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

Bausch + Lomb

Status and phase: Completed; Phase 2; Phase 1

Conditions: Seasonal Allergic Rhinitis

Treatments: Drug: bepotastine besilate nasal product - high dose; Drug: bepotastine besilate nasal product - low dose; Drug: bepotastine besilate nasal product - medium dose; Drug: placebo comparator nasal product

Study type: Interventional

Funder types: Industry

Identifiers

NCT01222299

S00032

Details and patient eligibility

About

The purpose of this study is to examine the safety and efficacy of bepotastine besilate nasal product in seasonal allergic rhinitis patients.

Enrollment: 89 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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89 participants in 4 patient groups, including a placebo group

Arm 1 - Low Dose

Experimental group

Description:

bepotastine besilate nasal product - low dose

Treatment:

Drug: bepotastine besilate nasal product - low dose

Arm 2 - Medium Dose

Experimental group

Description:

bepotastine besilate nasal product - medium dose

Treatment:

Drug: bepotastine besilate nasal product - medium dose

Arm 3 - High Dose

Experimental group

Description:

bepotastine besilate nasal product - high dose

Treatment:

Drug: bepotastine besilate nasal product - high dose

Arm 4 - Placebo

Placebo Comparator group

Description:

placebo comparator nasal product

Treatment:

Drug: placebo comparator nasal product