About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Stable COPD, defined as no exacerbation requiring treatment during the previous 4 weeks.
Confirmed COPD diagnosis based on post-bronchodilator FEV1/FVC < 70%
Disqualifiers
Main diagnosis of bronchiectasis, asthma, or any other significant respiratory disease.
Patients under legal protection.
Pregnant women.
Trial population
Adult patients with stable COPD followed in French hospital pulmonology centers.
Trial design
Cohort
Prospective
Treatments tested in this trial
Routine care / no study-specific intervention
Other 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.
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
Comparison of phenotypic profiles with the previous COPD-BPCO 1 cohort
Baseline and up to 3 years
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
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.
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Initiatives Bronchopneumopathie Chronique Obstructive (BPCO)
Lead sponsor
Clin-Experts
Collaborator