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

Conditions

• COPD
• Emphysema

Eligibility Criteria

Sex

ALL

Age

40 Years - 84 Years

Healthy Volunteers

Not accepted

Interventions

• 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. Treatment group subjects will also receive optimal medical management (OMM).
• 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. 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.

Study Details

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?

Key Dates

Start date

Jul 15, 2025

Status verified

Jan 2026

Primary completion

Sep 30, 2027

Completion

Dec 31, 2029

Study Design

Enrollment

250 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Apreo implants + Optimal Medical Management
  Treatment group participants will receive optimal medical management and will undergo a single bronchoscopy with bilateral placement of up to 3 implants per lung in appropriately selected targeted airways.
• Other: Optimal Medical Management
  Control group participants 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.

Primary Outcome Measure

Forced Expiratory Volume in 1 second (FEV1) Responder [ Time Frame: Month 12 ]

Central Contacts

• Cindy Holtz
  650-326-2656
  [email protected]
• Nina Mohmood
  [email protected]

Locations (18)

Find similar trials in Birmingham, AL

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