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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Parallel
Treatments tested in this trial
Apreo BREATHE Airway Scaffold
DeviceThe 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. Treatment group subjects will also receive optimal medical management (OMM).
Optimal Medical Management (OMM)
Other interventionSubjects 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 groups
Trial outcomes
Primary outcomes
Forced Expiratory Volume in 1 second (FEV1) Responder
Defined as a subject who experiences a reduction from baseline in post-bronchodilator FEV1 of ≥12%
Secondary outcomes
Residual Volume (RV) + St George's Respiratory Questionnaire for COPD (SGRQ-C)
Responder rate
St. George's Respiratory Questionnaire for COPD (SGRQ-C) Responder Rate
SGRQ-C total score
Modified Medical Research Council (mMRC) Responder Rate
mMRC dyspnea score
COPD Assessment Test (CAT) Responder Rate
CAT Score
Sponsors and contacts
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