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Clinical Trials/NCT02354677
NCT02354677CompletedNot Applicable

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

University Hospital, Montpellier2 sites in 1 country30 target enrollmentStarted: October 17, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
2
Primary Endpoint
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

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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
  • Severe cardiac failure

Arms & Interventions

Heathy volunteers, smokers and COPD

Experimental

Intervention: In vitro experiments on bronchial epithelial cells (Other)

Outcomes

Primary Outcomes

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 Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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