Seasonal Allergic Rhinitis
Conditions
Brief summary
This is an efficacy study of bepotastine besilate nasal spray in seasonal allergic rhinitis.
Interventions
DRUGBepotastine Besilate Nasal Spray 2% Twice a day
nasal spray
DRUGBepotastine Besilate Nasal Spray 3% Twice a day
nasal spray
DRUGBepotastine Besilate Nasal Spray 4% Twice a day
nasal spray
DRUGPlacebo Nasal Spray
nasal spray
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female at least 12 years of age with a history of mountain cedar allergy
Exclusion criteria
* No active nasal infection or nasal abnormality that would affect subject safety or symptom assessments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline (Pre-Dose) in Subject-rated Reflective TNSS | Baseline, 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 2% Twice a Day Bepotastine Besilate Nasal Spray 2% Twice a day
Bepotastine Besilate Nasal Spray 2% Twice a day: nasal spray | 150 |
| 3% Twice a Day Bepotastine Besilate Nasal Spray 3% Twice a day
Bepotastine Besilate Nasal Spray 3% Twice a day: nasal spray | 150 |
| 4% Twice a Day Bepotastine Besilate Nasal Spray 4% Twice a day
Bepotastine Besilate Nasal Spray 4% Twice a day: nasal spray | 149 |
| Placebo Placebo nasal spray
Placebo Nasal Spray: nasal spray | 152 |
| Total | 601 |
Baseline characteristics
| Characteristic | 2% Twice a Day | 3% Twice a Day | 4% Twice a Day | Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 40.0 years STANDARD_DEVIATION 15.2 | 40.9 years STANDARD_DEVIATION 15.6 | 41.6 years STANDARD_DEVIATION 15.9 | 39.5 years STANDARD_DEVIATION 14.9 | 40.5 years STANDARD_DEVIATION 15.4 |
| Sex: Female, Male Female | 92 Participants | 94 Participants | 87 Participants | 90 Participants | 363 Participants |
| Sex: Female, Male Male | 58 Participants | 56 Participants | 62 Participants | 62 Participants | 238 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 / 150 | 1 / 150 | 0 / 149 | 0 / 152 |
| other Total, other adverse events | 25 / 150 | 22 / 150 | 22 / 149 | 10 / 152 |
| serious Total, serious adverse events | 0 / 150 | 1 / 150 | 0 / 149 | 0 / 152 |
Outcome results
Primary
Mean Change From Baseline (Pre-Dose) in Subject-rated Reflective TNSS
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.
Time frame: Baseline, 14 days
Population: All randomized participants were included in the analysis population, with no imputation of missing data at 14 days.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2% Twice a Day | Mean Change From Baseline (Pre-Dose) in Subject-rated Reflective TNSS | -1.84 score on a scale | Standard Deviation 1.8 |
| 3% Twice a Day | Mean Change From Baseline (Pre-Dose) in Subject-rated Reflective TNSS | -1.71 score on a scale | Standard Deviation 1.97 |
| 4% Twice a Day | Mean Change From Baseline (Pre-Dose) in Subject-rated Reflective TNSS | -1.47 score on a scale | Standard Deviation 1.88 |
| Placebo | Mean Change From Baseline (Pre-Dose) in Subject-rated Reflective TNSS | -0.99 score on a scale | Standard Deviation 1.69 |