RecruitingNAINTERVENTIONAL

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

This study aims to find out if a new device, called Apreo BREATHE, is safe and effective for people with severe emphysema, a lung condition often caused by COPD. Emphysema causes air to get trapped in the lungs, making it hard to breathe. The Apreo BREATHE device is a small, permanent implant that gently holds airways open to help trapped air escape. The study will involve up to 250 adults aged 40-84 in the UK, USA, and Europe. Some participants will receive the Apreo BREATHE device plus their usual medical care, while others will only receive usual medical care. Researchers will follow participants for three years to see if the device helps improve breathing and quality of life.

At a glance

Status

Recruiting

Phase

Sponsor

Apreo Health, Inc.

Enrolment target

250

Start

15 Jul 2025

Estimated completion

31 Dec 2029

COPD Emphysema

What is this study about?

Imagine your lungs are like a sponge, but with emphysema, some parts become overinflated, like balloons that can't let air out. This 'trapped air' makes your lungs much larger than they should be, pushing down on your diaphragm (the muscle that helps you breathe) and making every breath difficult. This study is investigating a new way to help with this problem.

The new treatment involves a small, permanent device called the Apreo BREATHE Airway Scaffold. It's designed to be carefully placed in your airways to keep them slightly open. The idea is that by holding these airways open, the trapped air can escape, helping your lungs shrink back to a more normal size and making it easier for you to breathe.

Researchers want to see if this treatment, when combined with your regular medical care, is safer and more effective than just having regular medical care alone. They will compare how people feel and how their lungs work with and without the Apreo BREATHE device. The study will involve a number of people to get a good idea of how well it works and if there are any risks.

Key takeaways

This study evaluates a new internal device called Apreo BREATHE for severe emphysema.
It aims to help trapped air escape from the lungs to improve breathing.
Participants will receive either the device plus usual care, or usual care alone.
The study involves check-ups over three years to assess safety and effectiveness.
It targets adults aged 40-84 with specific types of severe emphysema.
The control group can choose to have the treatment after 12 months.

Who may be eligible?

To join this study, you would generally need to be between 40 and 84 years old and have been diagnosed with COPD and emphysema. You should also have symptoms like breathlessness, even though you're already receiving good medical care for your lung condition.

Doctors will check your medical history, including your body weight, and conduct special lung tests and scans to make sure your emphysema is the right type for this treatment. It's important that you haven't smoked recently and agree to stop smoking during the study.

You also need to be able to have a minor procedure called a bronchoscopy under general anaesthetic and be able to attend regular follow-up appointments for three years.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 40 and 84 years old?
Have you been diagnosed with COPD and emphysema?
Do you get breathless despite receiving good medical care for your lungs?
Have you participated in a lung rehabilitation programme in the last year?
Have you stopped smoking (including vapes) in the last 4 months and agree to stay smoke-free?
Are you able to have a minor procedure and attend regular appointments for three years?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be one of up to 250 people taking part over three years. Initially, some people will join a 'Roll-In' phase, while most will be randomly put into one of two groups: a treatment group or a control group. Neither you nor your doctor will get to choose which group you're in, as this helps ensure fair results.

If you're in the treatment group, you'll receive the Apreo BREATHE implants during a single bronchoscopy procedure, where a thin, flexible tube is passed into your airways while you're asleep. Up to three small implants will be placed in each lung. Both groups will continue to receive the best possible medical care for their COPD, including any necessary medications, vaccines, and support for exercise or rehabilitation programs. Those in the control group will have the option to receive the Apreo BREATHE treatment after 12 months if they wish.

Throughout the study, you'll have check-ups at 1, 3, 6, and 12 months after your procedure or randomisation, and then again after 2 and 3 years. These visits will involve checks for any side effects and questionnaires about how you're feeling.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might benefit from closer monitoring of your condition and potentially receive a new treatment that could improve your breathing. However, receiving the Apreo BREATHE device involves a medical procedure (bronchoscopy) which carries some risks, like any medical procedure. There might also be unknown side effects from the device itself. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (22)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of Alabama at Birmingham
Verified postcode
Birmingham, United States· Recruiting
Banner Health
Verified postcode
Gilbert, United States· Recruiting
University of California at Davis
Verified postcode
Sacramento, United States· Recruiting
Mayo Clinic
Verified postcode
Jacksonville, United States· Recruiting
Orlando Health
Verified postcode
Orlando, United States· Recruiting
University of Chicago
Verified postcode
Chicago, United States· Recruiting
OSF St Francis Medical Center
Verified postcode
Peoria, United States· Recruiting
University of Kansas Medical Center Research Institute
Verified postcode
Kansas City, United States· Recruiting
Beth Israel Deaconess Medical Center
Verified postcode
Boston, United States· Recruiting
University of Michigan
Verified postcode
Ann Arbor, United States· Recruiting
Cleveland Clinic Foundation
Verified postcode
Cleveland, United States· Recruiting
The Ohio State University
Verified postcode
Columbus, United States· Recruiting

Common questions

What is COPD?

COPD stands for Chronic Obstructive Pulmonary Disease, a common lung condition that causes breathing difficulties. Emphysema is a type of COPD that damages the air sacs in your lungs, making it hard to get enough air out.

What does 'optimal medical management' mean?

This means you'll receive the best usual care for your COPD, tailored to your needs. This can include medicines, advice on quitting smoking, vaccinations, and help with exercise or lung rehabilitation programs.

What is a bronchoscopy?

A bronchoscopy is a procedure where a doctor uses a thin, flexible tube with a camera to look inside your airways. For this study, it would be used to place the Apreo BREATHE devices while you are asleep under general anaesthesia.

Why is there a control group?

Having a control group, who receive standard care, helps researchers fairly compare the new treatment against what's already available. This way, they can be more certain if any improvements are due to the new device.

Can I still receive the new treatment if I'm in the control group?

Yes, if you are in the control group, you will be offered the chance to receive the Apreo BREATHE treatment after 12 months if you wish.

How to find out more

Cindy Holtz

cindy.holtz@apreohealth.com 650-326-2656 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.