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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bepotastine besilate formulation | Experimental | Nasal Spray |
|
| Fluticasone propionate | Experimental | Nasal Spray |
|
| Bepotastine besilate-fluticasone propionate | Experimental | Nasal Spray |
|
| Placebo Comparator | Placebo Comparator | Nasal Spray |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bepotastine besilate formulation | Drug | Nasal Spray |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tim McNamara, PharmD | ISTA Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ISTA Pharmaceuticals, Inc. | Irvine | California | 92618 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bepotastine Besilate-fluticasone Propionate | Nasal Spray Bepotastine besilate 4%-fluticasone propionate 0.05%: Nasal Spray |
| FG001 | Bepotastine Besilate Formulation | Nasal Spray Bepotastine besilate formulation 4%: Nasal Spray |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Fluticasone propionate |
| Drug |
Nasal Spray |
|
| Bepotastine besilate-fluticasone propionate | Drug | Nasal Spray |
|
| Placebo Comparator | Drug | Nasal Spray |
|
| FG002 | Fluticasone Propionate | Nasal Spray Fluticasone propionate 0.05%: Nasal Spray |
| FG003 | Placebo Comparator | Nasal Spray Placebo Comparator: Nasal Spray |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bepotastine Besilate-fluticasone Propionate | Nasal Spray Bepotastine besilate 4%-fluticasone propionate 0.05%: Nasal Spray |
| BG001 | Bepotastine Besilate Formulation | Nasal Spray Bepotastine besilate formulation 4%: Nasal Spray |
| BG002 | Fluticasone Propionate | Nasal Spray Fluticasone propionate 0.05%: Nasal Spray |
| BG003 | Placebo Comparator | Nasal Spray Placebo Comparator: Nasal Spray |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All randomized participants were included in the analysis population, with last observation carried forward used for missing data at 14 days. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 14 days |
|
|
|
14 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bepotastine Besilate-fluticasone Propionate | Nasal Spray Bepotastine besilate-fluticasone propionate: Nasal Spray | 0 | 152 | 0 | 152 | 9 | 152 |
| EG001 | Bepotastine Besilate Formulation | Nasal Spray Bepotastine besilate formulation: Nasal Spray | 0 | 152 | 0 | 152 | 8 | 152 |
| EG002 | Fluticasone Propionate | Nasal Spray Fluticasone propionate: Nasal Spray | 0 | 154 | 0 | 154 | 0 | 154 |
| EG003 | Placebo Comparator | Nasal Spray Placebo Comparator: Nasal Spray | 0 | 148 | 0 | 148 | 0 | 148 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild taste following instillation | General disorders | MedDRA (14.1) | Non-systematic Assessment |
|
Contact sponsor directly for details.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch Health | 908-300-9920 | susan.harris@bauschhealth.com |
| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Male |
|