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

Not Applicable

Completed

• Conditions: Smokers; COPD; Heathy Volunteers
• Interventions: Other: In vitro experiments on bronchial epithelial cells

• Registration Number: NCT02354677
• Lead Sponsor: University Hospital, Montpellier

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-17
• Study First Submitted: 2015-01-12
• Study First Submitted QC: 2015-01-29
• Study First Posted: 2015-02-03
• Primary Completion: 2018-04-17
• Study Completion: 2018-04-17
• Status Verified: 2018-05
• Last Update Submitted: 2019-09-23
• Last Update Posted: 2019-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Heathy volunteers, smokers and COPD	In vitro experiments on bronchial epithelial cells	-

Primary Outcome Measures

Name	Time	Method
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	1 day	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.

Secondary Outcome Measures

Name	Time	Method
Measurement of apoptosis and inflammation (IL8)	24 months	Determine the molecular mechanisms and deleterious cell leading to poor repair of the epithelium in patients with COPD
Measure the effect of the CC10 protein secreted by Clara cells on the repair of the bronchial epithelium.	24 months	Measuring the reprogramming of the epithelium of COPD patients to a control-type epithelium

Trial Locations

Locations (1)

Pneumology Department; 🇫🇷 Montpellier, France