💬In plain words
What the trial is, and whether it could suit you
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, which can make daily tasks more challenging. This breathlessness is partly caused by mucus accumulation within the airways and air getting trapped in the lungs. Both of these reduce the amount of fresh air that can enter with each breath and increase the effort required to breathe.
To manage symptoms, people with chronic obstructive pulmonary disease may use medications, oxygen therapy, or be referred to pulmonary rehabilitation programs. These programs often include exercise training, self-management strategies, and airway clearance techniques. While chest physiotherapists typically guide patients in these techniques, certain medical devices can also help individuals manage their conditio
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.).
💊
What it tests
- Active intermittent intrapulmonary deflation.
- Placebo intermittent intrapulmonary deflation.
ADIR Association
Rouen, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
HealthTeky