COPD ExacerbationCOPDregisterNCT06257329
Characteristics and Outcomes of Patients Admitted to ICU for a Severe Acute Exacerbation of COPD.
An observational study of COPD Exacerbation and ICU, run by Alexis FERRE at 4 sites in France.
Trial summary
The objective of this prospective observational study is to describe the epidemiological, clinical and biological characteristics of patients admitted in ICU for a severe acute exacerbation of COPD, and to assess the different treatment received received, to evaluate the prognosis with short, mid and long term ( 1… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD Exacerbation, ICU
- What is being tested?
- register
- How many people
- 2,000 participants
- Where
- 4 sitesFrance
- Study dates
- 1 Oct 2022to 1 Apr 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: patients with severe acute exacerbation of COPD admitted in ICU
Who may be able to join
- Age ≥ 40 years old
- COPD documented or strongly suspected
- Chronic respiratory symptoms (dyspnoea, cough and/or sputum)
- Exposure to a known risk factor for COPD (such as tobacco smoke)
- If available, respiratory function tests showing non- or partially reversible obstructive syndrom (post-bronchodilator ratio FEV1/CV < 0.7)
- Severe acute exacerbation, defined as a worsening of the patient's usual respiratory symptoms with signs of acute respiratory distress (polypnoea ≥ 30 cycles.min-1 or use of accessory respiratory muscles) and/or hypercapnic acidosis (with PaCO2 ≥ 45 mmHg and pH ≤ 7.35)
- Admission to an ICU, a step-up unit or a respiratory care unit
Who cannot join
- Known asthma (according to the criteria of the international "Global initiative for asthma" guidelines)
- Patient refusal to participate (information note, application for non-opposition)
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Laure Morisset contact
France4 sites, 4 recruiting
- Recruiting
CHU de Grenoble
Grenoble, 38700
Louis-Marie Galerneau, M.D., PhD., lmgalerneau@chu-grenoble.fr
- Recruiting
Centre hospitalier de Versailles
Le Chesnay, 78157
Alexis Ferré, M.D., +33.1.39.63.87.00, aferre@ght78sud.fr
Laure Morisset, lmorisset@ght78sud.fr
- Recruiting
CH Le Mans
Le Mans, 72037
Jean-Christophe Callahan, M.D., jccallahan@ch-lemans.fr
- Recruiting
CHU Rennes
Rennes, 35000
Nicolas Terzi, M.D., PhD., nicolas.terzi@chu-rennes.fr
About this study
Official title: Epidemiological, Clinical and Biological Characteristics, and Therapeutic Management of ICU Patients With Severe Acute Exacerbation of COPD. Evaluation of Prognosis and Factors Associated With Survival.
The objective of this prospective observational study is to describe the epidemiological, clinical and biological characteristics of patients admitted in ICU for a severe acute exacerbation of COPD, and to assess the different treatment received received, to evaluate the prognosis with short, mid and long term ( 1 year) mortality and the factors associated with survival.
Read the detailed description
This is a prospective study for which data will be collected from pseudonymised. General information on the research activity clinic of the Intensive Care Unit of the Versailles hospital is provided by poster, patient booklet or debrief hospitalization, indicating to relatives and/ or patients their possible participation in retrospective or prospective studies.
This research is conducted in accordance with the reference methodology MR 004 approved by the National Commission of Informatics and Libertés (CNIL) and to which the Centre hospitalier de Versailles is committed to comply. For this purpose, an information note will be given to each patient participating in this project in order to seek its non-opposition of participation in this study.
This prospective study is based solely on the examination of medical files. The data collected are non-sensitive medical data.
This study complies with legal and regulatory requirements. In addition, this research project was submitted to the Ethics Committee of the Société de Réanimation de Langue Française (French Intensive Care Society) which issued a favorable opinion on October, 6, 2022 (Registration number referenced: CE SRLF 22-056).
- Conditions
- COPD Exacerbation, ICU
- Being tested
- register
- Keywords
- COPD, exacerbation, characteristics, outcome, mortality
- 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.
registerOther
Multicentre prospective observational register
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU mortality
ICU mortality for patients admitted for a severe acute exacerbation of COPD
Measured: ICU discharge
Secondary outcomes (3)
Mortality at Day 30
Day 30 mortality for patients admitted for a severe acute exacerbation of COPD
Measured: Day 30
Mortality at Day 90
Day 90 mortality for patients admitted for a severe acute exacerbation of COPD
Measured: Day 90
ICU patients' characteristics
Description of epidemiological, clinical, and biological characteristics of patients admitted to ICU for a severe acute exacerbation of COPD
Measured: ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start1 Oct 2022
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD ExacerbationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Alexis FERRE
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alexis FERRE, Versailles Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257329
- Sponsor's protocol ID
- P22/13_BPCO register
- Acronym
- COPDregister
- Status last verified
- Oct 2026
- First submitted
- 6 Feb 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological, Clinical and Biological Characteristics, and Therapeutic Management of ICU Patients With Severe Acute Exacerbation of COPD. Evaluation of Prognosis and Factors Associated With Survival.
- ClinicalTrials.gov ID
- NCT06257329
- Acronym / sponsor ID
- COPDregister / P22/13_BPCO register
- Conditions
- COPD Exacerbation, ICU
- Keywords
- COPD, exacerbation, characteristics, outcome, mortality
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Alexis FERREUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 13 Feb 2024 (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 objective of this prospective observational study is to describe the epidemiological, clinical and biological characteristics of patients admitted in ICU for a severe acute exacerbation of COPD, and to assess the different treatment received received, to evaluate the prognosis with short, mid and long term ( 1 year) mortality and the factors associated with survival.
Detailed description
This is a prospective study for which data will be collected from pseudonymised. General information on the research activity clinic of the Intensive Care Unit of the Versailles hospital is provided by poster, patient booklet or debrief hospitalization, indicating to relatives and/ or patients their possible participation in retrospective or prospective studies.
This research is conducted in accordance with the reference methodology MR 004 approved by the National Commission of Informatics and Libertés (CNIL) and to which the Centre hospitalier de Versailles is committed to comply. For this purpose, an information note will be given to each patient participating in this project in order to seek its non-opposition of participation in this study.
This prospective study is based solely on the examination of medical files. The data collected are non-sensitive medical data.
This study complies with legal and regulatory requirements. In addition, this research project was submitted to the Ethics Committee of the Société de Réanimation de Langue Française (French Intensive Care Society) which issued a favorable opinion on October, 6, 2022 (Registration number referenced: CE SRLF 22-056).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with severe acute exacerbation of COPD admitted in ICU
Key inclusion criteria (7 listed)
- Age ≥ 40 years old
- COPD documented or strongly suspected
- Severe acute exacerbation, defined as a worsening of the patient's usual respiratory symptoms with signs of acute respiratory distress (polypnoea ≥ 30 cycles.min-1 or use of accessory respiratory muscles) and/or hypercapnic acidosis (with PaCO2 ≥ 45 mmHg and pH ≤ 7.35)
- Admission to an ICU, a step-up unit or a respiratory care unit
Key exclusion criteria (2 listed)
- Known asthma (according to the criteria of the international "Global initiative for asthma" guidelines)
- Patient refusal to participate (information note, application for non-opposition)
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 |
|---|---|---|
| registerMulticentre prospective observational register | Other | – |
Primary outcome
ICU mortality
Time frame: ICU discharge
ICU mortality for patients admitted for a severe acute exacerbation of COPD
3 secondary outcomes
Mortality at Day 30
Time frame: Day 30
Mortality at Day 90
Time frame: Day 90
ICU patients' characteristics
Time frame: ICU admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Undecided
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FreeDom: Innovative Strategy for the Management of COPD Exacerbations
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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.
Laure Morisset contact
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD Exacerbation and ICU, run by Alexis FERRE at 4 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 7 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 27 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 4 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexis Ferré, M.D. (+33.1.39.63.887.00, aferre@ght78sud.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU mortality (time frame: ICU discharge). 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 27 Oct 2026.