Background: The most commonly applied treatment for acute exacerbations of chronic obstructive pulmonary\ndisease (AECOPD) is a 5-day course of high-dose systemic corticosteroids. However, this treatment has not been\nshown to reduce mortality and can potentially have serious side effects.\nRecent research has shown that, presumably, only a subgroup of COPD patients identifieable by blood eosinophil count\nbenefit from a rescue course of prednisolone. By applying a biomarker-guided strategy, the aim of this study is to determine\nwhether it is possible to reduce the use of systemic corticosteroids in AECOPD without influencing the outcome.\nMethods: This is an ongoing prospective multicenter randomized controlled open label trial comprising 320 patients with\nAECOPD recruited from four hospitals in Denmark. The patients are randomized 1:1 to either standard care or eosinophilguided\ncorticosteroid-sparing therapy where prednisolone is not administered if the daily blood sampling reveals an eosinophil\nlevel below 0.3 Ã?â?? 109 cells/L. The primary endpoint is length of hospital stay within 14 days after recruitment. The secondary\nendpoints are treatment failure, 30-day mortality rate, COPD related re-admission rate, change in FEV1, and a number of\nadverse effect measures obtained within 3 months after the index hospitalisation date related to corticosteroid usage.\nDiscussion: This will be a very large RCT providing knowledge about the effectiveness of individualized biomarker-guided\ncorticosteroid therapy in hospitalised patients with AECOPD.
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