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

Chronic Obstructive Pulmonary Disease Clinical Trial

— FIBRO-COPD  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04005833
• Other study ID #: CHUBX 2017/43
• Status: Not yet recruiting
• Start date: September 19, 2019
• Est. completion date: June 1, 2023

Study information

• Verified date: June 2019
• Source: University Hospital, Bordeaux
• Contact: Emmanuel Prothon, MD
• Phone: +33662539394
• Email: emmanuel.prothon[@]u-bordeaux.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 230
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
France	Cabinet médical	Belin Beliet
France	Cabinet Médical	Cadillac

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of blood fibrocytes	blood fibrocytes level measured during the suspected exacerbation	Day 1
Primary	Forced Expiratory Volume (FEV)	FEV1 assessed by spirometry	month 36
Secondary	Forced Expiratory Volume (FEV)	FEV1 assessed by spirometry	month 2
Secondary	Forced Expiratory Volume (FEV)	FEV1 assessed by spirometry	month 12
Secondary	Score of modified Medical Research Council dyspnea scale	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.	month 2
Secondary	Score of modified Medical Research Council dyspnea scale	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.	month 12
Secondary	Score of modified Medical Research Council dyspnea scale	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.	month 36
Secondary	Score of Chronic obstructive pulmonary disease Assessment Test	health status measured by CAT (http://www.catestonline.org/english/index_France.htm)	month 2
Secondary	Score of Chronic obstructive pulmonary disease Assessment Test	health status measured by CAT (http://www.catestonline.org/english/index_France.htm)	month 12
Secondary	Score of Chronic obstructive pulmonary disease Assessment Test	health status measured by CAT (http://www.catestonline.org/english/index_France.htm)	month 36