Chronic Obstructive Pulmonary DiseaseFIREBROBNCT01196832
Role of Fibrocytes in Chronic Obstructive Pulmonary Disease
A study testing blood sample and Clinical and functional evaluation in people with Chronic Obstructive Pulmonary Disease, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a frequent airway disease characterized by both bronchial inflammation and remodelling. Bronchial mucosa is infiltrated by macrophages, neutrophils and lymphocytes. In addition, the number of eosinophils can be also increased during exacerbation. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- blood sample and Clinical and functional evaluation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteFrance
- Study dates
- 11 Mar 2011to 31 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients: diagnostic of Chronic obstructive pulmonary disease (COPD) exacerbation.
- Control group: subjects without any history of lung disease and with normal lung function testing. Subjects will be separated in 2 sub-groups according to smoking history (Never smokers, smokers (former or current) and paired to patients according to age and sex.
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Fibrocytes in the Bronchial Remodeling of Chronic Obstructive Pulmonary Disease
Chronic obstructive pulmonary disease (COPD) is a frequent airway disease characterized by both bronchial inflammation and remodelling.
Bronchial mucosa is infiltrated by macrophages, neutrophils and lymphocytes. In addition, the number of eosinophils can be also increased during exacerbation.
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 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- blood sample, Clinical and functional evaluation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleProcedure or surgery
blood sample for fibrocytes analysis
Clinical and functional evaluationProcedure or surgery
Plethysmography, Carbon monoxide capacity of transfer , arterial gaz
| Study group | Role | What they receive |
|---|---|---|
| Chronic obstructive pulmonary disease patients | Experimental | COPD patients with exacerbation will be recruited during hospitalization in Intensive care unit or as outpatients in the clinical investigation centre of the CHU de Bordeaux.
Inclusion visit: blood sample for fibrocytes analysis. Second visit 2 months ± 7 days after the exacerbation: clinical and functional evaluation (plethysmography, TLCO, arterial gaz), blood sample for fibrocytes analysis. Receives: Procedure: blood sample; Procedure: Clinical and functional evaluation |
| Control group | Other | Subjects without any history of lung disease and with normal lung function testing Receives: Procedure: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of circulating blood fibrocytes
Sampling of blood in Chronic obstructive pulmonary disease patients
Measured: Day 1
Number of circulating blood fibrocytes
Sampling of blood in Chronic obstructive pulmonary disease patients
Measured: 2 months
Secondary outcomes (6)
Characterization of fibrocytes
Sampling of blood
Measured: Day 1 and at 2 months
Differenciation of blood fibrocytes
Sampling of blood
Measured: Day 1 and at 2 months
Chemotactism of blood fibrocytes
Sampling of blood
Measured: Day 1 and at 2 months
Number of exacerbation
Measured: 12 months after V2
Mortality
Measured: 12 months after V2
Annual decline of ventilatory function
Measured: 12 months after V2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study start11 Mar 2011
- Primary completionMar 2016
- Study completion31 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick BERGER, PUPH, Principal investigator, University Hospital Bordeaux (France)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01196832
- Sponsor's protocol ID
- CHUBX 2010/05
- Other IDs
- 2010-A00248-31
- Acronym
- FIREBROB
- Status last verified
- Feb 2022
- First submitted
- 1 Jun 2010
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Dupin I, Allard B, Ozier A, Maurat E, Ousova O, Delbrel E, Trian T, Bui HN, Dromer C, Guisset O, Blanchard E, Hilbert G, Vargas F, Thumerel M, Marthan R, Girodet PO, Berger P. Blood fibrocytes are recruited during acute exacerbations of chronic obstructive pulmonary disease through a CXCR4-dependent pathway. J Allergy Clin Immunol. 2016 Apr;137(4):1036-1042.e7. doi: 10.1016/j.jaci.2015.08.043. Epub 2015 Oct 23.
PubMed 26602164
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 Remodeling of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01196832
- Acronym / sponsor ID
- FIREBROB / CHUBX 2010/05
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 11 Mar 2011 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- 31 May 2016 (actual)
- First posted
- 9 Sep 2010 (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.
Chronic obstructive pulmonary disease (COPD) is a frequent airway disease characterized by both bronchial inflammation and remodelling.
Bronchial mucosa is infiltrated by macrophages, neutrophils and lymphocytes. In addition, the number of eosinophils can be also increased during exacerbation.
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 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic obstructive pulmonary disease patients | Experimental | Procedure: blood sample, Procedure: Clinical and functional evaluationCOPD patients with exacerbation will be recruited during hospitalization in Intensive care unit or as outpatients in the clinical investigation centre of the CHU de Bordeaux. Inclusion visit: blood sample for fibrocytes analysis. Second visit 2 months ± 7 days after the exacerbation: clinical and functional evaluation (plethysmography, TLCO, arterial gaz), blood sample for fibrocytes analysis. |
| Control group | Other | Procedure: blood sampleSubjects without any history of lung disease and with normal lung function testing |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients: diagnostic of Chronic obstructive pulmonary disease (COPD) exacerbation.
- Control group: subjects without any history of lung disease and with normal lung function testing. Subjects will be separated in 2 sub-groups according to smoking history (Never smokers, smokers (former or current) and paired to patients according to age and sex.
- Written informed consent
Key exclusion criteria (3 listed)
- Subject without any social security or health insurance
- Asthma, lung fibrosis or idiopathic pulmonary hypertension
- Chronic viral infections (hepatitis, HIV)
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 |
|---|---|---|
| blood sampleblood sample for fibrocytes analysis | Procedure or surgery | Chronic obstructive pulmonary disease patients, Control group |
| Clinical and functional evaluationPlethysmography, Carbon monoxide capacity of transfer , arterial gaz | Procedure or surgery | Chronic obstructive pulmonary disease patients |
Primary outcome
Number of circulating blood fibrocytes
Time frame: Day 1
Sampling of blood in Chronic obstructive pulmonary disease patients
Number of circulating blood fibrocytes
Time frame: 2 months
Sampling of blood in Chronic obstructive pulmonary disease patients
6 secondary outcomes
Characterization of fibrocytes
Time frame: Day 1 and at 2 months
Differenciation of blood fibrocytes
Time frame: Day 1 and at 2 months
Chemotactism of blood fibrocytes
Time frame: Day 1 and at 2 months
Number of exacerbation
Time frame: 12 months after V2
Mortality
Time frame: 12 months after V2
Annual decline of ventilatory function
Time frame: 12 months after V2
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 26602164Dupin I, Allard B, Ozier A, Maurat E, Ousova O, Delbrel E, Trian T, Bui HN, Dromer C, Guisset O, Blanchard E, Hilbert G, Vargas F, Thumerel M, Marthan R, Girodet PO, Berger P. Blood fibrocytes are recruited during acute exacerbations of chronic obstructive pulmonary disease through a CXCR4-dependent pathway. J Allergy Clin Immunol. 2016 Apr;137(4):1036-1042.e7. doi: 10.1016/j.jaci.2015.08.043. Epub 2015 Oct 23.
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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.
Patrick BERGER, PUPH principal investigator
University Hospital Bordeaux (France)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample and Clinical and functional evaluation 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 3 inclusion and 3 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. 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?
Number of circulating 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?
On the ClinicalTrials.gov record for NCT01196832, which also lists 1 linked publication.
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.