Chronic Obstructive Pulmonary Disease SevereCYTODINENCT06229509
Study of the Cytokine Response During Exercise Dyspnea in Patients With Chronic Obstructive Pulmonary Disease (COPD). Effect of Body Composition
A study testing Effective noninvasive ventilation in people with Chronic Obstructive Pulmonary Disease Severe and Dyspnea, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Dyspnea, more commonly known as breathlessness, is a symptom found in the majority of patients with chronic obstructive pulmonary disease (COPD), with a major impact on quality of life and mortality. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease Severe, Dyspnea
- What is being tested?
- Effective noninvasive ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2024to Aug 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 18 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Patient affiliated to a social security scheme.
- Patient capable of giving free, informed, written and signed consent.
- Male gender
- Severe COPD (Chronic Obstructive Pulmonary Disease) diagnosed according to GOLD criteria, in a stable state, with a forced expiratory volume (FEV1) from 30 to 50% of the predicted value (measured within one year during respiratory function tests (RFT)
- History of smoking >10 pack-years with cessation of smoking for more than 12 months.
- Patient judged by the investigator to be able to tolerate inspiratory pressure during a preliminary cycling exercise test.
Who cannot join
- Severe anxiety disorders, assessed by the STAY Y-B form questionnaire; a score above 65 indicates very high day-to-day anxiety.
- Patient under guardianship/trusteeship/supervision of justice
- Chronic hypercapnia at rest (CO2 arterial pressure ≥ 50mmHg)
- Chronic use of non-invasive ventilation
- Known pulmonary hypertension
- Chronic administration of oral corticosteroids
- Unstable heart disease
Trial locations and contacts
1 site in 1 country.
France1 site
CHU Clermont-Ferrand
Clermont-Ferrand
Lise Laclautre, 0473751195, promo_interne_drci@chu-clermontferrand.fr
Camille ROLLAND-DEBORD
About this study
Official title: Study of Cytokine Response During Exercise Dyspnea in Patients With Chronic Obstructive Pulmonary Disease (COPD). Effect of Body Composition
Dyspnea, more commonly known as breathlessness, is a symptom found in the majority of patients with chronic obstructive pulmonary disease (COPD), with a major impact on quality of life and mortality.
COPD is a chronic inflammatory disease of the bronchi, affecting 8% of the French population (more than 3 million people). By 2030, it will be the third leading cause of death worldwide. Effective management of dyspnea in these patients is a priority.
Read more
In patients with severe COPD, physical exertion increases the workload of breathing, leading to dyspnea. At the same time, the respiratory muscles and fatty cells release cytokines, myokines and adipokines - a group of proteins involved in the inflammatory response. In addition, 15% of COPD patients suffer from sarcopenia (loss of muscle mass and strength) which increases respiratory effort and dyspnea.
Our research project aims to study the effect of dyspnea relief in COPD patients on cytokine, myokine and adipokine levels, taking into account the presence of sarcopenia. Indeed, it is possible to alleviate the workload of the respiratory muscles during exercise by means of respiratory assistance.
The ultimate goal is a better understanding of dyspnea mechanisms, to enable the development of cytokine-targeted therapies and improve quality of life and survival in these patients.
- Being tested
- Effective noninvasive ventilation, Sham noninvasive ventilation
- Keywords
- Cytokines, Myokines, Adipokines, Exercise, Noninvasive Ventilation, Sarcopenia
- Medical subject headings
- Dyspnea, Motor Activity, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effective noninvasive ventilationDevice
Noninvasive ventilation set to alleviate dyspnea Inspiratory aid set according to a preliminary test (aiming for a diminution of 2 points in Borg score)
Sham noninvasive ventilationDevice
Noninvasive ventilation set with an insufficient inspiratory aid to alleviate dyspnea
| Study group | Role | What they receive |
|---|---|---|
| Effective noninvasive ventilation | Experimental | Alleviate dyspnea (lower Borg Score by 2 points) Receives: Device: Effective noninvasive ventilation |
| Sham noninvasive ventilation | Sham comparator | Not described Receives: Device: Sham noninvasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in exercise-induced release of cytokines IL-1, IL-6, IL-8, IL-10 and TNF-alpha plasma concentrations (pg/mL) between the two ventilatory conditions (sham and effective)
Measured: At rest = baseline / right after the end of exercice / 45 minutes after the end of exercice
Variation in exercise-induced release of adipokines adiponectin and leptin concentrations (pg/mL) between the two ventilatory conditions (sham and effective)
Measured: At rest = baseline / right after the end of exercice / 45 minutes after the end of exercice
Secondary outcomes (3)
For each ventilatory condition, study of correlation between dyspnea descriptors (Borg scale score, Multidimensional Dyspnea Profil score) and cytokines, adipokines and myokines plasma concentrations (pg/mL)
Measured: At rest = baseline / right after the end of exercice / 45 minutes after the end of exercice
For each ventilatory condition, study of correlation between muscle mass (kg) and cytokines, adipokines and myokines plasma concentrations (pg/mL).
Measured: At rest = baseline / right after the end of exercice / 45 minutes after the end of exercice
For each ventilatory condition, study of correlation between fat mass (kg) and cytokines, adipokines and myokines plasma concentrations (pg/mL).
Measured: At rest = baseline / right after the end of exercice / 45 minutes after the end of exercice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study startFeb 2024 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease SevereStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06229509
- Sponsor's protocol ID
- AOI 2022 ROLLAND DEBORD
- Acronym
- CYTODINE
- Status last verified
- Jan 2024
- First submitted
- 9 Jan 2024
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Cytokine Response During Exercise Dyspnea in Patients With Chronic Obstructive Pulmonary Disease (COPD). Effect of Body Composition
- ClinicalTrials.gov ID
- NCT06229509
- Acronym / sponsor ID
- CYTODINE / AOI 2022 ROLLAND DEBORD
- Keywords
- Cytokines, Myokines, Adipokines, Exercise, Noninvasive Ventilation, Sarcopenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 29 Jan 2024 (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.
Dyspnea, more commonly known as breathlessness, is a symptom found in the majority of patients with chronic obstructive pulmonary disease (COPD), with a major impact on quality of life and mortality.
COPD is a chronic inflammatory disease of the bronchi, affecting 8% of the French population (more than 3 million people). By 2030, it will be the third leading cause of death worldwide. Effective management of dyspnea in these patients is a priority.
In patients with severe COPD, physical exertion increases the workload of breathing, leading to dyspnea. At the same time, the respiratory muscles and fatty cells release cytokines, myokines and adipokines - a group of proteins involved in the inflammatory response. In addition, 15% of COPD patients suffer from sarcopenia (loss of muscle mass and strength) which increases respiratory effort and dyspnea.
Our research project aims to study the effect of dyspnea relief in COPD patients on cytokine, myokine and adipokine levels, taking into account the presence of sarcopenia. Indeed, it is possible to alleviate the workload of the respiratory muscles during exercise by means of respiratory assistance.
The ultimate goal is a better understanding of dyspnea mechanisms, to enable the development of cytokine-targeted therapies and improve quality of life and survival in these patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Effective noninvasive ventilation | Experimental | Device: Effective noninvasive ventilationAlleviate dyspnea (lower Borg Score by 2 points) |
| Sham noninvasive ventilation | Sham comparator | Device: Sham noninvasive ventilation |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Patient affiliated to a social security scheme.
- Patient capable of giving free, informed, written and signed consent.
- Male gender
- Severe COPD (Chronic Obstructive Pulmonary Disease) diagnosed according to GOLD criteria, in a stable state, with a forced expiratory volume (FEV1) from 30 to 50% of the predicted value (measured within one year during respiratory function tests (RFT)
Key exclusion criteria (7 listed)
- Severe anxiety disorders, assessed by the STAY Y-B form questionnaire; a score above 65 indicates very high day-to-day anxiety.
- Patient under guardianship/trusteeship/supervision of justice
- Chronic hypercapnia at rest (CO2 arterial pressure ≥ 50mmHg)
- Chronic use of non-invasive ventilation
- Known pulmonary hypertension
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 |
|---|---|---|
| Effective noninvasive ventilationNoninvasive ventilation set to alleviate dyspnea Inspiratory aid set according to a preliminary test (aiming for a diminution of 2 points in Borg score) | Device | Effective noninvasive ventilation |
| Sham noninvasive ventilationNoninvasive ventilation set with an insufficient inspiratory aid to alleviate dyspnea | Device | Sham noninvasive ventilation |
Primary outcome
Variation in exercise-induced release of cytokines IL-1, IL-6, IL-8, IL-10 and TNF-alpha plasma concentrations (pg/mL) between the two ventilatory conditions (sham and effective)
Time frame: At rest = baseline / right after the end of exercice / 45 minutes after the end of exercice
Variation in exercise-induced release of adipokines adiponectin and leptin concentrations (pg/mL) between the two ventilatory conditions (sham and effective)
Time frame: At rest = baseline / right after the end of exercice / 45 minutes after the end of exercice
3 secondary outcomes
For each ventilatory condition, study of correlation between dyspnea descriptors (Borg scale score, Multidimensional Dyspnea Profil score) and cytokines, adipokines and myokines plasma concentrations (pg/mL)
Time frame: At rest = baseline / right after the end of exercice / 45 minutes after the end of exercice
For each ventilatory condition, study of correlation between muscle mass (kg) and cytokines, adipokines and myokines plasma concentrations (pg/mL).
Time frame: At rest = baseline / right after the end of exercice / 45 minutes after the end of exercice
For each ventilatory condition, study of correlation between fat mass (kg) and cytokines, adipokines and myokines plasma concentrations (pg/mL).
Time frame: At rest = baseline / right after the end of exercice / 45 minutes after the end of exercice
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Effective noninvasive ventilation in people with Chronic Obstructive Pulmonary Disease Severe and Dyspnea, run by University Hospital, Clermont-Ferrand 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 7 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: status not confirmed, as of the sponsor's last update on 29 Jan 2024. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (0473751195, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation in exercise-induced release of cytokines IL-1, IL-6, IL-8, IL-10 and TNF-alpha plasma concentrations (pg/mL) between the two ventilatory conditions (sham and effective) (time frame: At rest = baseline / right after the end of exercice / 45 minutes after the end of exercice). The study lists 2 primary outcomes in all. 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 29 Jan 2024; AzTrials last refreshed its copy on 7 Nov 2026.