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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Healthy controls from asthma translational study: approximately 50 healthy participants aged 30 or older. | ||
| Cohort B | pre-COPD or PRISm: approximately 110 participants at 30 to 50 years of age (inclusive) with respiratory symptoms and/or structural lung lesions and/or physiological abnormalities without airflow obstruction (FEV1/FVC >= 0.7 post-bronchodilation). PRISm is defined as preserved ratio (FEV1/FVC >= 0.7 post-bronchodilation) with impaired spirometry (FEV1 < 80% of reference post-bronchodilation). | ||
| Cohort C1 | Mild COPD (Cohort C): approximately 110 physician-diagnosed COPD participants in total with post-bronchodilation FEV1/FVC < 70% and FEV1 >= 80% of predicted. Cohort C1: participants at 30 to 50 years of age (inclusive). | ||
| Cohort C2 | Mild COPD (Cohort C): approximately 110 physician-diagnosed COPD participants in total with post-bronchodilation FEV1/FVC < 70% and FEV1 >= 80% of predicted. Cohort C2: participants elder than 50 years of age (exclusive) within Cohort C mild COPD (approximately 110 total across C1 and C2). | ||
| Corhort D | Moderate to very severe COPD: approximately 330 COPD participants (males and females aged 50 years or older) with moderate to very severe airflow limitation defined as post-bronchodilation FEV1/FVC < 70% and FEV1 >= 25% and < 80% of predicted, and presence of respiratory symptoms equivalent to CAT >= 10 or mMRC >= 2. |
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| Measure | Description | Time Frame |
|---|---|---|
| Medical History | Risk factors of COPD development or lung function decline | At Baseline |
| Occupation | Risk factors of COPD development or lung function decline | At Baseline |
| Birth Status | Risk factors of COPD development or lung function decline | At Baseline |
| Place of residence | Risk factors of COPD development or lung function decline | At Baseline |
| Smoking history and status | Risk factors of COPD development or lung function decline | At Baseline to week 56 |
| Family history | Risk factors of COPD development or lung function decline | At Baseline |
| Exacerbation/respiratory history and event | Measurement of disease control and burden | At Baseline to week 56 |
| COPD related HRU | Risk factors of COPD development or lung function decline | At Baseline to week 56 |
| SGRQ |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Recruiting | Beijing | China | |||
| Research Site |
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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Measurement of questionnaires |
| At Baseline to week 56 |
| CAT | Measurement of questionnaires | At Baseline to week 56 |
| MARS-5 (only applicable for COPD cohort) | Measurement of questionnaires | At Baseline to week 56 |
| Variables in COPD related medication, changes in medication | Measurement of treatment pattern | At Baseline to week 56 |
| FEV1 % | Measurement of lung function | At Baseline to week 56 |
| FEV1 /FVC | Measurement of lung function | At Baseline to week 56 |
| Forced Osc | Measurement of lung function | At Baseline to week 56 |
| FEF25-75 | Measurement of lung function | At Baseline to week 56 |
| DLCO | Measurement of lung function | At Baseline to week 56 |
| LAAinsp-950% | Measurement of lung structure profile and change through radiological parameters (CT scan) | At Baseline to week 56 |
| LAAexp-856% | Measurement of lung structure profile and change through radiological parameters (CT scan) | At Baseline to week 56 |
| WA% | Measurement of lung structure profile and change through radiological parameters (CT scan) | At Baseline to week 56 |
| Inflammatory differentials and counts in blood and BALF | Measurement of inflammatory cell locally and systemically | At Baseline to week 56 |
| Inflammatory cell infiltration | Measurement of inflammatory cell locally and systemically | At Baseline to week 56 |
| MUC5B/MUC5AC | Measurement of inflammatory biomarkers profile to develop clinical endotype andphenotype in Chinese COPD, pre-COPD or PRISm | At Baseline to week 56 |
| IL-33/ST2 complex | Measurement of inflammatory biomarkers profile to develop clinical endotype andphenotype in Chinese COPD, pre-COPD or PRISm | At Baseline to week 56 |
| IL-33 | Measurement of inflammatory biomarkers profile to develop clinical endotype andphenotype in Chinese COPD, pre-COPD or PRISm | At Baseline to week 56 |
| Air trapping index | Measurement of lung structure profile and change through radiological parameters (CT scan) | At Baseline to week 56 |
| hsCRP | Measurement of inflammatory biomarkers profile to develop clinical endotype andphenotype in Chinese COPD, pre-COPD or PRISm | At baseline to week 56 |
| Transcriptomic test in nasal, bronchial brushings, biopsies and BALF asmples | Measurement of inflammatory biomarkers profile to develop clinical endotype andphenotype in Chinese COPD, pre-COPD or PRISm | At baseline to week 56 |
| Proteomic test in blood, sputum, BALF and NLF samples | Measurement of inflammatory biomarkers profile to develop clinical endotype andphenotype in Chinese COPD, pre-COPD or PRISm | At baseline to week 56 |
| Recruiting |
| Changsha |
| China |
| Research Site | Recruiting | Chengdu | China |
| Research Site | Recruiting | Guangzhou | China |
| Research Site | Recruiting | Hefei | China |
| Research Site | Recruiting | Nanjing | China |
| Research Site | Recruiting | Nanning | China |
| Research Site | Recruiting | Shanghai | China |
| Research Site | Not yet recruiting | Shanghai | China |
| Research Site | Not yet recruiting | Shenyang | China |
| Research Site | Recruiting | Shenyang | China |
| Research Site | Recruiting | Wuhan | China |
| Research Site | Recruiting | Xuzhou | China |
| Research Site | Recruiting | Zhengzhou | China |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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