Dose of Corticosteroids in COPD

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.

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.