About this trial
This is an observational study into more comprehensive understanding, including the trajectories of lung function decline, inflammatory/immunological mechanisms on pre-COPD or PRISm, clinical outcomes and relevant endotypes on physician-diagnosed COPD. The sponsor will follow up all participants for 1-year period.
Eligibility criteria
Qualifiers
Capable of giving signed ICF
Able to perform acceptable lung function testing for FEV1 according to American Thoracic Society and European Respiratory Society 2019 acceptability criteria.
Able and willing to comply with the requirements of the protocol including ability to read, write, be fluent in the translated language of all participants facing questionnaires used at center.
Participants will be allowed to enroll into other non-intervention studies while taking part in this study.
Disqualifiers
The participant has a history of alcohol or drug abuse within the past year, which, in the opinion of the responsible physician, contra-indicates their participation.
The participant has an altered mental status at the time of informed consent.
Clinically significant abnormal laboratory values available vital signs, ECG, or laboratory testing at the screening assessment that, which in the opinion of the investigator, could interfere with the objectives of the study or safety of the participant. -Current diagnosis of asthma.
Clinically important pulmonary disease.
Trial design
Treatments tested in this trial
- Not listed