Corticosteroid Reduction in COPD (Cortico-cop)

February 7, 2019 updated by: Pradeesh Sivapalan, Chronic Obstructive Pulmonary Disease Trial Network, Denmark

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

318

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Bispebjerg University Hospital
      • Copenhagen, Denmark
        • Hvidovre University Hospital
      • Copenhagen, Denmark
        • North Zealand Hospital
      • Hellerup, Denmark, 2900
        • Gentofte University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Patients hospitalized with AECOPD
  • Age ≥ 40 years
  • Spirometry-verified COPD (defined as FEV1 / FVC ≤ 70%)
  • Chronic Obstructive Lung Disease (GOLD) class C or D
  • Inclusion within 24 hours after admission

Exclusion criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Blood eosinophil guided prednisolone treatment
Intravenous 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.
Drug: Prednisolone
Active Comparator: Standard of care
Intravenous 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
Drug: Prednisolone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Days alive and out of hospital within 14 days after recruitment
Time Frame: 14 days from recruitment
14 days from recruitment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment failure (Recurrence of AECOPD resulting in emergency room visits, hospitalization or need to intensify pharmacological treatment within 30 days)
Time Frame: 30 days
30 days
Change in lung function (ΔFEV1) on day 3, after 1 month and 3 month
Time Frame: 90 days
90 days
Mortality
Time Frame: 360 days
360 days
Infection requiring antibiotic treatment within 180 days after the index of AECOPD
Time Frame: 180 days
180 days
The period between index AECOPD and the next AECOPD exacerbation
Time Frame: 90 days
  1. Readmission with AECOPD or death
  2. Time to readmission with AECOPD or death
90 days
Cumulative corticosteroid dose at 1 and 3 month follow-up
Time Frame: 90 days
  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
90 days
Hyperglycemia during admission
Time Frame: 14 days
14 days
Changes in PTH and Vitamin D status between hospitalization and 3-month follow-up
Time Frame: 90 days
90 days
Change in bone marker levels (Serum P1NP, Serum CTX)
Time Frame: 90 days
90 days
Dyspepsia or ulcer complications (gastrointestinal bleeding)
Time Frame: 90 days
90 days
New onset or worsening of diabetes mellitus
Time Frame: 30 days
30 days
Increase in body mass index between hospitalization, at 30 days and 3-month follow-up
Time Frame: 90 days
90 days
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
Time Frame: 90 days
90 days
Changes in level of dyspnea using the Medical Research Council (MRC) Dyspnoea Scale between hospitalization, at 30 days and 3-month follow-up
Time Frame: 90 days
90 days
Osteoporotic fractures
Time Frame: 360 days
360 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chronic Obstructive Pulmonary Disease Trial Network, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

August 2, 2016

First Submitted That Met QC Criteria

August 2, 2016

First Posted (Estimate)

August 5, 2016

Study Record Updates

Last Update Posted (Actual)

February 8, 2019

Last Update Submitted That Met QC Criteria

February 7, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protocol_CORTICO-COP_PSJUJ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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