Not yet recruitingOBSERVATIONAL

A Study to Understand the Accuracy of a New Breathing Device Compared to Standard Testing for Asthma and COPD

The STARDUST study is looking into a new, simpler way to diagnose asthma and COPD. Currently, diagnosing these conditions can be difficult, uncomfortable, and take a long time, often requiring special equipment and experts. This study aims to find out if a new handheld device, called the N-Tidal Handset, can offer quicker, more accurate, and easier diagnoses. You just breathe normally into it for about 75 seconds. The device measures carbon dioxide in your breath. Researchers will then use artificial intelligence (AI) to see if this information can accurately identify asthma or COPD. If successful, this new method could help doctors in local clinics diagnose these conditions more easily, making testing more widely available and improving care.

At a glance

Status

Not yet recruiting

Sponsor

Liverpool Heart and Chest Hospital NHS Foundation Trust

Enrolment target

1,200

Start

01 Apr 2026

Estimated completion

19 May 2027

Asthma (Diagnosis)COPD (Chronic Obstructive Pulmonary Disease)

What is this study about?

When doctors try to figure out if someone has asthma or a lung condition called COPD (Chronic Obstructive Pulmonary Disease), it can sometimes be a bit of a process. They look at your symptoms and use different lung tests. One common test is called spirometry, where you have to breathe in and out very forcefully. This can be tricky and uncomfortable for some people, and it needs a trained expert to do it properly.

Because of these challenges, it can take a long time to get a diagnosis, and not everyone who needs testing can easily get it, especially in local doctor's surgeries. This study, called STARDUST, wants to change that. They are exploring new ways to diagnose asthma and COPD that are quick, accurate, and easy for both patients and healthcare staff to use.

The main idea is to use a small handheld device called the N-Tidal Handset. If you join the study, you'll simply breathe normally into this device for about 75 seconds. It measures how the carbon dioxide (CO2) in your breath changes. Researchers will then use clever computer programs, which use a type of artificial intelligence, to see if they can accurately figure out if someone has asthma or COPD just by looking at this breath data. If this new method works well, it could mean faster and more convenient diagnoses for many people in the future, right in their local GP clinic.

Key takeaways

Testing a new, easy-to-use breathing device for asthma and COPD.
Hopes to make diagnosis quicker and simpler than current methods.
You breathe normally into a small device for just 75 seconds.
Uses artificial intelligence to analyse your breath patterns.
Aims to improve access to accurate diagnosis in local clinics.
Your current diagnosis or treatment will not be changed by this study.

Who may be eligible?

To take part in this study, you need to be at least 18 years old. You must also have been sent to a clinic for lung tests because your doctor suspects you might have asthma or COPD. It's important that you understand what the study involves and are willing to give your permission to participate.

However, some people won't be able to join. If you've been sent for lung tests for a reason other than suspected asthma or COPD, you won't be eligible. Also, if the study team thinks you might struggle to follow the study's instructions, or if you can't give written permission, you won't be able to participate. If you're currently very unwell or can't breathe through your mouth (for example, if you have a tracheostomy), this study won't be suitable for you.

Quick self-check

Are you 18 years old or older?
Has your doctor referred you for lung tests because they suspect you have asthma or COPD?
Can you breathe through your mouth comfortably?
Are you generally feeling well enough to participate?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will simply breathe normally into a andheld device called the N-Tidal Handset for about 75 seconds. This will happen during a visit where you are already having routine lung tests. The information from this new device will not affect your current diagnosis or treatment. There are no extra hospital or clinic visits beyond your planned routine appointments. The total duration of your active participation will just be the short time you spend breathing into the device during your usual appointment.

Potential risks and benefits

This study aims to develop better ways to diagnose asthma and COPD in the future, which could lead to quicker and easier testing for others. For you, there are no direct health benefits, as the results from the new device won't change your current diagnosis or treatment during the study. Potential risks are very low, as you'll just be breathing normally into a device, similar to existing breathing tests. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, United Kingdom

Common questions

What is COPD?

COPD stands for Chronic Obstructive Pulmonary Disease. It's a long-term lung condition that makes it hard to breathe, often caused by smoking or exposure to harmful fumes.

Will this study change my asthma or COPD diagnosis?

No, the information gathered from the new device in this study will not be used to change your diagnosis while you are participating. It's purely for research purposes to develop a new test.

How long does the breathing test take?

You'll only need to breathe into the new handheld device for about 75 seconds during your routine lung test appointment.

Do I need to visit the clinic more often for this study?

No, your participation in the study will happen during an existing routine lung test appointment that you already have scheduled.

What does 'artificial intelligence' mean in this study?

Artificial intelligence (AI) here means clever computer programs that will learn from your breath patterns to see if they can accurately identify asthma or COPD. It's like teaching a computer to recognise different patterns.

How to find out more

Hassan Burhan, MBChB FRCP

Hassan.Burhan@liverpoolft.nhs.uk 0151 254 3036 Official trial record

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