A Cross Sectional, Diagnostic Accuracy Study to Validate the Use of a New Device(Inflammacheck™) … (NCT04024657) | Clinical Trial Compass
CompletedNot Applicable
A Cross Sectional, Diagnostic Accuracy Study to Validate the Use of a New Device(Inflammacheckâ„¢) in Diagnosing COPD
United Kingdom313 participantsStarted 2018-12-17
Plain-language summary
A cross-sectional, diagnostic accuracy study to evaluate the use of the 'Inflammacheckâ„¢' device in the diagnosis of COPD.
Participants will be asked to provide an exhaled breath sample for measurement of their EBC H2O2 using 'Inflammacheckâ„¢'. The result will be correlated with spirometry (FEV1/ FVC ratio)
Who can participate
Age range40 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or Female, aged ≥40 years.
* A confirmed, clinician made diagnosis of COPD supported by spirometric evidence of fixed airflow limitation (post-bronchodilator ratio of FEV1/FVC \<0.7) recorded at any time.
* OR no known history of lung disease (defined as no current clinical diagnosis of, or be receiving treatment for, a lung disease) and be a current non-smoker. Ex-smokers with a less than 5 pack year history of smoking (cigarettes and cannabis) and who have stopped smoking ≥6 months ago can be included.
* Willing and able to give informed consent for participation in the study.
Exclusion Criteria:
* Existing co-morbidities that may prevent them from performing spirometry (at the discretion of the clinical investigator).
* Known other lung, chest wall, neuromuscular, or cardiac disease (including end-stage disease or cancer) that would confound Inflammacheckâ„¢ measurements and spirometry (at the discretion of the clinical investigator).
* Has received treatment for an exacerbation of their COPD 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.
* 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
Level of exhaled breath condensate hydrogen peroxide (EBC H2O2)