COPDCOPD-BPCO 2NCT07627763
Prospective Dynamic Cohort Study of Phenotypic Profiles in Patients With Chronic Obstructive Pulmonary Disease
An observational study of COPD, run by Initiatives Bronchopneumopathie Chronique Obstructive (BPCO) at 7 sites in France.
Trial summary
This prospective, multicenter, real-world observational cohort study will describe phenotypic profiles, patient characteristics, and treatments in adults with stable chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Routine care / no study-specific intervention
- How many people
- 500 participants
- Where
- 7 sitesFrance
- Study dates
- 1 May 2026to 31 Dec 2029
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with stable COPD followed in French hospital pulmonology centers.
Who may be able to join
- Age 18 years or older.
- Stable COPD, defined as no exacerbation requiring treatment during the previous 4 weeks.
- Confirmed COPD diagnosis based on post-bronchodilator FEV1/FVC < 70%
Who cannot join
- Main diagnosis of bronchiectasis, asthma, or any other significant respiratory disease.
- Patients under legal protection.
- Pregnant women.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
José GARCIA-MACE contact
7 sites in 1 country
France7 sites, 7 recruiting
- Recruiting
Chu Bordeaux
Bordeaux
MAEVA ZYSMAN, maeva.zysman@chu-bordeaux.fr
- Recruiting
Chu Lille
Lille
OLIVIER LE ROUZIC, Olivier.LEROUZIC@chu-lille.fr
- Recruiting
Chu Lille
Lille
THIERRY PEREZ, Thierry.PEREZ@chu-lille.fr
- Recruiting
Chu Nancy-Brabois
Nancy
BRUNO RIBEIRO-BAPTISTA, B.RIBEIROBAPTISTA@chru-nancy.fr
- Recruiting
Hopital Cochin
Paris
PIERRE-REGIS BURGEL, pierre-regis.burgel@aphp.fr
- Recruiting
Chu Reims
Reims
GAETAN DESLEE, gdeslee@chu-reims.fr
- Recruiting
Chu Saint Etienne
Saint-Etienne
ISABELLE COURT-FORTUNE, isabelle.court_fortune@chu-st-etienne.fr
About this study
Official title: Prospective Multicenter Dynamic Cohort Study to Evaluate Phenotypic Profiles of Subjects With Chronic Obstructive Pulmonary Disease (COPD-BPCO 2 Study)
This prospective, multicenter, real-world observational cohort study will describe phenotypic profiles, patient characteristics, and treatments in adults with stable chronic obstructive pulmonary disease (COPD). The profiles observed in the current cohort will be compared with those of patients recruited between 2005 and 2018 in the previous COPD-BPCO 1 cohort. Patients will be followed for at least 3 years as part of routine care, with no study-specific visit or treatment.
Read the detailed description
COPD is a heterogeneous disease, and patient characteristics may be associated with prognosis and treatment response. The previous Initiative BPCO cohort recruited 1,720 subjects between 2005 and 2018 and identified clinically relevant COPD phenotypes, including subgroups associated with mortality risk. Because diagnostic strategies, risk factors, comorbidity management, and COPD treatments have evolved, this new prospective dynamic cohort will assess whether current COPD phenotypes differ from those previously identified and whether classification and regression tree (CART) algorithms developed in the previous cohort remain applicable. Data will be collected during routine care from hospital pulmonology centers in France. Baseline and follow-up data may include demographics, risk factors, comorbidities, usual treatments, patient-reported questionnaires, pulmonary function, arterial blood gases, 6-minute walk test, imaging, biology results, exacerbations, and mortality status.
- Conditions
- COPD
- Being tested
- Routine care / no study-specific intervention
- Keywords
- quality of life, dyspnea, pulmonary function, exacerbations, COPD, CART
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine care / no study-specific interventionOther
Patients will be managed according to usual care at the investigator's discretion. The study does not assign any treatment, medicinal product, or medical device.
| Study group | Role | What they receive |
|---|---|---|
| Patients with stable COPD | Adults with stable COPD confirmed by post-bronchodilator FEV1/FVC < 70%, recruited during routine pulmonology care Receives: Other: Routine care / no study-specific intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification and description of COPD phenotypic profiles
COPD phenotypic subgroups will be defined using unsupervised clustering and described according to patient characteristics, treatments, pulmonary function, symptoms, exacerbations, clinically important deterioration, and mortality
Measured: Baseline and up to 3 years
Secondary outcomes (4)
Comparison of phenotypic profiles with the previous COPD-BPCO 1 cohort
Baseline and up to 3 years
Measured: Current profiles will be compared with those observed in the previous cohort recruited between 2005 and 2018.
Prognosis of current patients compared with the previous cohort
Prognosis will be explored using mortality at 3 years, exacerbations, pulmonary function, dyspnea, health status, treatment modifications, and clinically important deterioration
Measured: 3 years
Applicability of previously developed CART algorithms
Classification and regression tree algorithms developed from COPD-BPCO 1 will be applied to the new cohort and, if needed, new classification trees will be developed.
Measured: Through study completion, an average of 3 years
Adverse events
Number and detailed description of adverse events collected as part of the study, although no adverse event related to the study itself is expected.
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start1 May 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Initiatives Bronchopneumopathie Chronique Obstructive (BPCO)
- Sponsor type
- University, hospital or other
- Collaborators
- Clin-Experts
- Responsible party
- Sponsor
- Investigators
- Nicolas ROCHE, Principal investigator, HOPITAL COCHIN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07627763
- Sponsor's protocol ID
- 2024-A00438-39 / COPD-BPCO 2
- Acronym
- COPD-BPCO 2
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 4 Jun 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 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Dynamic Cohort Study to Evaluate Phenotypic Profiles of Subjects With Chronic Obstructive Pulmonary Disease (COPD-BPCO 2 Study)
- ClinicalTrials.gov ID
- NCT07627763
- Acronym / sponsor ID
- COPD-BPCO 2 / 2024-A00438-39 / COPD-BPCO 2
- Conditions
- COPD
- Keywords
- quality of life, dyspnea, pulmonary function, exacerbations, COPD, CART
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Initiatives Bronchopneumopathie Chronique Obstructive (BPCO)University, hospital or other
- Collaborators
- Clin-Experts
- Study start
- 1 May 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 4 Jun 2026 (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.
This prospective, multicenter, real-world observational cohort study will describe phenotypic profiles, patient characteristics, and treatments in adults with stable chronic obstructive pulmonary disease (COPD). The profiles observed in the current cohort will be compared with those of patients recruited between 2005 and 2018 in the previous COPD-BPCO 1 cohort. Patients will be followed for at least 3 years as part of routine care, with no study-specific visit or treatment.
Detailed description
COPD is a heterogeneous disease, and patient characteristics may be associated with prognosis and treatment response. The previous Initiative BPCO cohort recruited 1,720 subjects between 2005 and 2018 and identified clinically relevant COPD phenotypes, including subgroups associated with mortality risk. Because diagnostic strategies, risk factors, comorbidity management, and COPD treatments have evolved, this new prospective dynamic cohort will assess whether current COPD phenotypes differ from those previously identified and whether classification and regression tree (CART) algorithms developed in the previous cohort remain applicable. Data will be collected during routine care from hospital pulmonology centers in France. Baseline and follow-up data may include demographics, risk factors, comorbidities, usual treatments, patient-reported questionnaires, pulmonary function, arterial blood gases, 6-minute walk test, imaging, biology results, exacerbations, and mortality status.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with stable COPD | – | Other: Routine care / no study-specific interventionAdults with stable COPD confirmed by post-bronchodilator FEV1/FVC < 70%, recruited during routine pulmonology care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with stable COPD followed in French hospital pulmonology centers.
Key inclusion criteria (3 listed)
- Age 18 years or older.
- Stable COPD, defined as no exacerbation requiring treatment during the previous 4 weeks.
- Confirmed COPD diagnosis based on post-bronchodilator FEV1/FVC < 70%
Key exclusion criteria (3 listed)
- Main diagnosis of bronchiectasis, asthma, or any other significant respiratory disease.
- Patients under legal protection.
- Pregnant women.
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 |
|---|---|---|
| Routine care / no study-specific interventionPatients will be managed according to usual care at the investigator's discretion. The study does not assign any treatment, medicinal product, or medical device. | Other | Patients with stable COPD |
Primary outcome
Identification and description of COPD phenotypic profiles
Time frame: Baseline and up to 3 years
COPD phenotypic subgroups will be defined using unsupervised clustering and described according to patient characteristics, treatments, pulmonary function, symptoms, exacerbations, clinically important deterioration, and mortality
4 secondary outcomes
Comparison of phenotypic profiles with the previous COPD-BPCO 1 cohort
Time frame: Current profiles will be compared with those observed in the previous cohort recruited between 2005 and 2018.
Prognosis of current patients compared with the previous cohort
Time frame: 3 years
Applicability of previously developed CART algorithms
Time frame: Through study completion, an average of 3 years
Adverse events
Time frame: Through study completion, an average of 3 years
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 4 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
José GARCIA-MACE contact
Nicolas ROCHE principal investigator
HOPITAL COCHIN
7 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, run by Initiatives Bronchopneumopathie Chronique Obstructive (BPCO) at 7 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 3 inclusion and 3 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 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 Renaud URBINELLI (+33756882093, etudes@clin-experts.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification and description of COPD phenotypic profiles (time frame: Baseline and up to 3 years). 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 4 Jun 2026.