Journal
BMC PULMONARY MEDICINE
Volume 17, Issue -, Pages -Publisher
BMC
DOI: 10.1186/s12890-017-0458-7
Keywords
Systemic corticosteroids; Copd; Exacerbations; Eosinophil-guided corticosteroid-sparing therapy; Randomized controlled trial; Aecopd; Gcp; Biomarker; Length of hospital stay
Categories
Funding
- Danish Regions
- Danish Council for Independent Research
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Background: The most commonly applied treatment for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) is a 5-day course of high-dose systemic corticosteroids. However, this treatment has not been shown to reduce mortality and can potentially have serious side effects. Recent research has shown that, presumably, only a subgroup of COPD patients identifieable by blood eosinophil count benefit from a rescue course of prednisolone. By applying a biomarker-guided strategy, the aim of this study is to determine whether it is possible to reduce the use of systemic corticosteroids in AECOPD without influencing the outcome. Methods: This is an ongoing prospective multicenter randomized controlled open label trial comprising 320 patients with AECOPD recruited from four hospitals in Denmark. The patients are randomized 1: 1 to either standard care or eosinophilguided corticosteroid-sparing therapy where prednisolone is not administered if the daily blood sampling reveals an eosinophil level below 0.3 x 10(9) cells/L. The primary endpoint is length of hospital stay within 14 days after recruitment. The secondary endpoints are treatment failure, 30-day mortality rate, COPD related re-admission rate, change in FEV1, and a number of adverse effect measures obtained within 3 months after the index hospitalisation date related to corticosteroid usage. Discussion: This will be a very large RCT providing knowledge about the effectiveness of individualized biomarker-guided corticosteroid therapy in hospitalised patients with AECOPD.
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