Prospective Dynamic Cohort Study of Phenotypic Profiles in Patients With Chronic Obstructive Pulmonary Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Routine care / no study-specific intervention.
- Who it may be relevant to
- Registry conditions: COPD. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Multicenter Dynamic Cohort Study to Evaluate Phenotypic Profiles of Subjects With Chronic Obstructive Pulmonary Disease (COPD-BPCO 2 Study)
Overview
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
- Other Routine 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.
Primary outcome measures
- Identification and description of COPD phenotypic profiles [Time frame: Baseline and up to 3 years]
Secondary outcome measures (4)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 7 centers
- Chu Bordeaux — Bordeaux
- Chu Lille — Lille
- Chu Lille — Lille
- Chu Nancy-Brabois — Nancy
- Hopital Cochin — Paris
- Chu Reims — Reims
- Chu Saint Etienne — Saint-Etienne
Identifiers
NCT: NCT07627763 · 2024-A00438-39 / COPD-BPCO 2