Clinical trial NCT01196832: Role of Fibrocytes in Chronic Obstructive Pulmonary Disease
Official title: Role of Fibrocytes in the Bronchial Remodeling of Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2010-09-09
Enrollment: 115
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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)

Primary outcomes:
measure: Number of circulating blood fibrocytes
timeFrame: Day 1
measure: Number of circulating blood fibrocytes
timeFrame: 2 months
Secondary outcomes:
measure: Characterization of fibrocytes
timeFrame: Day 1 and at 2 months
measure: Differenciation of blood fibrocytes
timeFrame: Day 1 and at 2 months
measure: Chemotactism of blood fibrocytes
timeFrame: Day 1 and at 2 months
measure: Number of exacerbation
timeFrame: 12 months after V2
measure: Mortality
timeFrame: 12 months after V2
measure: Annual decline of ventilatory function
timeFrame: 12 months after V2
Other outcomes:
Locations:
city: Pessac
country: France
facility: CHU de Bordeaux
Study officials:
affiliation: University Hospital Bordeaux (France)
name: Patrick BERGER, PUPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.