- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01692444
Role of Fibrocytes in the Bronchial Remodelling of Chronic Obstructive Pulmonary Disease (FIBROCHIR)
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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Pessac, France, 33604
- University hospital of Bordeaux, Hôpital du Haut Lévêque
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: COPD
15 patients with COPD from 1 to 4 according to the GOLD 2011
|
analyse the distribution and quantify the number of the peri-bronchial and blood circulating fibrocytes in patients
|
|
Placebo Comparator: Non smoker Control
15 patients without COPD and no smoking history
|
analyse the distribution and quantify the number of the peri-bronchial and blood circulating fibrocytes in patients
|
|
Active Comparator: Smoker Control
15 patients without COPD but a smoking history
|
analyse the distribution and quantify the number of the peri-bronchial and blood circulating fibrocytes in patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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)
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Lung tissues and blood samples will be collected at inclusion visit during surgery (Day 0)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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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)
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Lung tissues and blood samples will be collected at inclusion visit during surgery (Day 0)
|
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Correlation between lung attenuation and the number of fibrocytes
Time Frame: Assessed one year after inclusion visit (i.e. surgery date =Day 0)
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Assessed one year after inclusion visit (i.e. surgery date =Day 0)
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Correlation between plethysmography and the number of fibrocytes.
Time Frame: Assessed one year after inclusion visit (i.e. surgery date = Day 0)
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Assessed one year after inclusion visit (i.e. surgery date = Day 0)
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Nicholas MOORE, MD-PhD, University Hospital, Bordeaux
Publications and helpful links
General Publications
- Henrot 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.
- 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.
- Eyraud 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2011/34
- 2012-A00571-42 (Other Identifier: ANSM)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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