Bepotastine Besilate Nasal Sprays in the Treatment of Seasonal Allergic Rhinitis (SAR)

Bausch + Lomb

Status and phase: Completed; Phase 2

Conditions: Seasonal Allergic Rhinitis

Treatments: Drug: Bepotastine besilate; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01753739

823

Details and patient eligibility

About

This study will examine dose ranging characteristics of bepotastine besilate nasal spray compared to placebo nasal spray in 600 male or female subjects 12 years of age and older with active seasonal allergic rhinitis (SAR) and a demonstrated history of allergic sensitivity to Mountain Cedar pollen for at least 2 years prior to the study.

Enrollment: 617 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The subject is a male or female 12 years of age or older.
• Have a documented history of SAR resulting from exposure to Mountain Cedar pollen for a minimum of 2 years immediately preceding Screening Visit 1.
• Have demonstrated sensitivity to Mountain Cedar pollen through a standard skin prick test.
• Have a minimum rTNSS of at least 6 units for the morning (AM) assessment on the day of Visit 2 and Visit 3.
• Have a minimum average rTNSS score of at least 6 units for 3 of the worst 4 days prior to Visit 3 plus the AM assessment on the day of Visit 3.
• Have a minimum stuffy nose score of at least 2 units on the day of Visit 3.
• Have a minimum average stuffy nose score of at least 2 units for 3 of the worst 4 days prior to Visit 3 plus the AM assessment on the day of Visit 3.
• Have at least one score ≥ 2 units at Visit 3 of any of the RQLQ(S) questions #4-#6 regarding sleep.

Exclusion criteria

• Have a nasal condition which, in the opinion of the Investigator, interferes with successful nasal drug administration or absorption (in either nostril) within the last 60 days prior to Screening Visit 2.
• Have asthma requiring medication other than intermittent use of an inhaled short-acting β-agonist.
• Is participating or have participated in any investigational drug or device study within 30 days preceding Visit 2.
• Have had nasal or sinus surgery within 12 weeks of Visit 2.
• Have a known sensitivity to bepotastine besilate or any excipient component of the investigational product (IP).
• For female subjects 12 years of age or older (other than those who have been menopausal for at least 24 months or those who are surgically sterile), are pregnant, planning to become pregnant, or nursing/lactating, or refuses to abide by the contraception stipulations in the inclusion criteria.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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617 participants in 5 patient groups

Bepotastine besilate Concentration 1

Experimental group

Description:

Bepotastine besilate nasal spray, BID for 14 days.

Treatment:

Drug: Bepotastine besilate

Placebo

Active Comparator group

Description:

Placebo nasal spray BID for 14 days

Treatment:

Drug: Placebo

Bepotastine besilate Concentration 2

Experimental group

Description:

Bepotastine besilate nasal spray, BID for 14 days.

Treatment:

Drug: Bepotastine besilate

Bepotastine besilate Concentration 3

Experimental group

Description:

Bepotastine besilate nasal spray, BID for 14 days.

Treatment:

Drug: Bepotastine besilate

Bepotastine besilate Concentration 4

Experimental group

Description:

Bepotastine besilate nasal spray, BID for 14 days.

Treatment:

Drug: Bepotastine besilate