Background: Chronic obstructive pulmonary disease (COPD) is a major public health issue affecting approximately five to seven percent of the Swiss population. According to current guidelines for the inpatient setting, systemic corticosteroids are most important in the treatment of acute COPD exacerbations and should be given for five to seven days. Several studies suggest that corticosteroids accelerate the recovery of the FEV1 (forced expiratory volume in one second), enhance oxygenation, decrease duration of hospitalization and improve clinical outcome. However, the additional therapeutic benefit on FEV1 recovery appears to be most distinctive in the first three to five days. No data are available on the minimal necessary corticosteroid dose and treatment duration in primary care patients with acutely exacerbated COPD. Given the fact that many patients are treated in an outpatient setting, there is an urgent need to improve evidence about COPD management in this setting.
Methods: The proposed study is a prospective, double-blind, randomized controlled trial that is conducted in a primary care setting including an anticipated 470 patients with acutely exacerbated COPD. Participants receive systemic corticosteroid treatment equivalent of 40 mg prednisone daily for either five days (conventional arm, n = 235), or for three days, followed by two days of placebo (experimental arm, n = 235). Antibiotic treatment for seven days is given to all patients with CRP ≥ 50 mg/l, known diagnosis of bronchiectasis, or presenting with Anthonisen Type-I exacerbation. Additional treatment after inclusion are left at the discretion of the treating general pracititioner. Follow-up visits are performed on days three and seven by the treating general practitioners, followed by telephone interviews on das 30, 90 and 180 after inclusion into the study. Primary endpoint is the time to next exacerbation during index exacerbation, or during a six-months follow-up period, whichever occurs first.
Discussion: This study is designed to assess whether a three-day course of corticosteroid treatment is not inferior to the current conventional five-day treatment course in outpatients with exacerbated COPD. Depending on the results, this trial might lead to a further reduction of cumulative corticosteroid dose in COPD patients.