Role of Fibrocytes in Chronic Obstructive Pulmonary Disease (FIREBROB)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University Hospital, Bordeaux
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01196832
First received: June 1, 2010
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease
Procedure: blood sample
Procedure: Clinical and functional evaluation

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Role of Fibrocytes in the Bronchial Remodeling of Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Number of circulating blood fibrocytes [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Sampling of blood in Chronic obstructive pulmonary disease patients

  • Number of circulating blood fibrocytes [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Sampling of blood in Chronic obstructive pulmonary disease patients


Secondary Outcome Measures:
  • Characterization of fibrocytes [ Time Frame: Day 1 and at 2 months ] [ Designated as safety issue: No ]
    Sampling of blood

  • Differenciation of blood fibrocytes [ Time Frame: Day 1 and at 2 months ] [ Designated as safety issue: No ]
    Sampling of blood

  • Chemotactism of blood fibrocytes [ Time Frame: Day 1 and at 2 months ] [ Designated as safety issue: No ]
    Sampling of blood

  • Number of exacerbation [ Time Frame: 12 months after V2 ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: 12 months after V2 ] [ Designated as safety issue: Yes ]
  • Annual decline of ventilatory function [ Time Frame: 12 months after V2 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 160
Study Start Date: March 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Chronic obstructive pulmonary disease patients

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 sample
blood sample for fibrocytes analysis
Procedure: Clinical and functional evaluation
Plethysmography, Carbon monoxide capacity of transfer , arterial gaz
Control group
Subjects without any history of lung disease and with normal lung function testing
Procedure: blood sample
blood sample for fibrocytes analysis

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Male or female aged more than 40 years

  • Chronic obstructive pulmonary disease (CODP) patients recruited during hospitalization in Intensive care unit or as outpatients in the clinical investigation centre of the CHU de Bordeaux.
  • Control group: subjects without any history of lung disease and with normal lung function testing recruited following a normal lung function testing in the clinical investigation centre of the CHU de Bordeaux.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Subject without any social security or health insurance
  • Asthma, lung fibrosis or idiopathic pulmonary hypertension
  • Chronic viral infections (hepatitis, HIV)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01196832

Contacts
Contact: Patrick BERGER, PUPH (0)5 57 65 65 13
Contact: David LEGROS (0)5 57 65 65 13 david.legros@chu-bordeaux.fr

Locations
France
CHU de Bordeaux Recruiting
Pessac, France, 33604
Contact: Patrick BERGER, PUPH    (0)5 57 65 65 13      
Contact: David LEGROS       david.legros@chu-bordeaux.fr   
Principal Investigator: Patrick BERGER, PUPH         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Patrick BERGER, PUPH University Hospital Bordeaux (France)
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01196832     History of Changes
Other Study ID Numbers: CHUBX 2010/05
Study First Received: June 1, 2010
Last Updated: November 14, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 16, 2014