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

Association Between Blood Fibrocytes During an Exacerbation and Lung Function Decline in Patients With Early Stage Chronic Obstructive Pulmonary Disease (COPD) in Primary Care

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Diagnostic test: spirometry

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 Type: Observational
• Enrollment (Anticipated): 230

Contacts and Locations

• Study Contact: Name: Emmanuel Prothon, MD; Phone Number: +33662539394; Email: emmanuel.prothon@u-bordeaux.fr

Study Locations

• France
  • Belin Beliet, France, 33830
    • Cabinet Médical
    • Contact: Isabelle SPINDLER-FOSSE, MD; Phone Number: 05 56 72 88 73; Email: ifosse@protonmail.com
  • Cadillac, France, 33410
    • Cabinet Médical
    • Contact: Emmanuel PROTHON, MD; Email: drprothon@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COPD exacerbation; COPD exacerbation, compared according to blood fibrocytes level measured during the suspected exacerbation (Day 1)	Diagnostic test: spirometry; The lung function (FEV1) will be assessed at follow-up visits at 2 months, 12 months and 36 months after inclusion.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced Expiratory Volume (FEV)	FEV1 assessed by spirometry	month 2
Forced Expiratory Volume (FEV)	FEV1 assessed by spirometry	month 12
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
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
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
Score of Chronic obstructive pulmonary disease Assessment Test	health status measured by CAT (http://www.catestonline.org/english/index_France.htm)	month 2
Score of Chronic obstructive pulmonary disease Assessment Test	health status measured by CAT (http://www.catestonline.org/english/index_France.htm)	month 12
Score of Chronic obstructive pulmonary disease Assessment Test	health status measured by CAT (http://www.catestonline.org/english/index_France.htm)	month 36

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France
• Investigators: Principal Investigator: Emmanuel Prothon, MD, University of Bordeaux; Study Chair: Patrick Berger, MD/PhD, Hospital University, Bordeaux

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 19, 2019
• Primary Completion (ANTICIPATED): June 1, 2020
• Study Completion (ANTICIPATED): June 1, 2023

Study Registration Dates

• First Submitted: February 15, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (ACTUAL): July 2, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 2, 2019
• Last Update Submitted That Met QC Criteria: July 1, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Primary Health Care; Respiratory Function Tests; Pulmonary disease; chronic obstructive; Fibrocyte
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: CHUBX 2017/43

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No