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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

NCT ID: NCT01578278

Last Updated: 2020-10-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

606 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-08-31

Brief Summary

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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 an open exposure study with subjects who have 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-fluticasone propionate combination nasal spray, bepotastine besilate nasal spray, fluticasone propionate 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.

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Detailed Description

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Conditions

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Seasonal Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Bepotastine besilate formulation

Nasal Spray

Group Type EXPERIMENTAL

Bepotastine besilate formulation

Intervention Type DRUG

Nasal Spray

Fluticasone propionate

Nasal Spray

Group Type EXPERIMENTAL

Fluticasone propionate

Intervention Type DRUG

Nasal Spray

Bepotastine besilate-fluticasone propionate

Nasal Spray

Group Type EXPERIMENTAL

Bepotastine besilate-fluticasone propionate

Intervention Type DRUG

Nasal Spray

Placebo Comparator

Nasal Spray

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type DRUG

Nasal Spray

Interventions

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Bepotastine besilate formulation

Nasal Spray

Intervention Type DRUG

Fluticasone propionate

Nasal Spray

Intervention Type DRUG

Bepotastine besilate-fluticasone propionate

Nasal Spray

Intervention Type DRUG

Placebo Comparator

Nasal Spray

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tim McNamara, PharmD

Role: STUDY_DIRECTOR

ISTA Pharmaceuticals, Inc.

Locations

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ISTA Pharmaceuticals, Inc.

Irvine, California, United States

Site Status

Countries

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United States

Other Identifiers

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S00186

Identifier Type: -

Identifier Source: org_study_id

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