Apreo BREATHE for Emphysema

(BREATHE-3 Trial)

Recruiting at 12 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new treatment for people with emphysema, a type of COPD (chronic obstructive pulmonary disease) that makes breathing difficult. It tests tiny implants called the Apreo BREATHE Airway Scaffold, placed in the airways to release trapped air and ease breathing. The main goal is to determine if these implants are safe and effective. People with emphysema who experience frequent shortness of breath and have not found success with other treatments might be good candidates. Participants must have stopped smoking for at least four months and completed a pulmonary rehab program within the last year. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for emphysema.

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.

What prior data suggests that the Apreo BREATHE Airway Scaffold is safe for treating emphysema?

Research has shown that the Apreo BREATHE Airway Scaffold demonstrates promising safety results from earlier studies. One study examined serious side effects related to the procedure or device over six months. The findings were positive, indicating that most participants tolerated the treatment well during this period.

Another study found that earlier trials, BREATHE 1 and 2, achieved a 92.4% success rate in technical performance. This indicates that the device was placed correctly in nearly all cases, without causing major problems for the patients.

While this information provides a hopeful view of the treatment's safety, it is important to remember that every medical procedure carries some risk. However, the data so far suggests that the Apreo BREATHE Airway Scaffold is a safe option for individuals with emphysema seeking new treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Apreo BREATHE for emphysema because it introduces a new approach by using airway scaffolds. Unlike current treatments like bronchodilators or corticosteroids that focus on managing symptoms and inflammation, Apreo BREATHE involves placing tiny implants in the airways through a bronchoscopy. This innovative method aims to physically support and open up the airways, potentially improving lung function and breathing capacity more directly and effectively. This could represent a significant advancement in how emphysema is managed, offering hope for better quality of life for patients.

What evidence suggests that the Apreo BREATHE Airway Scaffold is effective for emphysema?

Research has shown that the Apreo BREATHE Airway Scaffold, which participants in this trial may receive, could help treat breathing problems caused by emphysema. Early studies have found that this treatment can support the airways and help release trapped air in the lungs. In one study, the procedure succeeded 92.4% of the time, indicating it usually works as planned. These results suggest that the scaffold might make breathing easier for people with emphysema by allowing more air to leave the lungs. While more research is needed, this treatment could offer relief for those whose symptoms aren't fully managed with current medical options. ^{1 2 3 6 7}

Who Is on the Research Team?

Gerard Criner, MD

Principal Investigator

Temple University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12264656/

Airway Scaffolds for Emphysema-related Hyperinflation This study provides the first clinical evidence of the feasibility, safety, and initial outcomes after treatment with airway scaffolds in patients with ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06891755

Study Details | NCT06891755 | Bronchoscopic RElease of ... 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 ...

3. biospace.com biospace.com/press-releases/apreo-health-presents-clinical-data-at-ers-2025-summarizing-patient-applicability-of-apreo-breathe-airway-scaffold

Apreo Health Presents Clinical Data at ERS 2025 ... The data are based on outcomes from Apreo's BREATHE 1&2 First In Human studies, which demonstrated 92.4% technical success and no post- ...

4. physicianresources.templehealth.org physicianresources.templehealth.org/news/temple-lung-center-performs-first-u-s-breathe-3-procedure-for-severe-emphysema

Temple Lung Center Performs First U.S. BREATHE-3 ... The Phase-3 trial of Apreo Health's bronchoscopic airway scaffold for severe emphysema and hyperinflation is now enrolling at the Temple Lung ...

5. businesswire.com businesswire.com/news/home/20250513460438/en/Apreo-Health-to-Present-First-in-Human-Data-for-Novel-Airway-Scaffold-in-Late-Breaking-Abstract-at-ATS-2025

Apreo Health to Present First-in-Human Data for Novel ... Apreo is developing the BREATHE Airway Scaffold, a first-of-its-kind implant designed to relieve pressure in overinflated lungs without removing or sacrificing ...

6. medicine.temple.edu medicine.temple.edu/news/2025/08/temple-university-hospital-treats-first-us-patient-breathe-3-clinical-trial

Temple University Hospital Treats First U.S. Patient in ... The primary measure of success will be an improvement in lung function (FEV1) of at least 12% after one year. This milestone builds on Temple's ...

7. medicaldevice-developments.com medicaldevice-developments.com/news/apreo-health-begins-clinical-trial-of-its-breathe-airway-scaffold/

Apreo Health begins clinical trial of its BREATHE Airway ... The trial builds on promising results from earlier feasibility studies, BREATHE 1 and 2, which showed a 92.4% technical success rate without ...