Clinical trial NCT04005833: Blood Fibrocytes During an Exacerbation and Lung Function Decline in Patients With COPD in Primary Care.
Official title: Association Between Blood Fibrocytes During an Exacerbation and Lung Function Decline in Patients With Early Stage Chronic Obstructive Pulmonary Disease (COPD) in Primary Care
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Pulmonary disease
chronic obstructive
Primary Health Care
Fibrocyte
Respiratory Function Tests
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2019-07-02
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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 GOLD guidelines (worsening of symptoms with the need for prescribing short acting bronchodilatators, antibiotics or oral corticosteroids).

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.

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

Primary outcomes:
measure: number of blood fibrocytes
timeFrame: Day 1
measure: Forced Expiratory Volume (FEV)
timeFrame: month 36
Secondary outcomes:
measure: Forced Expiratory Volume (FEV)
timeFrame: month 2
measure: Forced Expiratory Volume (FEV)
timeFrame: month 12
measure: Score of modified Medical Research Council dyspnea scale
timeFrame: month 2
measure: Score of modified Medical Research Council dyspnea scale
timeFrame: month 12
measure: Score of modified Medical Research Council dyspnea scale
timeFrame: month 36
measure: Score of Chronic obstructive pulmonary disease Assessment Test
timeFrame: month 2
measure: Score of Chronic obstructive pulmonary disease Assessment Test
timeFrame: month 12
measure: Score of Chronic obstructive pulmonary disease Assessment Test
timeFrame: month 36
Other outcomes:
Locations:
city: Belin Beliet
country: France
facility: Cabinet médical
city: Cadillac
country: France
facility: Cabinet Médical
Study officials:
affiliation: University of Bordeaux
name: Emmanuel Prothon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital University, Bordeaux
name: Patrick Berger, MD/PhD
role: STUDY_CHAIR
References: