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Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung - Study 3

Sponsor: Apreo Health, Inc.

NCT ID: NCT06891755

View on ClinicalTrials.gov ↗

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.

COPDEmphysema

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Gender· Tell us your sex for better matching

Still need:

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  • • 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
* Inclusion Criteria 1. Subject is at least 40, but not older than 84, years of age. 2. Subject has body mass index (BMI) of between 18 and 32, inclusive. 3. Subject has completed a documented pulmonary rehabilitation program within 12 months prior to Baseline. 4. Subject has mMRC score ≥ 2. 5. Subject can walk ≥100 meters in 6 minutes. 6. Subject has ≥25% emphysema destruction score in each lung as quantified on baseline HRCT scan (low attenuation area less than -950HU) as determined by the CT core lab. 7. Subject has homogeneous or heterogeneous emphysema, and at least one lung has a 15% difference between upper and lower lobes in emphysema destruction score (-910HU) as determined by the CT core lab. 8. Subject has bilateral heterogenous emphysema and pre-procedure post-bronchodilator RV ≥ 180% predicted, or one lung with homogenous emphysema and pre-procedure postbronchodilator RV ≥ 200% predicted. 9. Subject has pre-procedure post-bronchodilator FEV1/ FVC \< 0.70. 10. Subject has a pre-procedure post-bronchodilator FEV1 percent predicted of ≥15% and ≤45%. 11. Subject has pre-procedure post-bronchodilator RV/TLC ≥ 0.55. 12. Subject has pre-procedure DLCO ≥ 20%. 13. Subject has been receiving optimal medical management tailored to subject needs for 2 months prior to enrollment. 14. Subject has not actively smoked (including tobacco, marijuana, e-cigarettes, vaping, etc.) within the last 4 months, and agrees to smoking cessation during the study. 15. Subject has received preventative vaccinations (or documented clinical intolerance) against potential respiratory infections, including pneumococcus, influenza, RSV (subjects \>60 yrs. old) and Covid-19, consistent with local recommendations or policy. 16. In the opinion of the Primary investigator, subject can undergo bronchoscopy under general anesthesia and is able to adhere to the study follow-up schedule. 17. Subject has provided written informed consent. * Exclusion Criteria 1. Subject has known unresolved lower respiratory tract infection (e.g., pneumonia, mycobacterium avium-intracellulare infection (MAI), fungus, tuberculosis). 2. Subject has a steroid-dependent condition requiring (e.g. ≥10 mg oral corticosteroid per day). 3. Subject has bilateral lobar emphysematous destruction scores of \>70% percent of voxels with \<-950 Hounsfield units on thin slice inspiratory CT, as determined by the CT core lab. 4. Subject has arterial or capillary blood on room air: PaCO2 \> 50 mmHg (8 kPa) or PaO2 ≤ 45 mmHg (6 kPa). 5. Subject has had ≥2 hospitalization for acute exacerbations of COPD or ≥3 moderate exacerbations/respiratory infections in the year prior to enrollment. 6. Subject has had previous lung volume reduction surgery, lobectomy, pneumonectomy, segmentectomy, bullectomy, lung transplantation, vapor, glue, or other pulmonary device implant (unless the device has been removed at least 3 months prior to consent). 7. Subject has known or suspected history of pulmonary arterial hypertension (e.g. PASP \> 50mmHg on echocardiogram in absence of confirmation on a right heart catheterization or mPAP \> 25mmHg on a right heart catheterization). 8. Subject has presence of a giant bulla (≥ 30% of hemithorax). 9. Subject has significant symptom burden due to currently active adult asthma based on GINA criteria and/or chronic bronchitis as their primary diagnosis. 10. Subject has presence of suspicious radiological abnormalities on HRCT scan such as pulmonary nodule/infiltrate that in judgement of the PI, may require intervention during course of the study. 11. Subject has clinically significant bronchiectasis (\>4 TBS / 45mL mucus production/day, per subject estimate) influencing subject's COPD symptoms. 12. Subject has unresolved lung cancer. 13. Subject has a serious medical condition that, in the Primary investigator's opinion, could compromise patient safety or confound the interpretation of the patient's response to therapy (e.g., congestive heart failure, cardiomyopathy (documented LVEF ≤40%), or myocardial infarction in the past year, renal failure, liver disease cerebrovascular accident within the past 6 months, uncontrolled diabetes (HbA1c \>8%), uncontrolled hypertension (diastolic BP \>110 mmHg or systolic \>200 mmHg) or autoimmune disease requiring treatment with immunosuppressant medications or a disease requiring chemotherapy. 14. Subject is on anticoagulant or antiplatelet therapy for cardiovascular indications and, at the discretion of the Primary investigator, is unable to have anticoagulants withheld for a bronchoscopy procedure per institution's standard of care. 15. Subject has invasive mechanical ventilator dependency. 16. Subject is pregnant, lactating, or of childbearing potential and plans to become pregnant during study duration. 17. Subject has known hypersensitivity to Nitinol (nickel-titanium alloy) or its constituent metals (nickel or titanium). 18. Subject is significantly immunocompromised, such as organ transplant recipients, those with congenital immune deficiencies, AIDS, or severe rheumatoid arthritis. 19. Subject has sensitivity or allergy to medications necessary for bronchoscopy under general anesthesia. 20. Subject is currently participating in another study involving an investigational product that could confound the study results or affect the subject's COPD symptoms. 21. Subject has within the 2 years prior to consent, had a severe respiratory infection with SARS-CoV-2 (COVID-19) that required ICU support with non-invasive and/or invasive mechanical ventilation.

Where Is This Study? (2 UK sites)

St. Bartholomew's Hospital

London EC1A 7BE, United Kingdom

Recruiting
Site contact (verified)
Kelvin Lau, MDPrincipal Investigator

Royal Brompton Hospital

London SW36JY, United Kingdom

Recruiting
Site contact (verified)
Pallav Shah, ProfessorPrincipal Investigator

How to Get in Touch

Cindy Holtz

Sponsor contact

CONTACT

650-326-2656 cindy.holtz@apreohealth.com

Nina Mohmood

Sponsor contact

CONTACT

nina.mohmood@apreohealth.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-01