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New treatment option for Chronic Obstructive Pulmonary Disease (COPD)
Official title Intermittent Intrapulmonary Deflation and Dyspnea Following Exercise in People With Chronic Obstructive Pulmonary Disease
ClinicalTrials.gov ID: NCT06956742
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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;
You likely can't join if
- 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.).
See the full eligibility 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-
- 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...
- 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.
- 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.).
The study team makes the final eligibility decision.
Where it's taking place
- Rouen, Normandy, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rouen, Normandy, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.