Dose of Corticosteroids in COPD (DOSE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|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.
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, MDemail@example.com|
|Contact: Helaine Noveck, MPHfirstname.lastname@example.org|
|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|