Adults 50 to 80, any sex, with Pulmonary Disease, Chronic Obstructive. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Main Cohort: Rate of Moderate/Severe Exacerbations in COPD and Chronic Bronchitis CohortsSecondary· Up to 30 months
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), ge
Group
Value
95% CI
Participants With COPD - GOLD Grade I
0.08
0.06 – 0.10
Participants With COPD - GOLD Grade II
0.12
0.11 – 0.14
Participants With COPD - GOLD Grade III
0.26
0.21 – 0.33
Participants With COPD - GOLD Grade IV
0.35
0.25 – 0.49
Participants With Chronic Bronchitis
0.02
0.01 – 0.04
Main Cohort: Change From Baseline in COPD Assessment Test (CAT) Score at Month 30Secondary· Baseline (Day 1 of Month 1) and 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. Chan
Group
Value
95% CI
COPD Participants
-0.9
± 5.84
Participants With Chronic Bronchitis
-2.3
± 5.45
Never Smoker Healthy Control
0.3
± 2.46
Main Cohort: Absolute Values of CAT Score at Month 30Secondary· 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.
Group
Value
95% CI
COPD Participants
7.5
± 5.33
Participants With Chronic Bronchitis
5.7
± 4.18
Never Smoker Healthy Control
1.3
± 2.36
Main Cohort: Total Score of COPD Assessment in Primary Care to Identify Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE) at BaselineSecondary· At Baseline (Day 1 of Month 1)
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.
Group
Value
95% CI
COPD Participants
2.6
± 1.48
Participants With Chronic Bronchitis
2.0
± 1.37
Never Smoker Healthy Control
0.3
± 0.55
Main Cohort: Total Score of CAPTURE at Month 18Secondary· 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).
Group
Value
95% CI
COPD Participants
2.5
± 1.48
Participants With Chronic Bronchitis
1.8
± 1.49
Never Smoker Healthy Control
0.4
± 0.69
Main Cohort: Number of Participants With Any Clinically Important Deterioration (CID) Event and Its Components From Baseline to Month 6Secondary· Baseline (Day 1 of Month 1) 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
Group
Value
95% CI
COPD Participants
897
Participants With Chronic Bronchitis
90
Never Smoker Healthy Control
58
Exacerbation CID
Group
Value
95% CI
COPD Participants
153
Participants With Chronic Bronchitis
1
Never Smoker Healthy Control
0
FEV1 CID
Group
Value
95% CI
COPD Participants
431
Participants With Chronic Bronchitis
55
Never Smoker Healthy Control
36
CAT CID
Group
Value
95% CI
COPD Participants
567
Participants With Chronic Bronchitis
53
Never Smoker Healthy Control
31
Main Cohort: Number of Participants With Any CID Event and Its Components From Months 6 to 18Secondary· 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 componen
Any CID
Group
Value
95% CI
COPD Participants
1120
Participants With Chronic Bronchitis
97
Never Smoker Healthy Control
82
Exacerbation CID
Group
Value
95% CI
COPD Participants
211
Participants With Chronic Bronchitis
0
Never Smoker Healthy Control
0
FEV1 CID
Group
Value
95% CI
COPD Participants
524
Participants With Chronic Bronchitis
64
Never Smoker Healthy Control
42
CAT CID
Group
Value
95% CI
COPD Participants
794
Participants With Chronic Bronchitis
52
Never Smoker Healthy Control
60
Main Cohort: Number of Participants With Any CID Event and Its Components From Months 18 to 30Secondary· 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 componen
Any CID
Group
Value
95% CI
COPD Participants
1086
Participants With Chronic Bronchitis
93
Never Smoker Healthy Control
68
Exacerbation CID
Group
Value
95% CI
COPD Participants
177
Participants With Chronic Bronchitis
2
Never Smoker Healthy Control
0
FEV1 CID
Group
Value
95% CI
COPD Participants
594
Participants With Chronic Bronchitis
61
Never Smoker Healthy Control
37
CAT CID
Group
Value
95% CI
COPD Participants
771
Participants With Chronic Bronchitis
54
Never Smoker Healthy Control
48
Main Cohort: Number of Participants Who DiedSecondary· Up to 30 months
Number of participants who died during study have been presented.
Group
Value
95% CI
COPD Participants
41
Participants With Chronic Bronchitis
2
Never Smoker Healthy Control
0
Sub-cohort: Change From Baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) Total Scores From Months 1 to 6Secondary· Baseline (Day 1 of Month 1) and 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 scor
Group
Value
95% CI
COPD Participants
0.697
± 3.6181
Participants With Chronic Bronchitis
-0.018
± 2.8032
Never Smoker Healthy Control
0.020
± 1.2256
Sub-cohort: Change From Baseline in E-RS:COPD Total Scores From Months 18 to 24Secondary· Baseline (Day 1 of Month 1) and 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 scor
Group
Value
95% CI
COPD Participants
1.735
± 4.6876
Participants With Chronic Bronchitis
1.014
± 4.3033
Never Smoker Healthy Control
0.086
± 1.3097
Sub-cohort: Number of Participants With Exacerbation of COPD Tool (EXACT) Events From Months 1 to 6Secondary· 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 presente
Group
Value
95% CI
COPD Participants
59
Participants With Chronic Bronchitis
12
Never Smoker Healthy Control
1
Sponsor's own 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).
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 20 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04853225.