NCT04853225Completed
Investigation of Chronic Obstructive Pulmonary Disease (COPD) Phenotypes and Endotypes in China
Investigation of the Clinical, Radiological and Biological Factors Associated With Disease Progression, Phenotypes and Endotypes of COPD in China
Source: ClinicalTrials.gov · Last updated 20 Aug 2025
Brief summary (registry, in English)
This is a non-drug interventional cohort study, which aims to investigate the clinical, radiological and biological factors associated with disease progression in COPD in China. Participants will be recruited from multiple hospitals across Guangdong province categorized as Type A hospitals (those at prefecture-level and above) and Type B hospitals (those below prefecture-level).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 2005 (actual)
- First submitted
- 16 Apr 2021
- Start date
- 22 Apr 2020
- Primary completion date
- 25 Jun 2024
- Lead sponsor
- GlaxoSmithKline
- Diseases
- COPD
- NCT number
- NCT04853225
What you commit to
- Study type: Observational
- Participants enrolled: 2005
- From 22 Apr 2020 to the primary completion date, 25 Jun 2024
- 20 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Having undergone lung surgery.
- Participating or plan to participant in any clinical studies where investigational drugs were tested.
- Have evidence of alcohol or drug abuse.
- Have received a blood transfusion in the 4 weeks prior to study start.
- On long-term oral corticosteroids.
Other illness
- Known respiratory disorders or significant inflammatory disease other than COPD.
- Serious, uncontrolled disease (including serious psychological disorders)
- Confirmed cancer, unless participants in remission for more than or equal to (\>=)5 years.
- Known disorders other than COPD that may significantly impact clinical assessments
- Additional exclusion criteria for chronic bronchitis participants and healthy participants:
- Known disorders that may significantly impact clinical assessments.
Other
- Unable or unwilling to use required digital devices (sub- cohort only).
- Unable to walk.
- Unable to read and understand Mandarin Chinese.
- Additional exclusion criteria for COPD participants:
- Current primary diagnosis of asthma (participants with a primary diagnosis of COPD but who also had asthma \[Asthma COPD overlap {ACO}\] could be included).
- FVC \<80% Predicted.
Who the study is looking for
- Male or female participants, aged 50-80 years inclusive. A female is eligible only if she is of non-child bearing potential.
- Body mass index (BMI) less than (\<)35.
- A signed and dated written informed consent is obtained prior to participation.
- Additional inclusion criteria for COPD participants:
- A Baseline (post-bronchodilator) (FEV1/FVC) ratio \<70 percent (%).
- Clinically stable and has no exacerbations for at least 1 month prior to recruitment.
- Ever smoker or never smoker.
- Additional inclusion criteria for chronic bronchitis participants:
- Free from other significant diseases.
- Baseline post-bronchodilator FEV1/FVC ratio more than (\>)70%.
- Chronic bronchitis is defined as at least 3 months of cough and phlegm in a year in the past 2 years.
- Clinically stable and has no exacerbations for at least 1 month prior to recruitment.
- Ever smoker or never smoker
- Additional inclusion criteria for healthy participants:
- Free from any significant diseases
- Baseline post-bronchodilator FEV1/FVC ratio \>70%.
- A CAT score \<10.
- Never smoker. Passive smoker is not eligible.
Age in the registry: 50 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (20)
Sites in registry order. Save your city in your profile to sort them by distance.
Related publications
- Low sRAGE Level is Associated with Increased Future Exacerbation Risk in Mild-to-Moderate COPD and Patients with Chronic Bronchitis Symptoms.Int J Chron Obstruct Pulmon Dis · 2026 · PMID 42569464
This page is information, not medical advice. Discuss any trial with your doctor.