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Safety, Pharmacokinetics, and Efficacy of Bepotastine Besilate Nasal Product After Ragweed Pollen Exposure in an Environmental Chamber

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01222299
Recruitment Status : Completed
First Posted : October 18, 2010
Results First Posted : September 14, 2020
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

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
Seasonal Allergic Rhinitis Drug: bepotastine besilate nasal product - low dose Drug: bepotastine besilate nasal product - medium dose Drug: bepotastine besilate nasal product - high dose Drug: placebo comparator nasal product Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : May 2010
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever
Drug Information available for: Bepotastine

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




Primary Outcome Measures :
  1. Mean Change From Baseline (Pre-Dose) in Subject-rated Instantaneous TNSS [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01222299


Locations
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United States, California
ISTA Pharmaceuticals, Inc.
Irvine, California, United States, 92618
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
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Study Director: Tim McNamara, PharmD ISTA Pharmaceuticals, Inc.
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Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01222299    
Other Study ID Numbers: S00032
First Posted: October 18, 2010    Key Record Dates
Results First Posted: September 14, 2020
Last Update Posted: October 5, 2020
Last Verified: October 2020
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Bepotastine besilate
Anti-Allergic Agents