COPD
Conditions
Keywords
quality of life, dyspnea, pulmonary function, exacerbations, COPD, CART
Brief 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). 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.
Interventions
OTHERRoutine care / no study-specific intervention
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.
Sponsors
Initiatives Bronchopneumopathie Chronique Obstructive (BPCO)
Clin-Experts
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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%
Exclusion criteria
* Main diagnosis of bronchiectasis, asthma, or any other significant respiratory disease. * Patients under legal protection. * Pregnant women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identification and description of COPD phenotypic profiles | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of phenotypic profiles with the previous COPD-BPCO 1 cohort | Current profiles will be compared with those observed in the previous cohort recruited between 2005 and 2018. | Baseline and up to 3 years |
| Prognosis of current patients compared with the previous cohort | 3 years | Prognosis will be explored using mortality at 3 years, exacerbations, pulmonary function, dyspnea, health status, treatment modifications, and clinically important deterioration |
| Applicability of previously developed CART algorithms | Through study completion, an average of 3 years | 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. |
| Adverse events | Through study completion, an average of 3 years | Number and detailed description of adverse events collected as part of the study, although no adverse event related to the study itself is expected. |
Countries
France
Contacts
CONTACTRenaud URBINELLI
CONTACTJosé GARCIA-MACE
PRINCIPAL_INVESTIGATORNicolas ROCHE
HOPITAL COCHIN
Outcome results
None listed