Hypothalamic-Pituitary-Adrenal (HPA) Axis Study in Adult and Adolescent Subjects With Perennial Allergic Rhinitis (PAR)
This study has been completed.
Sponsor:
Teva Branded Pharmaceutical Products, R&D Inc.
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
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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:
MedlinePlus related topics:
Steroids
Drug Information available for:
Prednisone
Beclomethasone dipropionate
Beclomethasone dipropionate monohydrate
U.S. FDA Resources
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 May 16, 2013