At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Apreo BREATHE Airway Scaffold (device), Optimal Medical Management (OMM) (other)
- How long the study runs
- Study runs about 53 months (dates as stated)
- About the drug or intervention
- Apreo BREATHE Airway Scaffold — device: The experimental treatment involves placement of up to 6 Apreo BREATHE Airway Scaffolds (up to 3 per lung), in a single procedure using bronchoscopy and fluoroscopy. · Optimal Medical Management (OMM) — other: Subjects will receive optimal medical management tailored to patient needs and per standard of care and as outlined in the 2024 GOLD report.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by Apreo Health, Inc., looks at a procedure called bronchoscopic release of air trapped in over-inflated (hyperinflated) lungs affected by emphysema. Emphysema is a type of chronic obstructive pulmonary disease (COPD) where damaged lungs trap air. The trial is for people with COPD and emphysema.
Who can take part
- Aged between 40 and 84 years
- Body mass index (BMI, a measure of weight for height) between 18 and 32
- Has finished a documented pulmonary rehabilitation programme (exercise and education for lung conditions) within the 12 months before the start of the study
- Has a breathlessness (mMRC) score of 2 or more
- Can walk at least 100 metres in 6 minutes
- Has at least 25% emphysema damage in each lung, measured on a baseline chest scan (HRCT)
- Has emphysema spread evenly or unevenly in the lungs, with at least one lung showing a 15% difference in damage between upper and lower parts
- Has a high amount of air trapped in the lungs (measured as residual volume, RV, at or above 180% predicted for uneven emphysema in both lungs, or 200% for even emphysema in one lung)
- Has airflow blockage on a breathing test (FEV1/FVC below 0.70) after using an inhaler to open the airways
- FEV1 (amount of air breathed out in one second) between 15% and 45% of predicted after using an inhaler
- Air trapped in the lungs (RV/TLC) at or above 0.55 after using an inhaler
- DLCO (a measure of how well the lungs move oxygen into the blood) of at least 20%
- Has been on the best medical treatment for their needs for at least 2 months before joining
- Has not smoked anything (tobacco, cannabis, e-cigarettes or vaping) for at least 4 months and agrees not to smoke during the study
- Has had recommended vaccinations against respiratory infections (pneumococcus, flu, COVID-19, and RSV for over-60s), or a documented reason they cannot have them
- In the study doctor's view, can have a bronchoscopy (a camera test of the airways) under general anaesthesia and can attend follow-up visits
- Has given written informed consent
Who may not be able to
- Has an ongoing chest infection such as pneumonia, TB or a fungal infection
- Needs 10 mg or more of steroid tablets a day
- Has more than 70% emphysema destruction in lung areas on both sides, seen on a CT scan
- Has blood oxygen or carbon dioxide levels outside safe limits on room air (PaCO2 above 50 mmHg or PaO2 at or below 45 mmHg)
- Has had 2 or more hospital stays for COPD flare-ups, or 3 or more moderate flare-ups or chest infections, in the past year
- Has had previous lung volume reduction surgery, lung surgery, bullectomy, lung transplant, or lung treatments using vapour, glue or implanted devices (unless removed at least 3 months before joining)
- Has or may have pulmonary arterial hypertension (high blood pressure in the lungs)
- Has a very large air pocket in the lung (a giant bulla taking up 30% or more of one side of the chest)
- Has active asthma or chronic bronchitis as the main cause of symptoms
- Has suspicious areas on the chest scan that might need treatment during the study
- Has significant bronchiectasis (widened airways with lots of mucus) affecting COPD symptoms
- Has lung cancer that is not resolved
- Has a serious medical condition (for example heart failure, a recent heart attack, kidney or liver disease, a stroke in the last 6 months, uncontrolled diabetes or blood pressure, or a disease needing immunosuppressants or chemotherapy) that could affect safety or results
- Takes blood-thinning medicines that cannot be safely paused for the bronchoscopy
- Depends on a ventilator to breathe
- Is pregnant, breastfeeding, or planning to become pregnant during the study
- Is allergic to nitinol (a nickel-titanium metal) or to nickel or titanium
- Has a severely weakened immune system (for example organ transplant recipients, or people with AIDS)
- Is allergic or sensitive to medicines needed for general anaesthesia during bronchoscopy
- Is taking part in another study of an experimental product
- Has had severe COVID-19 needing intensive care with ventilation within the past 2 years
What taking part involves
- • The study looks at a procedure using a bronchoscope (a thin tube with a camera) to release air trapped in over-inflated emphysematous lungs, done under general anaesthesia (being put to sleep)
Time commitment: Not stated — ask the trial team about the number of visits, how long the study lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 40 Years to 84 Years
- Who
- All
- Number of participants
- 250
- Started
- 2025-07-15
- Last checked
- 2026-01
Plain English Summary
What is this study?
- • Testing a new treatment for copd
- • NA - 250 participants
- • The objective of this study is to assess the safety and efficacy of Apreo BREATHE system when used to support native airways and release trapped air in the treatment of adult COPD patients with emphysema suffering from dyspnea due to hyperinflation despite optimal medical treatment
Who can take part?
- • Ages 40 Years to 84 Years
- • Diagnosed with copd
Where?
- • London - St. Bartholomew's Hospital
- • London - Royal Brompton Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The objective of this study is to assess the safety and efficacy of Apreo BREATHE system when used to support native airways and release trapped air in the treatment of adult COPD patients with emphysema suffering from dyspnea due to hyperinflation despite optimal medical treatment. The Apreo BREATHE Airway Scaffold is a permanent implant designed to tent open native airways. The study will include up to 250 participants at up to 25 study centers located in the United States and Europe. Study subjects will be followed for 3 years. The main questions it aims to answer are: Is it safe? Does it work?
More detail
Prospective, randomized, two arm, parallel group, concurrently controlled, open-label, multi-center clinical trial following up to 250 participants to 3 years. Each site will participate in a Roll-In phase prior to participation in the randomized phase of the study. Each site will enroll up to 2 subjects in this phase. Up to 50 subjects may be enrolled into the Roll-In cohort. Up to 200 subjects with bilateral emphysema will be randomized at up to 25 centers in the United States centers and Europe. In the Randomized cohort, subjects will be randomized to either a Treatment or Control group in a 2:1 ratio. * Optimal Medical Management: All subjects (Roll-in and Randomized) will receive optimal medical management tailored to patient needs and per standard of care and as outlined in the 2024 GOLD report. This may include smoking cessation, vaccination, long-acting bronchodilator therapy, corticosteroids (when appropriate), and participation in or maintenance of an exercise program or pulmonary rehabilitation program. * Treatment group: 133 subjects will receive optimal medical management and Apreo Implant placements. Treatment group subjects will undergo a single bronchoscopy with bilateral placement of up to 3 implants per lung in appropriately selected target airways. Appropriate target segments shall be based on segmental and lobar information (i.e. airway dimensional, emphysematous destruction, volumetric information, hetero/homogeneity) provided in the Quantitative CT (QCT) report for each patient. * Control group: 67 subjects will receive optimal medical management. Control group subjects will be allowed the opportunity to cross over and receive the BREATHE treatment after their Month 12 visit and within 15 months from their baseline visit. Subjects will undergo follow-up assessments at Months 1, 3, 6 and 12, and Years 2 and 3 post-procedure (treatment group) or post-randomization (control group). These visits will involve adverse event assessment, questionnaires, pulmonary function testing, and inspiratory/ expiratory CT scans. Control group subjects electing crossover will then have additional follow-ups at 7- and 30-days post procedure, and 6 months post procedure. Control group subjects not electing crossover will be exited from the study after Month 12.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 40 Years - 84 Years
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ intervention during course of the study
- ✓ ICU support with non-invasive and/or invasive mechanical ventilation
What the study is looking for
- ✓Inclusion Criteria
- ✓Subject is at least 40, but not older than 84, years of age.
- ✓Subject has body mass index (BMI) of between 18 and 32, inclusive.
- ✓Subject has completed a documented lung rehabilitation program within 12 months prior to Baseline.
- ✓Subject has mMRC score ≥ 2.
See the full criteria
Where Is This Study? (2 UK sites)
St. Bartholomew's Hospital
London EC1A 7BE, United Kingdom
Royal Brompton Hospital
London SW36JY, United Kingdom
How to Get in Touch
Cindy Holtz
Sponsor contactCONTACT
Nina Mohmood
Sponsor contactCONTACT
