Clinical trial Recruiting at 1 site Observational Ages 18 to 110

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 typeObservational
Ages18 Years to 110 Years
SexAll
Enrollment1200 (estimated)
SponsorLiverpool Heart and Chest Hospital NHS Foundation Trust
Academic / other
Locations1 site (Liverpool, Merseyside)
StatusRecruiting
StartedSeptember 15, 2026
Main results expectedMay 19, 2027
Study endsMay 19, 2027
Registry record updatedOctober 15, 2026
Trial IDNCT07253883 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.