Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04467190 |
| Other study ID # |
PHT/2019/77 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 13, 2019 |
| Est. completion date |
October 13, 2022 |
Study information
| Verified date |
April 2023 |
| Source |
Portsmouth Hospitals NHS Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
People with lung conditions can suffer significantly with their symptoms and often require
multiple trips to their GP or secondary care before a diagnosis is made. It can be difficult
to diagnose lung disease and to differentiate between different lung conditions, so many
people may be misdiagnosed or incorrectly not given a diagnosis. The tests currently used to
diagnose lung diseases can be difficult or uncomfortable to do, especially if the person is
experiencing lots of symptoms, and therefore can give poor or unreliable results.A new quick
and easy to perform test is needed that can differentiate between various lung conditions and
people with no lung disease, that can be performed in primary and secondary care with
immediate results.
Description:
Lung disease is one of the largest contributors to morbidity and mortality in the UK, with
20% of the population diagnosed with, or receiving treatment for a respiratory condition.
Methods of diagnosis are still convoluted and can be difficult to perform, or very costly in
patient and clinician time. Some diagnostic tests only look for a specific type of
inflammation (e.g. Fractional exhaled Nitric Oxide) and so can overlook other causes. It can
be hard to differentiate between different conditions, and as a result there are thousands of
people in the UK who have undiagnosed or misdiagnosed respiratory disease.
Measurement of Exhaled Breath Condensate Hydrogen Peroxide (EBC H2O2) is performed during
normal tidal breathing, and is well tolerated even in patients with severe airways
obstruction and those unable to perform a consistent controlled exhalation. It is also not
limited to inflammatory cell specific inflammation.
In studies using the previous version of the Inflammacheck™ device, significant differences
have been demonstrated between levels of H2O2 in people with COPD, asthma, ILD and lung
cancer compared to healthy controls. These studies have been instrumental in the continued
improvement of the device, to ensure that the participant has the best experience, and
simplify the procedure, so that the H2O2 result can be obtained with a single test in under 3
minutes.
Although the primary result of the Inflammacheck™ device is EBC H2O2, it is now also able to
measure clinically important parameters including breath temperature, humidity, Carbon
Dioxide waveforms, and intra-thoracic pressure changes. These parameters, in combination with
the EBC H2O2 may be able to be used together to identify differences between people with
various respiratory diseases and healthy volunteers. The device has also been improved based
on the participant feedback, to ensure that it is user friendly and comfortable.
The investigators need to determine whether the parameters (H2O2, humidity, temperature,
exhaled CO2 waveform and intra-thoracic pressure), as measured by 'Inflammacheck™' can either
alone or in combination differentiate asthma, COPD, lung cancer, ILD, breathing pattern
disorder, bronchiectasis and pneumonia from other each other and from healthy controls.
