Conditions: Rhinitis, Allergic, Perennial
Keywords: Rhinitis, Allergic, Perennial BDP-HFA Hay fever Allergic rhinitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 529
Healthy volunteers: no

Brief summary:
Subjects with perennial allergic rhinitis will be randomized to 320 mcg of beclomethasone dipropionate (BDP) using a hydrofluoroalkane (HFA) propellant or placebo as a nasal aerosol. The subjects will be followed for safety and efficacy for a period of 30 or 52 weeks. BDP HFA is a steroid which is currently FDA approved for the treatment of asthma. BDP-HFA should be safe and effective as a "dry" nasal aerosol which may be preferred by some patients.

Detailed description:

Arms:
arm 1: During the 30-week (or 52-week, depending upon investigator site) 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 30-week (or 52-week, depending upon investigator site) 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 30-weeks (or 52-weeks, depending upon investigator site). intervention 2: Placebo nasal aerosol administered daily for 30-weeks (or 52-weeks, depending upon investigator site).

Protocol document: