Conditions: Perennial Allergic Rhinitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 107
Healthy volunteers: no

Brief summary:
The purpose of the study is to evaluate the effects of BDP HFA Nasal Aerosol on HPA-axis function.

Detailed description:

Arms:
arm 1: Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone. arm 2: Participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily each morning for 6 weeks (42 days). During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone. arm 3: Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a 10/mg a day prednisone capsule.

Interventions: intervention 1: Placebo Nasal Aerosol intervention 2: Prednisone capsules intervention 3: Placebo Prednisone Capsules intervention 4: Beclomethasone dipropionate
Intervention descriptions: intervention 1: Placebo nasal aerosol administered daily for 42 days of treatment intervention 2: Prednisone 10 mg capsule taken each day on the last 7 days of treatment intervention 3: Placebo prednisone capsule taken each day on the last 7 days of treatment intervention 4: Total daily dose of 320 micrograms per day of beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) applied as a nasal aerosol each morning for 42 days.

Protocol document: