Safety, Pharmacokinetics, and Efficacy of Bepotastine Besilate Nasal Product After Ragweed Pollen Exposure in an Environmental Chamber
Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT01222299
Collaborator
(none)
89
1
4
3
29.4
Study Details
Study Description
Brief Summary
The purpose of this study is to examine the safety and efficacy of bepotastine besilate nasal product in seasonal allergic rhinitis patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
89 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Study Start Date
:
May 1, 2010
Actual Primary Completion Date
:
Aug 1, 2010
Actual Study Completion Date
:
Aug 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm 1 - Low Dose bepotastine besilate nasal product - low dose |
Drug: bepotastine besilate nasal product - low dose
sterile nasal product
|
| Experimental: Arm 2 - Medium Dose bepotastine besilate nasal product - medium dose |
Drug: bepotastine besilate nasal product - medium dose
sterile nasal product
|
| Experimental: Arm 3 - High Dose bepotastine besilate nasal product - high dose |
Drug: bepotastine besilate nasal product - high dose
sterile nasal product
|
| Placebo Comparator: Arm 4 - Placebo placebo comparator nasal product |
Drug: placebo comparator nasal product
sterile nasal product
|
Outcome Measures
Primary Outcome Measures
- Mean Change From Baseline (Pre-Dose) in Subject-rated Instantaneous TNSS [Baseline, 20 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 maximum score for increased allergic response of 12 units. The minimum possible total score was 0.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Subjects 18 to 65 years of age with a positive skin prick test with ragweed allergen
Exclusion Criteria:
- No active respiratory tract infection
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | ISTA Pharmaceuticals, Inc. | Irvine | California | United States | 92618 |
Sponsors and Collaborators
- Bausch & Lomb Incorporated
Investigators
- Study Director: Tim McNamara, PharmD, ISTA Pharmaceuticals, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01222299
Other Study ID Numbers:
- S00032
First Posted:
Oct 18, 2010
Last Update Posted:
Oct 5, 2020
Last Verified:
Oct 1, 2020
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Placebo | Low Dose - 2% | Medium Dose - 4% | High Dose - 6% |
|---|---|---|---|---|
| Arm/Group Description | placebo comparator nasal product placebo comparator nasal product: sterile nasal product twice daily | bepotastine besilate nasal product - low dose bepotastine besilate nasal product - low dose: sterile nasal product twice daily | bepotastine besilate nasal product - medium dose bepotastine besilate nasal product - medium dose: sterile nasal product twice daily | bepotastine besilate nasal product - high dose bepotastine besilate nasal product - high dose: sterile nasal product twice daily |
| Period Title: Overall Study | ||||
| STARTED | 21 | 23 | 22 | 23 |
| COMPLETED | 21 | 21 | 20 | 18 |
| NOT COMPLETED | 0 | 2 | 2 | 5 |
Baseline Characteristics
| Arm/Group Title | Placebo | Low Dose - 2% | Medium Dose - 4% | High Dose - 6% | Total |
|---|---|---|---|---|---|
| Arm/Group Description | placebo comparator nasal product placebo comparator nasal product: sterile nasal product twice daily | bepotastine besilate nasal product - low dose bepotastine besilate nasal product - low dose: sterile nasal product twice daily | bepotastine besilate nasal product - medium dose bepotastine besilate nasal product - medium dose: sterile nasal product twice daily | bepotastine besilate nasal product - high dose bepotastine besilate nasal product - high dose: sterile nasal product twice daily | Total of all reporting groups |
| Overall Participants | 21 | 23 | 22 | 23 | 89 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
40.1
(10.5)
|
44.3
(9.5)
|
42.1
(10.2)
|
41.5
(10.7)
|
42.1
(10.2)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
13
61.9%
|
10
43.5%
|
12
54.5%
|
11
47.8%
|
46
51.7%
|
| Male |
8
38.1%
|
13
56.5%
|
10
45.5%
|
12
52.2%
|
43
48.3%
|
Outcome Measures
| Title | Mean Change From Baseline (Pre-Dose) in Subject-rated Instantaneous TNSS |
|---|---|
| Description | 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 maximum score for increased allergic response of 12 units. The minimum possible total score was 0. |
| Time Frame | Baseline, 20 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| The per protocol population was based on participants who completed the study. |
| Arm/Group Title | Placebo | Low Dose - 2% | Medium Dose - 4% | High Dose - 6% |
|---|---|---|---|---|
| Arm/Group Description | placebo comparator nasal product placebo comparator nasal product: sterile nasal product twice daily | bepotastine besilate nasal product - low dose bepotastine besilate nasal product - low dose: sterile nasal product twice daily | bepotastine besilate nasal product - medium dose bepotastine besilate nasal product - medium dose: sterile nasal product twice daily | bepotastine besilate nasal product - high dose bepotastine besilate nasal product - high dose: sterile nasal product twice daily |
| Measure Participants | 21 | 21 | 20 | 18 |
| Day 10 (after single dose) |
-1.17
(1.88)
|
-0.69
(2.42)
|
-2.43
(2.73)
|
-1.65
(1.95)
|
| Day 20 (after twice daily dosing) |
-1.63
(2.37)
|
-0.64
(2.93)
|
-2.52
(2.55)
|
-1.67
(2.22)
|
Adverse Events
| Time Frame | 20 days | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | Placebo | Low Dose - 2% | Medium Dose - 4% | High Dose - 6% | ||||
| Arm/Group Description | placebo comparator nasal product placebo comparator nasal product: sterile nasal product twice daily | bepotastine besilate nasal product - low dose bepotastine besilate nasal product - low dose: sterile nasal product twice daily | bepotastine besilate nasal product - medium dose bepotastine besilate nasal product - medium dose: sterile nasal product twice daily | bepotastine besilate nasal product - high dose bepotastine besilate nasal product - high dose: sterile nasal product twice daily | ||||
All Cause Mortality |
||||||||
| Placebo | Low Dose - 2% | Medium Dose - 4% | High Dose - 6% | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/21 (0%) | 0/23 (0%) | 0/22 (0%) | 0/23 (0%) | ||||
Serious Adverse Events |
||||||||
| Placebo | Low Dose - 2% | Medium Dose - 4% | High Dose - 6% | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/21 (0%) | 0/23 (0%) | 0/22 (0%) | 0/23 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Placebo | Low Dose - 2% | Medium Dose - 4% | High Dose - 6% | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 7/21 (33.3%) | 9/23 (39.1%) | 9/22 (40.9%) | 11/23 (47.8%) | ||||
| Gastrointestinal disorders | ||||||||
| Dyspepsia | 0/21 (0%) | 0/23 (0%) | 2/22 (9.1%) | 0/23 (0%) | ||||
| Nausea | 2/21 (9.5%) | 0/23 (0%) | 0/22 (0%) | 0/23 (0%) | ||||
| General disorders | ||||||||
| Mild taste following instillation | 1/21 (4.8%) | 5/23 (21.7%) | 5/22 (22.7%) | 6/23 (26.1%) | ||||
| Nervous system disorders | ||||||||
| Headache | 4/21 (19%) | 1/23 (4.3%) | 1/22 (4.5%) | 1/23 (4.3%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Epistaxis | 0/21 (0%) | 1/23 (4.3%) | 2/22 (9.1%) | 1/23 (4.3%) | ||||
| Nasal discomfort | 0/21 (0%) | 0/23 (0%) | 2/22 (9.1%) | 2/23 (8.7%) | ||||
| Rhinalgia | 1/21 (4.8%) | 2/23 (8.7%) | 2/22 (9.1%) | 1/23 (4.3%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Contact sponsor directly for details.
Results Point of Contact
| Name/Title | Study Director |
|---|---|
| Organization | Bausch Health |
| Phone | 908-300-9920 |
| susan.harris@bauschhealth.com |
Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01222299
Other Study ID Numbers:
- S00032
First Posted:
Oct 18, 2010
Last Update Posted:
Oct 5, 2020
Last Verified:
Oct 1, 2020