Status:
RECRUITING
Intermittent Intrapulmonary Deflation and Dyspnea Following Exercise in People With Chronic Obstructive Pulmonary Disease
Lead Sponsor:
ADIR Association
Collaborating Sponsors:
PhysioAssist
Conditions:
Chronic Obstructive Pulmonary Disease (COPD)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Chronic obstructive pulmonary disease is a long-term lung condition that causes breathing difficulties. People living with this disease often feel short of breath, especially during physical activity,...
Detailed Description
Dyspnea in chronic obstructive pulmonary disease is multifactorial and results from complex pathophysiological mechanisms. A key contributor is dynamic hyperinflation, caused by airflow obstruction an...
Eligibility Criteria
Inclusion
- 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
- 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.).
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2028
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT06956742
Start Date
June 1 2025
End Date
February 28 2028
Last Update
November 19 2025
Active Locations (1)
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1
ADIR Association
Rouen, Normandy, France, 76000