Oral or IV Prednisolone in the Treatment of COPD Exacerbations: A Randomized, Controlled, Double-Blind Study

This was a randomized, double-blind, non-inferiority study evaluating oral vs. intravenous prednisolone in hospitalized adult patients with acute chronic obstructive pulmonary disease (COPD) exacerbations between 2001 and 2003. Inclusion criteria were: age > 40 years, an exacerbation of COPD (defined as increased breathlessness for at least 24 h and at least two of the following three symptoms: increased cough frequency or severity, increased sputum volume or purulence, or increased wheeze), history of at least 10 pack-years of cigarette smoking, and evidence of airflow limitation (defined as FEV1/FVC < 70% and FEV1 of < 80% predicted). Patients with signs of a severe exacerbation upon admission, instability, history of asthma, previous study enrollment, significant chest X-ray study findings varying from COPD, a hypersensitivity to prednisolone, or known medication non-compliance were excluded. Patients received either 60 mg of i.v. or oral prednisolone for 5 days, followed by a taper. All patients received albuterol and ipratroprium nebulized four times a day, antibiotics, spirometry, and health status measurements (St. George Respiratory Questionnaire) on days 1 and 7, and daily quality of life measurements for the first 7 days using the Clinical COPD Questionnaire. The primary outcome measure was treatment failure (defined as death from any cause, Intensive Care Unit admission, readmission to the hospital for COPD, and intensified treatment). Treatment failure was divided into early and late (first 2 weeks vs. 2 weeks to 90 days). Secondary outcomes included airflow measurements, health status, quality of life, and length of hospital stay. There were 210 patients who met eligibility requirements and were randomized to one of the treatment arms. Baseline patient characteristics were similar between the two groups. Although treatment failures, specifically late failures, were higher than expected (59%), no differences between the two groups were found for any of the primary or secondary outcomes, leading the authors to conclude that oral prednisolone is not inferior to intravenous prednisolone for the treatment of acute COPD exacerbations.