We are looking for people who have been referred for a spirometry test. Spirometry is a test to look at how well the lungs are functioning, particularly forced breathing. It is usually requested when people have symptoms of cough, breathlessness or frequent chest infections, to investigate the cause. One of the conditions that spirometry looks for is COPD (Chronic Obstructive Pulmonary Disease). However, there are also other causes of the symptoms above. You have been invited to take part in this study because you have been referred to have a spirometry test and COPD is one of the potential causes of your symptoms.

COPD is common, but many people do not know they have it. In the UK almost half of people affected have not been diagnosed. Spirometry is the current standard test used by healthcare professionals to help diagnose COPD, it takes time, and requires specialist training to operate, and understand the results. At the moment spirometry testing is not available to all people around the UK, or there are very long waiting times. Prompt diagnosis of COPD is important because it means people can start treatments to reduce their symptoms, and stop them worsening, much sooner. We therefore want to research whether there are new tests which could be used to diagnose COPD instead of spirometry.

 The company TidalSense has built an easy-to-use device called N-Tidal Diagnose. Patients breathe in and out normally into an N-Tidal Handset for 75 seconds, which measures a gas that everyone breathes out called Carbon Dioxide (CO₂). The N-Tidal Handset is CE marked which means that the product complies with European law with regards to medical devices. The N-Tidal Diagnose computer program can distinguish between how the changes in the level of CO₂ in the breath over time are different between those with and without and COPD. This allows us to tell how likely it is that that person has COPD.

For this study, we hope to include around 500 participants across the UK. We want to find out how accurate N-Tidal Diagnose is at diagnosing COPD compared to the usual spirometry test, as well as ask some questions about how patients and health care professionals find the experience of using the N-Tidal device and spirometry.  If this study shows that N-Tidal Diagnose is sufficiently accurate to use in COPD diagnosis, patients with COPD could be diagnosed sooner and could reduce the cost to the NHS.

1. Test the accuracy of N-Tidal Diagnose in diagnosing COPD in Primary Care.
2. Gather information from healthcare professionals about how COPD is currently diagnosed, including costs.
3. Look at the costs and benefits of spirometry and N-Tidal Diagnose. This will help understand how N-Tidal Diagnose can best be used in the NHS to maximise its positive impact.
4. Assess the usability of N-Tidal Diagnose in order to identify and eliminate any potential difficulties in adopting the system.

Anyone aged 35 or older and has been booked to have a spirometry test to help to diagnose the cause of their breathing symptoms, and COPD might potentially be the cause may be eligible to participate. 

Your healthcare professional or someone from the research team will inform you about the study and give you the opportunity to ask any questions about taking part. This may be in-person or remote (email, text, phone call).

We will ask you to sign a consent form if you are happy to take part. This will be an electronic consent form and we will email you a copy.

Once you have consented to take part, we will ask you to complete a baseline questionnaire, including your medical history related to your breathing and general health. All of the baseline questionnaires will need to be completed at one time and should take around 20 minutes. You can ask someone else to help you with this, or complete over the phone with the study team, if you prefer.

Your spirometry test visit will take place as normal, but we will ask you to do an additional test, using the N-Tidal Diagnose device as well. The results from both of these tests will be recorded for the study. However, as N-Tidal is still being studied its results will not be used to influence your diagnosis. At the end of your test visit we will ask some questions about how you have found N-Tidal Diagnose and spirometry.

We will collect some information from your medical notes shortly after you enter into the study, as well as what your diagnosis from the spirometry test was once your test results have been looked at by your health care professional.

Patient representatives were involved in reviewing the design of this study as part of our oversight committee as well as specifically reviewing participant documents. 

TidalSense spoke to patients and health care professionals from the very beginning of developing N-Tidal to make sure it fits their needs.

The CORMORANT programme is funded by the National Institute for Health and Care Research (NIHR).The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.

The University of Oxford is the research sponsor. 

REC: 25/SC/0103

IRAS: 329554                        

Registration: ISRCTN18133836