Dose of Corticosteroids in COPD (DOSE)
Verified September 2016 by Rutgers, The State University of New Jersey
Information provided by (Responsible Party):
Jeffrey L Carson, MD, Rutgers, The State University of New Jersey
First received: December 3, 2012
Last updated: September 29, 2016
Last verified: September 2016
COPD (chronic obstructive pulmonary disease) is a long-lasting lung disease usually caused by long-term smoking. COPD can get worse, making people sick enough to need hospitalization. Corticosteroids are very effective and are almost always used, but nobody knows the right dose. High doses may work better but could cause more side effects than low doses. Typical treatment lengths last at least one week. This study will be comparing two common regimens: either 40mg of corticosteroids daily (low dose), or 80mg of corticosteroids daily (high dose). It is unknown which regimen works better..
Drug: Low Dose Corticosteroids
Drug: High Dose Corticosteroids
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||Determining Optimal Dose of Corticosteroids in COPD Exacerbations: A Pilot Study
Primary Outcome Measures:
- Treatment Failure [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Composite outcome of treatment failure defined as death, intubation, re-admission for COPD exacerbation, or intensification of therapy (increased steroid use, change of antibiotic therapy) within a 30-day follow-up period.
Secondary Outcome Measures:
Other Outcome Measures:
- Adverse Effects [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Composite outcome of short-term adverse effects. Defined as hyperglycemia, hypertension, adrenal suppression, psychiatric disturbance, infection, and gastrointestinal bleed that require a consultation, an invasive procedure, or initiation of a specific therapy.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2018 (Final data collection date for primary outcome measure)
Active Comparator: Low Dose Corticosteroids
10 mg IV q8hrs x 3 days*, then prednisone 40 mg PO daily x 4 days, then prednisone 30 mg daily x 1 day, then prednisone 20 mg daily x 1 day, then prednisone 10 mg daily x 1 day, then stop.
*If patient unable to receive IV medications, will give prednisone 20 mg PO bid for the first 3 days.
Drug: Low Dose Corticosteroids
Experimental: High Dose Corticosteroids
Methylprednisolone 40 mg IV q8hrs x 3 days*, then prednisone 80 mg PO daily x 4 days, then prednisone 60 mg daily x 1 day, then prednisone 40 mg daily x 1 day, then prednisone 20 mg daily x 1 day, then stop. *If patient unable to receive IV medications, will give prednisone 40 mg PO bid for the first 3 days.
Drug: High Dose Corticosteroids
The goal of the study is to determine whether a high-dose corticosteroid regimen in patients admitted to the hospital with COPD exacerbations is associated with better clinical outcomes and at acceptable risk of adverse effects compared to a low-dose corticosteroid regimen. Our hypothesis is that high-dose corticosteroids is associated with a decreased rate of treatment failure, shorter length of hospital stay, and improved quality of life with similar risk of adverse effects. The study population includes patients ≥ 40 years-old with a ≥ 10 pack-years smoking history and a diagnosis of COPD, emphysema, or chronic bronchitis who present to the emergency room with increased dyspnea, increased sputum, or increased cough that requires admission to the hospital. We will perform a prospective, randomized, double-blinded study to determine if a high-dose corticosteroid regimen, which is already in use in clinical practice, decreases treatment failure compared to a low-dose corticosteroid regimen that is based on national consensus guidelines.
|Ages Eligible for Study:
||40 Years and older (Adult, Senior)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
i. Patients with a diagnosis of COPD, emphysema, or chronic bronchitis ii. Age ≥ 40 years-old iii. Smoking history ≥ 10 pack-years iv. Presentation to the emergency room with increased dyspnea, increased sputum, or increased cough v. Admission to the hospital
i. Alternative diagnosis for cause of dyspnea, increased sputum or cough ii. Patients who requires intubation at time of recruitment iii. Patients who are unable to give consent iv. Patients who are pregnant or could be pregnant or are currently breast-feeding v. Women of child-bearing age who cannot use methods of contraception as described in the consent, including condoms, female condoms, cervical caps, diaphragms, and intra uterine devices.
vi. Patients who were previously entered into the trial and are re-admitted to the hospital with a new COPD exacerbation.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01742338
|Robert Wood Johnson University Hospital
|New Brunswick, New Jersey, United States, 08901 |
|Principal Investigator: Jeffrey L Carson, MD |
|University Medical Center at Princeton
|Plainsboro, New Jersey, United States, 08536 |
|Contact: Kenneth Goldblatt, MD 609-853-7272 firstname.lastname@example.org |
|Contact: Van Pham, MD 732-668-2712 email@example.com |
|Principal Investigator: Kenneth Goldblatt, MD |
University of Medicine and Dentistry of New Jersey
||Jeffrey L Carson, MD
||Rutgers, The State University of New Jersey
||Jeffrey L Carson, MD, Professor of Medicine, Rutgers, The State University of New Jersey
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 3, 2012
||September 29, 2016
||United States: Institutional Review Board
Keywords provided by Rutgers, The State University of New Jersey:
Chronic Obstructive Pulmonary Disease
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 09, 2016
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