A Translational Study for Prediction of Biomarkers and Identification of Phenotype and Endotype of COPD and Pre-COPD Outcomes in Chinese Population

ConditionCOPD
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30+
SponsorAstraZeneca

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 volunteers

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 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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

850 Participants
are grouped into 5 trial groups
Group A: Cohort A
Group B: Cohort B
Group C: Cohort C1
Group D: Cohort C2
Group E: Corhort D

Trial outcomes

Primary outcomes

1

Medical History

Risk factors of COPD development or lung function decline

Time frame
At Baseline
2

Occupation

Risk factors of COPD development or lung function decline

Time frame
At Baseline
3

Birth Status

Risk factors of COPD development or lung function decline

Time frame
At Baseline
4

Place of residence

Risk factors of COPD development or lung function decline

Time frame
At Baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

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