New handheld breathing device test for asthma or COPD diagnosis
Official title: A Diagnostic Accuracy Study: N-Tidal Assessment for Respiratory Diagnosis Compared to Using Standard Testing
Run by Liverpool Heart and Chest Hospital NHS Foundation Trust · NCT07253883 · Data updated 2026-11-12
A handheld device called the N-Tidal Handset is used for 75 seconds to see if a quick breathing test can accurately diagnose asthma or COPD in adults referred for routine lung testing.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 110 Years |
| Sex | All |
| Enrollment | 1200 (estimated) |
| Sponsor | Liverpool Heart and Chest Hospital NHS Foundation Trust Academic / other |
| Locations | 1 site (Liverpool, Merseyside) |
| Status | Recruiting |
| Started | September 15, 2026 |
| Main results expected | May 19, 2027 |
| Study ends | May 19, 2027 |
| Registry record updated | October 15, 2026 |
| Trial ID | NCT07253883 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 and over referred for respiratory diagnostic testing with clinical suspicion of asthma or COPD.
✕Probably not a fit
Patients with conditions other than asthma or COPD or those unable to tolerate the breathing test may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study tests a new tidal breathing approach alongside partial pressure of CO2, FENO, and spirometry to determine diagnostic accuracy for asthma and COPD. Participants are adults referred for respiratory testing and will undergo the handheld breathing test in addition to standard tests. The goal is to see if this quick test can provide accurate results in a clinical setting and help streamline diagnosis. The study is led by Liverpool Heart and Chest Hospital NHS Foundation Trust with collaboration from TidalSense and focuses on real-world diagnostic pathways. Results may support easier, faster testing outside traditional spirometry-centered workflows.
Why it matters
Potential benefit: If successful, the approach could enable faster, simpler diagnosis of asthma or COPD.
How similar studies have gone: Previous work suggests that novel breathing-based approaches can provide useful diagnostic information, though this exact method is exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where it's running
-
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, Merseyside, United Kingdom Recruiting
Study contacts
- Study coordinator: Hassan Burhan, MBChB FRCP
- Email: Hassan.Burhan@liverpoolft.nhs.uk
- Phone: 0151 254 3036
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.