Repair, Remodeling and Regeneration of the Bronchial Epithelium of COPD Patients (RRR)

September 23, 2019 updated by: University Hospital, Montpellier
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 30295
        • Pneumology department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Heathy volunteers, smokers and COPD
Other: In vitro experiments on bronchial epithelial cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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.
1 day

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: BOURDIN Aranud, MD, PhD, University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2014

Primary Completion (Actual)

April 17, 2018

Study Completion (Actual)

April 17, 2018

Study Registration Dates

First Submitted

January 12, 2015

First Submitted That Met QC Criteria

January 29, 2015

First Posted (Estimate)

February 3, 2015

Study Record Updates

Last Update Posted (Actual)

September 24, 2019

Last Update Submitted That Met QC Criteria

September 23, 2019

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 9244
  • 2013-A01405-40 (Other Identifier: RCB number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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