Blood Fibrocytes During an Exacerbation and Lung Function Decline in Patients With COPD in Primary Care.

NCT ID: NCT04005833

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 32 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-24
• Study Completion Date: 2021-06-09

Brief Summary

This study aims to estimate the association between blood fibrocytes measured during a suspected exacerbation and 3-year decline forced expiratory volume in one second (FEV1), in patients with Chronic obstructive pulmonary disease (COPD) in primary care, with a history of smoking, independently of the number of exacerbations and of tobacco or occupational exposure.

Detailed Description

COPD is highly prevalent in primary care. It is associated with tobacco smoke or toxic occupational exposure. Some COPD patients will experience a faster decline in quality of life and lung function. There is currently no prognostic marker allowing to identify those patients at higher risk of fast lung function decline. Recent data suggest that fibrocytes are involved in COPD's physiopathology. A higher blood fibrocytes level during an acute exacerbation has been associated with higher mortality in COPD patients at a late stage of the disease. In mice, fibrocytes role in lung function decline has been demonstrated at an early stage. To date, association between blood fibrocytes during an exacerbation and lung function decline has not been evaluated at the early stage of COPD in humans.

This study aims to estimate the association between blood fibrocytes measured during a suspected exacerbation and 3-year decline in forced expiratory volume in one second (FEV1), in patients with COPD in primary care, with a history of smoking, independently of the number of exacerbations and of tobacco or occupational exposure.

In this study, blood fibrocytes during a suspected exacerbation will be measured at inclusion. The lung function (FEV1) will be assessed at follow-up visits at 2 months, 12 months and 36 months after inclusion. COPD-related health status and severity of dyspnea will be assessed with COPD Assessment test (CAT) and the modified Medical Research Council dyspnea scale (mMRC) at follow-up visits at 2 months, 12 months and 36 months after inclusion.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

COPD exacerbation

COPD exacerbation, compared according to blood fibrocytes level measured during the suspected exacerbation (Day 1)

spirometry

Intervention Type: DIAGNOSTIC_TEST

The lung function (FEV1) will be assessed at follow-up visits at 2 months, 12 months and 36 months after inclusion.

Interventions

spirometry

The lung function (FEV1) will be assessed at follow-up visits at 2 months, 12 months and 36 months after inclusion.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• man or woman aged more than 40 years old,
• with tobacco exposure of more than 20 pack-years,
• Presenting to a General Practitioner with a suspected mild or moderate COPD exacerbation according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (worsening of symptoms with the need for prescribing short acting bronchodilatators, antibiotics or oral corticosteroids)
• Informed consent given
• Affiliated to a social insurance scheme

Exclusion Criteria

• Severe exacerbation of COPD according to GOLD guidelines (patient requires hospitalization or visits to the emergency room),
• More likely differential diagnosis than a COPD exacerbation, such as pneumonia, acute pulmonary oedema or other differential diagnosis,
• history of asthma, pulmonary fibrosis, primary pulmonary hypertension or chronic viral infections (HIV, hepatitis)
• person under care or protection of vulnerable adults

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emmanuel Prothon, MD

Role: PRINCIPAL_INVESTIGATOR

University of Bordeaux

Patrick Berger, MD/PhD

Role: STUDY_CHAIR

Hospital University, Bordeaux

Locations

Cabinet médical

Belin-Béliet, , France

Cabinet Médical

Cadillac, , France

Countries

France

Other Identifiers

CHUBX 2017/43

Identifier Type: -

Identifier Source: org_study_id