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

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ClinicalTrials.gov Identifier: NCT01133626
Recruitment Status : Completed
First Posted : May 31, 2010
Results First Posted : July 4, 2012
Last Update Posted : July 4, 2012
Sponsor:
Information provided by (Responsible Party):
Teva Branded Pharmaceutical Products R&D, Inc.

Study Description
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Brief Summary:
The purpose of the study is to evaluate the effects of BDP HFA Nasal Aerosol on HPA-axis function.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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)
Study Start Date : June 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. The 24-hour Serum Cortisol Weighted Mean After 42 Days of Treatment [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01133626


Locations
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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
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Study Director: Sudeesh K. Tantry, Ph.D. Teva Branded Pharmaceutical Products R&D, Inc.
More Information
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Publications of Results:
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Teva Branded Pharmaceutical Products R&D, Inc.
ClinicalTrials.gov Identifier: NCT01133626    
Other Study ID Numbers: BDP-AR-304
First Posted: May 31, 2010    Key Record Dates
Results First Posted: July 4, 2012
Last Update Posted: July 4, 2012
Last Verified: May 2012
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Respiratory Tract Infections
Infections
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
 Prednisone
Beclomethasone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anti-Asthmatic Agents
Respiratory System Agents