NCT04024657

A Cross Sectional, Diagnostic Accuracy Study to Validate the Use of a New Device(Inflammacheck™) in Diagnosing COPD

A Cross Sectional, Diagnostic Accuracy Study to Validate the Use of a New Device(Inflammacheck™) in Diagnosing COPD by Measuring the Level of Exhaled Breath Condensate Hydrogen Peroxide (EBC H2O2)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 313 (actual)
• Sponsor: Portsmouth Hospitals NHS Trust · Other Government
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

A cross-sectional, diagnostic accuracy study to evaluate the use of the 'Inflammacheck™' device in the diagnosis of COPD. Participants will be asked to provide an exhaled breath sample for measurement of their EBC H2O2 using 'Inflammacheck™'. The result will be correlated with spirometry (FEV1/ FVC ratio)

Detailed description

A key component of COPD is airway inflammation. Current tools for assessing airway inflammation and oxidative stress, such as fibre-optic bronchoscopy with bronchial wall biopsy and bronchial fluid lavage, are invasive procedures not suitable for routine clinical practice or regular repeat sampling. Sample analysis requires a series of laboratory measurements and results can take over 24 hours to become available. Non-invasive methods of measuring airway inflammation assess exhaled gases. Fractional exhaled Nitric Oxide (FeNO) measures eosinophilic airway inflammation. However, FeNO does not provide information about neutrophilic airway inflammation, a recognised component of Chronic Obstructive Pulmonary Disease (COPD). In contrast, 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. It has the potential to diagnose COPD and to give information about the degree of airway inflammation. Exhalation Technology Ltd. Have developed a novel, handheld device (Inflammacheck™) which can produce a measurement of EBC H2O2 levels at the patient's side. By detecting EBC H2O2 levels immediately, Inflammacheck™ could tell potentially clinicians and patients the current level of global airway inflammation in a simple, effort independent manner. This could be used by clinicians to diagnose COPD both in hospital and in the community. Previous studies using the 'Inflammacheck™' device have shown that there is a difference in the EBC H2O2 between participants with COPD and those with no underlying lung disease. It has the potential to further measure increased levels of airway inflammation that may indicate an exacerbation of a persons' respiratory disease. The 'Inflammacheck™' device now requires a study in a clinical setting to validate its use in accurately diagnosing COPD. The investigators hypothesise that the The 'Inflammacheck™' device will be able to accurately diagnose patients with COPD using EBC H2O2 as compared to the gold standard of Spirometry.

Conditions

• COPD Exacerbation

Timeline

• Start date: 2018-12-17
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2019-07-18
• Last updated: 2023-04-07

Locations

1 site across 1 country: United Kingdom