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

作者：Sivapalan Pradeesh^*; Moberg Mia; Eklof Josefin; Janner Julie; Vestbo Jorgen; laub Rasmus Rude; Browatzki Andrea; Armbruster Karin; Wilcke Jon Torgny; Seersholm Niels; Weinreich Ulla Moller; Titlestad Ingrid Louise; Andreassen Helle Frost; Ulrik Charlotte Suppli; Bodtger Uffe; Nielsen Thyge Lynghoj; Hansen Ejvind Frausing; Jensen Jens Ulrik Staehr

来源：BMC Pulmonary Medicine, 2017, 17(1): 114.

DOI：10.1186/s12890-017-0458-7

• Systemic corticosteroids
• Copd
• Exacerbations
• Eosinophil-guided corticosteroid-sparing therapy
• Randomized controlled trial
• Aecopd
• Gcp
• Biomarker
• Length of hospital stay

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.

• 出版日期2017-8-15