NCT01133626

Hypothalamic-Pituitary-Adrenal (HPA) Axis Study in Adult and Adolescent Subjects With Perennial Allergic Rhinitis (PAR)

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 12 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Perennial Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Placebo Nasal Aerosol	Placebo nasal aerosol administered daily for 42 days of treatment
DRUG	Prednisone capsules	Prednisone 10 mg capsule taken each day on the last 7 days of treatment
DRUG	Placebo Prednisone Capsules	Placebo prednisone capsule taken each day on the last 7 days of treatment
DRUG	Beclomethasone dipropionate	Total daily dose of 320 micrograms per day of beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) applied as a nasal aerosol each morning for 42 days.

Timeline

• Start date: 2010-06-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2010-05-31
• Last updated: 2012-07-04
• Results posted: 2012-07-04

Locations

3 sites across 1 country: United States