Clinical trial NCT01753739: Bepotastine Besilate Nasal Sprays in the Treatment of Seasonal Allergic Rhinitis (SAR)
Official title: A Dose-Ranging Study to Evaluate the Safety and Efficacy of Bepotastine Besilate Nasal Sprays in the Treatment of Seasonal Allergic Rhinitis (SAR) in Subjects With a Demonstrated History of Mountain Cedar Pollen Allergic Sensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2012-12-20
Enrollment: 617
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean Change From Baseline (Pre-Dose) Twice Daily Averaged Subject-rated Reflective Total Nasal Symptom Score (TNSS)
timeFrame: 14 Days
Secondary outcomes:
measure: Mean Change From Baseline (Pre-Dose) in Morning Averaged Subject-rated Reflective (TNSS)
timeFrame: 14 Days
measure: Mean Change From Baseline (Pre-Dose) in Evening Averaged Subject-rated Reflective Total Nasal Symptom Score (TNSS)
timeFrame: 14 Days
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Bausch & Lomb Incorporated
state: California
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Jon Williams, Ph.D.
role: STUDY_DIRECTOR
References: