Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Respiratory Disease
Type
Observational
Design
Observational Model: Case-CrossoverTime Perspective: Prospective

Participation Requirements

Age
Between 16 years and 125 years
Gender
Both males and females

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...

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.

Tracking Information

NCT #
NCT04467190
Collaborators
Not Provided
Investigators
Not Provided