Heathy VolunteersRRRNCT02354677
Repair, Remodeling and Regeneration of the Bronchial Epithelium of COPD Patients
A study testing In vitro experiments on bronchial epithelial cells in people with Heathy Volunteers and Smokers, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heathy Volunteers, Smokers, COPD
- What is being tested?
- In vitro experiments on bronchial epithelial cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 17 Oct 2014to 17 Apr 2018
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Controls - age superior or equal to 18
- no smoker (for 5 years)
- with a fibroscopy prescription
Who cannot join
- Xylocaine hypersensibility
- Porphyria
- severe hepatic failure
- Epilepsy
- Severe cardiac failure
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Heathy Volunteers, Smokers, COPD
- Being tested
- In vitro experiments on bronchial epithelial cells
- Keywords
- Bronchial epithelium, COPD, Repair, Remodelling, Club Cells
- 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.
In vitro experiments on bronchial epithelial cellsOther
| Study group | Role | What they receive |
|---|---|---|
| Heathy volunteers, smokers and COPD | Experimental | Not described Receives: Other: In vitro experiments on bronchial epithelial cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: 1 day
Secondary outcomes (2)
Measurement of apoptosis and inflammation (IL8)
Determine the molecular mechanisms and deleterious cell leading to poor repair of the epithelium in patients with COPD
Measured: 24 months
Measure the effect of the CC10 protein secreted by Clara cells on the repair of the bronchial epithelium.
Measuring the reprogramming of the epithelium of COPD patients to a control-type epithelium
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study start17 Oct 2014
- Primary completion17 Apr 2018
- Study completion17 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heathy VolunteersStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BOURDIN Aranud, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02354677
- Sponsor's protocol ID
- 9244
- Other IDs
- 2013-A01405-40
- Acronym
- RRR
- Status last verified
- May 2018
- First submitted
- 12 Jan 2015
- Last updated
- 24 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repair, Remodeling and Regeneration of the Bronchial Epithelium of COPD Patients
- ClinicalTrials.gov ID
- NCT02354677
- Acronym / sponsor ID
- RRR / 9244
- Conditions
- Heathy Volunteers, Smokers, COPD
- Keywords
- Bronchial epithelium, COPD, Repair, Remodelling, Club Cells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 17 Oct 2014 (actual)
- Primary completion
- 17 Apr 2018 (actual)
- Study completion
- 17 Apr 2018 (actual)
- First posted
- 3 Feb 2015 (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.
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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heathy volunteers, smokers and COPD | Experimental | Other: In vitro experiments on bronchial epithelial cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- Xylocaine hypersensibility
- Porphyria
- severe hepatic failure
- Epilepsy
- Severe cardiac failure
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 |
|---|---|---|
| In vitro experiments on bronchial epithelial cells | Other | Heathy volunteers, smokers and COPD |
Primary outcome
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.
2 secondary outcomes
Measurement of apoptosis and inflammation (IL8)
Time frame: 24 months
Measure the effect of the CC10 protein secreted by Clara cells on the repair of the bronchial epithelium.
Time frame: 24 months
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 24 Sep 2019.
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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.
BOURDIN Aranud, MD, PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In vitro experiments on bronchial epithelial cells in people with Heathy Volunteers and Smokers, run by University Hospital, Montpellier 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 9 inclusion and 5 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 24 Sep 2019. 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Sep 2019.