Background: In this randomized, double-blind, placebo-controlled trial, we studied the effectiveness of prednisone in reducing the risk of relapse after outpatient exacerbations of chronic obstructive pulmonary disease (COPD).
Methods: We enrolled 147 patients who were being discharged from the emergency department after an exacerbation of COPD and randomly assigned them to 10 days of treatment with 40 mg of oral prednisone once daily or identical-appearing placebo. All patients received oral antibiotics for 10 days, plus inhaled bronchodilators. The primary end point was relapse, defined as an unscheduled visit to a physician's office or a return to the emergency department because of worsening dyspnea, within 30 days after randomization.
Results: The overall rate of relapse at 30 days was lower in the prednisone group than in the placebo group (27 percent vs. 43 percent, P=0.05), and the time to relapse was prolonged in those taking prednisone (P=0.04). After 10 days of therapy, patients in the prednisone group had greater improvements in forced expiratory volume in one second than did patients in the placebo group (mean [+/-SD] increase from base line, 34+/-42 percent vs. 15+/-31 percent; P=0.007). Patients in the prednisone group also had significant improvements in dyspnea, as measured by the transitional dyspnea index (P=0.04) and by the dyspnea domain of the Chronic Respiratory Disease Index Questionnaire (P=0.02), but not in health-related quality of life (P=0.14).
Conclusions: Outpatient treatment with oral prednisone offers a small advantage over placebo in treating patients who are discharged from the emergency department with an exacerbation of COPD.
Copyright 2003 Massachusetts Medical Society