Status:
COMPLETED
A Cross Sectional, Diagnostic Accuracy Study to Validate the Use of a New Device(Inflammacheck™) in Diagnosing COPD
Lead Sponsor:
Portsmouth Hospitals NHS Trust
Conditions:
COPD Exacerbation
Eligibility:
All Genders
40+ years
Brief Summary
A cross-sectional, diagnostic accuracy study to evaluate the use of the 'Inflammacheck™' device in the diagnosis of COPD. Participants will be asked to provide an exhaled breath sample for measuremen...
Detailed Description
A key component of COPD is airway inflammation. Current tools for assessing airway inflammation and oxidative stress, such as fibre-optic bronchoscopy with bronchial wall biopsy and bronchial fluid la...
Eligibility Criteria
Inclusion
- 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
- 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 Inflammacheck™ 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.
Key Trial Info
Start Date :
December 17 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
313 Patients enrolled
Trial Details
Trial ID
NCT04024657
Start Date
December 17 2018
End Date
December 31 2019
Last Update
April 7 2023
Active Locations (1)
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1
Portsmouth Hospitals NHS Trust
Portsmouth, Hampshire, United Kingdom, PO6 3LY