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ClinicalTrials.gov ID

NCT07627763

Lead Sponsor

Initiatives Bronchopneumopathie Chronique Obstructive (BPCO)OTHER

Overall Status

Recruiting

Study Type

Observational

Enrollment

500Estimated

Last Update Posted

Jun 4, 2026Actual

Start Date

May 1, 2026Actual

Primary Completion Date

Dec 31, 2029Estimated

Completion Date

Dec 31, 2029Estimated

Official Title

Prospective Multicenter Dynamic Cohort Study to Evaluate Phenotypic Profiles of Subjects With Chronic Obstructive Pulmonary Disease (COPD-BPCO 2 Study)

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.

• COPD

• Routine care / no study-specific intervention

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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.

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Initiatives Bronchopneumopathie Chronique Obstructive (BPCO)OTHER

Collaborators

Clin-ExpertsINDUSTRY

Olivier.LEROUZIC@chu-lille.fr

Thierry.PEREZ@chu-lille.fr

pierre-regis.burgel@aphp.fr

gdeslee@chu-reims.fr