EXhaled Hydrogen Peroxide As a Marker of Lung diseasE (EXHALE) Pilot Study. (NCT03055923) | Clinical Trial Compass
CompletedNot Applicable
EXhaled Hydrogen Peroxide As a Marker of Lung diseasE (EXHALE) Pilot Study.
United Kingdom149 participantsStarted 2016-11-14
Plain-language summary
This Pilot study evaluates the use of a new device called Inflammacheck and whether it can consistently measure hydrogen peroxide levels in exhaled breath condensate. It will also assess whether exhaled breath condensate hydrogen peroxide levels as measured by Inflammacheck can differentiate people with asthma and COPD from healthy individuals.
Who can participate
Age range16 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject has a clinician made diagnosis of asthma with symptoms for ≥ 3 months supported by objective evidence of airflow variability, reversibility or airway hyper-responsiveness
* Subject has a confirmed, clinician made diagnosis of COPD for ≥ 3 months supported by spirometric evidence of fixed airflow limitation (post-bronchodilator ratio of FEV1/FVC \<0.7) recorded at any time
* Subject has no known history of lung disease (defined as no current clinical diagnosis of, or be receiving treatment for, a lung disease).
* Subject is willing and able to give informed consent for participation in the study.
Exclusion Criteria:
* Subject has existing co-morbidities that may prevent them from performing spirometry, FeNO or other study measurements (at the discretion of the clinical investigator).
* Subject has known other lung, chest wall, neuromuscular, or cardiac disease or abnormality (including end-stage disease or cancer) that would confound symptom scores and spirometry.
* Subject has received treatment for an exacerbation of their respiratory disease within the last 2 weeks.
* In the opinion of the clinical investigator, participant could be put at risk of harm by having to perform any of the study procedures.
* Subject is unable to comprehend the study and provide informed consent, e.g. insufficient command of English in the absence of someone to adequately interpret.
What they're measuring
1
Exhaled Breath Condensate hydrogen peroxide levels as measured by the inflammacheck device.