Conditions: Seasonal Allergic Rhinitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 617
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: Bepotastine besilate nasal spray, BID for 14 days. arm 2: Placebo nasal spray BID for 14 days arm 3: Bepotastine besilate nasal spray, BID for 14 days. arm 4: Bepotastine besilate nasal spray, BID for 14 days. arm 5: Bepotastine besilate nasal spray, BID for 14 days.

Interventions: intervention 1: Bepotastine besilate intervention 2: Placebo
Intervention descriptions: intervention 1: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days intervention 2: Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days

Protocol document: