- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01196832
Role of Fibrocytes in Chronic Obstructive Pulmonary Disease (FIREBROB)
Role of Fibrocytes in the Bronchial Remodeling of Chronic Obstructive Pulmonary Disease
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Pessac, France, 33604
- CHU de Bordeaux
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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.
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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. |
blood sample for fibrocytes analysis
Plethysmography, Carbon monoxide capacity of transfer , arterial gaz
|
|
Other: Control group
Subjects without any history of lung disease and with normal lung function testing
|
blood sample for fibrocytes analysis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of circulating blood fibrocytes
Time Frame: Day 1
|
Sampling of blood in Chronic obstructive pulmonary disease patients
|
Day 1
|
|
Number of circulating blood fibrocytes
Time Frame: 2 months
|
Sampling of blood in Chronic obstructive pulmonary disease patients
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Characterization of fibrocytes
Time Frame: Day 1 and at 2 months
|
Sampling of blood
|
Day 1 and at 2 months
|
|
Differenciation of blood fibrocytes
Time Frame: Day 1 and at 2 months
|
Sampling of blood
|
Day 1 and at 2 months
|
|
Chemotactism of blood fibrocytes
Time Frame: Day 1 and at 2 months
|
Sampling of blood
|
Day 1 and at 2 months
|
|
Number of exacerbation
Time Frame: 12 months after V2
|
12 months after V2
|
|
|
Mortality
Time Frame: 12 months after V2
|
12 months after V2
|
|
|
Annual decline of ventilatory function
Time Frame: 12 months after V2
|
12 months after V2
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Patrick BERGER, PUPH, University Hospital Bordeaux (France)
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Chronic Disease
- Disease Attributes
- Respiratory Tract Diseases
- Lung Diseases
- Lung Diseases, Obstructive
- Pathological Conditions, Signs and Symptoms
- Pulmonary Disease, Chronic Obstructive
- Investigative Techniques
- Specimen Handling
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Punctures
- Surgical Procedures, Operative
- Blood Specimen Collection
Other Study ID Numbers
- CHUBX 2010/05
- 2010-A00248-31 (Other Identifier: ANSM)
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