Overview

Dose of Corticosteroids in COPD

Status:
Suspended

Trial end date:
2022-09-01

Target enrollment:
0

Participant gender:
All

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..

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Rutgers, The State University of New Jersey
University of Medicine and Dentistry of New Jersey

Treatments:

Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Prednisone

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.