Prospective Dynamic Cohort Study of Phenotypic Profiles in Patients With Chronic Obstructive Pulmonary Disease

ConditionCOPD
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInitiatives Bronchopneumopathie Chronique Obstructive (BPCO)

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Routine care / no study-specific intervention

    Other 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.

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Patients with stable COPD1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline and up to 3 years

Secondary outcomes

1

Comparison of phenotypic profiles with the previous COPD-BPCO 1 cohort

Baseline and up to 3 years

Time frame
Current profiles will be compared with those observed in the previous cohort recruited between 2005 and 2018.
2

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

Time frame
3 years
3

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.

Time frame
Through study completion, an average of 3 years
4

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.

Time frame
Through study completion, an average of 3 years

Other outcomes

Sponsors and contacts

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