The purpose of the study is to evaluate the effects of BDP HFA Nasal Aerosol on HPA-axis function.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
107
Placebo nasal aerosol administered daily for 42 days of treatment
Prednisone 10 mg capsule taken each day on the last 7 days of treatment
Placebo prednisone capsule taken each day on the last 7 days of treatment
Teva Clinical Study Site
North Dartmouth, Massachusetts, United States
Teva Clinical Study Site
New Braunfels, Texas, United States
Teva Clinical Study Site
San Antonio, Texas, United States
The 24-hour Serum Cortisol Weighted Mean After 42 Days of Treatment
Geometric mean serum cortisol weighted mean values were calculated at baseline and after 6 weeks (42 days) of treatment. The geometric mean ratio of week 6 / baseline is reported. The primary outcome compares the BDP HFA and Placebo treatment arms. The comparison of active control (Placebo/Prednisone) and Placebo treatment arms is an "other pre-specified" outcome.
Time frame: Day 0 (Baseline), Day 42
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Total daily dose of 320 micrograms per day of beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) applied as a nasal aerosol each morning for 42 days.