The EXHALE 2 Study

  • Research type

    Research Study

  • Full title

    A longitudinal, cohort study measuring levels of Exhaled Breath Condensate Hydrogen Peroxide (EBC H2O2), in patients with asthma and COPD during exacerbations and when stable.

  • IRAS ID

    259152

  • Contact name

    Anoop Chauhan

  • Contact email

    anoop.chauhan@porthosp.nhs.uk

  • Sponsor organisation

    Portsmouth Hospitals NHS Trust

  • Clinicaltrials.gov Identifier

    NCT04061291

  • Duration of Study in the UK

    2 years, 0 months, 1 days

  • Research summary

    Chronic Obstructive Pulmonary Disease (COPD) affects 835,000 people in the UK, and another 2 million people may have the condition but do not yet have a diagnosis. Asthma affects over 5 million people in the UK, with 250,000 suffering from severe disease. Patients with asthma and COPD suffer significantly from breathlessness and recurrent lung infections and their condition can go undiagnosed or untreated for many years.\n\nAsthma and COPD attacks (or ‘exacerbations’ or ‘flare ups’) devastate people’s lives, causing frequent hospital admissions and repeat courses of strong medications such as steroids and antibiotics that can lead to long term harmful effects. \n\nA common feature of COPD and asthma is airway inflammation which worsens during attacks of their disease. Current ways of assessing airway inflammation could cause the patient discomfort and harm. If we can detect worsening airway inflammation, in an easy, safe, and quick way, we could detect asthma and COPD attacks earlier allowing patients to start the right medicines at the right time, reducing their symptoms and improving quality of life. \nInflammacheck 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 90 seconds.\nWe would like to test the Inflammacheck™ device to see how it can help in the management of asthma and COPD and to see how good the test is at detecting more severe inflammation when people are experiencing an attack.\nWe will recruit 250 participants to the EXHALE 2 study. This will include 100 people with asthma and 150 people with COPD and they will be asked to complete the study procedures when their lung condition is both stable and when they are unwell and experiencing an attack (known as an exacerbation) of their lung condition. A small number of participants will be asked to return for 2 further study visits to measure their EBC H2O2 levels when they have recovered from this attack, so we can see if there is a trend in these levels.

  • REC name

    South Central - Hampshire A Research Ethics Committee

  • REC reference

    19/SC/0145

  • Date of REC Opinion

    25 Apr 2019

  • REC opinion

    Favourable Opinion