Last updated: 08/04/2025 14:20:07
Investigation of Chronic Obstructive Pulmonary Disease (COPD) phenotypes and endotypes in China
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Investigation of the Clinical, Radiological and Biological factors associated with disease progression, phenotypes and endotypes of COPD in China
Trial description: 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).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Change from Baseline in Forced expiratory volume in 1 second (FEV1) and Forced vital capacity (FVC) (Milliliters)
Timeframe: Baseline and Up to 2.5 years
Rate of moderate and severe exacerbations per year
Timeframe: Up to 2.5 years
Secondary outcomes:
Change from Baseline in COPD assessment test (CAT) score
Timeframe: Baseline and Up to 2.5 years
Change from Baseline in lung density
Timeframe: Baseline and Up to 2.5 years
Change from Baseline in airway wall thickness
Timeframe: Baseline and Up to 2.5 years
Change from Baseline in daily step count
Timeframe: Baseline and Up to 1.5 years
Number of participants with changes in sputum microbiome
Timeframe: Up to 2.5 years
Interventions:
Other: Prospective observational cohort study
Enrollment:
2005
Observational study model:
Cohort
Primary completion date:
2024-25-06
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
vilanterol
Collaborators
Guangzhou Institute of Respiratory Health (GIRH)
Study date(s)
April 2020 to June 2024
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
50 - 80 Years
Accepts healthy volunteers
Yes
- 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.
- Having undergone lung surgery.
- Known respiratory disorders or significant inflammatory disease other than COPD.
Inclusion and exclusion criteria
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.
Trial location(s)
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
No study documents available
Recruitment status
Finalized
Actual primary completion date
2024-25-06
Actual study completion date
2024-25-06
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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