Trial Outcomes & Findings for Safety, Pharmacokinetics, and Efficacy of Bepotastine Besilate Nasal Product After Ragweed Pollen Exposure in an Environmental Chamber (NCT NCT01222299)
NCT ID: NCT01222299
Last Updated: 2020-10-05
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 maximum score for increased allergic response of 12 units. The minimum possible total score was 0.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
89 participants
Primary outcome timeframe
Baseline, 20 days
Results posted on
2020-10-05
Participant Flow
Participant milestones
| Measure |
Placebo
placebo comparator nasal product
placebo comparator nasal product: sterile nasal product twice daily
|
Low Dose - 2%
bepotastine besilate nasal product - low dose
bepotastine besilate nasal product - low dose: sterile nasal product twice daily
|
Medium Dose - 4%
bepotastine besilate nasal product - medium dose
bepotastine besilate nasal product - medium dose: sterile nasal product twice daily
|
High Dose - 6%
bepotastine besilate nasal product - high dose
bepotastine besilate nasal product - high dose: sterile nasal product twice daily
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
23
|
22
|
23
|
|
Overall Study
COMPLETED
|
21
|
21
|
20
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
2
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Pharmacokinetics, and Efficacy of Bepotastine Besilate Nasal Product After Ragweed Pollen Exposure in an Environmental Chamber
Baseline characteristics by cohort
| Measure |
Placebo
n=21 Participants
placebo comparator nasal product
placebo comparator nasal product: sterile nasal product twice daily
|
Low Dose - 2%
n=23 Participants
bepotastine besilate nasal product - low dose
bepotastine besilate nasal product - low dose: sterile nasal product twice daily
|
Medium Dose - 4%
n=22 Participants
bepotastine besilate nasal product - medium dose
bepotastine besilate nasal product - medium dose: sterile nasal product twice daily
|
High Dose - 6%
n=23 Participants
bepotastine besilate nasal product - high dose
bepotastine besilate nasal product - high dose: sterile nasal product twice daily
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
40.1 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
44.3 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
42.1 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
41.5 years
STANDARD_DEVIATION 10.7 • n=4 Participants
|
42.1 years
STANDARD_DEVIATION 10.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, 20 daysPopulation: The per protocol population was based on participants who completed the study.
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 maximum score for increased allergic response of 12 units. The minimum possible total score was 0.
Outcome measures
| Measure |
Placebo
n=21 Participants
placebo comparator nasal product
placebo comparator nasal product: sterile nasal product twice daily
|
Low Dose - 2%
n=21 Participants
bepotastine besilate nasal product - low dose
bepotastine besilate nasal product - low dose: sterile nasal product twice daily
|
Medium Dose - 4%
n=20 Participants
bepotastine besilate nasal product - medium dose
bepotastine besilate nasal product - medium dose: sterile nasal product twice daily
|
High Dose - 6%
n=18 Participants
bepotastine besilate nasal product - high dose
bepotastine besilate nasal product - high dose: sterile nasal product twice daily
|
|---|---|---|---|---|
|
Mean Change From Baseline (Pre-Dose) in Subject-rated Instantaneous TNSS
Day 10 (after single dose)
|
-1.17 units on a scale
Standard Deviation 1.88
|
-0.69 units on a scale
Standard Deviation 2.42
|
-2.43 units on a scale
Standard Deviation 2.73
|
-1.65 units on a scale
Standard Deviation 1.95
|
|
Mean Change From Baseline (Pre-Dose) in Subject-rated Instantaneous TNSS
Day 20 (after twice daily dosing)
|
-1.63 units on a scale
Standard Deviation 2.37
|
-0.64 units on a scale
Standard Deviation 2.93
|
-2.52 units on a scale
Standard Deviation 2.55
|
-1.67 units on a scale
Standard Deviation 2.22
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Low Dose - 2%
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Medium Dose - 4%
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
High Dose - 6%
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=21 participants at risk
placebo comparator nasal product
placebo comparator nasal product: sterile nasal product twice daily
|
Low Dose - 2%
n=23 participants at risk
bepotastine besilate nasal product - low dose
bepotastine besilate nasal product - low dose: sterile nasal product twice daily
|
Medium Dose - 4%
n=22 participants at risk
bepotastine besilate nasal product - medium dose
bepotastine besilate nasal product - medium dose: sterile nasal product twice daily
|
High Dose - 6%
n=23 participants at risk
bepotastine besilate nasal product - high dose
bepotastine besilate nasal product - high dose: sterile nasal product twice daily
|
|---|---|---|---|---|
|
General disorders
Mild taste following instillation
|
4.8%
1/21 • 20 days
|
21.7%
5/23 • 20 days
|
22.7%
5/22 • 20 days
|
26.1%
6/23 • 20 days
|
|
Nervous system disorders
Headache
|
19.0%
4/21 • 20 days
|
4.3%
1/23 • 20 days
|
4.5%
1/22 • 20 days
|
4.3%
1/23 • 20 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/21 • 20 days
|
4.3%
1/23 • 20 days
|
9.1%
2/22 • 20 days
|
4.3%
1/23 • 20 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/21 • 20 days
|
0.00%
0/23 • 20 days
|
9.1%
2/22 • 20 days
|
8.7%
2/23 • 20 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
4.8%
1/21 • 20 days
|
8.7%
2/23 • 20 days
|
9.1%
2/22 • 20 days
|
4.3%
1/23 • 20 days
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/21 • 20 days
|
0.00%
0/23 • 20 days
|
9.1%
2/22 • 20 days
|
0.00%
0/23 • 20 days
|
|
Gastrointestinal disorders
Nausea
|
9.5%
2/21 • 20 days
|
0.00%
0/23 • 20 days
|
0.00%
0/22 • 20 days
|
0.00%
0/23 • 20 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Contact sponsor directly for details.
- Publication restrictions are in place
Restriction type: OTHER