NCT01692444

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 25, 2012

Completed
7 months until next milestone

Study Start

First participant enrolled

April 10, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2016

Completed
Last Updated

June 9, 2026

Status Verified

February 1, 2022

Enrollment Period

3.1 years

First QC Date

September 17, 2012

Last Update Submit

June 5, 2026

Conditions

Keywords

Chronic Obstructive Pulmonary DiseaseFibrosisFibroblastLung attenuationPletysmography

Outcome Measures

Primary Outcomes (1)

  • Increased number of peri-bronchial and blood circulating fibrocytes gradually in each stages of COPD and compared to control subjects.

    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

    Lung tissues and blood samples will be collected at inclusion visit during surgery (Day 0)

  • Correlation between lung attenuation and the number of fibrocytes

    Assessed one year after inclusion visit (i.e. surgery date =Day 0)

  • Correlation between plethysmography and the number of fibrocytes.

    Assessed one year after inclusion visit (i.e. surgery date = Day 0)

Study Arms (3)

COPD

EXPERIMENTAL

15 patients with COPD from 1 to 4 according to the GOLD 2011

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

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

Biological: analyse the distribution and quantify the number of the peri-bronchial and blood circulating fibrocytes in patients

Interventions

analyse the distribution and quantify the number of the peri-bronchial and blood circulating fibrocytes in patients

COPDNon smoker ControlSmoker Control

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital of Bordeaux, Hôpital du Haut Lévêque

Pessac, 33604, France

Location

Related Publications (3)

  • 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.

  • 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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveFibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nicholas MOORE, MD-PhD

    University Hospital, Bordeaux

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2012

First Posted

September 25, 2012

Study Start

April 10, 2013

Primary Completion

May 20, 2016

Study Completion

May 20, 2016

Last Updated

June 9, 2026

Record last verified: 2022-02

Locations