Dose of Corticosteroids in COPD (DOSE)

• ClinicalTrials.gov Identifier: NCT01742338
• Recruitment Status: Recruiting
• First Posted: December 5, 2012
• Last Update Posted: November 22, 2019
• Sponsor: Rutgers, The State University of New Jersey
• Information provided by (Responsible Party): Jeffrey L Carson, MD, Rutgers, The State University of New Jersey

Study Description

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

• 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 2021
• Estimated Study Completion Date: July 2021

Arms and Interventions

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

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

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• 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

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

• Responsible Party: Jeffrey L Carson, MD, Professor of Medicine, Rutgers, The State University of New Jersey
• ClinicalTrials.gov Identifier: NCT01742338
• Other Study ID Numbers: 0220120019
• First Posted: December 5, 2012
• Last Update Posted: November 22, 2019
• Last Verified: November 2019

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:

Prednisone; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; 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