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

NCT07253883 | Not Yet Recruiting DMC

• 1 other identifier: 1694
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma (Diagnosis); COPD (Chronic Obstructive Pulmonary Disease)

Keywords

Asthma; COPD; End tidal CO2; Diagnostics; Machine learning

Outcome Measures

Primary Outcomes (2)

• Diagnostic accuracy of the diagnostic algorithms of N-Tidal Diagnose 1

  PPV, NPV, Sensitivity, Specificity compared to clinician diagnosis of COPD

  At time of testing

• Diagnostic accuracy of prototype diagnostic algorithms

  Prototype asthma diagnostic algorithms (index test; PPV, NPV, Sensitivity, Specificity) trained using a combined capnogram dataset from this and previous studies, compared to clinician diagnosis of asthma

  At time of testing

Secondary Outcomes (2)

• Diagnostic accuracy of the N-Tidal Diagnose 1 severity algorithm

  At time of diagnosis

• Feasibility and acceptability outcomes

  At time of diagnosis

Study Arms (2)

Asthma

Patients with suspected asthma

Diagnostic Test: Partial pressure of CO2 during tidal breathing; Diagnostic Test: FENO; Diagnostic Test: Spirometry

COPD

Patients with suspected COPD

Diagnostic Test: Partial pressure of CO2 during tidal breathing; Diagnostic Test: FENO; Diagnostic Test: Spirometry

Interventions

Partial pressure of CO2 during tidal breathing DIAGNOSTIC_TEST

Partial pressure of CO2 during tidal breathing for diagnosis of asthma or COPD

Asthma; COPD

FENO DIAGNOSTIC_TEST

Fractional exhaled nitric oxide

Also known as: Fractional exhaled nitric oxide

Asthma; COPD

Spirometry DIAGNOSTIC_TEST

Spirometry with or without bronchodilation (if indicated)

Asthma; COPD

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with a suspicion of asthma and/or COPD

You may qualify if:

• 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

You may not qualify if:

• Referred for respiratory diagnostic testing for a condition other than asthma or COPD, with no mention in the referral of a clinical suspicion of COPD or asthma
• Participants who, in the opinion of the chief investigator, or their delegate, are unlikely to comply with the requirements of the study
• Inability to give written informed consent
• Participants who are acutely unwell
• Patients unable to breathe through their mouths e.g. tracheostomy patients

Sponsors & Collaborators

• Liverpool Heart and Chest Hospital NHS Foundation Trust: lead
• TidalSense: collaborator

Study Sites (1)

Liverpool Heart and Chest Hospital NHS Foundation Trust

Liverpool, Merseyside, L14 3PE, United Kingdom

Location

MeSH Terms

Conditions

Asthma; Disease; Pulmonary Disease, Chronic Obstructive

Interventions

Fractional Exhaled Nitric Oxide Testing; Spirometry

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Chronic Disease; Disease Attributes

Intervention Hierarchy (Ancestors)

Breath Tests; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System

Central Study Contacts

Hassan Burhan, MBChB FRCP

CONTACT

0151 254 3036; Hassan.Burhan@liverpoolft.nhs.uk

Thomas FitzMaurice, MBChB BSc PGCME MRCP(UK) PhD

CONTACT

0151 254 3055

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 28, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 19, 2026
• Study Completion (Estimated): May 19, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)