Bepotastine Besilate Nasal Sprays in the Treatment of Seasonal Allergic Rhinitis (SAR)
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Bepotastine besilate; Placebo
Intervention description: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days; Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days
Intervention MeSH terms: Bepotastine besilate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 617.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

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.