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Safety and Efficacy of Bepotastine Besilate Nasal Spray in the Treatment of Seasonal Allergic Rhinitis

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: NCT01277341
Recruitment Status : Completed
First Posted : January 14, 2011
Results First Posted : September 14, 2020
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Brief Summary:
This is an efficacy study of bepotastine besilate nasal spray in seasonal allergic rhinitis.

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Drug: Bepotastine Besilate Nasal Spray 2% Twice a day Drug: Bepotastine Besilate Nasal Spray 3% Twice a day Drug: Bepotastine Besilate Nasal Spray 4% Twice a day Drug: Placebo Nasal Spray Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 601 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : December 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: 2% Twice a day
Bepotastine Besilate Nasal Spray 2% Twice a day
Drug: Bepotastine Besilate Nasal Spray 2% Twice a day
nasal spray

Experimental: 3% Twice a day
Bepotastine Besilate Nasal Spray 3% Twice a day
Drug: Bepotastine Besilate Nasal Spray 3% Twice a day
nasal spray

Experimental: 4% Twice a day
Bepotastine Besilate Nasal Spray 4% Twice a day
Drug: Bepotastine Besilate Nasal Spray 4% Twice a day
nasal spray

Placebo Comparator: Placebo
Placebo nasal spray
Drug: Placebo Nasal Spray
nasal spray




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



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female at least 12 years of age with a history of mountain cedar allergy

Exclusion Criteria:

  • No active nasal infection or nasal abnormality that would affect subject safety or symptom assessments

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): NCT01277341


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: NCT01277341    
Other Study ID Numbers: S00082
First Posted: January 14, 2011    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