COPDEPITHREGENCOPDNCT02873988
Regeneration of Bronchial Epithelium During Chronic Obstructive Pulmonary Disease
An observational study of COPD, run by CHU de Reims at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- bronchial epithelial cell culture
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2012to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for lung resection for cancer
Who may be able to join
- 6 Patients scheduled for lung resection for cancer
Who cannot join
- Patients with asthma, cystic fibrosis, bronchiectasis or pulmonary fibrosis were excluded
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- COPD
- Being tested
- bronchial epithelial cell culture
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bronchial epithelial cell cultureOther
| Study group | Role | What they receive |
|---|---|---|
| patients with COPD | patients with COPD Receives: Other: bronchial epithelial cell culture | |
| patients without COPD | patients without COPD Receives: Other: bronchial epithelial cell culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean speed of wound closure (MSWC) of wounded bronchial epithelial cell culture obtained from COPD and control patients
Measured: hour 18
Secondary outcomes (4)
Cell proliferation index in supernatants of bronchial epithelial cells 18 hours after cell wounding.
Measured: hour 18
Matrix metalloprotease (MMP)-2 level in supernatants of bronchial epithelial cells 18 hours after cell wounding.
Measured: hour 18
Matrix metalloprotease (MMP)-9 level in supernatants of bronchial epithelial cells 18 hours after cell wounding.
Measured: hour 18
Cytokines levels in supernatants of bronchial epithelial cells 18 hours after cell wounding.
Measured: hour 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study startMar 2012
- Primary completionDec 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02873988
- Sponsor's protocol ID
- PA11017
- Acronym
- EPITHREGENCOPD
- Status last verified
- Aug 2016
- First submitted
- 10 Aug 2016
- Last updated
- 22 Aug 2016
- Results posted
- No
Publications
Perotin JM, Adam D, Vella-Boucaud J, Delepine G, Sandu S, Jonvel AC, Prevost A, Berthiot G, Pison C, Lebargy F, Birembaut P, Coraux C, Deslee G. Delay of airway epithelial wound repair in COPD is associated with airflow obstruction severity. Respir Res. 2014 Nov 27;15(1):151. doi: 10.1186/s12931-014-0151-9.
PubMed 25427655
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regeneration of Bronchial Epithelium During Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02873988
- Acronym / sponsor ID
- EPITHREGENCOPD / PA11017
- Conditions
- COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 22 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with COPD | – | Other: bronchial epithelial cell culturepatients with COPD |
| patients without COPD | – | Other: bronchial epithelial cell culturepatients without COPD |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for lung resection for cancer
Key inclusion criteria (1 listed)
- 6 Patients scheduled for lung resection for cancer
Key exclusion criteria (1 listed)
- Patients with asthma, cystic fibrosis, bronchiectasis or pulmonary fibrosis were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bronchial epithelial cell culture | Other | patients with COPD, patients without COPD |
Primary outcome
Mean speed of wound closure (MSWC) of wounded bronchial epithelial cell culture obtained from COPD and control patients
Time frame: hour 18
4 secondary outcomes
Cell proliferation index in supernatants of bronchial epithelial cells 18 hours after cell wounding.
Time frame: hour 18
Matrix metalloprotease (MMP)-2 level in supernatants of bronchial epithelial cells 18 hours after cell wounding.
Time frame: hour 18
Matrix metalloprotease (MMP)-9 level in supernatants of bronchial epithelial cells 18 hours after cell wounding.
Time frame: hour 18
Cytokines levels in supernatants of bronchial epithelial cells 18 hours after cell wounding.
Time frame: hour 18
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2016.
- Background: PubMed 25427655Perotin JM, Adam D, Vella-Boucaud J, Delepine G, Sandu S, Jonvel AC, Prevost A, Berthiot G, Pison C, Lebargy F, Birembaut P, Coraux C, Deslee G. Delay of airway epithelial wound repair in COPD is associated with airflow obstruction severity. Respir Res. 2014 Nov 27;15(1):151. doi: 10.1186/s12931-014-0151-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean speed of wound closure (MSWC) of wounded bronchial epithelial cell culture obtained from COPD and control patients (time frame: hour 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02873988, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2016.