myAirvo 3 (High Flow Nasal Therapy; HFNT) for COPD Patients in the Home
This research study is investigating whether using a device called myAirvo 3, which delivers `high-flow` warmed and humidified air through your nose, can help people with severe Chronic Obstructive Pulmonary Disease (COPD). The study will compare patients who use the myAirvo 3 at home alongside their usual COPD care, against those who only receive their usual care. We want to find out if using the myAirvo 3 can reduce the number of COPD flare-ups (exacerbations), especially serious ones that might need a hospital stay. We also aim to see if it improves your quality of life, reduces breathlessness, and is generally safe and well-tolerated over one to two years.
At a glance
What is this study about?
This study is about helping people with a serious lung condition called Chronic Obstructive Pulmonary Disease, or COPD. If you have COPD, you know that `flare-ups` (also called exacerbations) can be very serious, often leading to hospital visits and making it harder to breathe. This particular study is focusing on people who have already had a severe flare-up that needed hospital treatment recently.
The main idea is to see if a special breathing device, called the myAirvo 3, can make a difference. This device delivers `high-flow therapy` through your nose. Think of it as a gentle, continuous stream of air that's carefully warmed and moisturized. The study wants to find out if using this device at home, in addition to your usual COPD medicines and care, can help prevent these difficult flare-ups from happening as often or being as severe. We’re also keen to understand if it can improve how you feel day-to-day and make breathing easier.
Over one to two years, we'll be carefully comparing people who use the myAirvo 3 with those who continue with their usual care. We'll be looking at things like how often flare-ups occur, how long hospital stays are, and how your quality of life changes. We also want to make sure the device is safe and comfortable to use. By doing this research, we hope to find new ways to better manage COPD and improve the lives of those affected by it.
Key takeaways
- This study investigates a new breathing device (myAirvo 3) for severe COPD.
- It aims to reduce COPD flare-ups and hospital stays for patients recently discharged from hospital.
- Participants will either use the device alongside usual care or continue just with usual care.
- The study lasts for 1-2 years, with daily device use (if applicable) and symptom tracking.
- It's for people aged 30+ with moderate to very severe COPD who recently had a severe flare-up.
- Your regular COPD treatment continues throughout the study.
Who may be eligible?
To join this study, you need to be at least 30 years old and have been diagnosed with moderate to very severe COPD. A key requirement is that you must have recently (within the last six weeks) had a severe COPD flare-up that required you to be admitted to the hospital, and your condition should now be stable after that hospital stay.
We need people who are willing to commit to using the myAirvo 3 device for at least 8 hours every day, ideally overnight, and to record some daily information about your symptoms and oxygen levels. You should also be comfortable giving your permission to take part and follow all study instructions for the whole time. Don't worry if you currently smoke, but if you do, you'll need to agree not to smoke while using the device or supplemental oxygen.
If you're a woman who could become pregnant, you'll need to be using effective contraception for at least a month before joining and throughout the study. Your medical team will do some breathing tests and check your overall health to make sure this study is right for you.
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 30 years old or older?
- Do you have a diagnosis of moderate to very severe COPD?
- Did you have a severe COPD flare-up needing hospitalisation within the last six weeks?
- Is your condition currently stable after that hospital stay?
- Are you willing to use a breathing device for at least 8 hours a day, if assigned to that group?
- Are you willing to record daily information about your symptoms and oxygen levels?
What does participation involve?
If you decide to take part, you'll be randomly put into one of two groups: either you'll use the myAirvo 3 device at home along with your usual COPD care, or you'll continue with your usual COPD care only. You won't get to choose which group you're in. The study will last for at least one year and could be up to two years.
Throughout this time, you'll have regular check-ups where your breathing will be assessed, and you'll complete questionnaires about your quality of life and breathlessness. You'll also use a small device called a `pulse oximeter` to record your daily oxygen levels and heart rate, and keep a diary of your symptoms. If you're in the group using the myAirvo 3, you'll receive full training on how to use it safely and effectively for at least 8 hours each day. All your usual COPD medications and care from your own doctor will continue as normal.
Potential risks and benefits
Locations (27)
- UAB School of Medicine/Lung Health CenterVerified postcodeBirmingham, United States· Recruiting
- Honor HealthVerified postcodeScottsdale, United States· Recruiting
- University of Florida, JacksonvilleVerified postcodeJacksonville, United States· Recruiting
- Alloy Clinical ResearchVerified postcodeKissimmee, United States· Recruiting
- Reliable Research, Inc.Verified postcodeMiami, United States· Recruiting
- NewGen Health GroupVerified postcodeMiami, United States· Recruiting
- Destiny ResearchVerified postcodePalmetto Bay, United States· Recruiting
- University of ChicagoVerified postcodeChicago, United States· Recruiting
- The Iowa ClinicVerified postcodeWest Des Moines, United States· Recruiting
- University of Maryland - BaltimoreVerified postcodeBaltimore, United States· Recruiting
- Tufts Medical CenterVerified postcodeBoston, United States· Recruiting
- Lahey Hospital and Medical CenterVerified postcodeBurlington, United States· Recruiting
Common questions
What is `high-flow nasal therapy`?
It's a way of delivering warmed and moist air, sometimes with extra oxygen, through small tubes (cannulas) that fit just inside your nose. The `high-flow` part means it provides a steady, strong stream of `air`.
Will I still get my regular COPD medicines if I join?
Yes, absolutely. This study looks at adding the myAirvo 3 device to your existing COPD care, not replacing it. You will continue to receive all your usual medications and care from your doctor.
How long will I need to use the myAirvo 3 device each day?
If you are in the device group, you will be asked to use the myAirvo 3 for at least 8 hours every day, preferably during the night.
What if I feel worse during the study?
Your safety is a top priority. You will have regular checks, and your study team will monitor your progress. You can also withdraw from the study at any time if you feel it's not right for you. Always contact your usual doctor if you have concerns about your health.
What does a `moderate exacerbation` or `severe exacerbation` mean?
A `COPD exacerbation` is a flare-up of your symptoms, like increased breathlessness or cough. A `moderate` one might need changes to your medicines, while a `severe` one usually requires hospital treatment.
How to find out more
Gerard Criner, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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