N/A
N=2,005
Investigation of Chronic Obstructive Pulmonary Disease (COPD) Phenotypes and Endotypes in China
Pulmonary Disease, Chronic Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT04853225 ↗Enrolled (actual)
2,005
Serious AEs
—
Results posted
Aug 2025
Primary outcome: Primary: Main Cohort: Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Month 30 — -158.9; -93.9; -1.2; -17.3 Milliliter
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Prospective observational cohort study (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Main Cohort: Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Month 30 |
-158.9; -93.9; -1.2; -17.3; -144.4; -53.6 | — |
| PRIMARY Main Cohort: Change From Baseline in Pre-bronchodilator and Post-bronchodilator Forced Vital Capacity (FVC) at Month 30 |
-229.2; -161.0; -58.6; -27.3; -139.8; -26.4 | — |
| SECONDARY Main Cohort: Rate of Moderate/Severe Exacerbations in COPD and Chronic Bronchitis Cohorts |
0.08; 0.12; 0.26; 0.35; 0.02 | — |
| SECONDARY Main Cohort: Change From Baseline in COPD Assessment Test (CAT) Score at Month 30 |
-0.9; -2.3; 0.3 | — |
| SECONDARY Main Cohort: Absolute Values of CAT Score at Month 30 |
7.5; 5.7; 1.3 | — |
| SECONDARY Main Cohort: Total Score of COPD Assessment in Primary Care to Identify Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE) at Baseline |
2.6; 2.0; 0.3 | — |
| SECONDARY Main Cohort: Total Score of CAPTURE at Month 18 |
2.5; 1.8; 0.4 | — |
| SECONDARY Main Cohort: Number of Participants With Any Clinically Important Deterioration (CID) Event and Its Components From Baseline to Month 6 |
897; 90; 58; 153; 1; 0 | — |
| SECONDARY Main Cohort: Number of Participants With Any CID Event and Its Components From Months 6 to 18 |
1120; 97; 82; 211; 0; 0 | — |
| SECONDARY Main Cohort: Number of Participants With Any CID Event and Its Components From Months 18 to 30 |
1086; 93; 68; 177; 2; 0 | — |
| SECONDARY Main Cohort: Number of Participants Who Died |
41; 2; 0 | — |
| SECONDARY Sub-cohort: Change From Baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) Total Scores From Months 1 to 6 |
0.697; -0.018; 0.020 | — |
| SECONDARY Sub-cohort: Change From Baseline in E-RS:COPD Total Scores From Months 18 to 24 |
1.735; 1.014; 0.086 | — |
| SECONDARY Sub-cohort: Number of Participants With Exacerbation of COPD Tool (EXACT) Events From Months 1 to 6 |
59; 12; 1 | — |
| SECONDARY Sub-cohort: Number of Participants With EXACT Events From Months 18 to 24 |
55; 13; 0 | — |
| SECONDARY Sub-cohort: Absolute Values of Digital Physical Activity at Baseline (Average of Days 1 to 7) |
7986.2; 8743.2; 12063.6 | — |
| SECONDARY Sub-cohort: Absolute Values of Digital Physical Activity at Month 1 (Average of Day 8 to Month 1) |
8461.3; 9284.5; 12790.5 | — |
| SECONDARY Sub-cohort: Absolute Values of Digital Physical Activity at Month 18 (Average of Months 18 to 19) |
6138.3; 6454.3; 7495.4 | — |
| SECONDARY Main Cohort: Absolute Values of Plasma Fibrinogen at Baseline |
337.1; 315.8; 304.4 | — |
| SECONDARY Main Cohort: Absolute Values of Plasma Fibrinogen at Month 30 |
341.2; 328.4; 315.9 | — |
| SECONDARY Main Cohort: Absolute Values of C-Reactive Protein at Baseline |
0.2791; 0.2463; 0.1654 | — |
| SECONDARY Main Cohort: Absolute Values of C-Reactive Protein at Month 30 |
0.3411; 0.2734; 0.1645 | — |
| SECONDARY Main Cohort: Absolute Values of Eosinophils and Neutrophils at Baseline |
0.231; 0.199; 0.109; 4.467; 4.180; 3.810 | — |
| SECONDARY Main Cohort: Absolute Values of Eosinophils and Neutrophils at Month 30 |
0.267; 0.228; 0.145; 4.516; 4.198; 3.667 | — |
| SECONDARY Main Cohort: Absolute Values of Hemoglobin at Baseline |
142.2; 141.6; 132.7 | — |
| SECONDARY Main Cohort: Absolute Values of Hemoglobin at Months 30 |
143.4; 144.3; 135.3 | — |
| SECONDARY 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 |
41.193; 36.025; 48.524; 907.135; 993.892; 1101.124 | — |
| SECONDARY Sub-cohort: Absolute Values of Serum IP-10 and Serum sRAGE at Month 30 |
54.435; 53.711; 35.103; 1046.746; 1287.528; 1166.739 | — |
| SECONDARY Sub-cohort: Absolute Values of Club Cell Protein (CC16) at Baseline |
8.8512; 9.2704; 7.8313 | — |
| SECONDARY Sub-cohort: Absolute Values of CC16 at Month 30 |
15.2812; 15.5412; 14.4739 | — |
| SECONDARY Sub-cohort: Absolute Values of Glycated Hemoglobin A1c (HbA1c) at Baseline |
5.68; 5.87; 5.66 | — |
| SECONDARY Sub-cohort: Absolute Values of HbA1c at Month 30 |
5.74; 5.99; 5.83 | — |
| SECONDARY Sub-cohort: Sputum Microbiome as Assessed by Molecular Methods |
— | — |
| SECONDARY Sub-cohort: Absolute Values of Total Cell Count of Sputum Sample at Baseline |
545.981; 529.603 | — |
| SECONDARY Sub-cohort: Absolute Values of Total Cell Count of Sputum Sample at Month 30 |
766.888; 550.053; 835.903 | — |
| SECONDARY Main Cohort: Number of Participants With COPD Medication |
1649; 102; 8; 115; 77; 19 | — |
| SECONDARY Main Cohort: Number of Participants With Change From Baseline in Treatment Pattern |
104; 0; 32; 10; 309; 1548 | — |
| SECONDARY Number of Participants With COPD Related Outpatient Visits |
1240; 50; 3 | — |
| SECONDARY Number of Participants With Non-COPD Related Outpatient Visits |
0; 0; 0 | — |
| SECONDARY Number of Participants With COPD Related Emergency Visits |
185; 5; 0 | — |
| SECONDARY Number of Participants With Non-COPD Related Emergency Visits |
291; 32; 24 | — |
| SECONDARY Number of Participants With COPD Related Hospitalizations Visits |
276; 6; 0 | — |
| SECONDARY Number of Participants With Non-COPD Related Hospitalizations Visits |
0; 0; 0 | — |
| SECONDARY Direct Medical Costs Associated With COPD Medications During Study Period |
25416.68; 20069.34; 9637.41; 2088.99; 1105.52; 58.00 | — |
| SECONDARY Sub-cohort: Absolute Values of Airway Wall Area at Baseline |
0.630; 0.623; 0.631 | — |
| SECONDARY Sub-cohort: Absolute Values of Airway Wall Area at Month 30 |
0.628; 0.627; 0.639 | — |
| SECONDARY Sub-cohort: Average of Airway Major Inner Diameter at Baseline |
5.505; 5.619; 5.301 | — |
| SECONDARY Sub-cohort: Average of Airway Major Inner Diameter at Month 30 |
5.371; 5.536; 5.128 | — |
| SECONDARY Sub-cohort: Average of Airway Minor Inner Diameter at Baseline |
4.058; 4.222; 3.973 | — |
| SECONDARY Sub-cohort: Average of Airway Minor Inner Diameter at Month 30 |
3.969; 4.174; 3.804 | — |
| SECONDARY Sub-cohort: Total Airway Count at Baseline |
353.5; 430.9; 352.0 | — |
| SECONDARY Sub-cohort: Total Airway Count at Month 30 |
425.8; 542.9; 392.9 | — |
| SECONDARY Sub-cohort: Absolute Values of Perimeter of 10 Millimeter (mm) (Pi10) at Baseline |
3.892; 3.917; 3.905 | — |
| SECONDARY Sub-cohort: Absolute Values of Pi10 at Month 30 |
3.836; 3.860; 3.842 | — |
| SECONDARY Sub-cohort: Computed Tomography (CT) Attenuation at the 15th Percentile of the Lung CT Histogram (Perc15) in Residual Volume at Baseline |
-893.654; -829.016; -804.517 | — |
| SECONDARY Sub-cohort: Perc15 in Residual Volume at Month 30 |
-900.234; -840.501; -825.538 | — |
| SECONDARY Sub-cohort: Perc15 in Total Lung Capacity at Baseline |
-929.370; -903.261; -885.743 | — |
| SECONDARY Sub-cohort: Perc15 in Total Lung Capacity at Month 30 |
-933.063; -908.850; -878.913 | — |
| SECONDARY Sub-cohort: Absolute Values of Low Attenuation Area -950 (LAA-950) at Baseline |
8.378; 1.707; 0.295 | — |
| SECONDARY Sub-cohort: Absolute Values of LAA-950 at Month 30 |
9.765; 1.977; 0.360 | — |
| SECONDARY Sub-cohort: Absolute Values of Disease Probability Measure (DPM) to Assess Gas Trapping at Baseline |
44.898; 28.978; 24.832 | — |
| SECONDARY Sub-cohort: Absolute Values of DPM to Assess Gas Trapping at Month 30 |
43.210; 29.414; 32.157 | — |
| SECONDARY Sub-cohort: Absolute Values of DPM to Assess Emphysema at Baseline |
13.068; 2.402; 0.254 | — |
| SECONDARY Sub-cohort: Absolute Values of DPM to Assess Emphysema at Month 30 |
15.093; 2.518; 0.877 | — |
| SECONDARY Sub-cohort: Absolute Values of DPM to Assess Normal Tissue at Baseline |
42.035; 68.620; 74.914 | — |
| SECONDARY Sub-cohort: Absolute Values of DPM to Assess Normal Tissue at Month 30 |
41.697; 68.068; 66.966 | — |
| SECONDARY Sub-cohort: Air Volume Ratio (RV/TLC) at Baseline |
62.821; 48.535; 45.617 | — |
| SECONDARY Sub-cohort: Air Volume Ratio (RV/TLC) at Month 30 |
61.276; 48.906; 51.562 | — |
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 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).
Eligibility 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 ( )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 =)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.
Data sourced from ClinicalTrials.gov (NCT04853225). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.