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Prospective Dynamic Cohort Study of Phenotypic Profiles in Patients With Chronic Obstructive Pulmonary Disease (COPD-BPCO 2)

2. juni 2026 opdateret af: Initiatives Bronchopneumopathie Chronique Obstructive (BPCO)

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

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

500

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: José GARCIA-MACE

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Adult patients with stable COPD followed in French hospital pulmonology centers.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Patients with stable COPD
Adults with stable COPD confirmed by post-bronchodilator FEV1/FVC < 70%, recruited during routine pulmonology care
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Identification and description of COPD phenotypic profiles
Tidsramme: Baseline and up to 3 years
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Comparison of phenotypic profiles with the previous COPD-BPCO 1 cohort
Tidsramme: Current profiles will be compared with those observed in the previous cohort recruited between 2005 and 2018.
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
Tidsramme: 3 years
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
Tidsramme: Through study completion, an average of 3 years
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
Tidsramme: Through study completion, an average of 3 years
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Initiatives Bronchopneumopathie Chronique Obstructive (BPCO)

Samarbejdspartnere

Clin-Experts

Efterforskere

  • Ledende efterforsker: Nicolas ROCHE, Hôpital Cochin

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. maj 2026

Primær færdiggørelse (Anslået)

31. december 2029

Studieafslutning (Anslået)

31. december 2029

Datoer for studieregistrering

Først indsendt

20. maj 2026

Først indsendt, der opfyldte QC-kriterier

2. juni 2026

Først opslået (Faktiske)

4. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2024-A00438-39 / COPD-BPCO 2

Plan for individuelle deltagerdata (IPD)

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UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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