Dose of Corticosteroids in COPD (DOSE)
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Purpose
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..
| Condition | Intervention | Phase |
|---|---|---|
|
COPD |
Drug: Low Dose Corticosteroids Drug: High Dose Corticosteroids |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Determining Optimal Dose of Corticosteroids in COPD Exacerbations: A Pilot Study |
- 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.
- Length of Stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]Length of hospital stay
- Quality of Life [ Time Frame: 30 days ] [ Designated as safety issue: No ]Quality of life measured by Clinical COPD Questionnaire. The Clinical COPD Questionnaire consists of 10 questions about the severity of COPD symptoms and limitation of activities over the prior week.
- 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: | 125 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
Other Names:
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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.
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Drug: High Dose Corticosteroids
Other Names:
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Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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
Exclusion Criteria:
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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01742338
| Contact: Jeffrey L Carson, MD | 732-235-7122 | jeffrey.carson@rutgers.edu | |
| Contact: Van Pham, MD | 732-668-2712 | vanpham316@gmail.com |
| United States, New Jersey | |
| Robert Wood Johnson University Hospital | Recruiting |
| New Brunswick, New Jersey, United States, 08901 | |
| Principal Investigator: Jeffrey L Carson, MD | |
| University Medical Center at Princeton | Not yet recruiting |
| Plainsboro, New Jersey, United States, 08536 | |
| Contact: Kenneth Goldblatt, MD 609-853-7272 kgoldblatt@princetonhcs.org | |
| Contact: Van Pham, MD 732-668-2712 vanpham316@gmail.com | |
| Principal Investigator: Kenneth Goldblatt, MD | |
| Principal Investigator: | Jeffrey L Carson, MD | Rutgers, The State University of New Jersey |
More Information
No publications provided
| Responsible Party: | rwjmsmedicine, Professor of Medicine, Rutgers, The State University of New Jersey |
| ClinicalTrials.gov Identifier: | NCT01742338 History of Changes |
| Other Study ID Numbers: | 0220120019 |
| Study First Received: | December 3, 2012 |
| Last Updated: | August 14, 2014 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Rutgers, The State University of New Jersey:
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Chronic Obstructive Pulmonary Disease COPD Chronic bronchitis emphysema Corticosteroids |
Additional relevant MeSH terms:
|
Methylprednisolone Methylprednisolone Hemisuccinate Methylprednisolone acetate Prednisolone Prednisolone acetate Prednisolone hemisuccinate Prednisolone phosphate Prednisone Anti-Inflammatory Agents Antiemetics Antineoplastic Agents Antineoplastic Agents, Hormonal |
Autonomic Agents Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Neuroprotective Agents Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Protective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on February 25, 2015