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

• Published in: BMC pulmonary medicine Vol. 17; no. 1; p. 114
• Main Authors: Sivapalan, Pradeesh, Moberg, Mia, Eklöf, Josefin, Janner, Julie, Vestbo, Jørgen, Laub, Rasmus Rude, Browatzki, Andrea, Armbruster, Karin, Wilcke, Jon Torgny, Seersholm, Niels, Weinreich, Ulla Møller, Titlestad, Ingrid Louise, Andreassen, Helle Frost, Ulrik, Charlotte Suppli, Bødtger, Uffe, Nielsen, Thyge Lynghøj, Hansen, Ejvind Frausing, Jensen, Jens Ulrik Stæhr
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 15.08.2017; BioMed Central; BMC
• Subjects: Aecopd; Analysis; Biomarkers; Bronchitis; Care and treatment; Chronic obstructive lung disease; Chronic obstructive pulmonary disease; Clinical outcomes; Complications and side effects; Copd; Corticosteroid drugs; Corticosteroids; Diabetes; Diagnosis; Dosage and administration; Drug therapy; Dyspnea; Eosinophil-guided corticosteroid-sparing therapy; Exacerbations; Health aspects; Hospitalization; Hyperglycemia; Inflammation; Leukocytes (eosinophilic); Lung diseases; Mortality; Obstructive lung disease; Prednisolone; Pulmonology; Randomized controlled trial; Side effects; Studies; Study Protocol; Systemic corticosteroids; Denmark; Copd; Systemic corticosteroids; Biomarker; Gcp; Length of hospital stay; Exacerbations; Aecopd; Eosinophil-guided corticosteroid-sparing therapy; Randomized controlled trial
• ISSN: 1471-2466; 1471-2466
• DOI: 10.1186/s12890-017-0458-7

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. 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 × 10 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 FEV , and a number of adverse effect measures obtained within 3 months after the index hospitalisation date related to corticosteroid usage. This will be a very large RCT providing knowledge about the effectiveness of individualized biomarker-guided corticosteroid therapy in hospitalised patients with AECOPD. Clinicaltrials.gov, NCT02857842 , 02-august-2016. Clinicaltrialregister.eu: Classification Code: 10,010,953, 02-marts-2016.