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New treatment option for COPD
Official title Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung - Study 3
ClinicalTrials.gov ID: NCT06891755
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 84
You may be able to join if
- 1. 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 pulmonary rehabilitation program within 12 months prior to Baseline.
- Subject has mMRC score ≥ 2.
- Subject can walk ≥100 meters in 6 minutes.
You likely can't join if
- Subject has known unresolved lower respiratory tract infection (e.g., pneumonia, mycobacterium avium-intracellulare infection (MAI), fungus...
- Subject has a steroid-dependent condition requiring (e.g. ≥10 mg oral corticosteroid per day).
- Subject has bilateral lobar emphysematous destruction scores of \>70% percent of voxels with \<-950 Hounsfield units on thin slice inspiratory CT, as...
- Subject has arterial or capillary blood on room air: PaCO2 \> 50 mmHg (8 kPa) or PaO2 ≤ 45 mmHg (6 kPa).
- Subject has had ≥2 hospitalization for acute exacerbations of COPD or ≥3 moderate exacerbations/respiratory infections in the year prior to...
- Subject has had previous lung volume reduction surgery, lobectomy, pneumonectomy, segmentectomy, bullectomy, lung transplantation, vapor, glue, or...
See the full eligibility criteria
Who can join
- 1. 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 pulmonary rehabilitation program within 12 months prior to Baseline.
- Subject has mMRC score ≥ 2.
- Subject can walk ≥100 meters in 6 minutes.
- 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.
- 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.
- 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.
- Subject has pre-procedure post-bronchodilator FEV1/ FVC \< 0.70.
- Subject has a pre-procedure post-bronchodilator FEV1 percent predicted of ≥15% and ≤45%.
- Subject has pre-procedure post-bronchodilator RV/TLC ≥ 0.55.
- Subject has pre-procedure DLCO ≥ 20%.
- Subject has been receiving optimal medical management tailored to subject needs for 2 months prior to enrollment.
- 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.
- Subject has received preventative vaccinations (or documented clinical intolerance) against potential respiratory infections, including pneumococcus, influenza, RSV (people \>60 yrs. old) and Covid-19, consistent with...
- 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.
- Subject has provided written informed consent.
What rules you out
- Subject has known unresolved lower respiratory tract infection (e.g., pneumonia, mycobacterium avium-intracellulare infection (MAI), fungus, tuberculosis).
- Subject has a steroid-dependent condition requiring (e.g. ≥10 mg oral corticosteroid per day).
- 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.
- Subject has arterial or capillary blood on room air: PaCO2 \> 50 mmHg (8 kPa) or PaO2 ≤ 45 mmHg (6 kPa).
- Subject has had ≥2 hospitalization for acute exacerbations of COPD or ≥3 moderate exacerbations/respiratory infections in the year prior to enrollment.
- 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...
- 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...
- Subject has presence of a giant bulla (≥ 30% of hemithorax).
- Subject has significant symptom burden due to currently active adult asthma based on GINA criteria and/or chronic bronchitis as their primary diagnosis.
- 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.
- Subject has clinically significant bronchiectasis (\>4 TBS / 45mL mucus production/day, per subject estimate) influencing subject's COPD symptoms.
- Subject has unresolved lung cancer.
- 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...
- 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...
- Subject has invasive mechanical ventilator dependency.
- Subject is pregnant, lactating, or of childbearing potential and plans to become pregnant during study duration.
- Subject has known hypersensitivity to Nitinol (nickel-titanium alloy) or its constituent metals (nickel or titanium).
- Subject is significantly immunocompromised, such as organ transplant recipients, those with congenital immune deficiencies, AIDS, or severe rheumatoid arthritis.
- Subject has sensitivity or allergy to medications necessary for bronchoscopy under general anesthesia.
- Subject is currently participating in another study involving an investigational product that could confound the study results or affect the subject's COPD symptoms.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Gilbert, Arizona, United States
- Sacramento, California, United States
- Jacksonville, Florida, United States
- Orlando, Florida, United States
- Chicago, Illinois, United States
- Peoria, Illinois, United States
- Kansas City, Kansas, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- DuBois, Pennsylvania, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Houston, Texas, United States
- Falls Church, Virginia, United States
- Milwaukee, Wisconsin, United States
- Vienna, Austria
- Groningen, Netherlands
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 40 years to 84 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Gilbert, Arizona, United States; Sacramento, California, United States; Jacksonville, Florida, United States; Orlando, Florida, United States; Chicago, Illinois, United States and 15 more location(s). 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.