Apreo BREATHE for Emphysema

(BREATHE-3 Trial)

Overseen By Nina Mohmood

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Apreo Health, Inc.

Must not be taking: Steroids, Anticoagulants

Disqualifiers: Respiratory infections, Lung surgery, Hypertension, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

250 Participants Needed

Trial Summary

What is the purpose of 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?

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that participants should have been on optimal medical management for at least 2 months before joining the study, which suggests you may need to continue your current treatment.

How is the Apreo BREATHE Airway Scaffold treatment different from other emphysema treatments?

The Apreo BREATHE Airway Scaffold is unique because it involves creating new passageways in the lungs to help trapped air escape, which is different from other treatments like surgery or valves that focus on reducing lung volume. This approach aims to improve breathing by directly addressing airway collapse. ^{1 2 3 4 5}

Research Team

Gerard Criner, MD

Principal Investigator

Temple University

Eligibility Criteria

This trial is for adults with COPD and emphysema who still feel short of breath despite being on the best medical treatments. Up to 250 participants will be recruited from various centers in the US and Europe. People with certain health conditions that could interfere with the study or pose a risk may not qualify.

Inclusion Criteria

Subject has body mass index (BMI) of between 18 and 32, inclusive.

I can walk 100 meters or more in 6 minutes.

My CT scan shows at least 25% lung damage due to emphysema.

Exclusion Criteria

I have severe lung damage that affects my COPD symptoms.

Subject has arterial or capillary blood on room air: PaCO2 > 50 mmHg or PaO2 ≤ 45 mmHg.

I have an ongoing lung infection that hasn't healed.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Roll-In

Each site enrolls up to 2 subjects in this phase to prepare for the randomized phase

Not specified

Randomized Treatment

Subjects are randomized to Treatment or Control group; Treatment group receives Apreo Implant placements

12 months

Visits at Months 1, 3, 6, and 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Visits at Years 2 and 3

Crossover (Control Group)

Control group subjects may opt to receive the BREATHE treatment after Month 12

15 months from baseline

Additional follow-ups at 7- and 30-days post procedure, and 6 months post procedure

Treatment Details

Interventions

• Apreo BREATHE Airway Scaffold

Trial Overview The trial is testing the Apreo BREATHE Airway Scaffold, a permanent implant designed to prop open airways and release trapped air, against Optimal Medical Management (OMM) alone. The goal is to see if it's safe and effective over three years.

Participant Groups

Group I: Optimal Medical Management Experimental Treatment 1 Intervention

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.

Group II: Apreo implants + Optimal Medical Management Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Apreo Health, Inc.

Lead Sponsor

Trials

3

Recruited

330+

References

1. England pubmed.ncbi.nlm.nih.gov

Design of the exhale airway stents for emphysema (EASE) trial: an endoscopic procedure for reducing hyperinflation. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of lung volume reduction surgery on gas exchange and breathing pattern during maximum exercise. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of lung volume reduction surgery on sleep quality and nocturnal gas exchange in patients with severe emphysema. [2014]

4. United States pubmed.ncbi.nlm.nih.gov

Predictors of Response to Endobronchial Coil Therapy in Patients With Advanced Emphysema. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

A randomized study of endobronchial valves for advanced emphysema. [2022]