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
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01742338
|Contact: Jeffrey L Carson, MDfirstname.lastname@example.org|
|Contact: Helaine Noveck, MPHemail@example.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||Completed|
|Plainsboro, New Jersey, United States, 08536|
|Principal Investigator:||Jeffrey L Carson, MD||Rutgers Robert Wood Johnson Medical School|