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

NCT02354677 | Completed

• 2 other identifiers: 92442013-A01405-40
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Heathy Volunteers; Smokers; COPD

Keywords

Bronchial epithelium; COPD; Repair; Remodelling; Club Cells

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Measurement of apoptosis and inflammation (IL8)

  24 months

• Measure the effect of the CC10 protein secreted by Clara cells on the repair of the bronchial epithelium.

  24 months

Study Arms (1)

Heathy volunteers, smokers and COPD

EXPERIMENTAL

Other: In vitro experiments on bronchial epithelial cells

Interventions

In vitro experiments on bronchial epithelial cells OTHER

Heathy volunteers, smokers and COPD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Xylocaine hypersensibility
• Porphyria
• severe hepatic failure
• Epilepsy
• Severe cardiac failure

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Pneumology Department

Montpellier, 30295, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• BOURDIN Aranud, MD, PhD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2015
• First Posted: February 3, 2015
• Study Start: October 17, 2014
• Primary Completion: April 17, 2018
• Study Completion: April 17, 2018
• Last Updated: September 24, 2019

Record last verified: 2018-05

Locations

FR (1)