Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02354677
Recruitment Status : Completed
First Posted : February 3, 2015
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Heathy Volunteers Smokers COPD Other: In vitro experiments on bronchial epithelial cells Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Repair, Remodeling and Regeneration of the Bronchial Epithelium of COPD Patients
Actual Study Start Date : October 17, 2014
Actual Primary Completion Date : April 17, 2018
Actual Study Completion Date : April 17, 2018

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



Primary Outcome Measures :
  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 [ 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.


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02354677


Locations
Layout table for location information
France
Pneumology Department
Montpellier, France, 30295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Layout table for investigator information
Principal Investigator: BOURDIN Aranud, MD, PhD University Hospital, Montpellier

Layout table for additonal information
Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02354677    
Other Study ID Numbers: 9244
2013-A01405-40 ( Other Identifier: RCB number )
First Posted: February 3, 2015    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: May 2018
Keywords provided by University Hospital, Montpellier:
Bronchial epithelium
COPD
Repair
Remodelling
Club Cells