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

Recruiting

• Conditions: COPD

• Registration Number: NCT06724848
• Lead Sponsor: AstraZeneca

Brief Summary

This is an observational study into more comprehensive understanding, including the trajectories of lung function decline, inflammatory/immunological mechanisms on early COPD, clinical outcomes and relevant endotypes on physician-diagnosed COPD. The sponsor will follow up all participants initially for 1-year period. The follow-up period may extend up to 3 y...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-05-08
• Study Start: 2024-06-05
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-05
• Last Update Submitted: 2024-12-05
• Study First Posted: 2024-12-09
• Last Update Posted: 2024-12-09
• Primary Completion: 2027-07-07
• Study Completion: 2027-07-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 850

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 studies while taking part in this study. However, permission from the Steering Committee must be obtained to enroll or allow the continued participation of a participant enrolled in another study.

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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 according to the Global Initiative for Asthma or other accepted guidelines, prior history of asthma, or asthma-COPD overlap. Childhood history of asthma is allowed and defined as asthma diagnosed and resolved (ie, not requiring the use of any maintenance or rescue medication) before the age of 18.
• Clinically important pulmonary disease (as discretion by local physician) other than COPD (eg, active lung infection, clinically significant bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha-1 anti-trypsin deficiency, and primary ciliary dyskinesia).
• COPD exacerbation, within 2 weeks prior to enrollment, that was treated with systemic corticosteroids and/or antibiotics, and/or led to hospitalization (based on last dose of corticosteroids or antibiotics, or last date of hospitalization, whichever occurred later).
• 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, including, but not limited to, autoimmune disease, diabetes, thyroid disease, significant cardio-renal disease (including significant hypertension, atrial fibrillation, hypertrophic cardiomyopathy, and significant cardiovascular disease).
• 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 investigational biologics within 3 months or 5 half-lives prior to visit 1, whichever is longer.
• Participants who are actively enrolled in an interventional clinical trial.
• Female participants who are pregnant.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	Measurement of disease control and burden
COPD related HRU	At Baseline	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
Air trapping (E/I ratio)	At Baseline to week 56	Measurement of lung structure profile and change through radiological parameters (CT scan)
Ratio of airway thickness to outer diameter (T/D ratio)	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
Pathological airway remodeling through IHC on biopsies	At Baseline to week 56	Measurement of inflammatory cell locally and systemically
MUC5AC	At Baseline to week 56	Measurement of inflammatory biomarkers profile to develop clinical endotype andphenotype in Chinese COPD, pre-COPD or PRISm
sST2	At Baseline to week 56	Measurement of inflammatory biomarkers profile to develop clinical endotype andphenotype in Chinese COPD, pre-COPD or PRISm
EPO	At Baseline to week 56	Measurement of inflammatory biomarkers profile to develop clinical endotype andphenotype in Chinese COPD, pre-COPD or PRISm
Isoprostanes (IsoPs)	At Baseline to week 56	Measurement of inflammatory biomarkers profile to develop clinical endotype andphenotype in Chinese COPD, pre-COPD or PRISm

Trial Locations

Locations (1)

Research Site; 🇨🇳 Zhengzhou, China