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Lung Diseases, ObstructivePhase 4Cortico-copNCT02857842

Corticosteroid Reduction in COPD

A Phase 4 study testing Prednisolone in people with Lung Diseases, Obstructive and Blood Eosinophil Count, run by Chronic Obstructive Pulmonary Disease Trial Network, Denmark at 4 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
Prednisolone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
318 participants
Where
4 sitesDenmark
Study dates
Aug 2016to Jan 2019
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients hospitalized with AECOPD
  • Age ≥ 40 years
  • Spirometry-verified COPD (defined as FEV1 / FVC ≤ 70%)
  • Chronic Obstructive Lung Disease (GOLD) class C or D

Who cannot join

  • 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
Show all 9Show fewer
  • Severe language problems or inability to provide written informed consent
  • Pregnancy and lactation
  • Systemic fungal infections

Trial locations and contacts

4 sites in 1 country.

Denmark4 sites

  • Bispebjerg University Hospital

    Copenhagen

  • Hvidovre University Hospital

    Copenhagen

  • North Zealand Hospital

    Copenhagen

  • Gentofte University Hospital

    Hellerup, 2900

Other trials in Denmark

About this study

Official title: The Effect of Reduced Corticosteroid Therapy in Patients With Acute Exacerbation of COPD

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.

Read the detailed description

The most commonly used treatment for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) is a 5-day treatment with corticosteroids in moderate-high dose. Some patients receive repeated treatments, although it has been shown that corticosteroids only have temporary beneficial effects and no effect in relation to serious incidents or mortality. It has been found that the higher accumulated prednisolone dose disables patients due to serious side effects, including pneumonia, dysregulated diabetes, bone fracture in the context of osteoporosis, mental disorder and adrenal insufficiency etc. However, the extent of the side effects is unknown. Recent research has shown that it is presumably only a small subset of COPD patients who benefit from corticosteroid therapy. This group can be identified by the biomarker "blood-eosinophils" as already measured on most AECOPD patients during hospitalization.

This is a randomized, controlled, multi-center, non-Inferiority trial evaluating the effect of eosinophil guided corticosteroid therapy to patients with AECOPD. The aim of the study is to investigate whether the accumulated dose corticosteroid treatment during admissions for AECOPD can be reduced, including the presumed side effects, while (still) remaining the optimal treatment effect.

Being tested
Prednisolone
Medical subject headings
Lung Diseases, Obstructive, Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02857842
Study groupRoleWhat they receive
Blood eosinophil guided prednisolone treatmentExperimentalIntravenous 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.
Receives: Drug: Prednisolone
Standard of careActive 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
Receives: Drug: Prednisolone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Days alive and out of hospital within 14 days after recruitment

    Measured: 14 days from recruitment

Secondary outcomes (15)

  1. Treatment failure (Recurrence of AECOPD resulting in emergency room visits, hospitalization or need to intensify pharmacological treatment within 30 days)

    Measured: 30 days

  2. Change in lung function (ΔFEV1) on day 3, after 1 month and 3 month

    Measured: 90 days

  3. Mortality

    Measured: 360 days

  4. Infection requiring antibiotic treatment within 180 days after the index of AECOPD

    Measured: 180 days

  5. The period between index AECOPD and the next AECOPD exacerbation

    1. Readmission with AECOPD or death
    2. Time to readmission with AECOPD or death

    Measured: 90 days

  6. Cumulative corticosteroid dose at 1 and 3 month follow-up

    1. Proportions of patients using corticosteroids during hospitalization (day 1 to day 5) between treatment arms
    2. Mean total cumulative dose from recruitment to 3-month follow-up

    Measured: 90 days

  7. Hyperglycemia during admission

    Measured: 14 days

  8. Changes in PTH and Vitamin D status between hospitalization and 3-month follow-up

    Measured: 90 days

  9. Change in bone marker levels (Serum P1NP, Serum CTX)

    Measured: 90 days

  10. Dyspepsia or ulcer complications (gastrointestinal bleeding)

    Measured: 90 days

  11. New onset or worsening of diabetes mellitus

    Measured: 30 days

  12. Increase in body mass index between hospitalization, at 30 days and 3-month follow-up

    Measured: 90 days

  13. The impact of COPD (cough, sputum, dysnea, chest tightsenes etc) on health status (COPD Assessment Test) between hospitalization, at 30 days and 3-month follow-up

    Measured: 90 days

  14. Changes in level of dyspnea using the Medical Research Council (MRC) Dyspnoea Scale between hospitalization, at 30 days and 3-month follow-up

    Measured: 90 days

  15. Osteoporotic fractures

    Measured: 360 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionSep 2018
  4. Study completionJan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
318 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02857842
Sponsor's protocol ID
Protocol_CORTICO-COP_PSJUJ
Acronym
Cortico-cop
Status last verified
Feb 2019
First submitted
2 Aug 2016
Last updated
8 Feb 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

Publications

  • 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.

    PubMed 33046053

  • Sivapalan 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.

    PubMed 31122894

  • Sivapalan 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.

    PubMed 28810909

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Prednisolone in people with Lung Diseases, Obstructive and Blood Eosinophil Count, run by Chronic Obstructive Pulmonary Disease Trial Network, Denmark at 4 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Days alive and out of hospital within 14 days after recruitment (time frame: 14 days from recruitment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02857842, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2019.

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