A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group, 6-Week Study Designed to Investigate the Effects of BDP HFA Nasal Aerosol on the Hypothalamic-Pituitary-Adrenal (HPA) Axis When Administered in Adolescent and Adult Subjects (12 to 45 Years of Age) With Perennial Allergic Rhinitis (PAR)

NCT01133626 Phase 3 COMPLETED Results posted

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

Details

Lead sponsor	Teva Branded Pharmaceutical Products R&D, Inc.
Phase	Phase 3
Status	COMPLETED
Enrolment	107
Start date	2010-06
Completion	2010-09

Conditions

• Perennial Allergic Rhinitis

Interventions

• Placebo Nasal Aerosol
• Prednisone capsules
• Placebo Prednisone Capsules
• Beclomethasone dipropionate

Primary outcomes

• The 24-hour Serum Cortisol Weighted Mean After 42 Days of Treatment — Day 0 (Baseline), Day 42
  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.

Countries

United States