Chronic Obstructive Pulmonary DiseaseFIBRO-COPDNCT04005833
Blood Fibrocytes During an Exacerbation and Lung Function Decline in Patients With COPD in Primary Care.
An observational study of Chronic Obstructive Pulmonary Disease, run by University Hospital, Bordeaux at 2 sites in France.
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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- spirometry
- How many people
- 32 participants
- Where
- 2 sitesFrance
- Study dates
- 24 Sep 2019to 9 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Cabinet médical
Belin-Béliet, 33830
Cabinet Médical
Cadillac, 33410
About this study
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
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- spirometry
- Keywords
- Pulmonary disease, chronic obstructive, Primary Health Care, Fibrocyte, Respiratory Function Tests
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spirometryDiagnostic test
The lung function (FEV1) will be assessed at follow-up visits at 2 months, 12 months and 36 months after inclusion.
| Study group | Role | What they receive |
|---|---|---|
| COPD exacerbation | COPD exacerbation, compared according to blood fibrocytes level measured during the suspected exacerbation (Day 1) Receives: Diagnostic Test: spirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of blood fibrocytes
blood fibrocytes level measured during the suspected exacerbation
Measured: Day 1
Forced Expiratory Volume (FEV)
FEV1 assessed by spirometry
Measured: month 36
Secondary outcomes (8)
Forced Expiratory Volume (FEV)
FEV1 assessed by spirometry
Measured: month 2
Forced Expiratory Volume (FEV)
FEV1 assessed by spirometry
Measured: 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.
Measured: 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.
Measured: 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.
Measured: month 36
Score of Chronic obstructive pulmonary disease Assessment Test
health status measured by CAT (http://www.catestonline.org/english/index_France.htm)
Measured: month 2
Score of Chronic obstructive pulmonary disease Assessment Test
health status measured by CAT (http://www.catestonline.org/english/index_France.htm)
Measured: month 12
Score of Chronic obstructive pulmonary disease Assessment Test
health status measured by CAT (http://www.catestonline.org/english/index_France.htm)
Measured: month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start24 Sep 2019
- Primary completion9 Mar 2021
- Study completion9 Jun 2021
Why it stopped: Inclusions were suspended due to the COVID-19 pandemic, and the inclusion rate would not increase during the resumption.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel Prothon, MD, Principal investigator, University of BordeauxPatrick Berger, MD/PhD, Study chair, Hospital University, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04005833
- Sponsor's protocol ID
- CHUBX 2017/43
- Acronym
- FIBRO-COPD
- Status last verified
- Aug 2024
- First submitted
- 15 Feb 2019
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04005833
- Acronym / sponsor ID
- FIBRO-COPD / CHUBX 2017/43
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Pulmonary disease, chronic obstructive, Primary Health Care, Fibrocyte, Respiratory Function Tests
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Inclusions were suspended due to the COVID-19 pandemic, and the inclusion rate would not increase during the resumption.
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- 9 Mar 2021 (actual)
- Study completion
- 9 Jun 2021 (actual)
- First posted
- 2 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD exacerbation | – | Diagnostic Test: spirometryCOPD exacerbation, compared according to blood fibrocytes level measured during the suspected exacerbation (Day 1) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spirometryThe lung function (FEV1) will be assessed at follow-up visits at 2 months, 12 months and 36 months after inclusion. | Diagnostic test | COPD exacerbation |
Primary outcome
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
8 secondary outcomes
Forced Expiratory Volume (FEV)
Time frame: month 2
Forced Expiratory Volume (FEV)
Time frame: month 12
Score of modified Medical Research Council dyspnea scale
Time frame: month 2
Score of modified Medical Research Council dyspnea scale
Time frame: month 12
Score of modified Medical Research Council dyspnea scale
Time frame: month 36
Score of Chronic obstructive pulmonary disease Assessment Test
Time frame: month 2
Score of Chronic obstructive pulmonary disease Assessment Test
Time frame: month 12
Score of Chronic obstructive pulmonary disease Assessment Test
Time frame: month 36
Results and safety
The study was stopped early (reason given: Inclusions were suspended due to the COVID-19 pandemic, and the inclusion rate would not increase during the resumption.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel Prothon, MD principal investigator
University of Bordeaux
Patrick Berger, MD/PhD study chair
Hospital University, Bordeaux
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by University Hospital, Bordeaux at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inclusions were suspended due to the COVID-19 pandemic, and the inclusion rate would not increase during the resumption.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of blood fibrocytes (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.