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

Terminated

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT04005833
• Lead Sponsor: University Hospital, Bordeaux

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.

Study Timeline

• Study First Submitted: 2019-02-15
• Study First Submitted QC: 2019-07-01
• Study First Posted: 2019-07-02
• Study Start: 2019-09-24
• Primary Completion: 2021-03-09
• Study Completion: 2021-06-09
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
number of blood fibrocytes	Day 1	blood fibrocytes level measured during the suspected exacerbation
Forced Expiratory Volume (FEV)	month 36	FEV1 assessed by spirometry

Secondary Outcome Measures

Name	Time	Method
Score of Chronic obstructive pulmonary disease Assessment Test	month 36	health status measured by CAT (http://www.catestonline.org/english/index_France.htm)
Forced Expiratory Volume (FEV)	month 12	FEV1 assessed by spirometry
Score of modified Medical Research Council dyspnea scale	month 36	The MMRC dyspnea scale is a standardized questionnaire validated and measuring the degree of dyspnea in patients with COPD. The scale is an ordinal variable into 5 classes from 0 to 4, a score of 4 representing a major dyspnea.

Trial Locations

Locations (2)

Cabinet médical; 🇫🇷 Belin Beliet, France

Cabinet Médical; 🇫🇷 Cadillac, France