Intermittent intrapulmonary deflation to ease breathlessness after exercise in COPD

Effect of Intermittent Intrapulmonary Deflation on the Sensory Dimension of Dyspnea After Exercise in Patients With Chronic Obstructive Pulmonary Disease: A Double-blind, Randomized Crossover Study

This trial will test whether a home device that applies intermittent negative pressure during exhalation reduces shortness of breath after exercise in adults with moderate to severe COPD.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 33 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: ADIR Association (Academic / other)
• Locations: 1 site (Rouen, Normandy)
• Trial ID: NCT06956742 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults over 18 with GOLD II–IV COPD who recently completed pulmonary rehabilitation, have significant dyspnea (mMRC ≥2), measurable pulmonary hyperinflation, and a 6-minute walk distance under 350 meters are ideal candidates.

Not a fit: People without dynamic hyperinflation, those with a different primary chronic respiratory diagnosis, individuals unable to perform exercise testing or use the device, and pregnant women are unlikely to benefit.

Why it matters

Potential benefit: If effective, this approach could decrease post-exertional breathlessness, improve mucus clearance and exercise tolerance, and make symptom management easier at home.

How similar studies have performed: Intermittent intrapulmonary deflation is a novel technique with limited prior clinical data, though related airway-clearance devices such as positive expiratory pressure devices have shown mixed results.

Eligibility criteria

Inclusion Criteria:

* Age \> 18 years;
* COPD stage GOLD II to IV;
* Completion of a pulmonary rehabilitation program within the last 6 months;
* 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 this trial is running

Rouen, Normandy

• ADIR Association — Rouen, Normandy, France (Recruiting)

Study contacts

• Principal investigator: Tristan Bonnevie, PhD — Association ADIR
• Study coordinator: Tristan Bonnevie, PhD

Conditions Chronic Obstructive Pulmonary Disease; COPD; Chronic obstructive pulmonary disease; Intermittent intrapulmonary deflation; Dypsnea; Exercise