Dose of Corticosteroids in COPD (DOSE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Rutgers, The State University of New Jersey
Sponsor:
Information provided by (Responsible Party):
rwjmsmedicine, University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT01742338
First received: December 3, 2012
Last updated: November 5, 2013
Last verified: November 2013
  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

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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:
  • 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

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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01742338

Contacts
Contact: Jeffrey L Carson, MD 732-235-7122 jeffrey.carson@rutgers.edu
Contact: Van Pham, MD 732-668-2712 vanpham316@gmail.com

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 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         
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Investigators
Principal Investigator: Jeffrey L Carson, MD Rutgers, The State University of New Jersey
  More Information

No publications provided

Responsible Party: rwjmsmedicine, Professor of Medicine, University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier: NCT01742338     History of Changes
Other Study ID Numbers: 0220120019
Study First Received: December 3, 2012
Last Updated: November 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
Chronic Obstructive Pulmonary Disease
COPD
Chronic bronchitis
emphysema
Corticosteroids

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 20, 2014