The EXHALE CE Study
Research type
Research Study
Full title
An observational Study to Determine the Usability of the Inflammacheck™ Device by Healthcare Providers in the Intended Use Environment
IRAS ID
265390
Contact name
Anoop Chauhan
Contact email
Sponsor organisation
Portsmouth Hospitals NHS Trust
Clinicaltrials.gov Identifier
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Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
Lung diseases affect millions of people in the UK with 5.4 million people diagnosed with asthma and a further 835,000 diagnosed with COPD. These conditions are the two most common lung diseases in the UK and they hugely impact quality of life, limiting day to day activities and causing frequent hospital admissions. Medications used in treating acute attacks (or exacerbations) of Asthma or COPD can also have long term side-effects. A common feature of both of these conditions is airway inflammation.
Inflammacheck™ is a hand-held device developed by Exhalation Technology Ltd. which identifies chemicals in the breath. These chemicals can give an indication about the severity of airway inflammation. To perform the test, participants will simply breathe as normal into the device for 60 seconds. The device measures the exhaled hydrogen peroxide gas which can be used as an indicator of airway inflammation.
This study is designed to test whether the Inflammacheck™ device is easy to use by healthcare professionals who would be using it in a clinic setting or in primary care. The data collected during this study will be used as part of the evidence needed to get the CE (Conformité Européenne) marking for the device.
CE marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA). CE marking is essential for any medical devices used in the UK or the EU.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
19/EM/0194
Date of REC Opinion
10 Jun 2019
REC opinion
Further Information Favourable Opinion