STARDUST: testing a faster, simpler way to diagnose asthma and COPD

A research study run by Liverpool Heart and Chest Hospital

What is STARDUST?

STARDUST (A Diagnostic Accuracy Study: N-Tidal Assessment for Respiratory Diagnosis compared to Using Standard Testing) is testing whether a new handheld breathing device, the N-Tidal Handset, can help doctors diagnose asthma and chronic obstructive pulmonary disease (COPD) more quickly and accurately than current methods.

Instead of the forced breathing manoeuvres used in standard spirometry, patients breathe normally into the device for 75 seconds. The device measures how carbon dioxide levels change in the breath, and this pattern is analysed to see whether it can help identify asthma or COPD.

Why does this matter?

Asthma and COPD affect millions of people in the UK, yet both are commonly under-diagnosed. An estimated 600,000 people in the UK are living with undiagnosed COPD, and a similar gap exists for asthma. Diagnosis currently relies on spirometry, which can be difficult for some patients to perform, takes time, and isn't always available where it's needed most, particularly in community settings.

STARDUST is evaluating whether N-Tidal technology could offer a quicker, easier alternative that could one day be used more widely, including outside hospital settings.

Who can take part?

We're inviting adults (18 and over) who have already been referred for routine lung function testing in Liverpool or Knowsley because of a suspected diagnosis of asthma or COPD. We're aiming to recruit up to 1,200 people from across the Liverpool and Knowsley area.

What would taking part involve?

• A member of the research team will call to explain the study and answer any questions before your appointment.
• If you agree to take part, you'll be asked to give consent (electronically, or on paper if preferred).
• At your usual lung function test appointment, you'll also be asked to breathe normally into the N-Tidal Handset, twice, for 75 seconds each time.
• You'll be asked a few brief questions about your breathing and how you found the new test.

Your standard care and the results of your usual tests are not affected in any way. The N-Tidal results are used for research only and do not change your diagnosis or treatment.

Is it safe?

Yes. The N-Tidal Handset only involves normal, relaxed breathing and has already been used safely in more than 70,000 tests across other studies, with no safety concerns identified.

How is my information protected?

Your data is held securely by Liverpool Heart and Chest Hospital NHS Foundation Trust in line with NHS data governance and UK GDPR. Only coded, non-identifiable information is shared with our research partner, TidalSense; your name, NHS number and contact details are never shared outside the Trust.

Who is running the study?

STARDUST is sponsored by Liverpool Heart and Chest Hospital NHS Foundation Trust, in collaboration with the University of Liverpool, and led by Chief Investigator Dr Freddy Frost, Consultant Respiratory Physician.

The study is funded by TidalSense, a UK respiratory technology company.

Want to know more, or have questions?

Contact the STARDUST research team at  Research.LHCH@lhch.nhs.uk

You can find out more about how we use your information at lhch.nhs.uk/research-data.