COPD PatientscDysEndoBPCONCT03774238
Determinants of the Vascular Response to Training in Chronic Obstructive Pulmonary Disease (COPD) Patients
A study testing FMD analysis in people with COPD Patients and Healthy, run by University Hospital, Montpellier at 2 sites in France.
Trial summary
Vascular comorbidities constitute a major burden in COPD patients. The atherosclerosis process is preceded by the onset of an endothelial dysfunction (assessed by the flow-mediated dilatation (FMD)), which is a risk factor for later ischemic vascular complications and death. Read more about this study
- Who is it for?
- Ages 35 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD Patients, Healthy
- What is being tested?
- FMD analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 2 sitesFrance
- Study dates
- 20 Feb 2019to 20 Nov 2024
- 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 35 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A/ COPD patients
- age between 35 and 85 years old
- spirometry showing an FEV1/VC < lower limit of normal
- with an indication for a pulmonary rehabilitation program
- written and informed consent for this study signed by the patient
- B/ Healthy subjects
Show all 9Show fewer
- age between 35 and 85 years old
- no cardiovascular or respiratory disease
- normal spirometry
Who cannot join
- Unstabilized comorbidity
- Subject in a period of exclusion relative to another protocol
- Major protected by law
- Subject participating in another research protocol
- Subject not affiliated to a social security scheme
- Pregnant or lactating woman
- Patient deprived of freedom by court or administrative order
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU Montpellier and CHU Nimes
Montpellier, 34295
University Hospital, Paris
Paris, 75015
About this study
Official title: Biological and Functional Determinants of the Endothelial and Vascular Response to Exercise Training in COPD Patients
Vascular comorbidities constitute a major burden in COPD patients. The atherosclerosis process is preceded by the onset of an endothelial dysfunction (assessed by the flow-mediated dilatation (FMD)), which is a risk factor for later ischemic vascular complications and death. In COPD, this endothelial dysfunction could be explained by intrinsic endothelial cell properties, or the effect of a pathogenic endothelial cell microenvironment (inflammation and/or oxidative stress). Exercise training constitue a powerful stimulus for the endothelial function, and could be mediated by the mobiliaztion and function of endothelial progenitors. While exercise training is an efficient intervention in COPD patients, its vascular effect appear blunted. The endothelial function response to training has appeared heterogeneous in COPD patients, and possibly linked to the endothelial cel lesion. Thus, endothelial function (assessed by the FMD) response to exercise training would be lower in COPD patients with a baseline impairment of the their FMD. In addition, of biological and functional factors could explained the magnitude of the FMD response in COPD patients.The aim of the study are thus :
To compare the FMD change in COPD patients with FMD above (FMD+) and under the median FMD (FMD-) after 4 weeks of exercise training in the whole study population.
Read more
To compare between COPD patients FMD+, COPD patients FMD- and healthy "control" subjects, the endothelial inflammation and senescence at baseline and the endothelial progenitor mobilization and function change induced by exercise (maximal exercise test and training).
To compare between COPD patients FMD+, COPD patients FMD- and healthy "control" subjects the effect of the endothelial microenvironment on the cellular pathways regulating the endothelial function in vitro at baseline and changes after exercise training.
To test in COPD patients the association between the magnitude of the FMD changes after training and biological, functional and clinical factors (inflammation oxidative stress markers, endothelial biomarkers, pulmonary impairment and phenotype, cardiovascular risks factors, vascular function, metabolic markers, physical activity level, …)
- Conditions
- COPD Patients, Healthy
- Being tested
- FMD analysis
- Keywords
- Flow-mediated dilatation, COPD, Pulmonary Rehabilitation, Comorbidities, endothelial cell, oxidative stress
- 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.
FMD analysisOther
Blood sample and vascular exploration.
| Study group | Role | What they receive |
|---|---|---|
| COPD patients | Experimental | FMD analysis Endothelial progenitors Exercise test Exercise training Receives: Other: FMD analysis |
| Healthy subject | Experimental | FMD analysis Endothelial progenitors Exercise test Receives: Other: FMD analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of Flow-Mediated Dilatation (FMD)
Measure of FMD by EndoPAT2000©
Measured: post exercise and after 4 +/- 2 weeks of training
Secondary outcomes (11)
Measure of biological vascular markers
E-selectin soluble (sE-sel), endotheline 1 (ET1), facteur von Willebrand (vWF), vascular endothelial growth factor A (VEGF-A), Fms-like tyrosine kinase receptor 1 soluble (sFlt-1), Angiopoietine 1 et 2 (Ang-1 Ang-2)
Measured: after 4 +/- 2 weeks of training
Number of colonies and function of Endothelial-Colony Formaing cells (ECFC) in vitro
Measured: post exercise and after 4 +/- 2 weeks of training
Number endothelial progenitors
CD34+, CD45+ and KDR + subpopulations by flow cytometry
Measured: post exercise and after 4 +/- 2 weeks of training
Vascular function parameters
Systolic pressure index (in AU)
Measured: after 4 +/- 2 weeks of training
Vascular function parameters
Intima-media thickness (in mm)
Measured: after 4 +/- 2 weeks of training
Vascular function parameters
Pulse-wave velocity (in ms-1)
Measured: after 4 +/- 2 weeks of training
Pulse-wave velocity (in ms-1)
Measured: after 4 +/- 2 weeks of training
Markers of systemic inflammation
C-Reactive protein (in ng/ml)
Measured: after 4 +/- 2 weeks of training
Markers of oxidative stress
Lipid peroxidation (in micromol/L)
Measured: after 4 +/- 2 weeks of training
Muscle function parameters
Maximum isometric voluntary contraction (in N.m)
Measured: after 4 +/- 2 weeks of training
Exercise capacity and vascular adaptation parameters
Maximal oxygen uptake (VO2max, in mL/kg/min)
Measured: after 4 +/- 2 weeks of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start20 Feb 2019
- Primary completion20 Nov 2024
- Study completion20 Nov 2024
Why it stopped: Analyses will be carried out with the recruited population.
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 COPD PatientsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Paris
- Responsible party
- Sponsor
- Investigators
- Fares Gouzi, MD, PhD, Principal investigator, UH Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774238
- Sponsor's protocol ID
- RECHMPL18_0439
- Other IDs
- 2018-A02886-49
- Acronym
- cDysEndoBPCO
- Status last verified
- Feb 2025
- First submitted
- 30 Oct 2018
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gouzi F, Dubois-Gamez AS, Lacoude P, Abdellaoui A, Hedon C, Charriot J, Boissin C, Vachier I, Hayot M, Molinari N, Bourdin A. Feasibility of a nasal breathing training during pulmonary rehabilitation. A pilot randomized controlled study. Respir Physiol Neurobiol. 2023 Feb;308:103987. doi: 10.1016/j.resp.2022.103987. Epub 2022 Nov 11.
PubMed 36372120
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological and Functional Determinants of the Endothelial and Vascular Response to Exercise Training in COPD Patients
- ClinicalTrials.gov ID
- NCT03774238
- Acronym / sponsor ID
- cDysEndoBPCO / RECHMPL18_0439
- Conditions
- COPD Patients, Healthy
- Keywords
- Flow-mediated dilatation, COPD, Pulmonary Rehabilitation, Comorbidities, endothelial cell, oxidative stress
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Analyses will be carried out with the recruited population.
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- University Hospital, Paris
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 12 Dec 2018 (actual)
- 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.
Vascular comorbidities constitute a major burden in COPD patients. The atherosclerosis process is preceded by the onset of an endothelial dysfunction (assessed by the flow-mediated dilatation (FMD)), which is a risk factor for later ischemic vascular complications and death. In COPD, this endothelial dysfunction could be explained by intrinsic endothelial cell properties, or the effect of a pathogenic endothelial cell microenvironment (inflammation and/or oxidative stress). Exercise training constitue a powerful stimulus for the endothelial function, and could be mediated by the mobiliaztion and function of endothelial progenitors. While exercise training is an efficient intervention in COPD patients, its vascular effect appear blunted. The endothelial function response to training has appeared heterogeneous in COPD patients, and possibly linked to the endothelial cel lesion. Thus, endothelial function (assessed by the FMD) response to exercise training would be lower in COPD patients with a baseline impairment of the their FMD. In addition, of biological and functional factors could explained the magnitude of the FMD response in COPD patients.The aim of the study are thus :
To compare the FMD change in COPD patients with FMD above (FMD+) and under the median FMD (FMD-) after 4 weeks of exercise training in the whole study population.
To compare between COPD patients FMD+, COPD patients FMD- and healthy "control" subjects, the endothelial inflammation and senescence at baseline and the endothelial progenitor mobilization and function change induced by exercise (maximal exercise test and training).
To compare between COPD patients FMD+, COPD patients FMD- and healthy "control" subjects the effect of the endothelial microenvironment on the cellular pathways regulating the endothelial function in vitro at baseline and changes after exercise training.
To test in COPD patients the association between the magnitude of the FMD changes after training and biological, functional and clinical factors (inflammation oxidative stress markers, endothelial biomarkers, pulmonary impairment and phenotype, cardiovascular risks factors, vascular function, metabolic markers, physical activity level, …)
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD patients | Experimental | Other: FMD analysisFMD analysis Endothelial progenitors Exercise test Exercise training |
| Healthy subject | Experimental | Other: FMD analysisFMD analysis Endothelial progenitors Exercise test |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- A/ COPD patients
- age between 35 and 85 years old
- spirometry showing an FEV1/VC < lower limit of normal
- with an indication for a pulmonary rehabilitation program
- written and informed consent for this study signed by the patient
Key exclusion criteria (7 listed)
- Unstabilized comorbidity
- Subject in a period of exclusion relative to another protocol
- Major protected by law
- Subject participating in another research protocol
- Subject not affiliated to a social security scheme
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 |
|---|---|---|
| FMD analysisBlood sample and vascular exploration. | Other | COPD patients, Healthy subject |
Primary outcome
Measure of Flow-Mediated Dilatation (FMD)
Time frame: post exercise and after 4 +/- 2 weeks of training
Measure of FMD by EndoPAT2000©
11 secondary outcomes
Measure of biological vascular markers
Time frame: after 4 +/- 2 weeks of training
Number of colonies and function of Endothelial-Colony Formaing cells (ECFC) in vitro
Time frame: post exercise and after 4 +/- 2 weeks of training
Number endothelial progenitors
Time frame: post exercise and after 4 +/- 2 weeks of training
Vascular function parameters
Time frame: after 4 +/- 2 weeks of training
Vascular function parameters
Time frame: after 4 +/- 2 weeks of training
Vascular function parameters
Time frame: after 4 +/- 2 weeks of training
Pulse-wave velocity (in ms-1)
Time frame: after 4 +/- 2 weeks of training
Markers of systemic inflammation
Time frame: after 4 +/- 2 weeks of training
Markers of oxidative stress
Time frame: after 4 +/- 2 weeks of training
Muscle function parameters
Time frame: after 4 +/- 2 weeks of training
Exercise capacity and vascular adaptation parameters
Time frame: after 4 +/- 2 weeks of training
Results and safety
The study was stopped early (reason given: Analyses will be carried out with the recruited population.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Results publication: PubMed 36372120Gouzi F, Dubois-Gamez AS, Lacoude P, Abdellaoui A, Hedon C, Charriot J, Boissin C, Vachier I, Hayot M, Molinari N, Bourdin A. Feasibility of a nasal breathing training during pulmonary rehabilitation. A pilot randomized controlled study. Respir Physiol Neurobiol. 2023 Feb;308:103987. doi: 10.1016/j.resp.2022.103987. Epub 2022 Nov 11.
Related trials for COPD Patients
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Recruiting
Evaluating the Safety and Efficacy of dNerva Lung Denervation System in Patients With COPD
COPD, Chronic Obstructive Pulmonary Disease
RecruitingPhase 1
Impact of Eradication Therapy on Helicobacter Pylori Infection With Chronic Obstructive Pulmonary Disease:
Chronic Obstructive Pulmonary Disease (COPD), With Poitive H Pylori
Active, not recruiting
Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery
COPD Exacerbation, Oxygen Toxicity
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
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.
Fares Gouzi, MD, PhD principal investigator
UH Montpellier
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FMD analysis in people with COPD Patients and Healthy, run by University Hospital, Montpellier at 2 sites 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 7 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: stopped early, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: Analyses will be carried out with the recruited population.). Results are not available in the source record.
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?
Measure of Flow-Mediated Dilatation (FMD) (time frame: post exercise and after 4 +/- 2 weeks of training). 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 NCT03774238, 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 12 Jun 2026.