Systemic Corticosteroids in Chronic Obstructive Pulmonary Disease Exacerbations (SCCOPE): rationale and design of an equivalence trial. Veterans Administration Cooperative Trials SCCOPE Study Group

Abstract

The Systemic Corticosteroids in Chronic Obstructive Pulmonary Disease Exacerbations Trial (SCCOPE) was a randomized, double-blind, placebo-controlled, multicenter trial sponsored by the U.S. Department of Veterans Affairs Cooperative Studies Program. Its principal purpose was to determine whether withholding systemic corticosteroids in patients hospitalized for exacerbations of chronic obstructive pulmonary disease (COPD) who were treated with other usual therapy resulted in a clinically significant increase in the rate of treatment failure. Because placebo was compared to a standard therapy, the study was designed as an equivalence trial. If corticosteroids proved effective, the study would also determine whether a short course was as effective as a long one. SCCOPE was to enroll up to 1100 subjects from more than 20 Veterans Administration Medical Centers over 3 years. Patients were screened shortly after hospital admission for acute exacerbation of COPD. Principal criteria for eligibility were age of 50 years or older, smoking history of 30 pack-years or more, clinical diagnosis of COPD as opposed to asthma, nonuse of systemic corticosteroids in the previous 30 days, and forced expiratory volume in 1 sec (FEV1) of 1500 ml or less. Eligible subjects were randomized to one of three treatment arms: (1) short course (2 weeks) of systemic corticosteroids, (2) long course (8 weeks) of systemic corticosteroids, or (3) placebo. We standardized most other aspects of care. We followed patients for 6 months. The primary endpoint of the study was treatment failure, defined as death, intubation with mechanical ventilation, hospital readmission for COPD, or intensification of pharmacologic therapy. Secondary endpoints included length of hospital stay, changes in FEV1, and changes in dyspnea score. We also evaluated possible adverse effects from systemic corticosteroids.