Occurrence of Potential Bacterial and Viral Pathogens in Stable Chronic Obstructive Pulmonary Disease and During Acute Exacerbations of the Disease, in Asia Pacific
CompletedNAResults postedLast updated 14 June 2021
What this trial tests
NA trial testing Sputum and blood sampling in Respiratory Disorders in 197 participants. Completed in 6 April 2020.
40 and older, any sex, with Respiratory Disorders. 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.
Percentage of Sputum Samples Positive for Bacterial Pathogens as Identified by Bacteriological Methods, in Any Stable COPD Patients and During AECOPDsPrimary· Over the course of one year from the study start (Month 0 to Month 12)
The proportion of sputum samples obtained at each visit (confirmed stable or AECOPD visits) and positive for specific bacterial pathogens by bacteriological methods (overall and by bacterial species). Numerator is the number of sputum samples positive for a given pathogen and denominator is the number of visits with a sputum sample tested for a given pathogen. Proportion is computed with 95% confidence intervals. A confirmed stable visit is defined as a scheduled study visit for which the investigator confirms that the subject is stable/ has recovered from a previous exacerbation. Bacterial pa
Any, Any stable visit
Group
Value
95% CI
Total Group
74.2
70.4 – 77.7
Any, Any AECOPD visit
Group
Value
95% CI
Total Group
78
72.1 – 83.2
Hi, Any stable visit
Group
Value
95% CI
Total Group
94.6
84.2 – 99.1
Hi, Any AECOPD visit
Group
Value
95% CI
Total Group
94.1
76.6 – 99.7
NTHi, Any stable visit
Group
Value
95% CI
Total Group
94.6
84.2 – 99.1
NTHi, Any AECOPD visit
Group
Value
95% CI
Total Group
94.1
76.6 – 99.7
Non-Hi, Any stable visit
Group
Value
95% CI
Total Group
5.4
0.9 – 15.8
Non-Hi, Any AECOPD visit
Group
Value
95% CI
Total Group
5.9
0.3 – 23.4
Percentage of Sputum Samples Positive for Viral Pathogens as Identified by Polymerase Chain Reaction (PCR) in Stable COPD Patients and During AECOPDsPrimary· Over the course of one year from the study start (Month 0 to Month 12)
The proportion of sputum samples obtained at each visit (confirmed stable visits and AECOPD visits) and positive for specific viral pathogens by PCR (overall and by viral species). The numerator is the number of sputum samples positive for a given pathogen and the denominator is the number of visits with a sputum sample tested for a given pathogen. The proportion is calculated with 95% confidence intervals. Viral pathogens, as identified by PCR, include respiratory syncytial virus (RSV), parainfluenza virus, enterovirus, human rhinovirus (HRV), metapneumovirus, influenza virus, adenovirus, boc
Any, Any stable visit
Group
Value
95% CI
Total Group
15
12.2 – 18.2
Any, Any AECOPD visit
Group
Value
95% CI
Total Group
35.6
29.1 – 42.5
RSV, Any stable visit
Group
Value
95% CI
Total Group
0.9
0.3 – 2.0
RSV, Any AECOPD visit
Group
Value
95% CI
Total Group
1
0.2 – 3.1
Parainfluenza virus, Any stable visit
Group
Value
95% CI
Total Group
0.7
0.2 – 1.7
Parainfluenza virus, Any AECOPD visit
Group
Value
95% CI
Total Group
4.7
2.3 – 8.2
Enterovirus, Any stable visit
Group
Value
95% CI
Total Group
0.6
0.1 – 1.4
Enterovirus, Any AECOPD visit
Group
Value
95% CI
Total Group
0
0.0 – 1.9
Percentage of Sputum Samples Positive for Bacterial Pathogens in Stable COPD Patients and During AECOPDs, as Identified by PCRSecondary· Over the course of one year from the study start (Month 0 to Month 12)
The proportion of sputum samples obtained at each confirmed stable/AECOPD visit and positive for specific bacterial pathogens as measured by real-time qualitative PCR/quantitative PCR, (overall and by bacterial species,) are computed with 95% confidence intervals. The numerator is the number of sputum samples positive for a given pathogen and the denominator is the number of visits with a sputum sample tested for a given pathogen. The bacterial pathogens include H. influenzae, M. catarrhalis, S. pneumoniae, S. aureus, P. aeruginosa and S. pyogenes. A confirmed stable visit is defined as a sche
Any, Any stable visit
Group
Value
95% CI
Total Group
67
63.0 – 70.9
Any, Any AECOPD visit
Group
Value
95% CI
Total Group
74.7
68.3 – 80.5
H. influenzae, Any stable visit
Group
Value
95% CI
Total Group
42.9
38.7 – 47.0
H. influenzae, Any AECOPD visit
Group
Value
95% CI
Total Group
39.7
33.0 – 46.7
M. catarrhalis, Any stable visit
Group
Value
95% CI
Total Group
13.7
11.0 – 16.8
M. catarrhalis, Any AECOPD visit
Group
Value
95% CI
Total Group
26.8
20.9 – 33.3
S. pneumoniae, Any stable visit
Group
Value
95% CI
Total Group
16.8
13.9 – 20.1
S. pneumoniae, Any AECOPD visit
Group
Value
95% CI
Total Group
19.1
14.0 – 25.0
Number of Sputum Samples in a Given Category Relative to All Combinations for Each Bacterial Pathogen, When Identified by Bacteriological Methods or PCR, at Any VisitSecondary· Over the course of one year from the study start (Month 0 to Month 12)
Concordance between bacteriological methods (culture) and PCR sputum results are described for all the combinations of bacterial presence by both measures. Each category name includes the following parameters: Bacteria species-Culture (yes/no)- PCR (yes/no). Concordance is expressed as the number of sputum samples in a given category among the total number of sputum samples assessed for the presence of bacterial pathogens by both culture and PCR
H. influenzae, Culture No, PCR No
Group
Value
95% CI
Total Group
425
H. influenzae, Culture No, PCR Yes
Group
Value
95% CI
Total Group
260
H. influenzae, Culture Yes, PCR No
Group
Value
95% CI
Total Group
4
H. influenzae, Culture Yes, PCR Yes
Group
Value
95% CI
Total Group
51
M. catarrhalis, Culture No, PCR No
Group
Value
95% CI
Total Group
613
M. catarrhalis, Culture No, PCR Yes
Group
Value
95% CI
Total Group
115
M. catarrhalis, Culture Yes, PCR No
Group
Value
95% CI
Total Group
0
M. catarrhalis, Culture Yes, PCR Yes
Group
Value
95% CI
Total Group
12
Number of Sputum Samples Positive for Bacterial Pathogens (Overall and by Species) in Stable COPD Patients, as Identified by Bacteriological Methods, and Classified by Global Initiative for Chronic Obstructive Lung Disease (GOLD) GradeSecondary· Over the course of one year from the study start (Month 0 to Month 12)
Number of sputum samples obtained at each confirmed stable visit, and positive for bacterial pathogens by bacteriological methods (overall and by bacterial species). The spirometric classification of airflow limitation in COPD patients is based on post-bronchodilator forced expiratory volume in 1 second (FEV1) and can be divided into four GOLD grades \[GOLD, 2013\]: GOLD 1 (MILD): FEV1 ≥ 80% predicted; GOLD 2 (Moderate)= 50% ≤ FEV1 \< 80% predicted; GOLD 3 (Severe) = 30% ≤ FEV1 \< 50% predicted; GOLD 4 (Very Severe) = FEV1 \< 30% predicted.
Any, GOLD 2
Group
Value
95% CI
Total Group
150
Any, GOLD 3
Group
Value
95% CI
Total Group
217
Any, GOLD 4
Group
Value
95% CI
Total Group
44
Hi, GOLD 2
Group
Value
95% CI
Total Group
12
Hi, GOLD 3
Group
Value
95% CI
Total Group
20
Hi, GOLD 4
Group
Value
95% CI
Total Group
3
NTHi, GOLD 2
Group
Value
95% CI
Total Group
12
NTHi, GOLD 3
Group
Value
95% CI
Total Group
20
Number of Sputum Samples Positive for Bacterial Pathogens (Overall and by Species) in Stable COPD Patients, as Identified by PCR, and Classified by GOLD GradeSecondary· Over the course of one year from the study start (Month 0 to Month 12)
Number of sputum samples obtained at each confirmed stable visit, and positive for bacterial pathogens by PCR (overall and by bacterial species). The spirometric classification of airflow limitation in COPD patients is based on post-bronchodilator forced expiratory volume in 1 second (FEV1) and can be divided into four GOLD grades \[GOLD, 2013\]: GOLD 1 (MILD): FEV1 ≥ 80% predicted; GOLD 2 (Moderate)= 50% ≤ FEV1 \< 80% predicted; GOLD 3 (Severe) = 30% ≤ FEV1 \< 50% predicted; GOLD 4 (Very Severe) = FEV1 \< 30% predicted.
Any, GOLD 2
Group
Value
95% CI
Total Group
146
Any, GOLD 3
Group
Value
95% CI
Total Group
184
Any, GOLD 4
Group
Value
95% CI
Total Group
36
H. influenzae, GOLD 2
Group
Value
95% CI
Total Group
95
H. influenzae, GOLD 3
Group
Value
95% CI
Total Group
120
H. influenzae, GOLD 4
Group
Value
95% CI
Total Group
19
M. catarrhalis, GOLD 2
Group
Value
95% CI
Total Group
30
M. catarrhalis, GOLD 3
Group
Value
95% CI
Total Group
42
Number of Sputum Samples Positive for Viral Pathogens (Overall and by Species) in Stable COPD Patients, as Identified by PCR, and Classified by GOLD GradeSecondary· Over the course of one year from the study start (Month 0 to Month 12)
Number of sputum samples obtained at each confirmed stable visit, and positive for virus pathogens by PCR (overall and by viral species). The spirometric classification of airflow limitation in COPD patients is based on post-bronchodilator forced expiratory volume in 1 second (FEV1) and can be divided into four GOLD grades \[GOLD, 2013\]: GOLD 1 (MILD): FEV1 ≥ 80% predicted; GOLD 2 (Moderate)= 50% ≤ FEV1 \< 80% predicted; GOLD 3 (Severe) = 30% ≤ FEV1 \< 50% predicted; GOLD 4 (Very Severe) = FEV1 \< 30% predicted.
Any, GOLD 2
Group
Value
95% CI
Total Group
25
Any, GOLD 3
Group
Value
95% CI
Total Group
52
Any, GOLD 4
Group
Value
95% CI
Total Group
5
RSV, GOLD 2
Group
Value
95% CI
Total Group
1
RSV, GOLD 3
Group
Value
95% CI
Total Group
3
RSV, GOLD 4
Group
Value
95% CI
Total Group
1
Parainfluenza virus, GOLD 2
Group
Value
95% CI
Total Group
1
Parainfluenza virus, GOLD 3
Group
Value
95% CI
Total Group
3
Number of Sputum Samples Positive for Bacterial Pathogens (Overall and by Species) in AECOPD Patients, as Identified by Bacteriological Methods and Classified by Severity of AECOPDSecondary· Over the course of one year from the study start (Month 0 to Month 12)
Number of sputum samples obtained at each AECOPD visit, and positive for bacterial pathogens by bacteriological methods (overall and by bacterial species). Classification of severity of AECOPD as follows: Mild = controlled with an increase in dosage of regular medications; Moderate = requires treatment with systemic corticosteroids and/or antibiotics; Severe = requires hospitalization.
Any, Mild AECOPD
Group
Value
95% CI
Total Group
9
Any, Moderate AECOPD
Group
Value
95% CI
Total Group
138
Any, Severe AECOPD
Group
Value
95% CI
Total Group
16
Hi, Mild AECOPD
Group
Value
95% CI
Total Group
3
Hi, Moderate AECOPD
Group
Value
95% CI
Total Group
11
Hi, Severe AECOPD
Group
Value
95% CI
Total Group
2
NTHi, Mild AECOPD
Group
Value
95% CI
Total Group
3
NTHi, Moderate AECOPD
Group
Value
95% CI
Total Group
11
Number of Sputum Samples Positive for Bacterial Pathogens (Overall and by Species) in AECOPD Patients, as Identified by PCR, and Classified by Severity of AECOPDSecondary· Over the course of one year from the study start (Month 0 to Month 12)
Number of sputum samples obtained at each AECOPD visit, and positive for bacterial pathogens by PCR (overall and by bacterial species). Classification of severity of AECOPD is as follows: Mild = controlled with an increase in dosage of regular medications; Moderate = requires treatment with systemic corticosteroids and/or antibiotics; Severe = requires hospitalization.
Any, Mild AECOPD
Group
Value
95% CI
Total Group
13
Any, Moderate AECOPD
Group
Value
95% CI
Total Group
117
Any, Severe AECOPD
Group
Value
95% CI
Total Group
15
H. influenzae, Mild AECOPD
Group
Value
95% CI
Total Group
10
H. influenzae, Moderate AECOPD
Group
Value
95% CI
Total Group
62
H. influenzae, Severe AECOPD
Group
Value
95% CI
Total Group
5
M. catarrhalis, Mild AECOPD
Group
Value
95% CI
Total Group
3
M. catarrhalis, Moderate AECOPD
Group
Value
95% CI
Total Group
44
Number of Sputum Samples Positive for Viral Pathogens (Overall and by Species) in AECOPD Patients, as Identified by PCR, and Classified by Severity of AECOPDSecondary· Over the course of one year from the study start (Month 0 to Month 12)
Number of sputum samples obtained at each AECOPD visit, and positive for viral pathogens by PCR (overall and by viral species). Classification of severity of AECOPD is as follows: Mild = controlled with an increase in dosage of regular medications; Moderate = requires treatment with systemic corticosteroids and/or antibiotics; Severe = requires hospitalization.
Any, Mild AECOPD
Group
Value
95% CI
Total Group
6
Any, Moderate AECOPD
Group
Value
95% CI
Total Group
56
Any, Severe AECOPD
Group
Value
95% CI
Total Group
7
RSV, Mild AECOPD
Group
Value
95% CI
Total Group
1
RSV, Moderate AECOPD
Group
Value
95% CI
Total Group
1
RSV, Severe AECOPD
Group
Value
95% CI
Total Group
0
Parainfluenza virus, Mild AECOPD
Group
Value
95% CI
Total Group
1
Parainfluenza virus, Moderate AECOPD
Group
Value
95% CI
Total Group
6
Incidence Rate (Per Subject Per Year) of Confirmed and Confirmed Plus Potential AECOPDs, Overall and by GOLD GradeSecondary· Over the course of one year from the study start (Month 0 to Month 12)
Incidence rate is estimated by the mean number of exacerbations per subject and per year from Negative Binomial model (or Poisson model in case of under dispersion) without covariates and computed with 95% confidence intervals (CI). Confirmed AECOPDs include AECOPD events plus missed AECOPD events (i.e.: all morning alerts confirmed by phone call (as well as cases with no morning alert) for which there has been no site visit but for which AECOPD medical records are available). Potential AECOPDs include all morning alert confirmed by phone call for which there has been no site visit and for whi
Total, Confirmed AECOPDs
Group
Value
95% CI
Total Group
1.27
1.04 – 1.54
GOLD 2, Confirmed AECOPDs
Group
Value
95% CI
Total Group
0.78
0.54 – 1.14
GOLD 3, Confirmed AECOPDs
Group
Value
95% CI
Total Group
1.51
1.17 – 1.94
GOLD 4, Confirmed AECOPDs
Group
Value
95% CI
Total Group
1.99
1.37 – 2.89
Total, Confirmed AECOPDs plus potential AECOPDs
Group
Value
95% CI
Total Group
1.3
1.07 – 1.58
GOLD 2, Confirmed AECOPDs plus potential AECOPDs
Group
Value
95% CI
Total Group
0.81
0.56 – 1.16
GOLD 3, Confirmed AECOPDs plus potential AECOPDs
Group
Value
95% CI
Total Group
1.56
1.20 – 2.01
GOLD 4, Confirmed AECOPDs plus potential AECOPDs
Group
Value
95% CI
Total Group
1.99
1.37 – 2.89
Number of Subjects With AECOPDs, Classified by Number of Exacerbations and by Severity of AECOPDSecondary· Over the course of one year from the study start (Month 0 to Month 12)
Classification of severity of AECOPD is as follows: Mild- Controlled AECOPD with an increase in dosage of regular medications; Moderate- Requires treatment with systemic corticosteroids and/ or antibiotics; Severe- Requires hospitalisation.
Mild AECOPD, 0
Group
Value
95% CI
Total Group
181
Moderate AECOPD, 0
Group
Value
95% CI
Total Group
115
Severe AECOPD, 0
Group
Value
95% CI
Total Group
168
Mild AECOPD, 1
Group
Value
95% CI
Total Group
12
Moderate AECOPD, 1
Group
Value
95% CI
Total Group
38
Severe AECOPD, 1
Group
Value
95% CI
Total Group
21
Mild AECOPD, 2
Group
Value
95% CI
Total Group
3
Moderate AECOPD, 2
Group
Value
95% CI
Total Group
15
Adverse events — posted to ClinicalTrials.gov
Time frame: Unsolicited adverse events and serious adverse events (SAE) related to study procedures have been collected during the whole study period (from Month 0 to Month 12..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Since the infectious aetiology of AECOPD has been suggested to vary according to geographical region, the primary purpose of this study (which will be conducted in several countries in Asia Pacific) is to evaluate the occurrence of bacterial and viral pathogens in the sputum of stable COPD patients and at the time of AECOPD. Given the increasing and projected burden of COPD in the Asia Pacific region, this study will also evaluate the frequency, severity and duration of AECOPD, as well as the impact of AECOPD on health-related quality of life (HRQOL), healthcare utilisation and lung function.
Publications & conference data
2 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: 14 June 2021
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/NCT03151395.