Seasonal Allergic Rhinitis
Conditions
Brief summary
The purpose of this study is to examine the safety and efficacy of bepotastine besilate nasal product in seasonal allergic rhinitis patients.
Interventions
DRUGbepotastine besilate nasal product - low dose
sterile nasal product
DRUGbepotastine besilate nasal product - medium dose
sterile nasal product
DRUGbepotastine besilate nasal product - high dose
sterile nasal product
DRUGplacebo comparator nasal product
sterile nasal product
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects 18 to 65 years of age with a positive skin prick test with ragweed allergen
Exclusion criteria
* No active respiratory tract infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline (Pre-Dose) in Subject-rated Instantaneous TNSS | Baseline, 20 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 maximum score for increased allergic response of 12 units. The minimum possible total score was 0. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo placebo comparator nasal product
placebo comparator nasal product: sterile nasal product twice daily | 21 |
| Low Dose - 2% bepotastine besilate nasal product - low dose
bepotastine besilate nasal product - low dose: sterile nasal product twice daily | 23 |
| Medium Dose - 4% bepotastine besilate nasal product - medium dose
bepotastine besilate nasal product - medium dose: sterile nasal product twice daily | 22 |
| High Dose - 6% bepotastine besilate nasal product - high dose
bepotastine besilate nasal product - high dose: sterile nasal product twice daily | 23 |
| Total | 89 |
Baseline characteristics
| Characteristic | Placebo | Low Dose - 2% | Medium Dose - 4% | High Dose - 6% | Total |
|---|---|---|---|---|---|
| Age, Continuous | 40.1 years STANDARD_DEVIATION 10.5 | 44.3 years STANDARD_DEVIATION 9.5 | 42.1 years STANDARD_DEVIATION 10.2 | 41.5 years STANDARD_DEVIATION 10.7 | 42.1 years STANDARD_DEVIATION 10.2 |
| Sex: Female, Male Female | 13 Participants | 10 Participants | 12 Participants | 11 Participants | 46 Participants |
| Sex: Female, Male Male | 8 Participants | 13 Participants | 10 Participants | 12 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 23 | 0 / 22 | 0 / 23 |
| other Total, other adverse events | 7 / 21 | 9 / 23 | 9 / 22 | 11 / 23 |
| serious Total, serious adverse events | 0 / 21 | 0 / 23 | 0 / 22 | 0 / 23 |
Outcome results
Primary
Mean Change From Baseline (Pre-Dose) in Subject-rated Instantaneous TNSS
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.
Time frame: Baseline, 20 days
Population: The per protocol population was based on participants who completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 |
| Placebo | 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 |
| Low Dose - 2% | Mean Change From Baseline (Pre-Dose) in Subject-rated Instantaneous TNSS | Day 20 (after twice daily dosing) | -0.64 units on a scale | Standard Deviation 2.93 |
| Low Dose - 2% | Mean Change From Baseline (Pre-Dose) in Subject-rated Instantaneous TNSS | Day 10 (after single dose) | -0.69 units on a scale | Standard Deviation 2.42 |
| Medium Dose - 4% | Mean Change From Baseline (Pre-Dose) in Subject-rated Instantaneous TNSS | Day 10 (after single dose) | -2.43 units on a scale | Standard Deviation 2.73 |
| Medium Dose - 4% | Mean Change From Baseline (Pre-Dose) in Subject-rated Instantaneous TNSS | Day 20 (after twice daily dosing) | -2.52 units on a scale | Standard Deviation 2.55 |
| High Dose - 6% | Mean Change From Baseline (Pre-Dose) in Subject-rated Instantaneous TNSS | Day 10 (after single dose) | -1.65 units on a scale | Standard Deviation 1.95 |
| High Dose - 6% | Mean Change From Baseline (Pre-Dose) in Subject-rated Instantaneous TNSS | Day 20 (after twice daily dosing) | -1.67 units on a scale | Standard Deviation 2.22 |