Corticosteroid Reduction in COPD
Cortico-cop
The Effect of Reduced Corticosteroid Therapy in Patients With Acute Exacerbation of COPD
1 other identifier
interventional
318
1 country
4
Brief Summary
This study explores whether patients hospitalized with chronic obstructive pulmonary disease (COPD) exacerbation may have fewer days with prednisolone and with the same treatment effect by controlling the treatment by daily measurements of eosinophils.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2016
Typical duration for phase_4
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 2, 2016
CompletedFirst Posted
Study publicly available on registry
August 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedFebruary 8, 2019
February 1, 2019
2.1 years
August 2, 2016
February 7, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Days alive and out of hospital within 14 days after recruitment
14 days from recruitment
Secondary Outcomes (15)
Treatment failure (Recurrence of AECOPD resulting in emergency room visits, hospitalization or need to intensify pharmacological treatment within 30 days)
30 days
Change in lung function (ΔFEV1) on day 3, after 1 month and 3 month
90 days
Mortality
360 days
Infection requiring antibiotic treatment within 180 days after the index of AECOPD
180 days
The period between index AECOPD and the next AECOPD exacerbation
90 days
- +10 more secondary outcomes
Study Arms (2)
Blood eosinophil guided prednisolone treatment
EXPERIMENTALIntravenous Solu-Medrol 80 mg, followed by prednisolone tablet 37.5 mg daily (maximum of 5 days in all) if the eosinophil count in the blood ≥ 0.3 x 10E9/L. Eosinophil count in the blood \<0.3 x 10E9/L results in no treatment with prednisolone. If the patient is discharged during the treatment period, given treatment from the last measured eosinophil count the remaining days.
Standard of care
ACTIVE COMPARATORIntravenous Solu-Medrol 80 mg on the first day followed by 37.5 mg of prednisolone tablets (1 x 25 mg plus 1 x 12.5 mg) daily for 5 days
Interventions
Eligibility Criteria
You may qualify if:
- Patients hospitalized with AECOPD
- Age ≥ 40 years
- Spirometry-verified COPD (defined as FEV1 / FVC ≤ 70%)
- Chronic Obstructive Lung Disease (GOLD) class C or D
You may not qualify if:
- Known with a diagnosis of asthma
- Life expectancy less than 30 days
- Serious exacerbation requiring invasive ventilation or admission to ICU
- Allergy to systemic corticosteroids
- Severe mental illness, which is not controlled by medication
- People who are detained under the act on the use of coercion in psychiatry
- Severe language problems or inability to provide written informed consent
- Pregnancy and lactation
- Systemic fungal infections
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Bispebjerg University Hospital
Copenhagen, Denmark
Hvidovre University Hospital
Copenhagen, Denmark
North Zealand Hospital
Copenhagen, Denmark
Gentofte University Hospital
Hellerup, 2900, Denmark
Related Publications (3)
Sivapalan P, Jorgensen NR, Mathioudakis AG, Eklof J, Lapperre T, Ulrik CS, Andreassen HF, Armbruster K, Sivapalan P, Janner J, Godtfredsen N, Weinreich UM, Nielsen TL, Seersholm N, Wilcke T, Schuetz P, Klausen TW, Marsa K, Vestbo J, Jensen JU. Bone turnover biomarkers in COPD patients randomized to either a regular or shortened course of corticosteroids: a substudy of the randomized controlled CORTICO-COP trial. Respir Res. 2020 Oct 12;21(1):263. doi: 10.1186/s12931-020-01531-9.
PMID: 33046053DERIVEDSivapalan P, Lapperre TS, Janner J, Laub RR, Moberg M, Bech CS, Eklof J, Holm FS, Armbruster K, Sivapalan P, Mosbech C, Ali AKM, Seersholm N, Wilcke JT, Brondum E, Sonne TP, Ronholt F, Andreassen HF, Ulrik CS, Vestbo J, Jensen JS. Eosinophil-guided corticosteroid therapy in patients admitted to hospital with COPD exacerbation (CORTICO-COP): a multicentre, randomised, controlled, open-label, non-inferiority trial. Lancet Respir Med. 2019 Aug;7(8):699-709. doi: 10.1016/S2213-2600(19)30176-6. Epub 2019 May 20.
PMID: 31122894DERIVEDSivapalan P, Moberg M, Eklof J, Janner J, Vestbo J, Laub RR, Browatzki A, Armbruster K, Wilcke JT, Seersholm N, Weinreich UM, Titlestad IL, Andreassen HF, Ulrik CS, Bodtger U, Nielsen TL, Hansen EF, Jensen JUS. 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. BMC Pulm Med. 2017 Aug 15;17(1):114. doi: 10.1186/s12890-017-0458-7.
PMID: 28810909DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Ph.d.-student
Study Record Dates
First Submitted
August 2, 2016
First Posted
August 5, 2016
Study Start
August 1, 2016
Primary Completion
September 1, 2018
Study Completion
January 1, 2019
Last Updated
February 8, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP