A multi-center randomized, controlled, open-label trial evaluating the effects of eosinophil-guided corticosteroid-sparing therapy in hospitalised patients with COPD exacerbations: The CORTICO steroid reduction in COPD (CORTICO-COP) study protocol
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Pradeesh Sivapalan, Mia Moberg, Josefin Eklöf, Julie Janner, Jørgen Vestbo, Rasmus Rude Laub, Andrea Browatzki, Karin Armbruster, Jon Torgny Wilcke, Niels Seersholm, Ulla Møller Weinreich, Ingrid Louise Titlestad, Helle Frost Andreassen, Charlotte Suppli Ulrik, Uffe Bødtger, Thyge Lynghøj Nielsen, Ejvind Frausing Hansen, Jens Ulrik Stæhr Jensen
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 eosinophil-guided corticosteroid-sparing therapy where prednisolone is not administered if the daily blood sampling reveals an eosinophil level below 0.3 × 109cells/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.
TRIAL REGISTRATION: Clinicaltrials.gov, NCT02857842 , 02-august-2016. Clinicaltrialregister.eu: Classification Code: 10,010,953, 02-marts-2016.
|Journal||B M C Pulmonary Medicine|
|Number of pages||7|
|Publication status||Published - 2017|
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