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OpenTrials
Completed

NCT Number: NCT02354677

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

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.

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Key information

Conditions

Heathy Volunteers COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Smokers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pneumology Department

Montpellier, 30295, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

In vitro experiments on bronchial epithelial cells

Other

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

    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

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Acronym: RRR

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Feb 3, 2015
Registry last updated
Sep 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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