NCT01196832

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Mar 2011

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 9, 2010

Completed
6 months until next milestone

Study Start

First participant enrolled

March 11, 2011

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2016

Completed
Last Updated

June 9, 2026

Status Verified

February 1, 2022

Enrollment Period

5 years

First QC Date

June 1, 2010

Last Update Submit

June 5, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Number of circulating blood fibrocytes

    Sampling of blood in Chronic obstructive pulmonary disease patients

    Day 1

  • Number of circulating blood fibrocytes

    Sampling of blood in Chronic obstructive pulmonary disease patients

    2 months

Secondary Outcomes (6)

  • Characterization of fibrocytes

    Day 1 and at 2 months

  • Differenciation of blood fibrocytes

    Day 1 and at 2 months

  • Chemotactism of blood fibrocytes

    Day 1 and at 2 months

  • Number of exacerbation

    12 months after V2

  • Mortality

    12 months after V2

  • +1 more secondary outcomes

Study Arms (2)

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.

Procedure: blood sampleProcedure: Clinical and functional evaluation

Control group

OTHER

Subjects without any history of lung disease and with normal lung function testing

Procedure: blood sample

Interventions

blood samplePROCEDURE

blood sample for fibrocytes analysis

Chronic obstructive pulmonary disease patientsControl group

Plethysmography, Carbon monoxide capacity of transfer , arterial gaz

Chronic obstructive pulmonary disease patients

Eligibility Criteria

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

You may qualify if:

  • 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

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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux

Pessac, 33604, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Patrick BERGER, PUPH

    University Hospital Bordeaux (France)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2010

First Posted

September 9, 2010

Study Start

March 11, 2011

Primary Completion

March 1, 2016

Study Completion

May 31, 2016

Last Updated

June 9, 2026

Record last verified: 2022-02

Locations