RecruitingNot applicable

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 84 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 12 visits
  • Time periods mentioned: 3 years
  • Procedures mentioned: CT scans, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Study subjects will be followed for 3 years."
  • "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."
  • "These visits will involve adverse event assessment, questionnaires, pulmonary function testing, and inspiratory/ expiratory CT scans."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether the Apreo BREATHE system is safe and works to release trapped air in the lungs. It is a permanent implant that holds airways open for adults with COPD and emphysema who still feel short of breath despite the best medical treatment. Participants will be followed for 3 years.

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?

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 40 to 84 years old, with a body mass index (BMI, a weight-to-height measure) of 18 to 32.
  • Have finished a documented lung exercise and education program within the past 12 months.
  • Have a breathlessness score of at least 2 on the study's scale and be able to walk at least 100 meters in 6 minutes.
  • Have emphysema damage in at least 25% of each lung on a CT scan, with the required pattern of damage.
  • Meet the study's breathing test limits for airflow, trapped air, and how well oxygen moves from the lungs into the blood.
  • Have received the best medical care for your needs for at least 2 months. Have had recommended vaccines against lung infections, or a documented medical reason you cannot tolerate them.
  • Have not smoked or vaped tobacco, marijuana, or other products for at least 4 months, and agree not to during the study.
  • Be able to have a procedure using a scope in the airways while fully asleep, attend follow-up visits, and give written consent.

Who can't join

  • Have an ongoing lung infection or untreated lung cancer; certain severe lung damage, large air pockets, or concerning CT findings; major symptoms from active asthma; chronic bronchitis as the main diagnosis; or widened airways with heavy mucus that affect COPD symptoms.
  • Have blood oxygen that is too low or carbon dioxide that is too high; need an invasive breathing machine; or have known or suspected high blood pressure in the lung arteries.
  • Have had at least 2 hospital stays for COPD flare-ups or at least 3 moderate flare-ups or lung infections in the past year. Also excluded: severe COVID-19 within 2 years that required intensive care and machine help with breathing.
  • Have had certain lung surgeries, a lung transplant, vapor or glue treatments, or a lung device implant, unless the device was removed at least 3 months before consent.
  • Have a condition needing daily oral steroids, a very weak immune system, or another serious illness that could make the study unsafe or affect its results.
  • Cannot safely stop blood-thinning medicines for the airway procedure, or are allergic to nickel, titanium, or medicines needed for the procedure.
  • Are pregnant, breastfeeding, or planning to become pregnant during the study.
  • Are in another study of an experimental product that could affect COPD symptoms or this study's results.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (18)

AL

AZ

CA

FL

IL

KS

  • University of Kansas Medical Center Research Institute · Kansas City, KS 66160Jamie Quigley · Study contact · 913-574-3036 · jtroxel@kumc.eduMaykol Postigo-Jasahui, MD · Principal investigatorLucas Pitts, MD · Sub-investigatorMario Castro, MD · Sub-investigatorMore trials in Kansas City

MA

MI

  • University of Michigan · Ann Arbor, MI 48109Kelly Rysso · Study contact · kahernan@med.umich.eduMelian Han, MD · Principal investigatorJose De Cardenas, MD · Sub-investigatorWassim Labaki, MD · Sub-investigatorMore trials in Ann Arbor

OH

PA

TX

VA

WI