The EXHALE 1V Study
Research type
Research Study
Full title
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).
IRAS ID
253642
Contact name
Anoop Chauhan
Contact email
Duration of Study in the UK
0 years, 5 months, 4 days
Research summary
Chronic Obstructive Pulmonary Disease (COPD) affects 835,000 people in the UK, with up to 2 million people still remaining undiagnosed. These groups of patients suffer significantly from breathlessness and recurrent lung infections that can go undiagnosed or untreated. COPD attacks (or ‘exacerbations’) devastate the lives of patients, causing frequent hospital admissions and repeat courses of strong medications such as steroids and antibiotics that can lead to long term harmful effects. There is a great need for new tests to diagnose COPD earlier and to facilitate earlier treatment to help symptoms and improve patient’s quality of life.
A feature of COPD is narrowing of the airways and airway inflammation. Current tests to detect airway narrowing and inflammation can take time, patients often find them difficult to perform and they can be invasive. There can also be a time delay before results are available to the medical team and to patients. If we can diagnose COPD, in an easy, safe, and quick way, patients could start the right medicines at the right time, reducing symptoms and improving patient quality of life .
Inflammacheck is a new test which identifies a chemical in exhaled breath. This chemical can give information about a patient's lungs. To do the test, patients will simply breathe into a small hand-held device at their normal rate of breathing for 1 minute. The device then gives an immediate result to the patient and their medical team.
'Inflammacheck' now needs to be tested to see if the device can help reliably diagnose COPD.We will recruit 260 people to the EXHALE 1V study, including 130 people with COPD and 130 people with no known lung disease (our 'healthy controls').
REC name
South Central - Berkshire Research Ethics Committee
REC reference
18/SC/0626
Date of REC Opinion
23 Nov 2018
REC opinion
Favourable Opinion