Chronic Obstructive Pulmonary Disease (COPD) Clinical Trials

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A Diagnostic Accuracy Study: N-Tidal Assessment for Respiratory Diagnosis Compared to Using Standard Testing

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

The diagnosis of either asthma or chronic obstructive pulmonary disease (COPD) is currently based on a combination of symptoms, different lung tests and sometimes a 'trial by treatment'. Both COPD and Asthma tests currently include forced breathing using a test known as spirometry which can be difficult and uncomfortable for people to perform and needs expert interpretation. Asthma can require multiple tests in sequence which can make the process of diagnosis long and inconvenient for patients. In the UK, there have been challenges providing enough testing for COPD and asthma, in part because the tests are challenging to provide in the community to everyone who needs one. The STARDUST study aims to test and develop new ways of diagnosing asthma and COPD that are quick, accurate and easy for patient and healthcare professionals to perform. People who have been referred for routine lung testing will breathe normally in and out into a handheld device called the N-Tidal Handset for 75 seconds. This device measures how the level of carbon dioxide (CO2) changes in the breath as people breath through it. The information gathered on the N-Tidal Handsets, called breath records or capnograms, will not be used to alter the diagnosis of any participants in the study. After the capnograms have been collected, the research team will test 'algorithms' that have been developed using artificial intelligence, to see if they can accurately identify the correct diagnosis. Information collected in the study will also be used to make improvements in these algorithms. If confirmed to be accurate, these algorithms could be used in clinical practice to help healthcare professionals make faster, more accessible and accurate diagnoses, especially in settings like GP clinics in the community where access to specialist tests may be limited.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 110
Healthy Volunteers: f
View:

• Age ≥ 18 years

• Referred for respiratory diagnostic testing with a clinical suspicion of asthma or COPD

• Participant is willing and able to provide informed consent

Locations
Other Locations
United Kingdom
Liverpool Heart and Chest Hospital NHS Foundation Trust
RECRUITING
Liverpool
Contact Information
Primary
Hassan Burhan, MBChB FRCP
Hassan.Burhan@liverpoolft.nhs.uk
0151 254 3036
Backup
Thomas FitzMaurice, MBChB BSc PGCME MRCP(UK) PhD
0151 254 3055
Time Frame
Start Date: 2026-09-15
Estimated Completion Date: 2027-05-19
Participants
Target number of participants: 1200
Treatments
Asthma
Patients with suspected asthma
COPD
Patients with suspected COPD
Sponsors
Leads: Liverpool Heart and Chest Hospital NHS Foundation Trust
Collaborators: TidalSense

This content was sourced from clinicaltrials.gov