CompletedNot SpecifiedObservational

Evaluation of N-Tidal in primary care COPD diagnosis

The CORMORANT study is checking if a new device, N-Tidal, can improve how doctors diagnose Chronic Obstructive Pulmonary Disease (COPD) in local clinics. Many people have COPD but don't know it, and the current test (spirometry) can be hard to access. N-Tidal is an easy-to-use device where you breathe normally for just over a minute. It measures gases in your breath to spot signs of COPD. The study wants to see how well N-Tidal works compared to the usual test, if it's cost-effective for the NHS, and if healthcare staff find it easy to use. This research could mean people get diagnosed and treated for COPD sooner.

At a glance

Status

Completed

Phase

Not Specified

Sponsor

University of Oxford

Enrolment target

500

Start

01 Jun 2025

Estimated completion

01 Mar 2026

Chronic Obstructive Pulmonary Disease

What is this study about?

COPD, or Chronic Obstructive Pulmonary Disease, is a common lung condition that makes it hard to breathe. Many people in the UK have COPD but haven't been diagnosed yet. Early diagnosis is really important because it means you can start treatments sooner to ease your symptoms and stop the condition from getting worse. Currently, the main test for COPD is called spirometry, but it can take time, needs special training to carry out, and isn't always easily available in all parts of the UK, leading to long waits.

This study, called CORMORANT, is looking at a new, simple device called N-Tidal Diagnose. To use it, you just breathe in and out normally into a small handset for about 75 seconds. The device measures a gas called carbon dioxide (CO2) that everyone breathes out. A computer program then looks at how the CO2 levels change over time to see if there are patterns that suggest someone has COPD. The N-Tidal device has a special safety mark (CE mark), meaning it meets European medical device standards.

The main goal of the CORMORANT study is to see how accurate and useful N-Tidal Diagnose is in GP practices, which is where it would most often be used. The research team will compare its results with the standard spirometry test in people who might have COPD. They will also talk to healthcare staff to understand how they currently diagnose COPD and how much it costs, looking at if N-Tidal could save money for the NHS. Finally, they will gather feedback from patients and staff about how easy the N-Tidal device is to use and understand, making sure any difficulties are found and fixed.

Key takeaways

A new device, N-Tidal, is being tested for diagnosing lung condition, COPD.
The study aims to make COPD diagnosis quicker and easier in GP practices.
Participants will do both the standard test (spirometry) and the new N-Tidal test.
Participation involves breathing into a device for 75 seconds and answering some questions.
This research could help improve care for future patients with breathing problems.

Who may be eligible?

You might be able to join this study if you are 35 years old or older and your doctor has booked you for a spirometry test because they think your breathing problems could be caused by COPD.

However, you cannot take part if you have already been officially diagnosed with COPD (unless your doctor is just re-testing you), or if the study team thinks you won't be able to follow the study instructions. Also, if you are very unwell, unable to give your full permission to take part, or simply can't breathe through your mouth (for example, if you have a tracheostomy), then this study isn't suitable for you. If you've already taken part before, you can't join again.

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 35 years old or over?
Has your doctor booked you for a spirometry test because of breathing symptoms?
Does your doctor think COPD might be a possible cause of your symptoms?
Have you NOT been officially diagnosed with COPD before (unless it's a re-test)?
Are you able to agree to take part and follow simple instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, first you'll be asked to read and sign an electronic consent form – we'll email you a copy for your records. Next, you'll fill out a questionnaire about your breathing and overall health (this takes about 20 minutes). When you go for your usual spirometry test, you'll also do the extra N-Tidal test. For this, you simply breathe normally into the N-Tidal device for 75 seconds. We'll collect the results from both tests. After the tests, we'll ask you some questions about your experience with both N-Tidal and spirometry. Lastly, we'll look at your medical notes shortly after you join and also find out what your final diagnosis is from your doctor after your spirometry results are reviewed. The total time for the N-Tidal test itself is very short, and other parts are integrated into your existing appointment.

Potential risks and benefits

The main benefit of taking part is that you'll be helping important research that could improve how COPD is diagnosed for others in the future. We don't yet know if N-Tidal will improve diagnosis and care, which is why we’re doing this study. This study is considered very low risk. You'll simply breathe normally into the N-Tidal device, which has been used thousands of times in previous studies without any safety concerns. A new, clean mouthpiece is used for every participant, so there's no extra risk of infection. You are free to withdraw from the study at any time without giving a reason, and this won't affect your medical care.

Locations (12)

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

East Midlands RRDN
City only
Leicester, United Kingdom
East of England RRDN
City only
Norwich, United Kingdom
North East and North Cumbria RRDN
City only
Newcastle upon Tyne, United Kingdom
North London RRDN
City only
London, United Kingdom
North West RRDN
City only
Manchester, United Kingdom
South Central RRDN
City only
Southampton, United Kingdom
South East RRDN
City only
Guildford, United Kingdom
South London RRDN
City only
London, United Kingdom
South West Central RRDN
City only
Bristol, United Kingdom
South West Peninsula RRDN
City only
Exeter, United Kingdom
West Midlands RRDN
Unverified
Wolverhampton, United Kingdom
Yorkshire and Humber RRDN
Unverified
Leeds, United Kingdom

Common questions

What is COPD?

COPD stands for Chronic Obstructive Pulmonary Disease, a common lung condition that makes it harder to breathe. Early diagnosis helps with quicker treatment.

What is spirometry?

Spirometry is the standard breathing test doctors use to help diagnose lung conditions like COPD, but it can be hard to access for some people.

How does the N-Tidal device work?

You breathe normally into a small device for about 75 seconds. It measures gases in your breath, and a computer checks these measurements for signs of COPD.

Will I get treatment for COPD if I join?

The study aims to improve diagnosis. Any treatment decisions will still be made by your doctor based on your diagnosis.

Who is paying for this study?

The study is funded by the National Institute for Health and Care Research (NIHR) in the UK.

How to find out more

Charlotte Latimer-Bell

Charlotte.latimer-bell@phc.ox.ac.uk - Official trial record

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