Randomized trials have shown that systemic corticosteroids are effective in the treatment of exacerbations of chronic obstructive pulmonary disease (COPD) that require hospitalization. However, no large, controlled trials have examined outpatient use of oral corticosteroids for milder exacerbations of COPD. Aaron and colleagues conducted a randomized controlled trial of an outpatient course of prednisone in patients who were seen at an emergency department for an exacerbation of symptoms of COPD.
The trial initially screened 1,087 patients who presented to an emergency department with an exacerbation of COPD, which was defined as the presence of at least two of the following three clinical criteria: increased dyspnea, increased sputum volume, or increased purulence of sputum. Patients included in the study were smokers who had been diagnosed with COPD for at least one year. Patients also had to be at least 35 years of age and have evidence of irreversible airflow obstruction after bronchodilator use. Exclusion criteria included being admitted to the hospital; the use of corticosteroids in the emergency department or within the previous 30 days; and a history of reversible obstructive disease, concurrent pneumonia, or congestive heart failure. The 147 subjects who met the inclusion criteria and signed consent forms were randomized to receive oral prednisone (40 mg, once daily for 10 days) or a matching placebo. Both groups received oral antibiotics (sulfamethoxazole-trimethoprim or doxycycline) and a 30-day course of inhaled albuterol (two puffs four times daily) and inhaled ipratropium (three puffs four times daily).
The rate of patient relapse, defined as an unscheduled visit to a physician's office or emergency department within 30 days of randomization, was 27 percent in those receiving prednisone and 43 percent in those receiving placebo. Spirometric measures were significantly improved by the use of prednisone. After 10 days, the forced expiratory volume in one second was improved by 34 percent in those receiving prednisone compared with 15 percent of those taking antibiotics and bronchodilators alone. Quality-of-life surveys showed decreased dyspnea-related scores with steroid use, but no significant change in life-quality status. No serious adverse effects were noted with prednisone use, but more patients in the prednisone group reported increased appetite, weight gain, insomnia, and symptoms of depression or anxiety.
The authors conclude that a 10-day course of oral prednisone in patients with exacerbations of COPD who do not require hospitalization is associated with fewer relapses in COPD symptoms after treatment and improved spirometric measures of lung function.
editor's note: Careful inclusion and exclusion criteria help to ensure that a proposed intervention is targeted to an appropriate population. However, when only 14 percent of the initially screened patients are enrolled in a trial, one has to wonder if too many clinical hairs have been split. The results of this study might have been generalized more easily if fewer subjects had been excluded. Most physicians treating patients with chronic obstructive pulmonary disorder have to do so in the setting of co-morbidities and would not have pre- and post-bronchodilator spirometry data readily available.—B.Z.