Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-24 @ 6:48 PM
NCT ID:
NCT04024657
Eligibility Criteria:
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 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT04024657
Study Brief:
Protocol Section:
NCT04024657