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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
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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 eosinophil-guided corticosteroid-sparing therapy where prednisolone is not administered if the daily blood sampling reveals an eosinophil level below 0.3 × 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.

TRIAL REGISTRATION: Clinicaltrials.gov, NCT02857842 , 02-august-2016. Clinicaltrialregister.eu: Classification Code: 10,010,953, 02-marts-2016.

Original languageEnglish
JournalBMC Pulmonary Medicine
Volume17
Issue number1
Pages (from-to)e114
ISSN1471-2466
DOIs
Publication statusPublished - 15 Aug 2017

    Research areas

  • Journal Article

ID: 51631581