New device may ease COPD breathlessness after exercise

NCT ID NCT06956742

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 33 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • ADIR Association

    RECRUITING

    Rouen, Normandy, 76000, France

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