Trial Outcomes & Findings for 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 (NCT NCT01578278)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

606 participants

Primary outcome timeframe

Baseline, 14 days

Results posted on

2020-10-05

Participant Flow

Participant milestones

Participant milestones
Measure	Bepotastine Besilate-fluticasone Propionate Nasal Spray Bepotastine besilate 4%-fluticasone propionate 0.05%: Nasal Spray	Bepotastine Besilate Formulation Nasal Spray Bepotastine besilate formulation 4%: Nasal Spray	Fluticasone Propionate Nasal Spray Fluticasone propionate 0.05%: Nasal Spray	Placebo Comparator Nasal Spray Placebo Comparator: Nasal Spray
Overall Study STARTED	152	152	154	148
Overall Study COMPLETED	148	150	150	139
Overall Study NOT COMPLETED	4	2	4	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bepotastine Besilate-fluticasone Propionate n=152 Participants Nasal Spray Bepotastine besilate 4%-fluticasone propionate 0.05%: Nasal Spray	Bepotastine Besilate Formulation n=152 Participants Nasal Spray Bepotastine besilate formulation 4%: Nasal Spray	Fluticasone Propionate n=154 Participants Nasal Spray Fluticasone propionate 0.05%: Nasal Spray	Placebo Comparator n=148 Participants Nasal Spray Placebo Comparator: Nasal Spray	Total n=606 Participants Total of all reporting groups
Age, Continuous	38.2 years STANDARD_DEVIATION 14.8 • n=5 Participants	43.4 years STANDARD_DEVIATION 14.4 • n=7 Participants	40.6 years STANDARD_DEVIATION 14.8 • n=5 Participants	43.6 years STANDARD_DEVIATION 13.9 • n=4 Participants	41.4 years STANDARD_DEVIATION 14.6 • n=21 Participants
Sex: Female, Male Female	110 Participants n=5 Participants	95 Participants n=7 Participants	89 Participants n=5 Participants	89 Participants n=4 Participants	383 Participants n=21 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	57 Participants n=7 Participants	65 Participants n=5 Participants	59 Participants n=4 Participants	223 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline, 14 days

Population: All randomized participants were included in the analysis population, with last observation carried forward used for missing data at 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.

Outcome measures

Outcome measures
Measure	Bepotastine Besilate-fluticasone Propionate n=152 Participants Nasal Spray Bepotastine besilate 4%-fluticasone propionate 0.05%: Nasal Spray	Bepotastine Besilate Formulation n=152 Participants Nasal Spray Bepotastine besilate formulation 4%: Nasal Spray	Fluticasone Propionate n=154 Participants Nasal Spray Fluticasone propionate 0.05%: Nasal Spray	Placebo Comparator n=148 Participants Nasal Spray Placebo Comparator: Nasal Spray
Mean Change From Baseline (Pre-Dose) in Morning and Evening Averaged Subject-rated Reflective TNSS	-3.57 score on a scale Standard Deviation 2.82	-2.31 score on a scale Standard Deviation 2.43	-2.96 score on a scale Standard Deviation 2.73	-1.48 score on a scale Standard Deviation 1.99

Adverse Events

Bepotastine Besilate-fluticasone Propionate

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Bepotastine Besilate Formulation

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Fluticasone Propionate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Comparator

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Bepotastine Besilate-fluticasone Propionate n=152 participants at risk Nasal Spray Bepotastine besilate-fluticasone propionate: Nasal Spray	Bepotastine Besilate Formulation n=152 participants at risk Nasal Spray Bepotastine besilate formulation: Nasal Spray	Fluticasone Propionate n=154 participants at risk Nasal Spray Fluticasone propionate: Nasal Spray	Placebo Comparator n=148 participants at risk Nasal Spray Placebo Comparator: Nasal Spray
General disorders Mild taste following instillation	5.9% 9/152 • 14 days	5.3% 8/152 • 14 days	0.00% 0/154 • 14 days	0.00% 0/148 • 14 days

Additional Information

Study Director

Bausch Health

Phone: 908-300-9920

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Contact sponsor directly for details.
Publication restrictions are in place

Restriction type: OTHER