Intermittent intrapulmonary deflation to ease breathlessness after exercise in COPD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, placebo-controlled interventional study compares active intermittent intrapulmonary deflation with a sham device in adults with GOLD II–IV COPD who have recent pulmonary rehabilitation and measurable hyperinflation. Participants will perform standardized exercise testing and then use the assigned device, with post-exertion dyspnea measured by validated scales and walking tests as primary outcomes. The device delivers intermittent negative pressure during passive exhalation to mobilize secretions and potentially reduce dynamic hyperinflation, and it is intended for self-administration at home. Secondary measures include safety, tolerability, exercise tolerance, and quality of life.

Why it matters

Who can join: the full rules

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.).

Where it's running

• ADIR Association
  Rouen, Normandy, France Recruiting

Study contacts

• Principal investigator: Tristan Bonnevie, PhD — Association ADIR
• Study coordinator: Tristan Bonnevie, PhD
• Email: t.bonnevie@adir-hautenormandie.com
• Phone: 0235592970

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.