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

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).

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Other: Prospective observational cohort study

• Study Type: Observational
• Enrollment (Actual): 2005

Contacts and Locations

Study Locations

• China
  • Dongguan, China, 523326
    • GSK Investigational Site
  • Dongguan, China, 523059
    • GSK Investigational Site
  • FoShan, China, 528000
    • GSK Investigational Site
  • Foshan, China, 528041
    • GSK Investigational Site
  • Foshan, China, 528200
    • GSK Investigational Site
  • Guangzhou, China, 510080
    • GSK Investigational Site
  • Guangzhou, China, 510120
    • GSK Investigational Site
  • Guangzhou, China, 510220
    • GSK Investigational Site
  • Guangzhou, China, 510260
    • GSK Investigational Site
  • Guangzhou, China, 510700
    • GSK Investigational Site
  • Guangzhou, China, 511400
    • GSK Investigational Site
  • Guangzhou, China, 510150
    • GSK Investigational Site
  • Guangzhou, China, 510515
    • GSK Investigational Site
  • Heyuan, China, 517199
    • GSK Investigational Site
  • Heyuan, China, 517300
    • GSK Investigational Site
  • Huizhou, China, 516001
    • GSK Investigational Site
  • Huizhou, China, 516000
    • GSK Investigational Site
  • Jiangmen, China, 529000
    • GSK Investigational Site
  • Jiangmen, China, 529700
    • GSK Investigational Site
  • Jieyang, China, 522000
    • GSK Investigational Site
  • Jieyang, China, 515300
    • GSK Investigational Site
  • Meizhou, China, 514700
    • GSK Investigational Site
  • Qingyuan, China, 510030
    • GSK Investigational Site
  • Shantou, China, 515031
    • GSK Investigational Site
  • Shantou, China, 515041
    • GSK Investigational Site
  • Shaoguan, China, 512026
    • GSK Investigational Site
  • Shenzhen, China, 518005
    • GSK Investigational Site
  • Shenzhen, China, 518020
    • GSK Investigational Site
  • Shenzhen, China, 518100
    • GSK Investigational Site
  • Shenzhen, China, 518101
    • GSK Investigational Site
  • Shenzhen, China, 518104
    • GSK Investigational Site
  • Shenzhen, China, 518116
    • GSK Investigational Site
  • Shunde, China, 528300
    • GSK Investigational Site
  • Wengyuan, China, 512600
    • GSK Investigational Site
  • Xiamen, China, 361004
    • GSK Investigational Site
  • Yunfu, China, 527400
    • GSK Investigational Site
  • Zhangshan, China, 528400
    • GSK Investigational Site
  • Zhangshan, China, 528415
    • GSK Investigational Site
  • Zhanjiang, China, 524001
    • GSK Investigational Site
  • Zhaoqing, China, 526400
    • GSK Investigational Site
  • Zhuhai, China, 519000
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Participants with COPD, chronic bronchitis without fixed airflow limitation and never smoker healthy participants will be included in the study.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Main cohort; COPD, chronic bronchitis and healthy participants (never smoker) from Type A and Type B hospitals will be included.	Other: Prospective observational cohort study; Prospective observational cohort study
Sub-cohort; COPD, chronic bronchitis and healthy participants (never smoker) from selected Type A hospitals will be included.	Other: Prospective observational cohort study; Prospective observational cohort study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Main Cohort: Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Month 30	FEV1 is a measure of lung function and is defined as the volume of air that can be forced out in one second after taking a deep breath. FEV1 was measured electronically by spirometry. Baseline value was the assessment with a non-missing value at Day 1 of Month 1. Change from Baseline was calculated as the value at Month 30 minus the value at Baseline. Change from Baseline in pre- and post-bronchodilator FEV1 was assessed and summarized. Also, yearly rate of change in FEV1 (pre- and post-bronchodilator) was analyzed using random coefficients models.	Baseline (Day 1 of Month 1) and at Month 30
Main Cohort: Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Vital Capacity (FVC) at Month 30	FVC is the total amount of air exhaled during FEV test and is a lung function test that is measured during spirometry. Baseline value was the assessment with a non-missing value at Day 1 of Month 1. Change from Baseline was calculated as the value at Month 30 minus the value at Baseline. Change from Baseline in pre- and post-bronchodilator FVC was assessed and summarized. Also, yearly rate of change in FVC (pre- and post-bronchodilator) was analyzed using random coefficients models.	Baseline (Day 1 of Month 1) and at Month 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Main Cohort: Rate of Moderate/Severe Exacerbations in COPD and Chronic Bronchitis Cohorts	Moderate exacerbations are defined as COPD exacerbations that require either systemic corticosteroids (intramuscular, intravenous, or oral) and/or antibiotics. Severe exacerbations are defined as COPD exacerbations requiring hospitalization (including intubation and admittance to an intensive care unit) or result in death. Exacerbation rate = number of moderate or sever exacerbation divided by total participants-years. Analysis performed using a generalized linear model assuming a negative binomial distribution with covariates of type of participants (i.e. GOLD I-IV and chronic bronchitis), gender, smoking status, exacerbation history (moderate/severe), site (type of hospital), maintenance therapy (Y/N) and inhaled corticosteroid (ICS) containing (Y/N), Childhood chest disease (Y/N) and biomass fuel exposure (Y/N), age, and with offset logarithm of time on study.	Up to 30 months
Main Cohort: Change From Baseline in COPD Assessment Test (CAT) Score at Month 30	The CAT is a validated 8-items questionnaire developed for use in routine clinical practice to measure the health status of participants with COPD. Participants rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment), higher score indicates greater impairment. A total CAT score was calculated by summing the non-missing scores of the eight items with a scoring range of 0 (no disease impact) to 40 (maximum disease impact). Higher scores indicated greater disease impact. Baseline value was the assessment with a non-missing value at Day 1 of Month 1. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.	Baseline (Day 1 of Month 1) and at Month 30
Main Cohort: Absolute Values of CAT Score at Month 30	The CAT is a validated 8-items questionnaire developed for use in routine clinical practice to measure the health status of participants with COPD. Participants rate their experience on a 6-point scale, ranging from 0 (no impairment) to 5 (maximum impairment), higher score indicates greater impairment. A total CAT score was calculated by summing the non-missing scores of the eight items with a scoring range of 0 (no disease impact) to 40 (maximum disease impact). Higher scores indicated greater disease impact.	At Month 30
Main Cohort: Total Score of COPD Assessment in Primary Care to Identify Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE) at Baseline	The CATPURE is a short, five-item questionnaire that can be easily completed by participants and are used to identify individuals who may have undiagnosed, clinically significant COPD. The algorithm is a simple summation of participants responses to each of the five items. For Question 1-4: Score 0 for 'No' and Score 1 for 'Yes'; Question 5: Score 0 for 'None', 1 for 'Once' and 2 for '2 or more'. Total score is ranging from 0 to 6, higher score means higher risk of COPD (0-1 is at low risk, 2-6 is at high risk). Baseline value was the assessment with a non-missing value at Day 1 of Month 1.	At Baseline (Day 1 of Month 1)
Main Cohort: Total Score of CAPTURE at Month 18	The CATPURE is a short, five-item questionnaire that can be easily completed by participants and are used to identify individuals who may have undiagnosed, clinically significant COPD. The algorithm is a simple summation of participants responses to each of the five items. For Question 1-4: Score 0 for 'No' and Score 1 for 'Yes'; Question 5: Score 0 for 'None', 1 for 'Once' and 2 for '2 or more'. Total score is ranging from 0 to 6, higher score means higher risk of COPD (0-1 is at low risk, 2-6 is at high risk).	At Month 18
Main Cohort: Number of Participants With Any Clinically Important Deterioration (CID) Event and Its Components From Baseline to Month 6	CID was defined as decrease of greater than or equal to (>=) 100 milliliter (mL) in post-bronchodilator FEV1 or increase of >=2 units in the CAT, or an occurrence of a moderate/severe exacerbation. CID was derived from three key clinical assessments: 1. moderate/severe exacerbations, 2. worsening of FEV1, and 3. worsening of health status using the CAT questionnaire. Baseline value was the assessment with a non-missing value at Day 1 of Month 1. A participant may have more than one CID components, hence total of participants with individual CID components may not match with participants with 'Any CID' category. Number of participants with any CID event and its components (Exacerbation CID, FEV1 CID and CAT CID) observed from Baseline to Month 6 have been presented.	Baseline (Day 1 of Month 1) to Month 6
Main Cohort: Number of Participants With Any CID Event and Its Components From Months 6 to 18	CID was defined as: decrease of greater than or equal to (>=) 100 milliliter (mL) in post-bronchodilator FEV1 or increase of >=2 units in the CAT, or an occurrence of a moderate/severe exacerbation. CID was derived from three key clinical assessments: 1. moderate/severe exacerbations, 2. worsening of FEV1, and 3. worsening of health status using the CAT questionnaire. A participant may have more than one CID components, hence total of participants with individual CID components may not match with participants with 'Any CID' category. Number of participants with any CID event and its components (Exacerbation CID, FEV1 CID and CAT CID) observed from Months 6 to 18 have been presented.	Months 6 to 18
Main Cohort: Number of Participants With Any CID Event and Its Components From Months 18 to 30	CID was defined as: decrease of greater than or equal to (>=) 100 milliliter (mL) in post-bronchodilator FEV1 or increase of >=2 units in the CAT, or an occurrence of a moderate/severe exacerbation. CID was derived from three key clinical assessments: 1. moderate/severe exacerbations, 2. worsening of FEV1, and 3. worsening of health status using the CAT questionnaire. A participant may have more than one CID components, hence total of participants with individual CID components may not match with participants with 'Any CID' category. Number of participants with any CID event and its components (Exacerbation CID, FEV1 CID and CAT CID) observed from Months 18 to 30 have been presented.	Months 18 to 30
Main Cohort: Number of Participants Who Died	Number of participants who died during study have been presented.	Up to 30 months
Sub-cohort: Change From Baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) Total Scores From Months 1 to 6	E-RS: COPD is a subset of Exacerbations of Chronic pulmonary Disease Tool (EXACT). E-RS: COPD is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: respiratory symptoms-breathlessness (RS-BRL) comprised of 5 items (2 items scored from 0-4 and 3 items scored from 0-3); RS-cough and sputum (RS-CSP) comprised of 3 items(2 items scored from 0-4 and 1 item scored from 0-3);and RS-chest symptoms (RS-CSY) comprised of 3 items (scored from 0-4). The total score was calculated by taking sum of all individual 11 item scores, which ranges between 0-40 and higher score indicates more severe symptoms. Baseline value was the assessment with a non-missing value at Day 1 of Month 1. The 1 to 6 month E-RS:COPD total score value was derived by calculating the average of E-RS:COPD total scores collected between month 1 and 6. Change from Baseline was calculated by subtracting Baseline value from 1-6 month average total score value.	Baseline (Day 1 of Month 1) and Months 1 to 6
Sub-cohort: Change From Baseline in E-RS:COPD Total Scores From Months 18 to 24	E-RS: COPD is a subset of Exacerbations of Chronic pulmonary Disease Tool (EXACT). E-RS: COPD is a tool that consists of 11 items from the 14 item EXACT instrument. The domains include: respiratory symptoms-breathlessness (RS-BRL) comprised of 5 items (2 items scored from 0-4 and 3 items scored from 0-3); RS-cough and sputum (RS-CSP) comprised of 3 items(2 items scored from 0-4 and 1 item scored from 0-3);and RS-chest symptoms (RS-CSY) comprised of 3 items (scored from 0-4). The total score was calculated by taking sum of all individual 11 item scores, which ranges between 0-40 and higher score indicates more severe symptoms. Baseline value was the assessment with a non-missing value at Day 1 of Month 1. The 18 to 24 month E-RS:COPD total score value was derived by calculating the average of E-RS:COPD total scores collected between month 18 and 24. Change from Baseline was calculated by subtracting Baseline value from 18-24 month average total score value.	Baseline (Day 1 of Month 1) and Months 18 to 24
Sub-cohort: Number of Participants With Exacerbation of COPD Tool (EXACT) Events From Months 1 to 6	The EXACT is a 14-item daily diary designed to provide a measure of patient-reported symptoms of COPD exacerbation. An EXACT Total Score, ranging from 0 to 100, where higher scores indicate a more severe condition. EXACT events were defined as magnitude of responder for symptomatic events defined as acute, sustained symptomatic worsening of COPD, defined as an increase in EXACT score >=9 points for 3 days or >=12 points for 2 days, above Baseline (Baseline value is average of 7-day period [Day 1 to 7]). Number of participants with EXACT events observed from Months 1 to 6 have been presented.	Months 1 to 6
Sub-cohort: Number of Participants With EXACT Events From Months 18 to 24	The EXACT is a 14-item daily diary designed to provide a measure of patient-reported symptoms of COPD exacerbation. An EXACT Total Score, ranging from 0 to 100, where higher scores indicate a more severe condition. EXACT events were defined as magnitude of responder for symptomatic events defined as acute, sustained symptomatic worsening of COPD, defined as an increase in EXACT score >=9 points for 3 days or >=12 points for 2 days, above Baseline (Baseline value is average of 7-day period [Day 1 to 7]). Number of participants with EXACT events observed from Months 18 to 24 have been presented.	Months 18 to 24
Sub-cohort: Absolute Values of Digital Physical Activity at Baseline (Average of Days 1 to 7)	Digital physical activity was evaluated by daily steps as assessed by a wrist band dispensed at Baseline. Participants were required to keep wearing the wrist band. The daily step data was based on the daily average steps (steps per day) for each participant. Baseline value was derived as the average value of first 7 days (Days 1 to 7 at Month 1).	At Baseline (Days 1 to 7 at Month 1)
Sub-cohort: Absolute Values of Digital Physical Activity at Month 1 (Average of Day 8 to Month 1)	Digital physical activity was evaluated by daily steps as assessed by a wrist band dispensed at Baseline. Participants were required to keep wearing the wrist band. The daily step data was based on the daily average steps (steps per day) for each participant. Month 1 value was derived as the average of daily step data up to 30 days from study Day 8.	Up to 30 days from study Day 8
Sub-cohort: Absolute Values of Digital Physical Activity at Month 18 (Average of Months 18 to 19)	Digital physical activity was evaluated by daily steps as assessed by a wrist band dispensed at Baseline. Participants were required to keep wearing the wrist band. The daily step data was based on the daily average steps (steps per day) for each participant. Month 18 value was derived as the average of daily step data up to 30 days from Month 18.	Up to 30 days from Month 18 (Months 18 to 19)
Main Cohort: Absolute Values of Plasma Fibrinogen at Baseline	Fibrinogen is a protein, specifically a clotting factor (factor I), that is essential for proper blood clot formation. Blood samples were collected to evaluate the amount of fibrinogen. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.	At Baseline (Day 1 of Month 1)
Main Cohort: Absolute Values of Plasma Fibrinogen at Month 30	Fibrinogen is a protein, specifically a clotting factor (factor I), that is essential for proper blood clot formation. Blood samples were collected to evaluate the amount of fibrinogen.	At Month 30
Main Cohort: Absolute Values of C-Reactive Protein at Baseline	Blood samples were collected for the analysis of C-Reactive Protein. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.	At Baseline (Day 1 of Month 1)
Main Cohort: Absolute Values of C-Reactive Protein at Month 30	Blood samples were collected for the analysis of C-Reactive Protein.	At Month 30
Main Cohort: Absolute Values of Eosinophils and Neutrophils at Baseline	Blood samples were collected for the analysis of eosinophils and neutrophils. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.	At Baseline (Day 1 of Month 1)
Main Cohort: Absolute Values of Eosinophils and Neutrophils at Month 30	Blood samples were collected for the analysis of eosinophils and neutrophils.	At Month 30
Main Cohort: Absolute Values of Hemoglobin at Baseline	Blood samples were collected for the analysis of hemoglobin. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.	At Baseline (Day 1 of Month 1)
Main Cohort: Absolute Values of Hemoglobin at Months 30	Blood samples were collected for the analysis of hemoglobin.	At Month 30
Sub-cohort: Absolute Values of Serum Interferon-gamma-inducible Protein -10 (IP-10) and Serum Soluble Receptor for Advanced Glycation End Products (sRAGE) at Baseline	Blood samples were collected at Baseline for the analysis of blood biomarkers serum IP-10 and serum sRAGE. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.	At Baseline (Day 1 of Month 1)
Sub-cohort: Absolute Values of Serum IP-10 and Serum sRAGE at Month 30	Blood samples were collected at Month 30 for the analysis of blood biomarkers serum IP-10 and serum sRAGE.	At Month 30
Sub-cohort: Absolute Values of Club Cell Protein (CC16) at Baseline	Blood samples were collected for the analysis of blood biomarker CC16. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.	At Baseline (Day 1 of Month 1)
Sub-cohort: Absolute Values of CC16 at Month 30	Blood samples were collected for the analysis of blood biomarker CC16.	At Month 30
Sub-cohort: Absolute Values of Glycated Hemoglobin A1c (HbA1c) at Baseline	Blood samples were collected for the analysis of HbA1c. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.	At Baseline (Day 1 of Month 1)
Sub-cohort: Absolute Values of HbA1c at Month 30	Blood samples were collected for the analysis of HbA1c.	At Month 30
Sub-cohort: Sputum Microbiome as Assessed by Molecular Methods	Sputum microbiome evaluation involves extraction of deoxyribonucleic acid from sputum samples and analyzing it to identify the microbial community present in the samples using molecular methods. There were not enough samples for analysis. Consequently, data was not analyzed, and data will never be analyzed for this outcome measure in the future.	Up to 30 months
Sub-cohort: Absolute Values of Total Cell Count of Sputum Sample at Baseline	Sputum samples were collected from the participants for assessment of total cell count. Baseline value was the assessment with a non-missing value at Day 1 of Month 1. Data was not collected for "Never Smoker Healthy Control" arm as sputum samples were not collected at Baseline visit for healthy control group as per the Protocol.	At Baseline (Day 1 of Month 1)
Sub-cohort: Absolute Values of Total Cell Count of Sputum Sample at Month 30	Sputum samples were collected from the participants for assessment of total cell count.	At Month 30
Main Cohort: Number of Participants With COPD Medication	Number of participants with COPD medications received have been presented in separate categories. Data was collected in following categories: Naïve, long-acting muscarinic antagonist (LAMA), long-acting beta agonist (LABA), inhaled corticosteroid (ICS)/LABA, LAMA/LABA, Triple (open), and Triple (closed).	Up to 30 months
Main Cohort: Number of Participants With Change From Baseline in Treatment Pattern	Data was collected in following categories: Step-up (the treatment pattern grade become larger than previous visit), Switch (the treatment pattern changed within a same grade (except grade 0), Stable (the treatment pattern remain the same (except grade 0), Step-down (participants receive treatment and the grade goes down compared with the previous visit), Stop/Missing (No treatment record in the period), and Naïve with respect to their treatment received. Baseline value was the assessment with a non-missing value at Day 1 of Month 1. Number of participants with change from Baseline in treatment pattern have been presented.	Baseline (Day 1 of Month 1) and Month 30
Number of Participants With COPD Related Outpatient Visits	Number of participants with COPD related outpatient visits have been presented.	Up to 30 months
Number of Participants With Non-COPD Related Outpatient Visits	Number of participants with non-COPD related outpatient visits have been presented.	Up to 30 months
Number of Participants With COPD Related Emergency Visits	Number of participants with COPD related emergency visits have been presented.	Up to 30 months
Number of Participants With Non-COPD Related Emergency Visits	Number of participants with non-COPD related emergency visits have been presented.	Up to 30 months
Number of Participants With COPD Related Hospitalizations Visits	Number of participants with COPD related hospitalizations visits have been presented.	Up to 30 months
Number of Participants With Non-COPD Related Hospitalizations Visits	Number of participants with non-COPD related hospitalizations visits have been presented.	Up to 30 months
Direct Medical Costs Associated With COPD Medications During Study Period	Direct medical costs of out-of-pocket payment and basic insurance were included for following items: Hospital, Outpatient, Emergency, Participant check, Participant therapy and Prescribing costs.	Up to 30 months
Sub-cohort: Absolute Values of Airway Wall Area at Baseline	Airway wall area, in ratio, at Baseline is calculated by dividing airway wall area by total airway area, using low-dose high-resolution computed tomography (HRCT) acquired at Baseline. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.	Baseline (Day 1 of Month 1)
Sub-cohort: Absolute Values of Airway Wall Area at Month 30	Airway wall area, in ratio, at Month 30 is calculated by dividing airway wall area by total airway area, using low-dose HRCT acquired at Month 30.	At Month 30
Sub-cohort: Average of Airway Major Inner Diameter at Baseline	Average of airway major inner diameter at Baseline is the averaged longest axis of the airway's cross-section in low-dose HRCT acquired at Baseline. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.	Baseline (Day 1 of Month 1)
Sub-cohort: Average of Airway Major Inner Diameter at Month 30	Average of airway major inner diameter at Month 30 is the averaged longest axis of the airway's cross-section in low-dose HRCT acquired at Month 30.	At Month 30
Sub-cohort: Average of Airway Minor Inner Diameter at Baseline	Average of airway minor inner diameter at Baseline is the averaged shortest axis of the airway's cross-section in low-dose high-resolution Computed Tomography (HRCT) acquired at Baseline. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.	Baseline (Day 1 of Month 1)
Sub-cohort: Average of Airway Minor Inner Diameter at Month 30	Average of airway minor inner diameter at Month 30 is the averaged shortest axis of the airway's cross-section in low-dose HRCT acquired at Month 30.	At Month 30
Sub-cohort: Total Airway Count at Baseline	Total airway count at Baseline is derived by summing the number of airway segments identified on low-dose HRCT acquired at Baseline. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.	Baseline (Day 1 of Month 1)
Sub-cohort: Total Airway Count at Month 30	Total airway count at Month 30 is derived by summing the number of airway segments identified on low-dose HRCT acquired at Month 30.	At Month 30
Sub-cohort: Absolute Values of Perimeter of 10 Millimeter (mm) (Pi10) at Baseline	Pi10 at Baseline is a measure of airway wall thickness, which is calculated by the square root of wall area for a theoretical airway with an internal perimeter of 10 millimeter, using low-dose HRCT acquired at Baseline. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.	Baseline (Day 1 of Month 1)
Sub-cohort: Absolute Values of Pi10 at Month 30	Pi10 at Month 30 is a measure of airway wall thickness, which is calculated by the square root of wall area for a theoretical airway with an internal perimeter of 10 millimeter, using low-dose HRCT acquired at Month 30.	At Month 30
Sub-cohort: Computed Tomography (CT) Attenuation at the 15th Percentile of the Lung CT Histogram (Perc15) in Residual Volume at Baseline	Perc15 in residual volume (RV) at Baseline is the cut-off value, in Hounsfield Unit (HU), below which are distributed the 15 percent of the voxels with the lowest density in low-dose HRCT, acquired at full expiration at Baseline. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.	Baseline (Day 1 of Month 1)
Sub-cohort: Perc15 in Residual Volume at Month 30	Perc15 in residual volume (RV) at Month 30 is the cut-off value, in Hounsfield Unit (HU), below which are distributed the 15 percent of the voxels with the lowest density in low-dose HRCT, acquired at full expiration at Month 30.	At Month 30
Sub-cohort: Perc15 in Total Lung Capacity at Baseline	Perc15 in total lung capacity (TLC) at Baseline is the cut-off value, in Hounsfield Unit (HU), below which are distributed the 15 percent of the voxels with the lowest density in low-dose HRCT, acquired at full inspiration at Baseline. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.	Baseline (Day 1 of Month 1)
Sub-cohort: Perc15 in Total Lung Capacity at Month 30	Perc15 in total lung capacity (TLC) at Month 30 is the cut-off value, in Hounsfield Unit (HU), below which are distributed the 15 percent of the voxels with the lowest density in low-dose HRCT, acquired at full inspiration at Month 30.	At Month 30
Sub-cohort: Absolute Values of Low Attenuation Area -950 (LAA-950) at Baseline	LAA-950 at Baseline is percentage (%) of voxels with attenuation less than or equal to (<=)-950 Hounsfield Unit (HU), which is associated with the extent of emphysema, computed using low-dose HRCT acquired at Baseline. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.	Baseline (Day 1 of Month 1)
Sub-cohort: Absolute Values of LAA-950 at Month 30	LAA-950 at Month 30 is percentage (%) of voxels with attenuation <=-950 Hounsfield Unit (HU), which is associated with the extent of emphysema, computed using low-dose HRCT acquired at Month 30.	At Month 30
Sub-cohort: Absolute Values of Disease Probability Measure (DPM) to Assess Gas Trapping at Baseline	Percentage of whole lung associated with gas trapping (GT) as measured by DPM at Baseline. DPM uses low-dose HRCT acquired at both full inspiration (total lung capacity [TLC]) and full expiration (residual volume [RV]) for calculating the percentage of lung volume associated with gas trapping. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.	Baseline (Day 1 of Month 1)
Sub-cohort: Absolute Values of DPM to Assess Gas Trapping at Month 30	Percentage of whole lung associated with gas trapping (GT) as measured by DPM at Week 30. DPM uses low-dose HRCT acquired at both full inspiration (total lung capacity [TLC]) and full expiration (residual volume [RV]) for calculating the percentage of lung volume associated with gas trapping.	At Month 30
Sub-cohort: Absolute Values of DPM to Assess Emphysema at Baseline	Percentage of whole lung associated with emphysema as measured by DPM at Baseline. DPM uses low-dose HRCT acquired at both full inspiration (total lung capacity [TLC]) and full expiration (residual volume [RV]) for calculating the percentage of lung volume associated with emphysema. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.	Baseline (Day 1 of Month 1)
Sub-cohort: Absolute Values of DPM to Assess Emphysema at Month 30	Percentage of whole lung associated with emphysema as measured by DPM at Month 30. DPM uses low-dose HRCT acquired at both full inspiration (total lung capacity [TLC]) and full expiration (residual volume [RV]) for calculating the percentage of lung volume associated with emphysema.	At Month 30
Sub-cohort: Absolute Values of DPM to Assess Normal Tissue at Baseline	Percentage of whole lung associated with normal tissue (NT) as measured by DPM at Baseline. DPM uses low-dose HRCT acquired at both full inspiration (total lung capacity [TLC]) and full expiration (residual volume [RV]) for calculating the percentage of lung volume associated with normal tissue. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.	Baseline (Day 1 of Month 1)
Sub-cohort: Absolute Values of DPM to Assess Normal Tissue at Month 30	Percentage of whole lung associated with normal tissue (NT) as measured by DPM at Month 30. DPM uses low-dose HRCT acquired at both full inspiration (total lung capacity [TLC]) and full expiration (residual volume [RV]) for calculating the percentage of lung volume associated with normal tissue.	At Month 30
Sub-cohort: Air Volume Ratio (RV/TLC) at Baseline	Air volume ratio at Baseline is defined as air volume at full expiration (FE) (residual volume [RV]) divided by air volume at full inspiration (FI) (total lung capacity [TLC]) multiplied by 100 (expressed as percentage), measured using low-dose HRCT acquired at Baseline. Baseline value was the assessment with a non-missing value at Day 1 of Month 1.	Baseline (Day 1 of Month 1)
Sub-cohort: Air Volume Ratio (RV/TLC) at Month 30	Air volume ratio at Month 30 is defined as air volume at full expiration (FE) (residual volume [RV]) divided by air volume at full inspiration (FI) (total lung capacity [TLC]) multiplied by 100 (expressed as percentage), measured using low-dose HRCT acquired at Month 30.	At Month 30

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Collaborators: Guangzhou Institute of Respiratory Health (GIRH)
• Investigators: Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2020
• Primary Completion (Actual): June 25, 2024
• Study Completion (Actual): June 25, 2024

Study Registration Dates

• First Submitted: April 16, 2021
• First Submitted That Met QC Criteria: April 16, 2021
• First Posted (Actual): April 21, 2021

Study Record Updates

• Last Update Posted (Actual): August 20, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: China; COPD; Phenotypes; Endotypes; Chronic bronchitis; Healthy control
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 208630

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No