Repair, Remodeling and Regeneration of the Bronchial Epithelium of COPD Patients

COPD Clinical Trial

— RRR  

Official title:

Repair, Remodeling and Regeneration of the Bronchial Epithelium of COPD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02354677
• Other study ID #: 9244
• Secondary ID: 2013-A01405-40
• Status: Completed
• Phase: N/A
• Start date: October 17, 2014
• Est. completion date: April 17, 2018

Study information

• Verified date: May 2018
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

COPD is characterized by exagerated decline FEV1 related to obstructive non reversible airflow. This could be the consequence of structural changes and inflammatory pattern of the bronchial wall. Lesions could lead to normal but also abnormal remodeling specially in COPD including a decrease in Club cells number and function.There is no treatment actually available targeted to a normal repair of the epithelium. The objective of this work is to identify potential targets for reprograming bronchial epithelial cells I order to achieve a good repair.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 17, 2018
• Est. primary completion date: April 17, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

COPD - Smokers or ex smokers > 30p/yr

• FEV1/FVC < 0.7

• With a fibroscopy prescription

Smokers - Smokers or ex smokers > 30p/yr

• FEV1/FVC > 0.7

• With a fibroscopy prescription

Controls - age superior or equal to 18

• no smoker (for 5 years)

• with a fibroscopy prescription

Exclusion Criteria:

• Xylocaine hypersensibility

• Porphyria

• severe hepatic failure

• Epilepsy

• Severe cardiac failure

Related Conditions & MeSH terms

• COPD
• Heathy Volunteers
• Smokers

Intervention

Other:
• In vitro experiments on bronchial epithelial cells

Locations

Country	Name	City	State
France	Pneumology Department	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Full recovery one day after injury (yes / no) proportion of cells showing the repair, remodeling or regeneration of the epithelium (ciliated cells, mucus cells, Clara cells) in culture in air-liquid interface in the three groups	The study will be judged on the proportion of cells showing the repair, remodeling or regeneration of the epithelium (ciliated cells, mucus cells, Clara cells) in culture in air-liquid interface in the three groups.	1 day
Secondary	Measurement of apoptosis and inflammation (IL8)	Determine the molecular mechanisms and deleterious cell leading to poor repair of the epithelium in patients with COPD	24 months
Secondary	Measure the effect of the CC10 protein secreted by Clara cells on the repair of the bronchial epithelium.	Measuring the reprogramming of the epithelium of COPD patients to a control-type epithelium	24 months