Bepotastine Besilate-corticosteroid Nasal Spray Combination Compared to Placebo, Bepotastine Besilate Nasal Spray, and Corticosteroid Nasal Spray in the Treatment of Patients With Seasonal Allergic Rhinitis

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01578278
• Collaborator: (none)
• Enrollment: 606
• Location: 1
• Arms: 4
• Duration (Months): 8
• Patients Per Site Per Month: 75.6

Study Details

Study Description

Brief Summary

This is a clinical study to evaluate the safety and efficacy of a bepotastine besilate-corticosteroid combination nasal spray for the treatment of seasonal allergic rhinitis (SAR) in an open exposure study with subjects who have a demonstrated history of Mountain Cedar pollen allergy. The primary study objective is to assess the reduction from baseline in averaged morning (AM) and evening (PM) values of reflective total nasal symptom scores for each of 3 nasal sprays (bepotastine besilate-fluticasone propionate combination nasal spray, bepotastine besilate nasal spray, fluticasone propionate nasal spray) compared to placebo nasal spray. For enrolled subjects, the study will involve a 7-10 day run-in screening period dosing with placebo nasal spray and then a 14-day treatment period where subjects will dose twice a day with 1 of the 4 test agent nasal sprays and record reflective and instantaneous scores for both nasal and ocular symptoms prior to each dosing.

Condition or Disease	Intervention/Treatment	Phase
Seasonal Allergic Rhinitis	Drug: Bepotastine besilate formulation; Drug: Fluticasone propionate; Drug: Bepotastine besilate-fluticasone propionate; Drug: Placebo Comparator	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 606 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Dec 1, 2011
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bepotastine besilate formulation Nasal Spray	Drug: Bepotastine besilate formulation; Nasal Spray
Experimental: Fluticasone propionate Nasal Spray	Drug: Fluticasone propionate; Nasal Spray
Experimental: Bepotastine besilate-fluticasone propionate Nasal Spray	Drug: Bepotastine besilate-fluticasone propionate; Nasal Spray
Placebo Comparator: Placebo Comparator Nasal Spray	Drug: Placebo Comparator; Nasal Spray

Outcome Measures

Primary Outcome Measures

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

   Total nasal symptom scores (TNSS) was the summed scores for nasal pruritus [itching], rhinorrhea [runny nose], nasal congestion, and sneezing. Individual nasal symptoms were 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 and a maximum score of 12 units, with higher score corresponding to increased severity of nasal allergy symptoms. The 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 demonstrated history of Mountain Cedar pollen 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: NCT01578278
• Other Study ID Numbers: S00186
• First Posted: Apr 16, 2012
• Last Update Posted: Oct 5, 2020
• Last Verified: Oct 1, 2020

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

Study Results

Participant Flow

Arm/Group Title	Bepotastine Besilate-fluticasone Propionate	Bepotastine Besilate Formulation	Fluticasone Propionate	Placebo Comparator
Arm/Group Description	Nasal Spray Bepotastine besilate 4%-fluticasone propionate 0.05%: Nasal Spray	Nasal Spray Bepotastine besilate formulation 4%: Nasal Spray	Nasal Spray Fluticasone propionate 0.05%: Nasal Spray	Nasal Spray Placebo Comparator: Nasal Spray
Period Title: Overall Study
STARTED	152	152	154	148
COMPLETED	148	150	150	139
NOT COMPLETED	4	2	4	9

Baseline Characteristics

Arm/Group Title	Bepotastine Besilate-fluticasone Propionate	Bepotastine Besilate Formulation	Fluticasone Propionate	Placebo Comparator	Total
Arm/Group Description	Nasal Spray Bepotastine besilate 4%-fluticasone propionate 0.05%: Nasal Spray	Nasal Spray Bepotastine besilate formulation 4%: Nasal Spray	Nasal Spray Fluticasone propionate 0.05%: Nasal Spray	Nasal Spray Placebo Comparator: Nasal Spray	Total of all reporting groups
Overall Participants	152	152	154	148	606
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38.2 (14.8)	43.4 (14.4)	40.6 (14.8)	43.6 (13.9)	41.4 (14.6)
Sex: Female, Male (Count of Participants)
Female	110 72.4%	95 62.5%	89 57.8%	89 60.1%	383 63.2%
Male	42 27.6%	57 37.5%	65 42.2%	59 39.9%	223 36.8%

Outcome Measures

1. Primary Outcome

Title	Mean Change From Baseline (Pre-Dose) in Morning and Evening Averaged Subject-rated Reflective TNSS
Description	Total nasal symptom scores (TNSS) was the summed scores for nasal pruritus [itching], rhinorrhea [runny nose], nasal congestion, and sneezing. Individual nasal symptoms were 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 and a maximum score of 12 units, with higher score corresponding to increased severity of nasal allergy symptoms. The 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 last observation carried forward used for missing data at 14 days.

Arm/Group Title	Bepotastine Besilate-fluticasone Propionate	Bepotastine Besilate Formulation	Fluticasone Propionate	Placebo Comparator
Arm/Group Description	Nasal Spray Bepotastine besilate 4%-fluticasone propionate 0.05%: Nasal Spray	Nasal Spray Bepotastine besilate formulation 4%: Nasal Spray	Nasal Spray Fluticasone propionate 0.05%: Nasal Spray	Nasal Spray Placebo Comparator: Nasal Spray
Measure Participants	152	152	154	148
Mean (Standard Deviation) [score on a scale]	-3.57 (2.82)	-2.31 (2.43)	-2.96 (2.73)	-1.48 (1.99)

Adverse Events

Time Frame	14 days
Arm/Group Title	Bepotastine Besilate-fluticasone Propionate		Bepotastine Besilate Formulation		Fluticasone Propionate		Placebo Comparator
Arm/Group Description	Nasal Spray Bepotastine besilate-fluticasone propionate: Nasal Spray		Nasal Spray Bepotastine besilate formulation: Nasal Spray		Nasal Spray Fluticasone propionate: Nasal Spray		Nasal Spray Placebo Comparator: Nasal Spray
All Cause Mortality
	Bepotastine Besilate-fluticasone Propionate		Bepotastine Besilate Formulation		Fluticasone Propionate		Placebo Comparator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/152 (0%)		0/152 (0%)		0/154 (0%)		0/148 (0%)
Serious Adverse Events
	Bepotastine Besilate-fluticasone Propionate		Bepotastine Besilate Formulation		Fluticasone Propionate		Placebo Comparator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/152 (0%)		0/152 (0%)		0/154 (0%)		0/148 (0%)
Other (Not Including Serious) Adverse Events
	Bepotastine Besilate-fluticasone Propionate		Bepotastine Besilate Formulation		Fluticasone Propionate		Placebo Comparator
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/152 (5.9%)		8/152 (5.3%)		0/154 (0%)		0/148 (0%)
General disorders
Mild taste following instillation	9/152 (5.9%)		8/152 (5.3%)		0/154 (0%)		0/148 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Contact sponsor directly for details.