RecruitingNAINTERVENTIONAL

Home High Flow Oxygen to Reduce Acute Exacerbation of COPD

This research is investigating if a special type of oxygen therapy, called High Flow Oxygen, can help people with severe Chronic Obstructive Pulmonary Disease (COPD) stay healthier at home. Specifically, it wants to find out if using this high-flow oxygen after a serious COPD flare-up leads to fewer future flare-ups or reduces the risk of death, compared to the usual oxygen methods. The study focuses on people who have recently been in hospital due to a severe worsening of their COPD and already need, or now need, long-term oxygen support. By comparing these two types of oxygen therapy, researchers hope to find a better way to manage severe COPD and improve daily life for patients.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Rouen

Enrolment target

406

Start

26 Aug 2022

Estimated completion

26 Aug 2026

Chronic Obstructive Pulmonary Disease

What is this study about?

This research study is about finding better ways to help people in the UK who have severe Chronic Obstructive Pulmonary Disease (COPD). COPD is a common lung condition that makes it hard to breathe, and sometimes people have sudden worsenings of their symptoms, called flare-ups. These flare-ups can be very serious and often require a hospital stay. When someone has severe COPD, they might need extra oxygen to help them breathe more easily at home.

Currently, there are different ways to give oxygen therapy. This study is focusing on a type of oxygen machine called 'Home High Flow Oxygen'. It aims to see if using this specific kind of oxygen-delivery system at home, after a serious COPD flare-up that put someone in hospital, can prevent future severe flare-ups or reduce the risk of death. Researchers will compare how well High Flow Oxygen works against the standard oxygen therapy that people typically receive at home.

The goal of this study is to discover if Home High Flow Oxygen could be a more effective treatment option for suitable individuals with severe COPD. Finding better ways to manage COPD flare-ups is really important for improving quality of life and helping people stay out of hospital for longer.

Key takeaways

The study compares 'Home High Flow Oxygen' to standard oxygen for severe COPD.
It aims to reduce serious COPD flare-ups and hospital admissions.
Participants must have recently been hospitalised for a severe COPD flare-up.
All participants will continue to receive oxygen therapy, either high-flow or standard.
This research focuses on people who already need, or now need, long-term oxygen.
Your usual COPD medications will continue unchanged if you participate.

Who may be eligible?

To take part in this study, participants generally need to be adults between 18 and 85 years old who have been diagnosed with COPD according to specific medical guidelines. A key requirement is that you must have recently been admitted to the hospital because of a serious flare-up of your COPD. Also, you must already be receiving long-term oxygen therapy at home, or your oxygen levels must be very low after you've recovered from your recent hospital stay, indicating a need for long-term oxygen.

There are also some reasons why you might not be able to join the study. For example, if you are currently using a different type of breathing support machine at home for conditions like severe sleep apnoea or very high carbon dioxide levels, you would likely be excluded. People with a very high Body Mass Index (BMI over 35), or those admitted to hospital specifically for acute COVID-19, would also not be able to participate. If you are a woman who could become pregnant, you would need to use effective contraception throughout the study.

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 18 and 85 years old?
Do you have a confirmed diagnosis of COPD?
Have you recently been in hospital for a serious COPD flare-up?
Do you already use long-term oxygen therapy, or have you been told you now need it after your recent hospital stay?
Are you able to provide your informed consent to participate?
If you are a woman who could become pregnant, are you willing to use reliable contraception during the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be assigned to either receive Home High Flow Oxygen or continue with standard oxygen therapy at home. Your health would be carefully monitored by the research team over a period of time. This would likely involve regular check-ups, which might include clinic visits or possibly home visits, to see how you are responding to the treatment and to keep an eye on your COPD symptoms. You would have your oxygen use and breathing assessed. You would continue to take your usual COPD medications as prescribed. The exact number of visits, tests, and the total length of your participation would be fully explained by the study team, but it will involve ongoing assessments as the researchers track your progress. You would be fully supported by the study team throughout your involvement.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that High Flow Oxygen therapy might prove to be more effective at reducing severe COPD flare-ups than standard oxygen, which could improve your health and quality of life. However, it's also possible that High Flow Oxygen might not work better for you, or it could have side effects, just like any medical treatment or device. You might find the assessments and visits time-consuming. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care. The study team will discuss all potential risks and benefits with you in detail.

Locations (1)

UHRouen
Verified postcode
Rouen, France· Recruiting

Common questions

What is 'High Flow Oxygen'?

High Flow Oxygen is a special oxygen machine that delivers warm, moist oxygen at a higher flow rate than standard home oxygen systems, through tubes in your nose.

Why is this study important for people with COPD?

This study is important because it aims to find out if a different type of oxygen therapy could help people with severe COPD have fewer serious flare-ups, which could mean fewer hospital stays and a better quality of life.

Will I stop my usual COPD medications if I join?

No, you would continue to take all your regular COPD medications as prescribed by your doctor throughout the study. This study is about the oxygen therapy, not stopping other treatments.

What happens if I change my mind after joining?

You are free to leave the study at any time, for any reason. Your decision will not affect the medical care you receive.

Who is funding this research?

The information provided doesn't specify the funding source, but you can ask the research team for details on who is sponsoring or funding the study.

How to find out more

Antoine CUVELIER, Pr

antoine.cuvelier@chu-rouen.fr +33232889059 Official trial record

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