Mortality
	2% Twice a Day		3% Twice a Day		4% Twice a Day		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/150 (0%)		1/150 (0.7%)		0/149 (0%)		0/152 (0%)
Serious Adverse Events
	2% Twice a Day		3% Twice a Day		4% Twice a Day		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/150 (0%)		1/150 (0.7%)		0/149 (0%)		0/152 (0%)
General disorders
Death	0/150 (0%)		1/150 (0.7%)		0/149 (0%)		0/152 (0%)
Other (Not Including Serious) Adverse Events
	2% Twice a Day		3% Twice a Day		4% Twice a Day		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	25/150 (16.7%)		22/150 (14.7%)		22/149 (14.8%)		10/152 (6.6%)
General disorders
Mild taste following instillation	25/150 (16.7%)	150	22/150 (14.7%)	150	22/149 (14.8%)	149	10/152 (6.6%)	152

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Please contact sponsor directly for details.