Status:
COMPLETED
Investigation of Chronic Obstructive Pulmonary Disease (COPD) Phenotypes and Endotypes in China
Lead Sponsor:
GlaxoSmithKline
Collaborating Sponsors:
Guangzhou Institute of Respiratory Health (GIRH)
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
50-80 years
Brief Summary
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 r...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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.
- Exclusion criteria:
- Having undergone lung surgery.
- 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.
- Participating or plan to participant in any clinical studies where investigational drugs were tested.
- Unable or unwilling to use required digital devices (sub- cohort only).
- 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.
- 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).
- 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.
- FVC \<80% Predicted.
Exclusion
Key Trial Info
Start Date :
April 22 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 25 2024
Estimated Enrollment :
2005 Patients enrolled
Trial Details
Trial ID
NCT04853225
Start Date
April 22 2020
End Date
June 25 2024
Last Update
August 20 2025
Active Locations (41)
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1
GSK Investigational Site
Dongguan, China, 523059
2
GSK Investigational Site
Dongguan, China, 523326
3
GSK Investigational Site
Foshan, China, 528000
4
GSK Investigational Site
Foshan, China, 528041