Chronic Obstructive Pulmonary DiseaseFIBROCHIRNCT01692444
Role of Fibrocytes in the Bronchial Remodelling of Chronic Obstructive Pulmonary Disease
A study testing analyse the distribution and quantify the number of the peri-bronchial and blood circulating fibrocytes in patients in people with Chronic Obstructive Pulmonary Disease, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Airway remodelling is an abnormal tissue repair following bronchial inflammation, which contributes to none reversible pathological features, such as bronchial and peri-bronchial fibrosis. It also influences the prognosis of Chronic Obstructive Pulmonary Disease (COPD) and its mechanisms remain largely unknown. 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?
- analyse the distribution and quantify the number of the peri-bronchial and blood circulating fibrocytes in patients
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 10 Apr 2013to 20 May 2016
- Phase
- Interventional
- 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
Who may be able to join
- Male or female aged more than 40 yr
- Patient needed a thoracic surgery such as lobectomy for cancer or lung transplantation or lung reduction volume surgery.
- COPD group: diagnostic of COPD and differentiation of the stage from 1 to 4 according to the GOLD guidelines.
- Control group: subjects with normal lung function testing and no chronic symptoms (cough or expectoration). Subjects will be separated in 2 groups according to smoking history (Never smokers, smokers (former or current) and paired to patients according to age and sex.
- with a written informed consent
Who cannot join
- Subject without any social security or health insurance
- Asthma, lung fibrosis or idiopathic pulmonary hypertension
- Chronic viral infections (hepatitis, HIV)
- Pregnant woman or breastfeeding
- Subject included for cancer surgery with a Pn0 diagnosis not confirmed after the intervention.
Trial locations and contacts
1 site in 1 country.
France1 site
University hospital of Bordeaux, Hôpital du Haut Lévêque
Pessac, 33604
About this study
Airway remodelling is an abnormal tissue repair following bronchial inflammation, which contributes to none reversible pathological features, such as bronchial and peri-bronchial fibrosis. It also influences the prognosis of Chronic Obstructive Pulmonary Disease (COPD) and its mechanisms remain largely unknown. The role of fibrocytes has been demonstrated in the pathophysiology of asthma, lung fibrosis or pulmonary hypertension. However, the recruitment of blood fibrocytes and their involvement in COPD airway remodelling remain unknown.
The main objective of the study is to analyse the distribution and quantify the number of the peri-bronchial and blood circulating fibrocytes in patients with different stages of COPD compared to control subjects.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- analyse the distribution and quantify the number of the peri-bronchial and blood circulating fibrocytes in patients
- Keywords
- Chronic Obstructive Pulmonary Disease, Fibrosis, Fibroblast, Lung attenuation, Pletysmography
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
analyse the distribution and quantify the number of the peri-bronchial and blood circulating fibrocytes in patientsBiological
analyse the distribution and quantify the number of the peri-bronchial and blood circulating fibrocytes in patients
| Study group | Role | What they receive |
|---|---|---|
| COPD | Experimental | 15 patients with COPD from 1 to 4 according to the GOLD 2011 Receives: Biological: analyse the distribution and quantify the number of the peri-bronchial and blood circulating fibrocytes in patients |
| Non smoker Control | Placebo comparator | 15 patients without COPD and no smoking history Receives: Biological: analyse the distribution and quantify the number of the peri-bronchial and blood circulating fibrocytes in patients |
| Smoker Control | Active comparator | 15 patients without COPD but a smoking history Receives: Biological: analyse the distribution and quantify the number of the peri-bronchial and blood circulating fibrocytes in patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased number of peri-bronchial and blood circulating fibrocytes gradually in each stages of COPD and compared to control subjects.
Measured: Lung tissues and blood samples will be collected at inclusion visit during surgery (Day 0)
Secondary outcomes (3)
Characterization of fibrocytes: expression of chemokines receptors, Toll Like Receptors, HLA class II
Measured: Lung tissues and blood samples will be collected at inclusion visit during surgery (Day 0)
Correlation between lung attenuation and the number of fibrocytes
Measured: Assessed one year after inclusion visit (i.e. surgery date =Day 0)
Correlation between plethysmography and the number of fibrocytes.
Measured: Assessed one year after inclusion visit (i.e. surgery date = Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study start10 Apr 2013
- Primary completion20 May 2016
- Study completion20 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas MOORE, MD-PhD, Study chair, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692444
- Sponsor's protocol ID
- CHUBX 2011/34
- Other IDs
- 2012-A00571-42
- Acronym
- FIBROCHIR
- Status last verified
- Feb 2022
- First submitted
- 17 Sep 2012
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Dupin I, Thumerel M, Maurat E, Coste F, Eyraud E, Begueret H, Trian T, Montaudon M, Marthan R, Girodet PO, Berger P. Fibrocyte accumulation in the airway walls of COPD patients. Eur Respir J. 2019 Sep 5;54(3):1802173. doi: 10.1183/13993003.02173-2018. Print 2019 Sep.
PubMed 31196946Eyraud E, Maurat E, Sac-Epee JM, Henrot P, Zysman M, Esteves P, Trian T, Dupuy JW, Leipold A, Saliba AE, Begueret H, Girodet PO, Thumerel M, Hustache-Castaing R, Marthan R, Levet F, Vallois P, Contin-Bordes C, Berger P, Dupin I. Short-range interactions between fibrocytes and CD8+ T cells in COPD bronchial inflammatory response. Elife. 2023 Jul 26;12:RP85875. doi: 10.7554/eLife.85875.
PubMed 37494277Henrot P, Beaufils F, Thumerel M, Eyraud E, Boudoussier A, Begueret H, Maurat E, Girodet PO, Marthan R, Berger P, Dupin I, Zysman M. Circulating fibrocytes as a new tool to predict lung cancer progression after surgery? Eur Respir J. 2021 Dec 9;58(6):2101221. doi: 10.1183/13993003.01221-2021. Print 2021 Dec. No abstract available.
PubMed 34561289
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Fibrocytes in the Bronchial Remodelling of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01692444
- Acronym / sponsor ID
- FIBROCHIR / CHUBX 2011/34
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, Fibrosis, Fibroblast, Lung attenuation, Pletysmography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 10 Apr 2013 (actual)
- Primary completion
- 20 May 2016 (actual)
- Study completion
- 20 May 2016 (actual)
- First posted
- 25 Sep 2012 (estimated)
- 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.
Airway remodelling is an abnormal tissue repair following bronchial inflammation, which contributes to none reversible pathological features, such as bronchial and peri-bronchial fibrosis. It also influences the prognosis of Chronic Obstructive Pulmonary Disease (COPD) and its mechanisms remain largely unknown. The role of fibrocytes has been demonstrated in the pathophysiology of asthma, lung fibrosis or pulmonary hypertension. However, the recruitment of blood fibrocytes and their involvement in COPD airway remodelling remain unknown.
The main objective of the study is to analyse the distribution and quantify the number of the peri-bronchial and blood circulating fibrocytes in patients with different stages of COPD compared to control subjects.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COPD | Experimental | Biological: analyse the distribution and quantify the number of the peri-bronchial and blood circulating fibrocytes in patients15 patients with COPD from 1 to 4 according to the GOLD 2011 |
| Non smoker Control | Placebo comparator | Biological: analyse the distribution and quantify the number of the peri-bronchial and blood circulating fibrocytes in patients15 patients without COPD and no smoking history |
| Smoker Control | Active comparator | Biological: analyse the distribution and quantify the number of the peri-bronchial and blood circulating fibrocytes in patients15 patients without COPD but a smoking history |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female aged more than 40 yr
- Patient needed a thoracic surgery such as lobectomy for cancer or lung transplantation or lung reduction volume surgery.
- COPD group: diagnostic of COPD and differentiation of the stage from 1 to 4 according to the GOLD guidelines.
- Control group: subjects with normal lung function testing and no chronic symptoms (cough or expectoration). Subjects will be separated in 2 groups according to smoking history (Never smokers, smokers (former or current) and paired to patients according to age and sex.
- with a written informed consent
Key exclusion criteria (5 listed)
- Subject without any social security or health insurance
- Asthma, lung fibrosis or idiopathic pulmonary hypertension
- Chronic viral infections (hepatitis, HIV)
- Pregnant woman or breastfeeding
- Subject included for cancer surgery with a Pn0 diagnosis not confirmed after the intervention.
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 |
|---|---|---|
| analyse the distribution and quantify the number of the peri-bronchial and blood circulating fibrocytes in patientsanalyse the distribution and quantify the number of the peri-bronchial and blood circulating fibrocytes in patients | Biological | COPD, Non smoker Control, Smoker Control |
Primary outcome
Increased number of peri-bronchial and blood circulating fibrocytes gradually in each stages of COPD and compared to control subjects.
Time frame: Lung tissues and blood samples will be collected at inclusion visit during surgery (Day 0)
3 secondary outcomes
Characterization of fibrocytes: expression of chemokines receptors, Toll Like Receptors, HLA class II
Time frame: Lung tissues and blood samples will be collected at inclusion visit during surgery (Day 0)
Correlation between lung attenuation and the number of fibrocytes
Time frame: Assessed one year after inclusion visit (i.e. surgery date =Day 0)
Correlation between plethysmography and the number of fibrocytes.
Time frame: Assessed one year after inclusion visit (i.e. surgery date = Day 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Results publication: PubMed 31196946Dupin I, Thumerel M, Maurat E, Coste F, Eyraud E, Begueret H, Trian T, Montaudon M, Marthan R, Girodet PO, Berger P. Fibrocyte accumulation in the airway walls of COPD patients. Eur Respir J. 2019 Sep 5;54(3):1802173. doi: 10.1183/13993003.02173-2018. Print 2019 Sep.
- Derived from this study: PubMed 37494277Eyraud E, Maurat E, Sac-Epee JM, Henrot P, Zysman M, Esteves P, Trian T, Dupuy JW, Leipold A, Saliba AE, Begueret H, Girodet PO, Thumerel M, Hustache-Castaing R, Marthan R, Levet F, Vallois P, Contin-Bordes C, Berger P, Dupin I. Short-range interactions between fibrocytes and CD8+ T cells in COPD bronchial inflammatory response. Elife. 2023 Jul 26;12:RP85875. doi: 10.7554/eLife.85875.
- Derived from this study: PubMed 34561289Henrot P, Beaufils F, Thumerel M, Eyraud E, Boudoussier A, Begueret H, Maurat E, Girodet PO, Marthan R, Berger P, Dupin I, Zysman M. Circulating fibrocytes as a new tool to predict lung cancer progression after surgery? Eur Respir J. 2021 Dec 9;58(6):2101221. doi: 10.1183/13993003.01221-2021. Print 2021 Dec. No abstract available.
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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.
Nicholas MOORE, MD-PhD study chair
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing analyse the distribution and quantify the number of the peri-bronchial and blood circulating fibrocytes in patients in people with Chronic Obstructive Pulmonary Disease, run by University Hospital, Bordeaux at 1 site 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 5 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: finished, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Increased number of peri-bronchial and blood circulating fibrocytes gradually in each stages of COPD and compared to control subjects. (time frame: Lung tissues and blood samples will be collected at inclusion visit during surgery (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01692444, which also lists 3 linked publications.
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 9 Jun 2026.