Assessment of Exhaled Breath Condensate Hydrogen Peroxide (EBC H2O2) as Measured Using a New Device (Inflammacheck™) in Patients With Interstitial Lung Disease, Lung Cancer and Healthy Volunteers. (EXHALE 1B)
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|ClinicalTrials.gov Identifier: NCT04061356|
Recruitment Status : Recruiting
First Posted : August 19, 2019
Last Update Posted : August 19, 2019
|Condition or disease|
|Interstitial Lung Disease Lung Cancer|
Inflammation and oxidative stress are processes that occur early in the disease process within both ILD and lung cancer. Current tools for assessing inflammation and oxidative stress, such as fibre-optic bronchoscopy with bronchial wall biopsy and bronchial fluid lavage, are invasive procedures not suitable for regular repeat sampling. Sample analysis requires a series of laboratory measurements and results can take over 24 hours to become available.
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 patient's 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 ILD and even Lung Cancer.
The 'Inflammacheck™' device now requires a study in a clinical setting to determine whether it can detect ILD and Lung Cancer. The acceptability and ease of use of the device also needs to be assessed for both patients and clinicians.
|Study Type :||Observational|
|Estimated Enrollment :||75 participants|
|Official Title:||Assessment of Exhaled Breath Condensate Hydrogen Peroxide (EBC H2O2) as Measured Using a New Device (Inflammacheck™) in Patients With Interstitial Lung Disease, Lung Cancer and Healthy Volunteers. The EXHALE 1B Study|
|Actual Study Start Date :||October 30, 2018|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||October 2019|
- Level of exhaled breath condensate hydrogen peroxide (EBC H2O2) [ Time Frame: 1 day study visit ]Respiratory outcome EBC H2O2 levels as measured by 'Inflammacheck™'
- Experience outcome [ Time Frame: 1 day study visit ]rating of ease of use of test and participants perception of device as assessed by self completion questionnaire
- Disease Stage (lung cancer) [ Time Frame: 1 day study visit ]measured by Tumour, Node, Metastasis stage
- Disease stage (interstitial lung disease) [ Time Frame: 1 day study visit ]measured by the GAP index
- safety outcome [ Time Frame: 1 day study visit ]incidence of adverse events reported during the study procedures
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): NCT04061356
|Contact: Anoop Chauhan||02392286000 ext firstname.lastname@example.org|
|Contact: Elaine Baddeley||02392286000 ext email@example.com|
|Portsmouth Hospitals NHS Trust||Recruiting|
|Portsmouth, Hampshire, United Kingdom, PO6 3LY|
|Contact: Alice Mortlock 02392 286000 ext 6236 firstname.lastname@example.org|