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

May 27, 2010
May 31, 2012
June 2010
September 2010   (final data collection date for primary outcome measure)
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.
24-hour serum cortisol weighted mean for BDP HFA nasal aerosol and placebo [ Time Frame: 42 days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01133626 on ClinicalTrials.gov Archive Site
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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)

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Perennial Allergic Rhinitis
  • 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.
    Other Name: QNASL(TM)
  • 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.
    Interventions:
    • Drug: Placebo Nasal Aerosol
    • Drug: Placebo Prednisone Capsules
  • 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.
    Interventions:
    • Drug: Placebo Prednisone Capsules
    • Drug: Beclomethasone dipropionate
  • 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.
    Interventions:
    • Drug: Placebo Nasal Aerosol
    • Drug: Prednisone capsules

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
107
September 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
12 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01133626
BDP-AR-304
No
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
Teva Branded Pharmaceutical Products, R&D Inc.
Not Provided
Study Director: Sudeesh K. Tantry, Ph.D. Teva Branded Pharmaceutical Products, R&D Inc.
Teva Pharmaceutical Industries
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP