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

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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Abstract

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
Article number114
JournalB M C Pulmonary Medicine
Volume17
Number of pages7
ISSN1471-2466
DOIs
Publication statusPublished - 15. Aug 2017

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Eosinophils
Chronic Obstructive Pulmonary Disease
Adrenal Cortex Hormones
Length of Stay
Denmark
Treatment Failure
Research

Keywords

  • Chronic obstructive pulmonary disease (COPD)
  • Eosinophils
  • Corticosteroids
  • Treatment
  • Randomised controlled trial
  • Multicenter Study
  • Admission
  • Copd
  • Systemic corticosteroids
  • Biomarker
  • Aecopd
  • Randomized controlled trial
  • Gcp
  • Length of hospital stay
  • Exacerbations
  • Eosinophil-guided corticosteroid-sparing therapy

Cite this

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. / 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. In: B M C Pulmonary Medicine. 2017 ; Vol. 17.
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abstract = "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.",
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author = "Pradeesh Sivapalan and Mia Moberg and Josefin Ekl{\"o}f and Julie Janner and J{\o}rgen Vestbo and Laub, {Rasmus Rude} and Andrea Browatzki and Karin Armbruster and Wilcke, {Jon Torgny} and Niels Seersholm and Weinreich, {Ulla M{\o}ller} and Titlestad, {Ingrid Louise} and Andreassen, {Helle Frost} and Ulrik, {Charlotte Suppli} and Uffe B{\o}dtger and Nielsen, {Thyge Lyngh{\o}j} and Hansen, {Ejvind Frausing} and Jensen, {Jens Ulrik St{\ae}hr}",
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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. / 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.

In: B M C Pulmonary Medicine, Vol. 17, 114, 15.08.2017.

Research output: Contribution to journalJournal articleResearchpeer-review

TY - JOUR

T1 - A multi-center randomized, controlled, open-label trial evaluating the effects of eosinophil-guided corticosteroid-sparing therapy in hospitalised patients with COPD exacerbations

T2 - The CORTICO steroid reduction in COPD (CORTICO-COP) study protocol

AU - Sivapalan, Pradeesh

AU - Moberg, Mia

AU - Eklöf, Josefin

AU - Janner, Julie

AU - Vestbo, Jørgen

AU - Laub, Rasmus Rude

AU - Browatzki, Andrea

AU - Armbruster, Karin

AU - Wilcke, Jon Torgny

AU - Seersholm, Niels

AU - Weinreich, Ulla Møller

AU - Titlestad, Ingrid Louise

AU - Andreassen, Helle Frost

AU - Ulrik, Charlotte Suppli

AU - Bødtger, Uffe

AU - Nielsen, Thyge Lynghøj

AU - Hansen, Ejvind Frausing

AU - Jensen, Jens Ulrik Stæhr

PY - 2017/8/15

Y1 - 2017/8/15

N2 - 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.

AB - 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.

KW - Chronic obstructive pulmonary disease (COPD)

KW - Eosinophils

KW - Corticosteroids

KW - Treatment

KW - Randomised controlled trial

KW - Multicenter Study

KW - Admission

KW - Copd

KW - Systemic corticosteroids

KW - Biomarker

KW - Aecopd

KW - Randomized controlled trial

KW - Gcp

KW - Length of hospital stay

KW - Exacerbations

KW - Eosinophil-guided corticosteroid-sparing therapy

U2 - 10.1186/s12890-017-0458-7

DO - 10.1186/s12890-017-0458-7

M3 - Journal article

C2 - 28810909

VL - 17

JO - B M C Pulmonary Medicine

JF - B M C Pulmonary Medicine

SN - 1471-2466

M1 - 114

ER -