New device may ease COPD breathlessness after exercise
NCT ID NCT06956742
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a device that uses gentle pressure changes to clear mucus and trapped air from the lungs can reduce shortness of breath after walking in people with COPD. About 33 adults who have completed pulmonary rehab will use the active device or a placebo at home for one week each. The goal is to see if this simple, non-drug method can make daily activities easier.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 33 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age \> 18 years; * COPD stage GOLD II to IV; * Had completed a pulmonary rehabilitation programme at the investigational site; * 6-minute walk test \< 350 meters before and/or after completing the pulmonary; rehabilitation program; * mMRC dyspnea scale ≥ 2; * Pulmonary hyperinflation (ratio between residual volume to total lung capacity superior to 50%, and either total lung capacity superior to 130% or functional residual capacity superior to 130%); * With or without oxygen supplementation; * Stable condition (no exacerbation or change in treatment in the last 4 weeks); * Naïve to intermittent intrapulmonary deflation. * Regulatory criteria (social security affiliation; adult patient who has read and understood the information letter and signed the informed consent form). Non-inclusion Criteria: * Pregnant women or likely to be; * Patients under guardianship or curatorship; * Inability to consent; * Primary diagnosis of another chronic obstructive respiratory disease such as asthma or primary bronchiectasis; * Orthopedic, neurological, vascular, or neuromuscular conditions that limit walking or require walking aids; * Severe or unstable cardiovascular disease (uncontrolled cardiac arrhythmias, severe heart failure, recent myocardial infarction, unstable angina); * Patients actively requiring assistance with inspiration (e.g. ventilatory assistance with endotracheal tube, tracheostomy tube, or ventilated with a mask; patients with neuromuscular disease with respiratory muscle weakness; patients with inability to cough forcefully and independently); * Hemodynamic instability; * Recent pneumothorax (within the last 3 months); * Recent pulmonary or upper airway surgery (within the last month); * Referral to a pulmonary rehabilitation program in preparation for thoracic surgery (lung volume reduction, lung transplantation, or lung resection for non-small cell lung cancer); * Use of an electrical mechanical device for airway clearance during the study period (in-exsufflator, high-frequency chest oscillation, etc.); * Active cancer; * Severe episode of hemoptysis in the last 3 months; * Severe tracheomalacia. Exclusion Criteria: * Withdrawal of consent; * Acute COPD exacerbation between visits or onset of cardiorespiratory instability; * Use of an electrical mechanical device for airway clearance during the study period (in-exsufflator, high-frequency chest oscillation, etc.).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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ADIR Association
RECRUITINGRouen, Normandy, 76000, France
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