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

Study acronym: STARDUST
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Dec 19, 2026 → May 19, 2027
See other at-risk trials from Liverpool Heart and Chest Hospital NHS Foundation Trust

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Recruitment opened Show 6 more changesShow less
    • Start date changed from estimate of Apr 1, 2026 to Sep 15, 2026
    • Primary completion pushed from Dec 19, 2026 to May 19, 2027
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Site details revised
    • Study description expanded, about 4 words
  2. Notable Start date: Dec 19, 2025 to Apr 1, 2026
    • Secondary endpoints: details revised at 1 of 2 entries
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07253883
Lead Sponsor Liverpool Heart and Chest Hospital NHS Foundation Trust
Collaborators: TidalSense
Conditions
(from sponsor)
Asthma (Diagnosis), COPD (Chronic Obstructive Pulmonary Disease)
Related terms Asthma, Disease, Pulmonary Disease, Chronic Obstructive
Enrollment 1,200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov