Not yet recruitingNAINTERVENTIONAL

Effects of Vibrating Mesh Nebulisation in Patients With COPD During Non-invasive Ventilation (VMN-NIV)

This study looks at two different ways of giving medicines through a nebuliser to people with Chronic Obstructive Pulmonary Disease (COPD) who use a special breathing machine (non-invasive ventilation, or NIV) at home. One way is the common 'jet nebuliser', and the other is a newer 'vibrating mesh nebuliser'. We want to understand how each method affects breathing — things like the effort your body uses to breathe, how easy or hard it is for air to move in and out of your lungs, your heart rate, and any changes in your spirometry tests (which measure how much air you can breathe out). We also want to know if one method makes you feel less breathless. The aim is to find out if the newer method offers better treatment for people with COPD using NIV.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Enrolment target

Start

21 Mar 2025

Estimated completion

01 May 2026

COPD (Chronic Obstructive Pulmonary Disease)Non-invasive Ventilation

What is this study about?

COPD is a common lung condition in the UK that makes it hard to breathe. Sometimes, people with COPD have flare-ups (called exacerbations), which can make their breathing much worse and may mean they need to go to hospital. When this happens, or even if they're managing at home, doctors often prescribe medicines given through a nebuliser. These medicines help open up the airways and make breathing easier.

Some people with COPD use a special breathing machine at home called Non-Invasive Ventilation (NIV). This machine helps support their breathing. If you use NIV, you might still need to use your nebuliser medicines while the machine is on. There are two main types of nebulisers used with these breathing machines: a traditional 'jet nebuliser' and a newer 'vibrating mesh nebuliser'. The vibrating mesh nebuliser is designed to deliver medicine more effectively, hopefully meaning more medicine reaches your lungs where it's needed.

This study wants to compare these two nebuliser types to see if one works better for people with COPD who use NIV. We'll be looking at various things like how your breathing muscles work, how easily air moves in and out of your lungs, your heart rate, and how breathless you feel. The goal is to figure out if the newer vibrating mesh nebuliser can improve your breathing and overall comfort more than the traditional method.

Key takeaways

Compares two nebuliser types (jet vs. vibrating mesh) for COPD patients using home breathing machines (NIV).
Aims to find out if one method delivers medicine better and improves breathing more effectively.
Looks at breathing effort, lung function, heart rate, and breathlessness.
Participation involves a single study visit.
Could help improve future treatments for people with COPD.
You must already use a home breathing machine (NIV) and be stable before joining.

Who may be eligible?

This study is looking for people with COPD who are already using a breathing machine at home, called non-invasive ventilation (NIV), for at least four hours a day. You must be between 18 and 80 years old, able to communicate how you're feeling to the study team, and happy to give your permission to take part.

It’s important that your health has been stable before you can join; this means you shouldn't have had any COPD flare-ups for at least two weeks prior to starting the study. You also shouldn't have other serious health problems that aren't related to your breathing, such as severe heart failure, end-stage kidney failure, or serious cancer.

You also can't take part if you have other serious lung problems that need urgent treatment, like pneumonia or a collapsed lung, or if you have severe memory problems or other social or personal reasons that would make it difficult to complete 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.

Do I have COPD and use a home breathing machine (NIV)?
Am I between 18 and 80 years old?
Have I been stable (no COPD flare-ups) for at least 2 weeks?
Can I understand and give permission to take part?
Do I have any other severe health conditions that might prevent me from joining?
Would I be able to attend a study visit?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would visit the study centre. During your visit, researchers will measure your breathing using special equipment to see how your lungs and breathing muscles are working. You will receive your nebuliser medicine twice during the visit, once using the traditional jet nebuliser and once using the newer vibrating mesh nebuliser. The order in which you receive these will be decided randomly, like flipping a coin. Doctors and nurses will monitor you carefully throughout. These visits are usually designed to be completed within a single day. There are no additional medications specifically for the study. The total duration of your participation would involve the single study visit.

Potential risks and benefits

Participating in this study might help us understand how to improve nebuliser treatments for people with COPD who use breathing machines, which could benefit others in the future. You will also have careful monitoring of your breathing during the study. Possible risks are likely minimal, as you will be receiving medication you already use. There's a small chance of feeling side effects from the nebulised medicine, but these will be closely monitored. Remember, taking part is completely voluntary, and you can withdraw from the study at any time without it affecting your medical care.

Locations (1)

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

Lane Fox Unit, St Thomas' Hospital, Guy's and St Thomas' NHS Foundation Trust
Verified postcode
London, United Kingdom

Common questions

What is COPD?

COPD stands for Chronic Obstructive Pulmonary Disease. It's a common lung condition that makes it hard to breathe, often caused by long-term exposure to harmful gases or particles, like cigarette smoke.

What is a nebuliser?

A nebuliser is a device that turns liquid medicine into a fine mist, which you can breathe in through a mask or mouthpiece to deliver the medicine directly to your lungs.

What is Non-Invasive Ventilation (NIV)?

NIV is a type of breathing support that uses a mask worn over your nose or mouth to help you breathe more easily, without needing a tube placed directly into your windpipe.

What's the difference between the two nebulisers being tested?

One is a traditional 'jet nebuliser' which uses air to create the mist. The other is a newer 'vibrating mesh nebuliser' which uses vibrations to create a fine mist, often thought to deliver medicine more efficiently.

Will I get to choose which nebuliser I use if I join?

No, the type of nebuliser you would use at different points in the study will be chosen randomly, so neither you nor the researchers know beforehand, making the comparison fair.

How to find out more

Eui-Sik Suh, MBBS MChem(Oxon) PhD FRCP

euisik.suh@gstt.nhs.uk +44 207 188 7727 Official trial record

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