NCT06956742 Intermittent Intrapulmonary Deflation and Dyspnea Following Exercise in People With Chronic Obstructive Pulmonary Disease

Eligibility & Interventions

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This trial targets 33 participants in total. It began in 2025-06-01 with a primary completion date of 2028-02-28.

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, 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 condition independently at home. One such device uses a method called intermittent intrapulmonary deflation, which involves applying gentle pressure changes through a mouthpiece to help loosen mucus and release trapped air from the lungs. Although some individuals already use this kind of device as part of their daily care, more scientific evidence is needed to determine whether the improvements in airway clearance and reduced air trapping actually lead to measurable relief of breathlessness. The goal of this clinical trial is to find out whether this type of medical device designed to remove airway mucus and trapped air in the lungs (using intermittent intrapulmonary deflation) can help reduce breathlessness (dyspnea) after physical activity in people with COPD. The main questions this study aims to answer are: * Does using the device at home for one week reduce the intensity of breathlessness after walking? * Does it also improve walking distance, reduce the feeling of muscle fatigue, or increase satisfaction with the airway clearance method? Researchers will compare the active device to a placebo device that looks and feels identical but does not deliver the active treatment. This comparison will help determine whether the observed effects are due to the device itself or other factors such as expectations or chance. Participants in this study will be adults diagnosed with moderate to very severe chronic obstructive pulmonary disease. All participants must have recently completed a pulmonary rehabilitation program, continue to experience breathlessness while walking, and show signs of lung hyperinflation (when air remains trapped in the lungs). People will not be included if they have other serious health conditions that could make walking difficult or unsafe, or if they have any contraindications to using the device. Participants who agree to participante in the study will: * Attend a visit at the pulmonary rehabilitation center for baseline testing and to learn how to use the device; * Be randomly assigned to use either the active device or the placebo device at home for 7 days; * Return to the center for walking tests, lung function tests, and questionnaires about breathing and fatigue; * After a one-week break, use the device with alternative settings (the one not used in the first phase) for another 7 days; * Complete a final visit at the end of the study to repeat the same tests. Participants will also be invited to take part in an ancillary study during their first clinic visit to examine how a single session with the device affects breathlessness immediately after walking. This research will help determine whether this non-pharmacological, device-based method of clearing mucus and reducing trapped air can bring meaningful improvement in breathlessness for people with chronic obstructive pulmonary disease, especially when used at home. If effective, it may offer a simple and convenient way to help people breathe more comfortably during everyday activities. Participants will receive compensation for their time and travel.

Eligibility Criteria

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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