Dose of Corticosteroids in COPD (DOSE)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
COPD	Drug: Low Dose Corticosteroids; Drug: High Dose Corticosteroids	Phase 4

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.

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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: prednisone; methylprednisolone; Solumedrol
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; Other Names: prednisone; methylprednisolone; Solumedrol

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Length of Stay [ Time Frame: 30 days ]
   Length of hospital stay
2. 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.

Other Outcome Measures:

1. 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.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	40 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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 Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Jeffrey L Carson, MD	732-235-7122	jeffrey.carson@rutgers.edu
Contact: Helaine Noveck, MPH	732-235-6581	helaine.noveck@rutgers.edu

Locations

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

Sponsors and Collaborators

Rutgers, The State University of New Jersey

Investigators

Principal Investigator:	Jeffrey L Carson, MD	Rutgers Robert Wood Johnson Medical School

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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