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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier:
NCT01133626
First received: May 27, 2010
Last updated: May 31, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
Perennial Allergic Rhinitis
Drug: Placebo Nasal Aerosol
Drug: Prednisone capsules
Drug: Placebo Prednisone Capsules
Drug: Beclomethasone dipropionate
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • The 24-hour Serum Cortisol Weighted Mean After 42 Days of Treatment [ Time Frame: Day 0 (Baseline), Day 42 ] [ Designated as safety issue: No ]
    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.


Enrollment: 107
Study Start Date: June 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
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.
Drug: Placebo Nasal Aerosol
Placebo nasal aerosol administered daily for 42 days of treatment
Drug: Placebo Prednisone Capsules
Placebo prednisone capsule taken each day on the last 7 days of treatment
Experimental: BDP HFA 320 µg/day
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.
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.
Other Name: QNASL(TM)
Active Comparator: Prednisone
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.
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

  Eligibility

Ages Eligible for Study:   12 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01133626

Locations
United States, Massachusetts
Teva Clinical Study Site
North Dartmouth, Massachusetts, United States, 02747
United States, Texas
Teva Clinical Study Site
New Braunfels, Texas, United States, 78130
Teva Clinical Study Site
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
Investigators
Study Director: Sudeesh K. Tantry, Ph.D. Teva Branded Pharmaceutical Products, R&D Inc.
  More Information

Publications:
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 adolescent subjects with perennial allergic rhinitis. J Allergy Clin Immunol 2012; 129:AB188
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):A118.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier: NCT01133626     History of Changes
Other Study ID Numbers: BDP-AR-304
Study First Received: May 27, 2010
Results First Received: April 23, 2012
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Beclomethasone
Prednisone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 23, 2014