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
This trial does not accept healthy volunteersQualifiers
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 population
This is a multi-center, longitudinal, observational study which includes COPD group with external healthy controls. External healthy controls will be selected from the healthy volunteers enrolled in the asthma translational study (D2287R00186, sponsored by AstraZeneca), whose characteristics match as the entry criteria for Cohort A in the study. Other than participating the procedures of asthma translational study with additional specific activities for COPD, no other activities will be performed in this COPD translational study for Cohort A.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Medical History
Risk factors of COPD development or lung function decline
Occupation
Risk factors of COPD development or lung function decline
Birth Status
Risk factors of COPD development or lung function decline
Place of residence
Risk factors of COPD development or lung function decline
Sponsors and contacts
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