Chronic Obstructive Pulmonary DiseasePhase 3CorticopNCT04163536
Comparison of Corticosteroids vs Placebo on Duration of Ventilatory Support During Severe Acute Exacerbations of COPD Patients in the ICU
A Phase 3 study testing Methylprednisolone in people with Chronic Obstructive Pulmonary Disease, run by Versailles Hospital at 23 sites in France.
Trial 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 acute on chronic… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Methylprednisolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 440 participants
- Where
- 23 sitesFrance
- Study dates
- 25 Oct 2021to 17 Apr 2025
- Phase
- Phase 3
- 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 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)
- Severe acute exacerbation, defined by the presence of the two following criteria:
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- COPD exacerbation defined by a change in the patient baseline respiratory symptoms and requiring a change in regular respiratory medication
- Acute respiratory failure (polypnea ≥ 30 breaths.min-1 or use of accessory respiratory muscles) requiring mechanical ventilation, either invasive 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 <24h
- Written 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.
Who cannot join
- Previous diagnostic of asthma ("GINA" international guidelines)
- Current and proven active SARS-CoV2 infection
- Contra-indication of systemic corticosteroids treatment: allergy to corticosteroids, uncontrolled severe arterial hypertension, uncontrolled diabetes mellitus, gastro-intestinal ulcer bleeding
- Underlying disease requiring chronic daily use of systemic steroids
- Pneumothorax at inclusion
- Extracorporeal life support (ECMO or ECCO2R) at inclusion
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- Moribund patient
- 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
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
France23 sites
CHU Angers
Angers
CH Argenteuil
Argenteuil
CH métropole savoie
Chambéry
CHU Louis Mourier
Colombes
CHU Dijon
Dijon
CHU Grenoble
Grenoble
CHD Vendée
La Roche-sur-Yon
André Mignot Hospital, Intensive care unit
Le Chesnay, Les Yvelines, 78150
CHU de Bicêtre
Le Kremlin-Bicêtre, France, 94270
CH Le Mans
Le Mans
CHRU lille
Lille
CHU Lyon
Lyon
CH d'Annecy Genevois
Metz-Tessy, 74370
CHU Nice
Nice
CHR orléans
Orléans
CHU Cochin
Paris
Hôpital européen Georges pompidou
Paris
Pitié-Salpêtrière
Paris
CHU Poitiers
Poitiers
CHU de Rennes
Rennes
Hopital Foch
Suresnes
CHRU Tours
Tours
CH Vannes
Vannes
About this study
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
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 acute on chronic respiratory failure (ACRF) requiring ventilatory support, either invasive or non-invasive.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Methylprednisolone, Placebos
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlacebosDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| cortisteroids arm | Active comparator | Not described Receives: Drug: Methylprednisolone |
| placebo arm | Placebo comparator | Not described Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 28
Secondary outcomes (15)
NIV failure rate
NIV failure rate, defined by intubation within day 7
Measured: day 7
Duration of NIV and of invasive mechanical ventilation
Duration of Non Invasive Ventilation and of invasive mechanical ventilation
Measured: at day 90
Circulatory and renal support-free days and alive at day 28
Circulatory and renal support-free days and alive at day 28
Measured: at day 28
Severe hyperglycemia requiring intravenous insulin during the five first days
Severe hyperglycemia requiring intravenous insulin during the five first days
Measured: during the five first days
Gastro-intestinal bleeding
acute loss of 2 g/dL of hemoglobin requiring red blood cell transfusion or gastroscopic evaluation
Measured: between inclusion and day 28
Uncontrolled arterial hypertension
unusual hypertension requiring to introduce/add antihypertensive medication (compared to usual medications)
Measured: between inclusion and day 28
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
Measured: at day 28
ICU-acquired infections (especially Ventilator-Associated Pneumonia)
Intensive Care Unit -acquired infections (especially Ventilator-Associated Pneumonia)
Measured: at the time of ICU discharge or day 90
Length of ICU and hospital stay
Length of ICU and hospital stay
Measured: at day 90
ICU and hospital mortality
ICU and hospital mortality
Measured: between inclusion and day 28 or day 90
Day 28 and Day 90 mortality
Day 28 and Day 90 mortality
Measured: at Day 28 and Day 90
Standardized mortality ratio (SMR)
Standardized mortality ratio (SMR)
Measured: between inclusion and day 90
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
Measured: at 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
Measured: at day 90
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
Measured: at day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start25 Oct 2021
- Primary completion24 Nov 2024
- Study completion17 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 440 participants (actual)
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexis FERRE, Versailles Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04163536
- Sponsor's protocol ID
- P17/15_corticop
- Acronym
- Corticop
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2019
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04163536
- Acronym / sponsor ID
- Corticop / P17/15_corticop
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 24 Nov 2024 (actual)
- Study completion
- 17 Apr 2025 (actual)
- First posted
- 14 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 acute on chronic respiratory failure (ACRF) requiring ventilatory support, either invasive or non-invasive.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cortisteroids arm | Active comparator | Drug: Methylprednisolone |
| placebo arm | Placebo comparator | Drug: Placebos |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients aged ≥ 40 years
- Strongly suspected or documented COPD, defined by the presence of the following criterias:
- Severe acute exacerbation, defined by the presence of the two following criteria:
- Admission to an ICU, a step-up unit or a respiratory care unit <24h
- Written 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.
Key exclusion criteria (11 listed)
- Previous diagnostic of asthma ("GINA" international guidelines)
- Current and proven active SARS-CoV2 infection
- Contra-indication of systemic corticosteroids treatment: allergy to corticosteroids, uncontrolled severe arterial hypertension, uncontrolled diabetes mellitus, gastro-intestinal ulcer bleeding
- Underlying disease requiring chronic daily use of systemic steroids
- Pneumothorax at inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethylprednisoloneIn 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. | Drug | cortisteroids arm |
| Placebosin 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. | Drug | placebo arm |
Primary outcome
the number of ventilator-free days (VFD) and alive at day 28.
Time frame: 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.
15 secondary outcomes
NIV failure rate
Time frame: day 7
Duration of NIV and of invasive mechanical ventilation
Time frame: at day 90
Circulatory and renal support-free days and alive at day 28
Time frame: at day 28
Severe hyperglycemia requiring intravenous insulin during the five first days
Time frame: during the five first days
Gastro-intestinal bleeding
Time frame: between inclusion and day 28
Uncontrolled arterial hypertension
Time frame: between inclusion and day 28
ICU acquired weakness (MRC-score < 48/60) assessed on day 28 or at the time of ICU discharge
Time frame: at day 28
ICU-acquired infections (especially Ventilator-Associated Pneumonia)
Time frame: at the time of ICU discharge or day 90
Length of ICU and hospital stay
Time frame: at day 90
ICU and hospital mortality
Time frame: between inclusion and day 28 or day 90
Day 28 and Day 90 mortality
Time frame: at Day 28 and Day 90
Standardized mortality ratio (SMR)
Time frame: between inclusion and day 90
Number of new exacerbation(s)/hospitalization(s) between hospital discharge and Day 90
Time frame: at day 90
Dyspnea (patient reported outcome) at Day 90 evaluated by clinical assessment test and dyspnea mMRC score
Time frame: at day 90
respiratory comfort (patient reported outcome) at Day 90 evaluated by clinical assessment test and dyspnea mMRC score
Time frame: at day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methylprednisolone in people with Chronic Obstructive Pulmonary Disease, run by Versailles Hospital at 23 sites in France.
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 11 inclusion and 11 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 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in France. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
the number of ventilator-free days (VFD) and alive at day 28. (time frame: day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2026.