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Comparison of Corticosteroids vs Placebo on Duration of Ventilatory Support During Severe Acute Exacerbations of COPD Patients in the ICU (Corticop)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Methylprednisolone
Placebos
Sponsored by
Versailles Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients aged ≥ 40 years

  2. Strongly suspected or documented COPD, defined by the presence of the following criterias:

    • Persistent respiratory symptoms (dyspnoea, chronic cough or sputum)
    • History of exposure to a risk factor such as tobacco smoke
    • If available, pulmonary function tests showing airflow limitation not fully reversible (post-bronchodilator ratio of FEV1/ FVC ratio < 0.7)

  3. ACRF, defined by the presence of the two following criteria:

    • COPD exacerbation defined by a change in the patient baseline respiratory symptoms at least 24 hours and requiring a change in regular respiratory medication
    • Acute respiratory failure <24h (polypnea ≥ 30 breaths.min-1 or use of accessory respiratory muscles) requiring ventilatory support, either invasive (implemented because of respiratory distress) or NIV (implemented because of hypercapnic acidosis with PaCO2 ≥ 45 mmHg and pH ≤ 7.35).
  4. Admission to an ICU, a step-up unit or a respiratory care unit
  5. Inform consent from the patient or his surrogates. In patients who are not able to consent on admission an emergency inclusion procedure will be allowed, with a mandatory delayed consent.
  6. Affiliation to (or benefit from) French health insurance system

Exclusion Criteria:

  • Previous diagnostic of asthma, according to "GINA" international guidelines (40)
  • Recent use of systemic corticosteroids, defined by systemic corticosteroids use in the past 7 days
  • Contra-indication of systemic corticosteroids treatment: allergy to corticosteroids, uncontrolled severe arterial hypertension, uncontrolled diabetes mellitus, gastro-intestinal ulcer bleeding
  • Pneumothorax at randomization
  • Extracorporeal life support (ECMO or ECCO2R) at inclusion
  • Moribund patient life expectancy < 3 months
  • Pregnancy
  • Patients protected by law
  • Exclusion period due to other interventional clinical trial enrolment which can influence primary outcome
  • Previous inclusion in the present study

Sites / Locations

  • André Mignot Hospital, Intensive care unitRecruiting
  • CHU AngersRecruiting
  • CH métropole savoie
  • CHU Louis MourierRecruiting
  • CHU Henri mondor
  • CHU DijonRecruiting
  • CHU GrenobleRecruiting
  • CHD VendéeRecruiting
  • CHU de BicêtreRecruiting
  • CH Le MansRecruiting
  • CHRU lilleRecruiting
  • CHU LyonRecruiting
  • CH d'Annecy GenevoisRecruiting
  • CHU Nantes
  • CHR orléansRecruiting
  • CHU CochinRecruiting
  • Hôpital européen Georges pompidouRecruiting
  • Pitié-SalpêtrièreRecruiting
  • CHU PoitiersRecruiting
  • CHU de RennesRecruiting
  • CHU de Rouen
  • Hopital Foch
  • CHRU ToursRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

cortisteroids arm

placebo arm

Arm Description

Outcomes

Primary Outcome Measures

the number of ventilator-free days (VFD) and alive at day 28.
To determine if the systemic administration of corticosteroids, as compared to placebo, increases the number of ventilator-free days (VFD) and alive at day 28 in COPD patients admitted to an ICU, a step-up unit or a respiratory care unit for an ACRF requiring ventilatory support, either invasive or non-invasive.

Secondary Outcome Measures

NIV failure rate
NIV failure rate, defined by intubation within day 7
Duration of NIV and of invasive mechanical ventilation
Duration of Non Invasive Ventilation and of invasive mechanical ventilation
Circulatory and renal support-free days and alive at day 28
Circulatory and renal support-free days and alive at day 28
Severe hyperglycemia requiring intravenous insulin during the five first days
Severe hyperglycemia requiring intravenous insulin during the five first days
Gastro-intestinal bleeding
acute loss of 2 g/dL of hemoglobin requiring red blood cell transfusion or gastroscopic evaluation
Uncontrolled arterial hypertension
unusual hypertension requiring to introduce/add antihypertensive medication (compared to usual medications)
ICU acquired weakness (MRC-score < 48/60) assessed on day 28 or at the time of ICU discharge
Intensive Care Unit acquired weakness (MRC-score < 48/60) assessed on day 28 or at the time of ICU discharge
ICU-acquired infections (especially Ventilator-Associated Pneumonia)
Intensive Care Unit -acquired infections (especially Ventilator-Associated Pneumonia)
Length of ICU and hospital stay
Length of ICU and hospital stay
ICU and hospital mortality
ICU and hospital mortality
Day 28 and Day 90 mortality
Day 28 and Day 90 mortality
Standardized mortality ratio (SMR)
Standardized mortality ratio (SMR)
Number of new exacerbation(s)/hospitalization(s) between hospital discharge and Day 90
Number of new exacerbation(s)/hospitalization(s) between hospital discharge and Day 90
Dyspnea (patient reported outcome) at Day 90 evaluated by clinical assessment test and dyspnea mMRC score
Dyspnea (patient reported outcome) at Day 90 evaluated by clinical assessment test and dyspnea mMRC score
respiratory comfort (patient reported outcome) at Day 90 evaluated by clinical assessment test and dyspnea mMRC score
respiratory comfort (patient reported outcome) at Day 90 evaluated by clinical assessment test and dyspnea mMRC score

Full Information

First Posted
October 29, 2019
Last Updated
October 16, 2023
Sponsor
Versailles Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04163536
Brief Title
Comparison of Corticosteroids vs Placebo on Duration of Ventilatory Support During Severe Acute Exacerbations of COPD Patients in the ICU
Acronym
Corticop
Official Title
Comparison of Corticosteroids Versus Placebo on Duration of Ventilatory Support During Severe Acute Exacerbations of COPD Patients in the Intensive Care Unit: a Multicentre Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2021 (Actual)
Primary Completion Date
October 25, 2025 (Anticipated)
Study Completion Date
March 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Versailles Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main objective of this study is to determine if the systemic (intravenous) administration of corticosteroids, as compared to placebo, increases the number of ventilator-free days (VFD) and alive at day 28 in COPD patients admitted to an ICU, a step-up unit or a respiratory care unit for an ACRF requiring ventilatory support, either invasive or non-invasive.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
440 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cortisteroids arm
Arm Type
Active Comparator
Arm Title
placebo arm
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Intervention Description
In the experimental group, methylprednisolone will be administered intravenously for 5 days at a dose of 1 mg/kg/day. Methylprednisolone will be provided for reconstitution and dilution in 50 ml of NaCl 0.9% solution and administered over 15 minutes, once a day.
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
in the control group, placebo will be administered intravenously for 5 days. Placebo will be identical (color and aspect) to experimental substance, will be provide as a 50 mL of NaCl 0.9% solution and administered intravenously over 15 minutes, once a day.
Primary Outcome Measure Information:
Title
the number of ventilator-free days (VFD) and alive at day 28.
Description
To determine if the systemic administration of corticosteroids, as compared to placebo, increases the number of ventilator-free days (VFD) and alive at day 28 in COPD patients admitted to an ICU, a step-up unit or a respiratory care unit for an ACRF requiring ventilatory support, either invasive or non-invasive.
Time Frame
day 28
Secondary Outcome Measure Information:
Title
NIV failure rate
Description
NIV failure rate, defined by intubation within day 7
Time Frame
day 7
Title
Duration of NIV and of invasive mechanical ventilation
Description
Duration of Non Invasive Ventilation and of invasive mechanical ventilation
Time Frame
at day 90
Title
Circulatory and renal support-free days and alive at day 28
Description
Circulatory and renal support-free days and alive at day 28
Time Frame
at day 28
Title
Severe hyperglycemia requiring intravenous insulin during the five first days
Description
Severe hyperglycemia requiring intravenous insulin during the five first days
Time Frame
during the five first days
Title
Gastro-intestinal bleeding
Description
acute loss of 2 g/dL of hemoglobin requiring red blood cell transfusion or gastroscopic evaluation
Time Frame
between inclusion and day 28
Title
Uncontrolled arterial hypertension
Description
unusual hypertension requiring to introduce/add antihypertensive medication (compared to usual medications)
Time Frame
between inclusion and day 28
Title
ICU acquired weakness (MRC-score < 48/60) assessed on day 28 or at the time of ICU discharge
Description
Intensive Care Unit acquired weakness (MRC-score < 48/60) assessed on day 28 or at the time of ICU discharge
Time Frame
at day 28
Title
ICU-acquired infections (especially Ventilator-Associated Pneumonia)
Description
Intensive Care Unit -acquired infections (especially Ventilator-Associated Pneumonia)
Time Frame
at the time of ICU discharge or day 90
Title
Length of ICU and hospital stay
Description
Length of ICU and hospital stay
Time Frame
at day 90
Title
ICU and hospital mortality
Description
ICU and hospital mortality
Time Frame
between inclusion and day 28 or day 90
Title
Day 28 and Day 90 mortality
Description
Day 28 and Day 90 mortality
Time Frame
at Day 28 and Day 90
Title
Standardized mortality ratio (SMR)
Description
Standardized mortality ratio (SMR)
Time Frame
between inclusion and day 90
Title
Number of new exacerbation(s)/hospitalization(s) between hospital discharge and Day 90
Description
Number of new exacerbation(s)/hospitalization(s) between hospital discharge and Day 90
Time Frame
at day 90
Title
Dyspnea (patient reported outcome) at Day 90 evaluated by clinical assessment test and dyspnea mMRC score
Description
Dyspnea (patient reported outcome) at Day 90 evaluated by clinical assessment test and dyspnea mMRC score
Time Frame
at day 90
Title
respiratory comfort (patient reported outcome) at Day 90 evaluated by clinical assessment test and dyspnea mMRC score
Description
respiratory comfort (patient reported outcome) at Day 90 evaluated by clinical assessment test and dyspnea mMRC score
Time Frame
at day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged ≥ 40 years Strongly suspected or documented COPD, defined by the presence of the following criterias: Persistent respiratory symptoms (dyspnoea, chronic cough or sputum) History of exposure to a risk factor such as tobacco smoke If available, pulmonary function tests showing airflow limitation not fully reversible (post-bronchodilator ratio of FEV1/ FVC ratio < 0.7) ACRF, defined by the presence of the two following criteria: COPD exacerbation defined by a change in the patient baseline respiratory symptoms at least 24 hours and requiring a change in regular respiratory medication Acute respiratory failure <24h (polypnea ≥ 30 breaths.min-1 or use of accessory respiratory muscles) requiring ventilatory support, either invasive (implemented because of respiratory distress) or NIV (implemented because of hypercapnic acidosis with PaCO2 ≥ 45 mmHg and pH ≤ 7.35). Admission to an ICU, a step-up unit or a respiratory care unit Inform consent from the patient or his surrogates. In patients who are not able to consent on admission an emergency inclusion procedure will be allowed, with a mandatory delayed consent. Affiliation to (or benefit from) French health insurance system Exclusion Criteria: Previous diagnostic of asthma, according to "GINA" international guidelines (40) Recent use of systemic corticosteroids, defined by systemic corticosteroids use in the past 7 days Contra-indication of systemic corticosteroids treatment: allergy to corticosteroids, uncontrolled severe arterial hypertension, uncontrolled diabetes mellitus, gastro-intestinal ulcer bleeding Pneumothorax at randomization Extracorporeal life support (ECMO or ECCO2R) at inclusion Moribund patient life expectancy < 3 months Pregnancy Patients protected by law Exclusion period due to other interventional clinical trial enrolment which can influence primary outcome Previous inclusion in the present study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
virginie chatagner
Phone
0139239776
Email
vchatagner@ght78sud.fr
Facility Information:
Facility Name
André Mignot Hospital, Intensive care unit
City
Le Chesnay
State/Province
Les Yvelines
ZIP/Postal Code
78150
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexis FERRE
Facility Name
CHU Angers
City
Angers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
françois beloncle
Facility Name
CH métropole savoie
City
Chambéry
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent Peigne
Facility Name
CHU Louis Mourier
City
Colombes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jean damien ricard
Facility Name
CHU Henri mondor
City
Créteil
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Armand Mekontso-Dessap
Facility Name
CHU Dijon
City
Dijon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Pierre Quenot
Facility Name
CHU Grenoble
City
Grenoble
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas Terzi
Facility Name
CHD Vendée
City
La Roche-sur-Yon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gwenhaël Colin
Facility Name
CHU de Bicêtre
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94270
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadia Anguel
Facility Name
CH Le Mans
City
Le Mans
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe Guitton
Facility Name
CHRU lille
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saad NSEIR
Facility Name
CHU Lyon
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mehdi MEZIDI
Facility Name
CH d'Annecy Genevois
City
Metz-Tessy
ZIP/Postal Code
74370
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michel Muller, Dr
Facility Name
CHU Nantes
City
Nantes
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Reignier
Facility Name
CHR orléans
City
Orléans
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Toufik Kamel
Facility Name
CHU Cochin
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean daniel Chiche
Facility Name
Hôpital européen Georges pompidou
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Planquette
Facility Name
Pitié-Salpêtrière
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre Demoule
Facility Name
CHU Poitiers
City
Poitiers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnaud Thille
Facility Name
CHU de Rennes
City
Rennes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnaud Gacouin
Facility Name
CHU de Rouen
City
Rouen
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaëtan Beduneau
Facility Name
Hopital Foch
City
Suresnes
Country
France
Individual Site Status
Active, not recruiting
Facility Name
CHRU Tours
City
Tours
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane Ehrmann

12. IPD Sharing Statement

Learn more about this trial

Comparison of Corticosteroids vs Placebo on Duration of Ventilatory Support During Severe Acute Exacerbations of COPD Patients in the ICU

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