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Bepotastine Besilate-corticosteroid Nasal Spray Combination Compared to Placebo, Bepotastine Besilate Nasal Spray, and Corticosteroid Nasal Spray in the Treatment of Patients With Seasonal Allergic Rhinitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01578278
First received: January 18, 2012
Last updated: January 3, 2013
Last verified: January 2013
History of Changes
  Purpose

This is a clinical study to evaluate the safety and efficacy of a bepotastine besilate-corticosteroid combination nasal spray for the treatment of seasonal allergic rhinitis (SAR) in subjects with a demonstrated history of Mountain Cedar pollen allergy. The primary study objective is to assess the reduction from baseline in averaged morning (AM) and evening (PM) values of reflective total nasal symptom scores for each of 3 nasal sprays (bepotastine besilate-corticosteroid combination nasal spray, bepotastine besilate nasal spray, corticosteroid nasal spray) compared to placebo nasal spray. For enrolled subjects, the study will involve a 7-10 day run-in screening period dosing with placebo nasal spray and then a 14-day treatment period where subjects will dose twice a day with 1 of the 4 test agent nasal sprays and record reflective and instantaneous scores for both nasal and ocular symptoms prior to each dosing.


Condition Intervention Phase
Seasonal Allergic Rhinitis
 Drug: Bepotastine besilate formulation
Drug: Synthetic corticosteroid
Drug: Bepotastine besilate-Synthetic corticosteroid
Drug: Placebo Comparator
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Hay Fever Steroids
Drug Information available for: Bepotastine
U.S. FDA Resources

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Change from baseline in 12-hour averaged AM & PM reflective total nasal symptom score [ Time Frame: Day -10 to Day 14 ] [ Designated as safety issue: No ]

Enrollment: 606
Study Start Date: December 2011
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bepotastine besilate formulation
Nasal Spray
 Drug: Bepotastine besilate formulation
Nasal Spray
Experimental: Synthetic corticosteroid
Nasal Spray
 Drug: Synthetic corticosteroid
Nasal Spray
Experimental: Bepotastine besilate-Synthetic corticosteroid
Nasal Spray
 Drug: Bepotastine besilate-Synthetic corticosteroid
Nasal Spray
Placebo Comparator: Placebo Comparator
Nasal Spray
 Drug: Placebo Comparator
Nasal Spray

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female at least 12 years of age with a demonstrated history of Mountain Cedar pollen allergy

Exclusion Criteria:

  • No active nasal infection or nasal abnormality that would affect subject safety or symptom assessments
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01578278

Locations
United States, California
ISTA Pharmaceuticals, Inc.
Irvine, California, United States, 92618
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Tim McNamara, PharmD ISTA Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01578278     History of Changes
Other Study ID Numbers: S00186
Study First Received: January 18, 2012
Last Updated: January 3, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
 Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on May 23, 2013