Understanding biomarkers and outcomes in COPD among the Chinese population

A Translational Study in Patients With COPD and Early COPD to Describe Patient Clinical Characteristics, Treatment Patterns, Biomarkers and to Identify Phenotypes and Endotypes Associated With Differential Outcomes That May Support Future Development of Personalized Treatment Strategies in Chinese Population

This study looks at how chronic obstructive pulmonary disease (COPD) affects lung function and health outcomes in Chinese patients to help improve their care and treatment.

Quick facts

• Study type: Observational
• Enrollment: 850 (estimated)
• Ages: 30 Years and up
• Sex: All
• Sponsor: AstraZeneca (Industry-sponsored)
• Locations: 12 sites (Beijing and 11 other locations)
• Trial ID: NCT06724848 on ClinicalTrials.gov

What this trial studies

This observational study aims to gain a deeper understanding of chronic obstructive pulmonary disease (COPD) by examining the decline in lung function, inflammatory and immunological mechanisms, and clinical outcomes in diagnosed patients. Participants will be followed for an initial period of one year, with the possibility of extending follow-up to three years based on emerging data. The study focuses on identifying specific phenotypes and endotypes of COPD to improve patient management and outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals diagnosed with COPD who can provide informed consent and meet specific lung function testing criteria.

Not a fit: Patients with a history of substance abuse or significant mental health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better-targeted treatments and improved management strategies for COPD patients.

How similar studies have performed: While there have been studies on COPD, this particular approach focusing on biomarkers and phenotypes in the Chinese population is relatively novel.

Eligibility criteria

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.

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.

Where this trial is running

Beijing and 11 other locations

• Research Site — Beijing, China (Not_yet_recruiting)
• Research Site — Changsha, China (Not_yet_recruiting)
• Research Site — Chengdu, China (Not_yet_recruiting)
• Research Site — Guangzhou, China (Recruiting)
• Research Site — Hefei, China (Not_yet_recruiting)
• Research Site — Nanjing, China (Not_yet_recruiting)
• Research Site — Nanning, China (Not_yet_recruiting)
• Research Site — Shanghai, China (Not_yet_recruiting)
• Research Site — Shenyang, China (Not_yet_recruiting)
• Research Site — Wuhan, China (Not_yet_recruiting)
• Research Site — Xuzhou, China (Not_yet_recruiting)
• Research Site — Zhengzhou, China (Not_yet_recruiting)

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center

Conditions COPD