Dose of Corticosteroids in COPD (DOSE)
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ClinicalTrials.gov Identifier: NCT01742338 |
Recruitment Status
:
Recruiting
First Posted
: December 5, 2012
Last Update Posted
: December 26, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
COPD | Drug: Low Dose Corticosteroids Drug: High Dose Corticosteroids | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 125 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Determining Optimal Dose of Corticosteroids in COPD Exacerbations: A Pilot Study |
Study Start Date : | May 2012 |
Estimated Primary Completion Date : | June 2019 |
Estimated Study Completion Date : | July 2019 |

Arm | Intervention/treatment |
---|---|
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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- Treatment Failure [ Time Frame: 30 days ]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 ]Length of hospital stay
- Quality of Life [ Time Frame: 30 days ]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 ]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.

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Ages Eligible for Study: | 40 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
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.

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): NCT01742338
Contact: Jeffrey L Carson, MD | 732-235-7122 | jeffrey.carson@rutgers.edu | |
Contact: Helaine Noveck, MPH | 732-235-6581 | helaine.noveck@rutgers.edu |
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 | Completed |
Plainsboro, New Jersey, United States, 08536 |
Principal Investigator: | Jeffrey L Carson, MD | Rutgers Robert Wood Johnson Medical School |
Responsible Party: | Jeffrey L Carson, MD, Professor of Medicine, Rutgers, The State University of New Jersey |
ClinicalTrials.gov Identifier: | NCT01742338 History of Changes |
Other Study ID Numbers: |
0220120019 |
First Posted: | December 5, 2012 Key Record Dates |
Last Update Posted: | December 26, 2017 |
Last Verified: | December 2017 |
Keywords provided by Jeffrey L Carson, MD, Rutgers, The State University of New Jersey:
Chronic Obstructive Pulmonary Disease COPD Chronic bronchitis emphysema Corticosteroids |
Additional relevant MeSH terms:
Prednisolone acetate Methylprednisolone acetate Prednisone Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone Prednisolone hemisuccinate Prednisolone phosphate Anti-Inflammatory Agents Glucocorticoids Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents Neuroprotective Agents Protective Agents |