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 (EXHALE 1A)
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|ClinicalTrials.gov Identifier: NCT04061291|
Recruitment Status : Completed
First Posted : August 19, 2019
Last Update Posted : August 19, 2019
|Condition or disease|
|Asthma COPD Exacerbation|
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.
|Study Type :||Observational|
|Actual Enrollment :||252 participants|
|Official Title:||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.|
|Actual Study Start Date :||February 3, 2018|
|Actual Primary Completion Date :||August 8, 2018|
|Actual Study Completion Date :||August 8, 2018|
- Level of exhaled breath condensate hydrogen peroxide (EBC H2O2), [ Time Frame: 1 day study visit ]EBC H202 as measured by the by Inflammacheck™ sensor
- Quality of life (asthma specific) [ Time Frame: 1 day study visit ]
measured by asthma quality of life questionnaire
- Disease severity ( measured by GINA Stage for asthma, GOLD Stage for COPD)
- Disease control (ACQ (asthma))
- Quality of life (COPD specific) [ Time Frame: 1 day study visit ]
COPD assessment test
- Rating of whether test is acceptable to participant
- Participant's perception of device using the self perception questionnaire
- Safety outcome [ Time Frame: 1 day study visit ]incidence of adverse events reported during the study procedures
- Disease Severity Asthma [ Time Frame: 1 day study visit ]measured by Global Initiative for Asthma
- Disease Severity COPD [ Time Frame: 1 day study visit ]measured by Global Initiative for Chronic Obstructive Lung Disease
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04061291
|Portsmouth Hospitals NHS Trust|
|Portsmouth, Hampshire, United Kingdom, PO6 3LY|