COPD
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * COPD exacerbation, within 2 weeks prior to enrollment or during screening period. * History of partial or total lung resection (single lobe or segmentectomy is acceptable). Surgical or endoscopic (eg, valves) lung volume reduction within the 6 months prior to enrollment. Expected need for lung volume reduction surgery during the study. * Unstable disorders. * Malignancy, current or within the past 5 years, except for adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma-in-situ treated with apparent success more than one year prior to enrollment. Suspected malignancy or undefined neoplasms. * Terminal disease and/or organ failure or participants otherwise considered not appropriate for the study participation. * Participants receipt marketed or investigational biologics biologics within 3 months or 5 half-lives prior to visit 1, whichever is longer. * Female participants who are pregnant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medical History | At Baseline | Risk factors of COPD development or lung function decline |
| Occupation | At Baseline | Risk factors of COPD development or lung function decline |
| Birth Status | At Baseline | Risk factors of COPD development or lung function decline |
| Place of residence | At Baseline | Risk factors of COPD development or lung function decline |
| Smoking history and status | At Baseline to week 56 | Risk factors of COPD development or lung function decline |
| Family history | At Baseline | Risk factors of COPD development or lung function decline |
| Exacerbation/respiratory history and event | At Baseline to week 56 | Measurement of disease control and burden |
| COPD related HRU | At Baseline to week 56 | Risk factors of COPD development or lung function decline |
| SGRQ | At Baseline to week 56 | Measurement of questionnaires |
| CAT | At Baseline to week 56 | Measurement of questionnaires |
| MARS-5 (only applicable for COPD cohort) | At Baseline to week 56 | Measurement of questionnaires |
| Variables in COPD related medication, changes in medication | At Baseline to week 56 | Measurement of treatment pattern |
| FEV1 % | At Baseline to week 56 | Measurement of lung function |
| FEV1 /FVC | At Baseline to week 56 | Measurement of lung function |
| Forced Osc | At Baseline to week 56 | Measurement of lung function |
| FEF25-75 | At Baseline to week 56 | Measurement of lung function |
| DLCO | At Baseline to week 56 | Measurement of lung function |
| LAAinsp-950% | At Baseline to week 56 | Measurement of lung structure profile and change through radiological parameters (CT scan) |
| LAAexp-856% | At Baseline to week 56 | Measurement of lung structure profile and change through radiological parameters (CT scan) |
| WA% | At Baseline to week 56 | Measurement of lung structure profile and change through radiological parameters (CT scan) |
| Inflammatory differentials and counts in blood and BALF | At Baseline to week 56 | Measurement of inflammatory cell locally and systemically |
| Inflammatory cell infiltration | At Baseline to week 56 | Measurement of inflammatory cell locally and systemically |
| MUC5B/MUC5AC | At Baseline to week 56 | Measurement of inflammatory biomarkers profile to develop clinical endotype andphenotype in Chinese COPD, pre-COPD or PRISm |
| IL-33/ST2 complex | At Baseline to week 56 | Measurement of inflammatory biomarkers profile to develop clinical endotype andphenotype in Chinese COPD, pre-COPD or PRISm |
| IL-33 | At Baseline to week 56 | Measurement of inflammatory biomarkers profile to develop clinical endotype andphenotype in Chinese COPD, pre-COPD or PRISm |
| Air trapping index | At Baseline to week 56 | Measurement of lung structure profile and change through radiological parameters (CT scan) |
| hsCRP | At baseline to week 56 | Measurement of inflammatory biomarkers profile to develop clinical endotype andphenotype in Chinese COPD, pre-COPD or PRISm |
| Transcriptomic test in nasal, bronchial brushings, biopsies and BALF asmples | At baseline to week 56 | Measurement of inflammatory biomarkers profile to develop clinical endotype andphenotype in Chinese COPD, pre-COPD or PRISm |
| Proteomic test in blood, sputum, BALF and NLF samples | At baseline to week 56 | Measurement of inflammatory biomarkers profile to develop clinical endotype andphenotype in Chinese COPD, pre-COPD or PRISm |
Countries
China
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed