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出境医 / 临床实验 / Blood Fibrocytes During an Exacerbation and Lung Function Decline in Patients With COPD in Primary Care. (FIBRO-COPD)

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

Study Description
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.

Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease 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 Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 230 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : September 19, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2023
Arms 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.

Outcome Measures
Primary Outcome Measures :
  1. number of blood fibrocytes [ Time Frame: Day 1 ]
    blood fibrocytes level measured during the suspected exacerbation

  2. Forced Expiratory Volume (FEV) [ Time Frame: month 36 ]
    FEV1 assessed by spirometry


Secondary Outcome Measures :
  1. Forced Expiratory Volume (FEV) [ Time Frame: month 2 ]
    FEV1 assessed by spirometry

  2. Forced Expiratory Volume (FEV) [ Time Frame: month 12 ]
    FEV1 assessed by spirometry

  3. Score of modified Medical Research Council dyspnea scale [ Time Frame: month 2 ]
    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.

  4. Score of modified Medical Research Council dyspnea scale [ Time Frame: month 12 ]
    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.

  5. Score of modified Medical Research Council dyspnea scale [ Time Frame: 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.

  6. Score of Chronic obstructive pulmonary disease Assessment Test [ Time Frame: month 2 ]
    health status measured by CAT (http://www.catestonline.org/english/index_France.htm)

  7. Score of Chronic obstructive pulmonary disease Assessment Test [ Time Frame: month 12 ]
    health status measured by CAT (http://www.catestonline.org/english/index_France.htm)

  8. Score of Chronic obstructive pulmonary disease Assessment Test [ Time Frame: month 36 ]
    health status measured by CAT (http://www.catestonline.org/english/index_France.htm)


Biospecimen Retention:   Samples Without DNA
Specific to research: the determination of fibrocytes on EDTA tubes (with Ethylenediaminetetraacetic acid) The samples will be transported fresh to measure the rate of circulating blood fibrocytes by flow cytometry.

Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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
Contacts and Locations

Contacts
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Contact: Emmanuel Prothon, MD +33662539394 emmanuel.prothon@u-bordeaux.fr

Locations
Layout table for location information
France
Cabinet médical
Belin Beliet, France, 33830
Contact: Isabelle SPINDLER-FOSSE, MD    05 56 72 88 73    ifosse@protonmail.com   
Cabinet Médical
Cadillac, France, 33410
Contact: Emmanuel PROTHON, MD       drprothon@gmail.com   
Sponsors and Collaborators
University Hospital, Bordeaux
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Layout table for investigator information
Principal Investigator: Emmanuel Prothon, MD University of Bordeaux
Study Chair: Patrick Berger, MD/PhD Hospital University, Bordeaux
Tracking Information
First Submitted Date February 15, 2019
First Posted Date July 2, 2019
Last Update Posted Date July 2, 2019
Estimated Study Start Date September 19, 2019
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 1, 2019)
  • number of blood fibrocytes [ Time Frame: Day 1 ]
    blood fibrocytes level measured during the suspected exacerbation
  • Forced Expiratory Volume (FEV) [ Time Frame: month 36 ]
    FEV1 assessed by spirometry
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 1, 2019)
  • Forced Expiratory Volume (FEV) [ Time Frame: month 2 ]
    FEV1 assessed by spirometry
  • Forced Expiratory Volume (FEV) [ Time Frame: month 12 ]
    FEV1 assessed by spirometry
  • Score of modified Medical Research Council dyspnea scale [ Time Frame: month 2 ]
    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.
  • Score of modified Medical Research Council dyspnea scale [ Time Frame: month 12 ]
    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.
  • Score of modified Medical Research Council dyspnea scale [ Time Frame: 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.
  • Score of Chronic obstructive pulmonary disease Assessment Test [ Time Frame: month 2 ]
    health status measured by CAT (http://www.catestonline.org/english/index_France.htm)
  • Score of Chronic obstructive pulmonary disease Assessment Test [ Time Frame: month 12 ]
    health status measured by CAT (http://www.catestonline.org/english/index_France.htm)
  • Score of Chronic obstructive pulmonary disease Assessment Test [ Time Frame: month 36 ]
    health status measured by CAT (http://www.catestonline.org/english/index_France.htm)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Specific to research: the determination of fibrocytes on EDTA tubes (with Ethylenediaminetetraacetic acid) The samples will be transported fresh to measure the rate of circulating blood fibrocytes by flow cytometry.
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).
Condition Chronic Obstructive Pulmonary Disease
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.
Study Groups/Cohorts COPD exacerbation
COPD exacerbation, compared according to blood fibrocytes level measured during the suspected exacerbation (Day 1)
Intervention: Diagnostic Test: spirometry
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: July 1, 2019)
230
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 1, 2023
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Emmanuel Prothon, MD +33662539394 emmanuel.prothon@u-bordeaux.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04005833
Other Study ID Numbers CHUBX 2017/43
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Hospital, Bordeaux
Study 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
PRS Account University Hospital, Bordeaux
Verification Date June 2019