Seasonal Allergic Rhinitis
Conditions
Brief summary
This is a clinical study to evaluate the safety and efficacy of a bepotastine besilate-corticosteroid combination nasal spray for the treatment of seasonal allergic rhinitis (SAR) in an open exposure study with subjects who have a demonstrated history of Mountain Cedar pollen allergy. The primary study objective is to assess the reduction from baseline in averaged morning (AM) and evening (PM) values of reflective total nasal symptom scores for each of 3 nasal sprays (bepotastine besilate-fluticasone propionate combination nasal spray, bepotastine besilate nasal spray, fluticasone propionate nasal spray) compared to placebo nasal spray. For enrolled subjects, the study will involve a 7-10 day run-in screening period dosing with placebo nasal spray and then a 14-day treatment period where subjects will dose twice a day with 1 of the 4 test agent nasal sprays and record reflective and instantaneous scores for both nasal and ocular symptoms prior to each dosing.
Interventions
DRUGBepotastine besilate formulation
Nasal Spray
DRUGFluticasone propionate
Nasal Spray
DRUGBepotastine besilate-fluticasone propionate
Nasal Spray
DRUGPlacebo Comparator
Nasal Spray
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, 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 demonstrated history of Mountain Cedar pollen 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 Morning and Evening Averaged Subject-rated Reflective TNSS | Baseline, 14 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 minimum score of 0 and a maximum score of 12 units, with higher score corresponding to increased severity of nasal allergy symptoms. The morning and evening scores were averaged. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bepotastine Besilate-fluticasone Propionate Nasal Spray
Bepotastine besilate 4%-fluticasone propionate 0.05%: Nasal Spray | 152 |
| Bepotastine Besilate Formulation Nasal Spray
Bepotastine besilate formulation 4%: Nasal Spray | 152 |
| Fluticasone Propionate Nasal Spray
Fluticasone propionate 0.05%: Nasal Spray | 154 |
| Placebo Comparator Nasal Spray
Placebo Comparator: Nasal Spray | 148 |
| Total | 606 |
Baseline characteristics
| Characteristic | Bepotastine Besilate-fluticasone Propionate | Bepotastine Besilate Formulation | Fluticasone Propionate | Placebo Comparator | Total |
|---|---|---|---|---|---|
| Age, Continuous | 38.2 years STANDARD_DEVIATION 14.8 | 43.4 years STANDARD_DEVIATION 14.4 | 40.6 years STANDARD_DEVIATION 14.8 | 43.6 years STANDARD_DEVIATION 13.9 | 41.4 years STANDARD_DEVIATION 14.6 |
| Sex: Female, Male Female | 110 Participants | 95 Participants | 89 Participants | 89 Participants | 383 Participants |
| Sex: Female, Male Male | 42 Participants | 57 Participants | 65 Participants | 59 Participants | 223 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 / 152 | 0 / 152 | 0 / 154 | 0 / 148 |
| other Total, other adverse events | 9 / 152 | 8 / 152 | 0 / 154 | 0 / 148 |
| serious Total, serious adverse events | 0 / 152 | 0 / 152 | 0 / 154 | 0 / 148 |
Outcome results
Primary
Mean Change From Baseline (Pre-Dose) in Morning and Evening Averaged Subject-rated Reflective 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 minimum score of 0 and a maximum score of 12 units, with higher score corresponding to increased severity of nasal allergy symptoms. The morning and evening scores were averaged.
Time frame: Baseline, 14 days
Population: All randomized participants were included in the analysis population, with last observation carried forward used for missing data at 14 days.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bepotastine Besilate-fluticasone Propionate | Mean Change From Baseline (Pre-Dose) in Morning and Evening Averaged Subject-rated Reflective TNSS | -3.57 score on a scale | Standard Deviation 2.82 |
| Bepotastine Besilate Formulation | Mean Change From Baseline (Pre-Dose) in Morning and Evening Averaged Subject-rated Reflective TNSS | -2.31 score on a scale | Standard Deviation 2.43 |
| Fluticasone Propionate | Mean Change From Baseline (Pre-Dose) in Morning and Evening Averaged Subject-rated Reflective TNSS | -2.96 score on a scale | Standard Deviation 2.73 |
| Placebo Comparator | Mean Change From Baseline (Pre-Dose) in Morning and Evening Averaged Subject-rated Reflective TNSS | -1.48 score on a scale | Standard Deviation 1.99 |