NCT04061291

Study to Explore the Relationship Between the Level of Exhaled Breath Condensate Hydrogen Peroxide (EBC H2O2) as Measured Using a New Device Against Existing Measures of Lung Disease

A Cross-sectional Study to Explore the Relationship Between the Level of Exhaled Breath Condensate Hydrogen Peroxide (EBC H2O2) as Measured Using a New Device (Inflammacheck™) Against Existing Measurements of Lung Disease and Inflammation in Patients With Asthma and COPD, and Healthy Volunteers.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 252 (actual)
• Sponsor: Portsmouth Hospitals NHS Trust · Other Government
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

A cross-sectional, observational study of EBC H2O2 levels, as measured by a novel device, 'Inflammacheck™', and other markers of disease severity and symptom control in patients with Asthma and COPD and volunteers with no history of lung disease.

Detailed description

Current tools for assessing airway inflammation and oxidative stress, such as fibre-optic bronchoscopy with bronchial wall biopsy and bronchial fluid lavage, are mostly invasive procedures that are 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. Induced sputum analysis is a semi-invasive means of assessing airway inflammation but is not always well tolerated by patients and again is not suitable for repeat sampling. Non-invasive methods of measuring airway inflammation assess exhaled gases. Fractional exhaled Nitric Oxide (FeNO) measures eosinophilic airway inflammation. However, this test requires controlled exhalation for at least 6 seconds, making the test unsuitable for patients with impaired lung function, who are often not able to sustain this length of breath. Furthermore FeNO does not provide information about neutrophilic airway inflammation, a recognised component of steroid insensitive asthma and 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. To date, the measurement of EBC H2O2 has been used as a research tool only, due to the complex multiple procedural steps required to deliver a result from the collected exhaled breath. Exhalation Technology Ltd. have now developed a novel, handheld device (Inflammacheck™) which can produce an immediate measurement of EBC H2O2 levels at the patients side. By detecting EBC H2O2 levels immediately, Inflammacheck™ could tell clinicians and patients the current level of global airway inflammation in a simple, effort independent manner. This could be used by clinicians to diagnose asthma and COPD, to determine a patient's phenotype and to guide correct and personalised treatment. It could also measure increased levels of airway inflammation that may indicate an exacerbation. The 'Inflammacheck™' device now requires a study in a clinical setting to determine whether it can differentiate asthma and COPD from healthy, whether it can distinguish mild from severe disease and whether it can detect an acute exacerbation of these chronic respiratory conditions. The acceptability and ease of use of the device also needs to be assessed for both patients and clinicians.

Conditions

• Asthma
• COPD Exacerbation

Timeline

• Start date: 2018-02-03
• Primary completion: 2018-08-08
• Completion: 2018-08-08
• First posted: 2019-08-19
• Last updated: 2019-08-19

Locations

1 site across 1 country: United Kingdom