Chronic Obstructive Pulmonary Disease (COPD)AVE-BPCONCT07125989
Effect of Exercise Ventilatory Support Pressure on Endurance in Patients With Severe Chronic Obstructive Pulmonary Disease - AVE-BPCO
A study testing non-invasive ventilation in people with Chronic Obstructive Pulmonary Disease (COPD), run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a chronic respiratory disease characterized by progressive obstruction of the airways. In advanced stages, it can progress to chronic respiratory failure with major respiratory repercussions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- non-invasive ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2025to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -COPD stage GOLD III or IV
- Baseline hypercapnia PaCO2 > 45 mmHg OR Alveolar hypoventilation during exercise (increase in PaCO2 > 5 mmHg),
- Exhaustion of more than 80% of ventilatory reserve OR max power < 50 Watts
- Affiliation or entitlement to social security coverage
- Signature of informed consent
Who cannot join
- BMI > 35
- Recent acute respiratory exacerbation < 4 weeks
- Severe unstable cardiac disease
- Pneumothorax or pneumomediastinum
- Pathological hypotension
- Cerebrospinal fluid leak, recent head trauma, or cranial surgery
Show all 11Show fewer
- Severe bulbar disorder
- Dehydration
- Severe orthopedic or neurological disorder compromising rehabilitation.
- Patient deprived of liberty or patient under guardianship
- Pregnant woman
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Chronic obstructive pulmonary disease (COPD) is a chronic respiratory disease characterized by progressive obstruction of the airways. In advanced stages, it can progress to chronic respiratory failure with major respiratory repercussions.
Biologically, hyperinflation manifests as alveolar hypoventilation, which causes hypercapnia. Mechanically, it is responsible for an increase in ventilatory work associated with diaphragmatic muscle dysfunction and fatigue, leading to exercise incapacity.
Read more
Physical inactivity is a major predictor of mortality in patients with COPD. The recommendations of the European Respiratory Society (ERS) and the American Thoracic Society (ATS) emphasize the importance of exercise in the treatment and management of COPD.
Respiratory rehabilitation has been shown to have an indisputable effect on dyspnea and the quality of life of COPD patients. Current guidelines for respiratory rehabilitation recommend interventions at a frequency of at least 2 to 3 supervised high-intensity training sessions per week. A minimum of 4 weeks of physical training is necessary to achieve a significant improvement in quality of life, dyspnea, and endurance.
A reduction in the duration and intensity of sessions is often necessary, thus limiting the desired benefits of respiratory rehabilitation.
Non-invasive ventilation (NIV) provides mechanical respiratory assistance by helping inspiration and optimizing expiration through a non-invasive interface such as a mask. Its use during exercise in severe COPD is to try to correct hypercapnia, reduce dynamic hyperinflation by helping the respiratory muscles to improve their work, and reduce dyspnea and the feeling of muscle weakness.
However, the modalities in terms of ventilation mode and inspiratory support pressures are not clearly established.
Read the detailed description
The objective of this study is therefore to compare different levels of ventilatory assistance during exercise to determine whether the level of inspiratory assistance during exercise significantly improves endurance in these patients and, in particular, whether high-intensity ventilatory assistance (inspiratory assistance 21 +/- 3 cmH20) provides a greater benefit in terms of endurance time compared to moderate intensity (inspiratory assistance 13 +/- 3 cmH20) or low intensity (inspiratory assistance < 6 cmH20).
- Being tested
- non-invasive ventilation
- Keywords
- Chronic obstructive pulmonary disease, respiratory rehabilitation, non-invasive ventilation
- 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.
non-invasive ventilationDevice
During the patient's first three respiratory rehabilitation sessions, each test on the cycle ergometer will be performed at 70% of maximum power (defined during the initial oxygen consumption (VO2) test) with ventilatory assistance at a different intensity (Low, moderate or high intensity).
| Study group | Role | What they receive |
|---|---|---|
| Low intensity | Sham comparator | Non-invasive ventilation less han 6 cmH2O Receives: Device: non-invasive ventilation |
| Moderate intensity | Active comparator | Non-invasive ventilation 13 +/-3 cmH2O Receives: Device: non-invasive ventilation |
| High intensity | Experimental | Non-invasive ventilation 21 +/-3 cmH2O Receives: Device: non-invasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pedaling time limit (in seconds)
Endurance capacity will be measured by the time limit for pedaling (in seconds) on a cycloergometer, performed during a respiratory rehabilitation session, at 70% of the maximum power developed during the maximum test.
Measured: Day 1, Day 3, Day 5
Secondary outcomes (4)
Partial pressure of oxygen (PaO2) in mmHg
PaO2 measured by capillary blood gas analysis performed at peak exercise during a respiratory rehabilitation session
Measured: Day 1, Day 3, Day 5
Partial pressure of carbon dioxide (PaCO2) in mmHg
PaCO2 measured by capillary blood gas analysis performed at peak exercise during a respiratory rehabilitation session
Measured: Day 1, Day 3, Day 5
Lactate in mmol/l
Lactate measured by capillary blood gas analysis performed at peak exercise during a respiratory rehabilitation session
Measured: Day 1, Day 3, Day 5
Peripheral muscle oxygenation (% SmO2)
Measurement of peripheral muscle oxygenation (% SmO2) using near-infrared spectroscopy (NIRS) during exercise in an endurance test during a respiratory rehabilitation session.
Measured: Day 1, Day 3, Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start1 Oct 2025 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (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 (COPD)Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric ROCHE, MD-PhD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125989
- Sponsor's protocol ID
- 24CH126
- Other IDs
- 2025-A00555-44
- Acronym
- AVE-BPCO
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Exercise Ventilatory Support Pressure on Endurance in Patients With Severe Chronic Obstructive Pulmonary Disease - AVE-BPCO
- ClinicalTrials.gov ID
- NCT07125989
- Acronym / sponsor ID
- AVE-BPCO / 24CH126
- Keywords
- Chronic obstructive pulmonary disease, respiratory rehabilitation, non-invasive ventilation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 15 Aug 2025 (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.
Chronic obstructive pulmonary disease (COPD) is a chronic respiratory disease characterized by progressive obstruction of the airways. In advanced stages, it can progress to chronic respiratory failure with major respiratory repercussions.
Biologically, hyperinflation manifests as alveolar hypoventilation, which causes hypercapnia. Mechanically, it is responsible for an increase in ventilatory work associated with diaphragmatic muscle dysfunction and fatigue, leading to exercise incapacity.
Physical inactivity is a major predictor of mortality in patients with COPD. The recommendations of the European Respiratory Society (ERS) and the American Thoracic Society (ATS) emphasize the importance of exercise in the treatment and management of COPD.
Respiratory rehabilitation has been shown to have an indisputable effect on dyspnea and the quality of life of COPD patients. Current guidelines for respiratory rehabilitation recommend interventions at a frequency of at least 2 to 3 supervised high-intensity training sessions per week. A minimum of 4 weeks of physical training is necessary to achieve a significant improvement in quality of life, dyspnea, and endurance.
A reduction in the duration and intensity of sessions is often necessary, thus limiting the desired benefits of respiratory rehabilitation.
Non-invasive ventilation (NIV) provides mechanical respiratory assistance by helping inspiration and optimizing expiration through a non-invasive interface such as a mask. Its use during exercise in severe COPD is to try to correct hypercapnia, reduce dynamic hyperinflation by helping the respiratory muscles to improve their work, and reduce dyspnea and the feeling of muscle weakness.
However, the modalities in terms of ventilation mode and inspiratory support pressures are not clearly established.
Detailed description
The objective of this study is therefore to compare different levels of ventilatory assistance during exercise to determine whether the level of inspiratory assistance during exercise significantly improves endurance in these patients and, in particular, whether high-intensity ventilatory assistance (inspiratory assistance 21 +/- 3 cmH20) provides a greater benefit in terms of endurance time compared to moderate intensity (inspiratory assistance 13 +/- 3 cmH20) or low intensity (inspiratory assistance < 6 cmH20).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low intensity | Sham comparator | Device: non-invasive ventilationNon-invasive ventilation less han 6 cmH2O |
| Moderate intensity | Active comparator | Device: non-invasive ventilationNon-invasive ventilation 13 +/-3 cmH2O |
| High intensity | Experimental | Device: non-invasive ventilationNon-invasive ventilation 21 +/-3 cmH2O |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- -COPD stage GOLD III or IV
- Baseline hypercapnia PaCO2 > 45 mmHg OR Alveolar hypoventilation during exercise (increase in PaCO2 > 5 mmHg),
- Exhaustion of more than 80% of ventilatory reserve OR max power < 50 Watts
- Affiliation or entitlement to social security coverage
- Signature of informed consent
Key exclusion criteria (11 listed)
- BMI > 35
- Recent acute respiratory exacerbation < 4 weeks
- Severe unstable cardiac disease
- Pneumothorax or pneumomediastinum
- Pathological hypotension
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 |
|---|---|---|
| non-invasive ventilationDuring the patient's first three respiratory rehabilitation sessions, each test on the cycle ergometer will be performed at 70% of maximum power (defined during the initial oxygen consumption (VO2) test) with ventilatory assistance at a different intensity (Low, moderate or high intensity). | Device | High intensity, Low intensity, Moderate intensity |
Primary outcome
Pedaling time limit (in seconds)
Time frame: Day 1, Day 3, Day 5
Endurance capacity will be measured by the time limit for pedaling (in seconds) on a cycloergometer, performed during a respiratory rehabilitation session, at 70% of the maximum power developed during the maximum test.
4 secondary outcomes
Partial pressure of oxygen (PaO2) in mmHg
Time frame: Day 1, Day 3, Day 5
Partial pressure of carbon dioxide (PaCO2) in mmHg
Time frame: Day 1, Day 3, Day 5
Lactate in mmol/l
Time frame: Day 1, Day 3, Day 5
Peripheral muscle oxygenation (% SmO2)
Time frame: Day 1, Day 3, Day 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
Frédéric ROCHE, MD-PhD principal investigator
CHU de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-invasive ventilation in people with Chronic Obstructive Pulmonary Disease (COPD), run by Centre Hospitalier Universitaire de Saint Etienne 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 5 inclusion and 11 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: opening soon, as of the sponsor's last update on 15 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frédéric ROCHE, MD-PhD (+33(0)477829109, frederic.roche@univ-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pedaling time limit (in seconds) (time frame: Day 1, Day 3, Day 5). 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 15 Aug 2025.