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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01196832
Other study ID # CHUBX 2010/05
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 11, 2011
Est. completion date May 31, 2016

Study information

Verified date February 2022
Source University Hospital, Bordeaux
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 115
Est. completion date May 31, 2016
Est. primary completion date March 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
blood sample
blood sample for fibrocytes analysis
Clinical and functional evaluation
Plethysmography, Carbon monoxide capacity of transfer , arterial gaz

Locations

Country Name City State
France CHU de Bordeaux Pessac

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of circulating blood fibrocytes Sampling of blood in Chronic obstructive pulmonary disease patients Day 1
Primary Number of circulating blood fibrocytes Sampling of blood in Chronic obstructive pulmonary disease patients 2 months
Secondary Characterization of fibrocytes Sampling of blood Day 1 and at 2 months
Secondary Differenciation of blood fibrocytes Sampling of blood Day 1 and at 2 months
Secondary Chemotactism of blood fibrocytes Sampling of blood Day 1 and at 2 months
Secondary Number of exacerbation 12 months after V2
Secondary Mortality 12 months after V2
Secondary Annual decline of ventilatory function 12 months after V2
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