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

Perennial Allergic Rhinitis Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01133626
• Other study ID #: BDP-AR-304
• Status: Completed
• Phase: Phase 3
• First received: May 27, 2010
• Last updated: May 31, 2012
• Start date: June 2010
• Est. completion date: September 2010

Study information

• Verified date: May 2012
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 45 Years

Eligibility

Inclusion Criteria:

• Informed Consent

• Male or female subjects 12-45 years of age

• Documented history of perennial allergic rhinitis

• General good health

• Other criteria apply

Exclusion Criteria:

• History of physical findings of nasal pathology (within 60 days prior to Screening Visit 1)

• Participation in any investigational drug study 30 days preceding Screening Visit 1

• History of respiratory infection/disorder with 14 days preceding Screening Visit 1

• Use of any prohibited concomitant medications

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Perennial Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic, Perennial

Intervention

Drug:
• Placebo Nasal Aerosol
Placebo nasal aerosol administered daily for 42 days of treatment
• Prednisone capsules
Prednisone 10 mg capsule taken each day on the last 7 days of treatment
• Placebo Prednisone Capsules
Placebo prednisone capsule taken each day on the last 7 days of treatment
• 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.

Locations

Country	Name	City	State
United States	Teva Clinical Study Site	New Braunfels	Texas
United States	Teva Clinical Study Site	North Dartmouth	Massachusetts
United States	Teva Clinical Study Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products, R&D Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

Hampel FC, Ratner PH, Miller SD, Melchior A, Dunbar SA, Tantry SK, Dorinsky PM. Once-daily treatment with beclomethasone dipropionate hydrofluoroalkane nasal aerosol (320 mcg/d) is not associated with hypothalamic-pituitary-adrenal axis suppression in ado

Ratner PH, Miller SD, Hampel FC, A, Dunbar SA, Tantry SK, Dorinsky PM (2011). BDP HFA Nasal Aerosol 320 µg Once Daily g Once Daily Is Not Associated with HPA-Axis Suppression in Subjects With Perennial Allergic Rhinitis. Ann Allergy Asthma Immunol. 107(11

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 0 (Baseline), Day 42	No