Conditions: Seasonal Allergic Rhinitis Hay Fever
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 340
Healthy volunteers: no

Brief summary:
The purpose of the study is to assess the efficacy and safety of an investigational nasal aerosol compared with placebo nasal aerosol in the treatment of seasonal allergic rhinitis.

Detailed description:

Arms:
arm 1: During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily each morning. arm 2: During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.

Interventions: intervention 1: Beclomethasone dipropionate intervention 2: Placebo Nasal Aerosol
Intervention descriptions: intervention 1: Total daily dose of 320 micrograms per day of beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) applied as a nasal aerosol each morning for two weeks. intervention 2: Placebo nasal aerosol administered each morning for two weeks.

Protocol document: