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A Translational Study in Patients With COPD and Pre-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
Led by AstraZeneca · Updated on 2026-06-02
850
Participants Needed
14
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are conducting an observational study to better understand the progression of lung function decline, inflammatory and immune mechanisms in people with pre-COPD or preserved ratio impaired spirometry (PRISm), as well as clinical outcomes and subtypes related to physician-diagnosed COPD. The study will follow participants for one year to gather detailed information on these aspects. The study includes several groups: healthy controls aged 30 or older; individuals aged 30 to 50 with respiratory symptoms or lung abnormalities but without airflow obstruction (pre-COPD or PRISm); mild COPD patients split into two cohorts based on age (30-50 and over 50); and participants aged 50 or older with moderate to very severe COPD. Each group is observed without treatment interventions, focusing on clinical features and biomarkers. Participants will provide medical, occupational, and family history and undergo lung function tests and questionnaires at the start and throughout the 56-week study. Researchers will monitor lung function measures, inflammation markers, respiratory symptoms, medication use, and other biological tests. This comprehensive monitoring aims to identify patient subtypes and support future personalized COPD treatments.
CONDITIONS
Brief Title
A Translational Study for Prediction of Biomarkers and Identification of Phenotype and Endotype of COPD and Pre-COPD Outcomes in Chinese Population
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Capable of giving signed informed consent form
- Able to perform acceptable lung function testing for FEV1 according to American Thoracic Society and European Respiratory Society 2019 criteria
- Able and willing to comply with protocol requirements including reading and writing in the study language
- Allowed to enroll in other non-intervention studies during participation
You will not qualify if you...
- History of alcohol or drug abuse within the past year, contraindicating participation
- Altered mental status at time of informed consent
- Clinically significant abnormal vital signs, ECG, or lab tests interfering with study or safety
- Current diagnosis of asthma
- Clinically important pulmonary disease other than COPD
- COPD exacerbation within 2 weeks prior to enrollment or during screening
- History of lung resection (except single lobe or segmentectomy)
- Lung volume reduction surgery or procedures within 6 months prior or expected during study
- Unstable medical disorders
- Current or recent malignancy within 5 years except certain treated skin or cervical cancers
- Terminal disease or organ failure
- Receipt of marketed or investigational biologics within 3 months or 5 half-lives prior to visit 1
- Pregnant female participants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline visit
Participants undergo assessments including medical history, lung function testing, and biomarker sampling to characterize their clinical status and phenotype.
1 baseline visit (in-person)
Duration - Up to 56 weeks
Participants are observed over time with assessments of respiratory symptoms, lung function, biomarker levels, and medication changes to track disease progression and outcomes.
Multiple visits during 56 weeks; visit frequency depends on cohort assignment
Trial Site Locations
Total: 14 locations
1
Research Site
Beijing, China
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2
Research Site
Changsha, China
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3
Research Site
Chengdu, China
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4
Research Site
Guangzhou, China
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5
Research Site
Hefei, China
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6
Research Site
Nanjing, China
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7
Research Site
Nanning, China
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8
Research Site
Shanghai, China
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9
Research Site
Shanghai, China
Not Yet Recruiting
10
Research Site
Shenyang, China
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11
Research Site
Shenyang, China
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12
Research Site
Wuhan, China
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13
Research Site
Xuzhou, China
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14
Research Site
Zhengzhou, China
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Research Team
A
AstraZeneca Clinical Study Information Center
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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