Role of Fibrocytes in the Bronchial Remodelling of Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

— FIBROCHIR  

Official title:

Role of Fibrocytes in the Bronchial Remodelling of Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01692444
• Other study ID #: CHUBX 2011/34
• Status: Completed
• Start date: April 10, 2013
• Est. completion date: May 20, 2016

Study information

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

Clinical Trial Summary

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 Chronic Obstructive Pulmonary Disease (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.

The main objective of the study is to analyse the distribution and quantify the number of the peri-bronchial and blood circulating fibrocytes in patients with different stages of COPD compared to control subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 20, 2016
• Est. primary completion date: May 20, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Male or female aged more than 40 yr

• Patient needed a thoracic surgery such as lobectomy for cancer or lung transplantation or lung reduction volume surgery.

• COPD group: diagnostic of COPD and differentiation of the stage from 1 to 4 according to the GOLD guidelines.

• Control group: subjects with normal lung function testing and no chronic symptoms (cough or expectoration). Subjects will be separated in 2 groups according to smoking history (Never smokers, smokers (former or current) and paired to patients according to age and sex.

• with a 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)

• Pregnant woman or breastfeeding

• Subject included for cancer surgery with a Pn0 diagnosis not confirmed after the intervention.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
France	University hospital of Bordeaux, Hôpital du Haut Lévêque	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	Increased number of peri-bronchial and blood circulating fibrocytes gradually in each stages of COPD and compared to control subjects.		Lung tissues and blood samples will be collected at inclusion visit during surgery (Day 0)
Secondary	Characterization of fibrocytes: expression of chemokines receptors, Toll Like Receptors, HLA class II		Lung tissues and blood samples will be collected at inclusion visit during surgery (Day 0)
Secondary	Correlation between lung attenuation and the number of fibrocytes		Assessed one year after inclusion visit (i.e. surgery date =Day 0)
Secondary	Correlation between plethysmography and the number of fibrocytes.		Assessed one year after inclusion visit (i.e. surgery date = Day 0)