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| Name | Class |
|---|---|
| Clin-Experts | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with stable COPD | Adults with stable COPD confirmed by post-bronchodilator FEV1/FVC < 70%, recruited during routine pulmonology care |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Routine care / no study-specific intervention | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of phenotypic profiles with the previous COPD-BPCO 1 cohort | Baseline and up to 3 years | 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 |
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Inclusion Criteria:
Age 18 years or older.
Exclusion Criteria:
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Adult patients with stable COPD followed in French hospital pulmonology centers.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Renaud URBINELLI | Contact | +33756882093 | etudes@clin-experts.fr | |
| José GARCIA-MACE | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Nicolas ROCHE | HOPITAL COCHIN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Bordeaux | Recruiting | Bordeaux | France |
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Prognosis will be explored using mortality at 3 years, exacerbations, pulmonary function, dyspnea, health status, treatment modifications, and clinically important deterioration |
| 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. | 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. | Through study completion, an average of 3 years |
| Chu Lille | Recruiting | Lille | France |
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| Chu Lille | Recruiting | Lille | France |
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| Chu Nancy-Brabois | Recruiting | Nancy | France |
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| Hopital Cochin | Recruiting | Paris | France |
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| Chu Reims | Recruiting | Reims | France |
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| Chu Saint Etienne | Recruiting | Saint-Etienne | France |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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