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This study will examine dose ranging characteristics of bepotastine besilate nasal spray compared to placebo nasal spray in 600 male or female subjects 12 years of age and older with active seasonal allergic rhinitis (SAR) and a demonstrated history of allergic sensitivity to Mountain Cedar pollen for at least 2 years prior to the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bepotastine besilate Concentration 1 | Experimental | Bepotastine besilate nasal spray, BID for 14 days. |
|
| Placebo | Active Comparator | Placebo nasal spray BID for 14 days |
|
| Bepotastine besilate Concentration 2 | Experimental | Bepotastine besilate nasal spray, BID for 14 days. |
|
| Bepotastine besilate Concentration 3 | Experimental | Bepotastine besilate nasal spray, BID for 14 days. |
|
| Bepotastine besilate Concentration 4 | Experimental | Bepotastine besilate nasal spray, BID for 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bepotastine besilate | Drug | Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline (Pre-Dose) Twice Daily Averaged Subject-rated Reflective Total Nasal Symptom Score (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. | 14 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline (Pre-Dose) in Morning Averaged 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon Williams, Ph.D. | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb Incorporated | Irvine | California | 92618-2301 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo nasal spray BID for 14 days Placebo: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days |
| FG001 | Bepotastine Besilate 0.5% | Bepotastine besilate nasal spray, BID for 14 days. Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days |
| FG002 | Bepotastine Besilate 1% | Bepotastine besilate nasal spray, BID for 14 days. Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days |
| FG003 | Bepotastine Besilate 2% | Bepotastine besilate nasal spray, BID for 14 days. Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days |
| FG004 | Bepotastine Besilate 4% | Bepotastine besilate nasal spray, BID for 14 days. Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo nasal spray BID for 14 days Placebo: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days |
| BG001 | Bepotastine Besilate 0.5% |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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) Twice Daily Averaged Subject-rated Reflective Total Nasal Symptom Score (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. | The analysis population included randomized participants who had received at least 1 dose of study drug. There was no imputation of missing data at Day 14. | Posted | Mean | Standard Deviation | score on a scale | 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 | Placebo | Placebo nasal spray BID for 14 days Placebo: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days |
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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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch Health | 908-300-9920 | susan.harris@bauschhealth.com |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C511534 | bepotastine besilate |
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| Placebo | Drug | Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days |
|
| 14 Days |
| Mean Change From Baseline (Pre-Dose) in Evening Averaged Subject-rated Reflective Total Nasal Symptom Score (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. | 14 Days |
Bepotastine besilate nasal spray, BID for 14 days.
Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days
| BG002 | Bepotastine Besilate 1% | Bepotastine besilate nasal spray, BID for 14 days. Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days |
| BG003 | Bepotastine Besilate 2% | Bepotastine besilate nasal spray, BID for 14 days. Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days |
| BG004 | Bepotastine Besilate 4% | Bepotastine besilate nasal spray, BID for 14 days. Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Bepotastine Besilate 0.5% | Bepotastine besilate nasal spray, BID for 14 days. Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days |
| OG002 | Bepotastine Besilate 1% | Bepotastine besilate nasal spray, BID for 14 days. Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days |
| OG003 | Bepotastine Besilate 2% | Bepotastine besilate nasal spray, BID for 14 days. Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days |
| OG004 | Bepotastine Besilate 4% | Bepotastine besilate nasal spray, BID for 14 days. Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days |
|
|
| Secondary | Mean Change From Baseline (Pre-Dose) in Morning Averaged 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. | The analysis population included randomized participants who had received at least 1 dose of study drug. There was no imputation of missing data at Day 14. | Posted | Mean | Standard Deviation | score on a scale | 14 Days |
|
|
|
| Secondary | Mean Change From Baseline (Pre-Dose) in Evening Averaged Subject-rated Reflective Total Nasal Symptom Score (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. | The analysis population included randomized participants who had received at least 1 dose of study drug. There was no imputation of missing data at Day 14. | Posted | Mean | Standard Deviation | score on a scale | 14 Days |
|
|
|
| 0 |
| 124 |
| 0 |
| 124 |
| 1 |
| 124 |
| EG001 | Bepotastine Besilate 0.5% | Bepotastine besilate nasal spray, BID for 14 days. Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days | 0 | 123 | 0 | 123 | 8 | 123 |
| EG002 | Bepotastine Besilate 1% | Bepotastine besilate nasal spray, BID for 14 days. Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days | 0 | 123 | 0 | 123 | 12 | 123 |
| EG003 | Bepotastine Besilate 2% | Bepotastine besilate nasal spray, BID for 14 days. Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days | 0 | 124 | 0 | 124 | 15 | 124 |
| EG004 | Bepotastine Besilate 4% | Bepotastine besilate nasal spray, BID for 14 days. Bepotastine besilate: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days | 0 | 123 | 0 | 123 | 18 | 123 |
Contact sponsor directly for details.
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |