- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02873988
Regeneration of Bronchial Epithelium During Chronic Obstructive Pulmonary Disease (EPITHREGENCOPD)
August 16, 2016 updated by: CHU de Reims
Airway epithelium integrity is essential to maintain its role of mechanical and functional barrier.
Recurrent epithelial injuries require a complex mechanism of repair to restore its integrity.
In chronic obstructive pulmonary disease (COPD), an abnormal airway epithelial repair may participate in airway remodelling.
The objective was to determine if airway epithelial wound repair of airway epithelium is abnormal in COPD.
Study Overview
Detailed Description
Patients scheduled for lung resection were prospectively recruited.
Demographic, clinical data and pulmonary function tests results were recorded.
Emphysema was visually scored and histological remodelling features were noted.
Primary bronchial epithelial cells (BEC) were extracted and cultured for wound closure assay.
The investigators determined the mean speed of wound closure (MSWC) and cell proliferation index, matrix metalloprotease (MMP)-2, MMP-9 and cytokines levels in supernatants of BEC 18 hours after cell wounding.
In a subset of patients, bronchiolar epithelial cells were also cultured for wound closure assay for MSWC analyze.
Study Type
Observational
Enrollment (Actual)
25
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
-
-
-
Reims, France, 51092
- CHU de Reims
-
-
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
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients scheduled for lung resection for cancer
Description
Inclusion Criteria:
6 Patients scheduled for lung resection for cancer
Exclusion Criteria:
- Patients with asthma, cystic fibrosis, bronchiectasis or pulmonary fibrosis were excluded
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
patients with COPD
|
|
patients without COPD
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean speed of wound closure (MSWC) of wounded bronchial epithelial cell culture obtained from COPD and control patients
Time Frame: hour 18
|
hour 18
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cell proliferation index in supernatants of bronchial epithelial cells 18 hours after cell wounding.
Time Frame: hour 18
|
hour 18
|
Matrix metalloprotease (MMP)-2 level in supernatants of bronchial epithelial cells 18 hours after cell wounding.
Time Frame: hour 18
|
hour 18
|
Matrix metalloprotease (MMP)-9 level in supernatants of bronchial epithelial cells 18 hours after cell wounding.
Time Frame: hour 18
|
hour 18
|
Cytokines levels in supernatants of bronchial epithelial cells 18 hours after cell wounding.
Time Frame: hour 18
|
hour 18
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
March 1, 2012
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
August 10, 2016
First Submitted That Met QC Criteria
August 16, 2016
First Posted (Estimate)
August 22, 2016
Study Record Updates
Last Update Posted (Estimate)
August 22, 2016
Last Update Submitted That Met QC Criteria
August 16, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PA11017
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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