Trial Outcomes & Findings for Bepotastine Besilate Nasal Sprays in the Treatment of Seasonal Allergic Rhinitis (SAR) (NCT NCT01753739)

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

617 participants

Primary outcome timeframe

14 Days

Results posted on

2020-10-05

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo 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 0.5% 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 1% 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 2% 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 4% 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
Overall Study STARTED	124	123	123	124	123
Overall Study COMPLETED	120	118	118	117	120
Overall Study NOT COMPLETED	4	5	5	7	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=124 Participants 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 0.5% n=123 Participants 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 1% n=123 Participants 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 2% n=124 Participants 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 4% n=123 Participants 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 n=617 Participants Total of all reporting groups
Age, Continuous	41.9 years STANDARD_DEVIATION 14.7 • n=5 Participants	41.3 years STANDARD_DEVIATION 15.5 • n=7 Participants	41.3 years STANDARD_DEVIATION 14.7 • n=5 Participants	42.4 years STANDARD_DEVIATION 15.1 • n=4 Participants	39.8 years STANDARD_DEVIATION 14.6 • n=21 Participants	41.3 years STANDARD_DEVIATION 14.9 • n=8 Participants
Sex: Female, Male Female	76 Participants n=5 Participants	74 Participants n=7 Participants	81 Participants n=5 Participants	77 Participants n=4 Participants	73 Participants n=21 Participants	381 Participants n=8 Participants
Sex: Female, Male Male	48 Participants n=5 Participants	49 Participants n=7 Participants	42 Participants n=5 Participants	47 Participants n=4 Participants	50 Participants n=21 Participants	236 Participants n=8 Participants

PRIMARY outcome

Timeframe: 14 Days

Population: 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.

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	Placebo n=122 Participants 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 0.5% n=121 Participants 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 1% n=122 Participants 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 2% n=122 Participants 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 4% n=123 Participants 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
Mean Change From Baseline (Pre-Dose) Twice Daily Averaged Subject-rated Reflective Total Nasal Symptom Score (TNSS)	-1.19 score on a scale Standard Deviation 2.22	-1.58 score on a scale Standard Deviation 2.28	-1.68 score on a scale Standard Deviation 2.24	-1.63 score on a scale Standard Deviation 2.21	-1.55 score on a scale Standard Deviation 2.23

SECONDARY outcome

Timeframe: 14 Days

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Placebo n=122 Participants 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 0.5% n=121 Participants 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 1% n=122 Participants 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 2% n=122 Participants 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 4% n=123 Participants 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
Mean Change From Baseline (Pre-Dose) in Morning Averaged Subject-rated Reflective (TNSS)	-1.29 score on a scale Standard Deviation 2.28	-1.68 score on a scale Standard Deviation 2.35	-1.72 score on a scale Standard Deviation 2.22	-1.71 score on a scale Standard Deviation 2.31	-1.66 score on a scale Standard Deviation 2.31

SECONDARY outcome

Timeframe: 14 Days

Population: 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.

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.