Trial Outcomes & Findings for Safety and Efficacy of Bepotastine Besilate Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (NCT NCT01277341)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

601 participants

Primary outcome timeframe

Baseline, 14 days

Results posted on

2020-10-05

Participant Flow

Participant milestones

Participant milestones
Measure	2% Twice a Day Bepotastine Besilate Nasal Spray 2% Twice a day Bepotastine Besilate Nasal Spray 2% Twice a day: nasal spray	3% Twice a Day Bepotastine Besilate Nasal Spray 3% Twice a day Bepotastine Besilate Nasal Spray 3% Twice a day: nasal spray	4% Twice a Day Bepotastine Besilate Nasal Spray 4% Twice a day Bepotastine Besilate Nasal Spray 4% Twice a day: nasal spray	Placebo Placebo nasal spray Placebo Nasal Spray: nasal spray
Overall Study STARTED	150	150	149	152
Overall Study COMPLETED	146	145	145	146
Overall Study NOT COMPLETED	4	5	4	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	2% Twice a Day n=150 Participants Bepotastine Besilate Nasal Spray 2% Twice a day Bepotastine Besilate Nasal Spray 2% Twice a day: nasal spray	3% Twice a Day n=150 Participants Bepotastine Besilate Nasal Spray 3% Twice a day Bepotastine Besilate Nasal Spray 3% Twice a day: nasal spray	4% Twice a Day n=149 Participants Bepotastine Besilate Nasal Spray 4% Twice a day Bepotastine Besilate Nasal Spray 4% Twice a day: nasal spray	Placebo n=152 Participants Placebo nasal spray Placebo Nasal Spray: nasal spray	Total n=601 Participants Total of all reporting groups
Age, Continuous	40.0 years STANDARD_DEVIATION 15.2 • n=5 Participants	40.9 years STANDARD_DEVIATION 15.6 • n=7 Participants	41.6 years STANDARD_DEVIATION 15.9 • n=5 Participants	39.5 years STANDARD_DEVIATION 14.9 • n=4 Participants	40.5 years STANDARD_DEVIATION 15.4 • n=21 Participants
Sex: Female, Male Female	92 Participants n=5 Participants	94 Participants n=7 Participants	87 Participants n=5 Participants	90 Participants n=4 Participants	363 Participants n=21 Participants
Sex: Female, Male Male	58 Participants n=5 Participants	56 Participants n=7 Participants	62 Participants n=5 Participants	62 Participants n=4 Participants	238 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline, 14 days

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

Outcome measures

Outcome measures
Measure	2% Twice a Day n=135 Participants Bepotastine Besilate Nasal Spray 2% Twice a day Bepotastine Besilate Nasal Spray 2% Twice a day: nasal spray	3% Twice a Day n=134 Participants Bepotastine Besilate Nasal Spray 3% Twice a day Bepotastine Besilate Nasal Spray 3% Twice a day: nasal spray	4% Twice a Day n=128 Participants Bepotastine Besilate Nasal Spray 4% Twice a day Bepotastine Besilate Nasal Spray 4% Twice a day: nasal spray	Placebo n=130 Participants Placebo nasal spray Placebo Nasal Spray: nasal spray
Mean Change From Baseline (Pre-Dose) in Subject-rated Reflective TNSS	-1.84 score on a scale Standard Deviation 1.80	-1.71 score on a scale Standard Deviation 1.97	-1.47 score on a scale Standard Deviation 1.88	-0.99 score on a scale Standard Deviation 1.69

Adverse Events

2% Twice a Day

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

3% Twice a Day

Serious events: 1 serious events

Other events: 22 other events

Deaths: 1 deaths

4% Twice a Day

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	2% Twice a Day n=150 participants at risk Bepotastine Besilate Nasal Spray 2% Twice a day Bepotastine Besilate Nasal Spray 2% Twice a day: nasal spray	3% Twice a Day n=150 participants at risk Bepotastine Besilate Nasal Spray 3% Twice a day Bepotastine Besilate Nasal Spray 3% Twice a day: nasal spray	4% Twice a Day n=149 participants at risk Bepotastine Besilate Nasal Spray 4% Twice a day Bepotastine Besilate Nasal Spray 4% Twice a day: nasal spray	Placebo n=152 participants at risk Placebo nasal spray Placebo Nasal Spray: nasal spray
General disorders Death	0.00% 0/150 • 14 days	0.67% 1/150 • 14 days	0.00% 0/149 • 14 days	0.00% 0/152 • 14 days

Other adverse events

Other adverse events
Measure	2% Twice a Day n=150 participants at risk Bepotastine Besilate Nasal Spray 2% Twice a day Bepotastine Besilate Nasal Spray 2% Twice a day: nasal spray	3% Twice a Day n=150 participants at risk Bepotastine Besilate Nasal Spray 3% Twice a day Bepotastine Besilate Nasal Spray 3% Twice a day: nasal spray	4% Twice a Day n=149 participants at risk Bepotastine Besilate Nasal Spray 4% Twice a day Bepotastine Besilate Nasal Spray 4% Twice a day: nasal spray	Placebo n=152 participants at risk Placebo nasal spray Placebo Nasal Spray: nasal spray
General disorders Mild taste following instillation	16.7% 25/150 • Number of events 150 • 14 days	14.7% 22/150 • Number of events 150 • 14 days	14.8% 22/149 • Number of events 149 • 14 days	6.6% 10/152 • Number of events 152 • 14 days

Additional Information

Study Director

Bausch Health

Phone: 908-300-9920

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER