Hypothalamic-Pituitary-Adrenal (HPA) Axis Study in Adult and Adolescent Subjects With Perennial Allergic Rhinitis (PAR)
NCT ID: NCT01133626
Last Updated: 2012-07-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
107 participants
INTERVENTIONAL
2010-06-30
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
Placebo Nasal Aerosol
Placebo nasal aerosol administered daily for 42 days of treatment
Placebo Prednisone Capsules
Placebo prednisone capsule taken each day on the last 7 days of treatment
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.
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.
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.
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
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female subjects 12-45 years of age
* Documented history of perennial allergic rhinitis
* General good health
* Other criteria apply
Exclusion Criteria
* 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
12 Years
45 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Sudeesh K. Tantry, Ph.D.
Role: STUDY_DIRECTOR
Teva Branded Pharmaceutical Products R&D, Inc.
Locations
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Teva Clinical Study Site
North Dartmouth, Massachusetts, United States
Teva Clinical Study Site
New Braunfels, Texas, United States
Teva Clinical Study Site
San Antonio, Texas, United States
Countries
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References
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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.
Ratner PH, Miller SD, Hampel FC Jr, Melchior A, Dunbar SA, Tantry SK. Once-daily treatment with beclomethasone dipropionate nasal aerosol does not affect hypothalamic-pituitary-adrenal axis function. Ann Allergy Asthma Immunol. 2012 Nov;109(5):336-41. doi: 10.1016/j.anai.2012.08.005.
Other Identifiers
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BDP-AR-304
Identifier Type: -
Identifier Source: org_study_id