Seasonal Allergic Rhinitis
Conditions
Brief summary
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.
Interventions
Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days
DRUGPlacebo
Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days
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
* The subject is a male or female 12 years of age or older. * Have a documented history of SAR resulting from exposure to Mountain Cedar pollen for a minimum of 2 years immediately preceding Screening Visit 1. * Have demonstrated sensitivity to Mountain Cedar pollen through a standard skin prick test. * Have a minimum rTNSS of at least 6 units for the morning (AM) assessment on the day of Visit 2 and Visit 3. * Have a minimum average rTNSS score of at least 6 units for 3 of the worst 4 days prior to Visit 3 plus the AM assessment on the day of Visit 3. * Have a minimum stuffy nose score of at least 2 units on the day of Visit 3. * Have a minimum average stuffy nose score of at least 2 units for 3 of the worst 4 days prior to Visit 3 plus the AM assessment on the day of Visit 3. * Have at least one score ≥ 2 units at Visit 3 of any of the RQLQ(S) questions #4-#6 regarding sleep.
Exclusion criteria
* Have a nasal condition which, in the opinion of the Investigator, interferes with successful nasal drug administration or absorption (in either nostril) within the last 60 days prior to Screening Visit 2. * Have asthma requiring medication other than intermittent use of an inhaled short-acting β-agonist. * Is participating or have participated in any investigational drug or device study within 30 days preceding Visit 2. * Have had nasal or sinus surgery within 12 weeks of Visit 2. * Have a known sensitivity to bepotastine besilate or any excipient component of the investigational product (IP). * For female subjects 12 years of age or older (other than those who have been menopausal for at least 24 months or those who are surgically sterile), are pregnant, planning to become pregnant, or nursing/lactating, or refuses to abide by the contraception stipulations in the inclusion criteria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline (Pre-Dose) Twice Daily Averaged Subject-rated Reflective Total Nasal Symptom Score (TNSS) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline (Pre-Dose) in Morning Averaged Subject-rated Reflective (TNSS) | 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. |
| Mean Change From Baseline (Pre-Dose) in Evening Averaged Subject-rated Reflective Total Nasal Symptom Score (TNSS) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 124 |
| 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 | 123 |
| 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 | 123 |
| 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 | 124 |
| 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 | 123 |
| Total | 617 |
Baseline characteristics
| Characteristic | Placebo | Bepotastine Besilate 0.5% | Bepotastine Besilate 1% | Bepotastine Besilate 2% | Bepotastine Besilate 4% | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 41.9 years STANDARD_DEVIATION 14.7 | 41.3 years STANDARD_DEVIATION 15.5 | 41.3 years STANDARD_DEVIATION 14.7 | 42.4 years STANDARD_DEVIATION 15.1 | 39.8 years STANDARD_DEVIATION 14.6 | 41.3 years STANDARD_DEVIATION 14.9 |
| Sex: Female, Male Female | 76 Participants | 74 Participants | 81 Participants | 77 Participants | 73 Participants | 381 Participants |
| Sex: Female, Male Male | 48 Participants | 49 Participants | 42 Participants | 47 Participants | 50 Participants | 236 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 124 | 0 / 123 | 0 / 123 | 0 / 124 | 0 / 123 |
| other Total, other adverse events | 1 / 124 | 8 / 123 | 12 / 123 | 15 / 124 | 18 / 123 |
| serious Total, serious adverse events | 0 / 124 | 0 / 123 | 0 / 123 | 0 / 124 | 0 / 123 |
Outcome results
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.
Time frame: 14 Days
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline (Pre-Dose) Twice Daily Averaged Subject-rated Reflective Total Nasal Symptom Score (TNSS) | -1.19 score on a scale | Standard Deviation 2.22 |
| Bepotastine Besilate 0.5% | Mean Change From Baseline (Pre-Dose) Twice Daily Averaged Subject-rated Reflective Total Nasal Symptom Score (TNSS) | -1.58 score on a scale | Standard Deviation 2.28 |
| Bepotastine Besilate 1% | Mean Change From Baseline (Pre-Dose) Twice Daily Averaged Subject-rated Reflective Total Nasal Symptom Score (TNSS) | -1.68 score on a scale | Standard Deviation 2.24 |
| Bepotastine Besilate 2% | Mean Change From Baseline (Pre-Dose) Twice Daily Averaged Subject-rated Reflective Total Nasal Symptom Score (TNSS) | -1.63 score on a scale | Standard Deviation 2.21 |
| Bepotastine Besilate 4% | Mean Change From Baseline (Pre-Dose) Twice Daily Averaged Subject-rated Reflective Total Nasal Symptom Score (TNSS) | -1.55 score on a scale | Standard Deviation 2.23 |
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.
Time frame: 14 Days
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline (Pre-Dose) in Evening Averaged Subject-rated Reflective Total Nasal Symptom Score (TNSS) | -1.14 score on a scale | Standard Deviation 2.24 |
| Bepotastine Besilate 0.5% | Mean Change From Baseline (Pre-Dose) in Evening Averaged Subject-rated Reflective Total Nasal Symptom Score (TNSS) | -1.55 score on a scale | Standard Deviation 2.34 |
| Bepotastine Besilate 1% | Mean Change From Baseline (Pre-Dose) in Evening Averaged Subject-rated Reflective Total Nasal Symptom Score (TNSS) | -1.70 score on a scale | Standard Deviation 2.33 |
| Bepotastine Besilate 2% | Mean Change From Baseline (Pre-Dose) in Evening Averaged Subject-rated Reflective Total Nasal Symptom Score (TNSS) | -1.60 score on a scale | Standard Deviation 2.23 |
| Bepotastine Besilate 4% | Mean Change From Baseline (Pre-Dose) in Evening Averaged Subject-rated Reflective Total Nasal Symptom Score (TNSS) | -1.50 score on a scale | Standard Deviation 2.25 |
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.
Time frame: 14 Days
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Mean Change From Baseline (Pre-Dose) in Morning Averaged Subject-rated Reflective (TNSS) | -1.29 score on a scale | Standard Deviation 2.28 |
| Bepotastine Besilate 0.5% | Mean Change From Baseline (Pre-Dose) in Morning Averaged Subject-rated Reflective (TNSS) | -1.68 score on a scale | Standard Deviation 2.35 |
| Bepotastine Besilate 1% | Mean Change From Baseline (Pre-Dose) in Morning Averaged Subject-rated Reflective (TNSS) | -1.72 score on a scale | Standard Deviation 2.22 |
| Bepotastine Besilate 2% | Mean Change From Baseline (Pre-Dose) in Morning Averaged Subject-rated Reflective (TNSS) | -1.71 score on a scale | Standard Deviation 2.31 |
| Bepotastine Besilate 4% | Mean Change From Baseline (Pre-Dose) in Morning Averaged Subject-rated Reflective (TNSS) | -1.66 score on a scale | Standard Deviation 2.31 |