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Occurrence of Potential Bacterial and Viral Pathogens in Stable Chronic Obstructive Pulmonary Disease and During Acute Exacerbations of the Disease, in Asia Pacific

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03151395
Recruitment Status : Completed
First Posted : May 12, 2017
Results First Posted : June 14, 2021
Last Update Posted : June 14, 2021
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Respiratory Disorders
Intervention Other: Sputum and blood sampling
Enrollment 197
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Total Group
Hide Arm/Group Description Moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) patients with at least 1 documented moderate or severe Acute exacerbation of COPD (AECOPD) in the year before enrolment and for whom sputum and blood samples are collected during specified visits.
Period Title: Overall Study
Started 197
Completed 182
Not Completed 15
Reason Not Completed
Adverse Event             2
CONSENT WITHDRAWAL NOT DUE TO ADV. EVENT             6
Subjects could not perform last visit before study completion date due to local COVID19 restrictions             3
Unspecified reason             4
Arm/Group Title Total Group
Hide Arm/Group Description Moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) patients with at least 1 documented moderate or severe Acute exacerbation of COPD (AECOPD) in the year before enrolment and for whom sputum and blood samples are collected during specified visits.
Overall Number of Baseline Participants 197
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 197 participants
68.5  (7.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 197 participants
Female
10
   5.1%
Male
187
  94.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 197 participants
ASIAN - EAST ASIAN HERITAGE
126
  64.0%
ASIAN - SOUTH EAST ASIAN HERITAGE
71
  36.0%
1.Primary Outcome
Title Percentage of Sputum Samples Positive for Bacterial Pathogens as Identified by Bacteriological Methods, in Any Stable COPD Patients and During AECOPDs
Hide Description 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 pathogens include Haemophilus influenzae (Hi), Non-typeable Haemophilus influenzae (NTHi), non-Haemophilus influenzae (Non-Hi), Moraxella catarrhalis (M. catarrhalis), Streptococcus pneumoniae (S. pneumoniae), Staphylococcus aureus (S. aureus), Pseudomonas aeruginosa (P. aeruginosa), Klebsiella pneumoniae (K. pseumoniae), Acinetobacter baumannii (A. baumannii).
Time Frame Over the course of one year from the study start (Month 0 to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Full Analysis Set which included all screened subjects who were enrolled except for those subjects who discontinued the study at Month 0 visit.
Arm/Group Title Total Group
Hide Arm/Group Description:
Moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) patients with at least 1 documented moderate or severe Acute exacerbation of COPD (AECOPD) in the year before enrolment and for whom sputum and blood samples are collected during specified visits.
Overall Number of Participants Analyzed 196
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of sputum samples
Any, Any stable visit Number Analyzed 196 participants
74.2
(70.4 to 77.7)
Any, Any AECOPD visit Number Analyzed 88 participants
78
(72.1 to 83.2)
Hi, Any stable visit Number Analyzed 29 participants
94.6
(84.2 to 99.1)
Hi, Any AECOPD visit Number Analyzed 13 participants
94.1
(76.6 to 99.7)
NTHi, Any stable visit Number Analyzed 29 participants
94.6
(84.2 to 99.1)
NTHi, Any AECOPD visit Number Analyzed 13 participants
94.1
(76.6 to 99.7)
Non-Hi, Any stable visit Number Analyzed 29 participants
5.4
(0.9 to 15.8)
Non-Hi, Any AECOPD visit Number Analyzed 13 participants
5.9
(0.3 to 23.4)
M. catarrhalis, Any stable visit Number Analyzed 196 participants
0.9
(0.3 to 1.9)
M. catarrhalis, Any AECOPD visit Number Analyzed 88 participants
3.3
(1.5 to 6.4)
S. pneumoniae, Any stable visit Number Analyzed 196 participants
2.5
(1.4 to 4.1)
S. pneumoniae, Any AECOPD visit Number Analyzed 88 participants
2.4
(0.9 to 5.1)
S. aureus, Any stable visit Number Analyzed 196 participants
3.1
(1.8 to 4.7)
S. aureus, Any AECOPD visit Number Analyzed 88 participants
3.3
(1.5 to 6.4)
P. aeruginosa, Any stable visit Number Analyzed 196 participants
8.5
(6.4 to 11.0)
P. aeruginosa, Any AECOPD visit Number Analyzed 88 participants
14.4
(10.0 to 19.5)
K. pneumoniae, Any stable visit Number Analyzed 196 participants
26.4
(22.8 to 30.1)
K. pneumoniae, Any AECOPD visit Number Analyzed 88 participants
24.9
(19.3 to 31.0)
A. baumannii, Any stable visit Number Analyzed 196 participants
2.2
(1.2 to 3.6)
A. baumannii, Any AECOPD visit Number Analyzed 88 participants
4.3
(2.1 to 7.6)
Other bacteria, Any stable visit Number Analyzed 196 participants
47.7
(43.5 to 51.8)
Other bacteria, Any AECOPD visit Number Analyzed 88 participants
45
(38.3 to 51.8)
2.Primary Outcome
Title Percentage of Sputum Samples Positive for Viral Pathogens as Identified by Polymerase Chain Reaction (PCR) in Stable COPD Patients and During AECOPDs
Hide Description 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, bocavirus and coronavirus.
Time Frame Over the course of one year from the study start (Month 0 to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Full Analysis Set which included all screened subjects who were enrolled except for those subjects who discontinued the study at Month 0 visit.
Arm/Group Title Total Group
Hide Arm/Group Description:
Moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) patients with at least 1 documented moderate or severe Acute exacerbation of COPD (AECOPD) in the year before enrolment and for whom sputum and blood samples are collected during specified visits.
Overall Number of Participants Analyzed 195
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of sputum samples
Any, Any stable visit Number Analyzed 195 participants
15
(12.2 to 18.2)
Any, Any AECOPD visit Number Analyzed 88 participants
35.6
(29.1 to 42.5)
RSV, Any stable visit Number Analyzed 195 participants
0.9
(0.3 to 2.0)
RSV, Any AECOPD visit Number Analyzed 88 participants
1
(0.2 to 3.1)
Parainfluenza virus, Any stable visit Number Analyzed 195 participants
0.7
(0.2 to 1.7)
Parainfluenza virus, Any AECOPD visit Number Analyzed 88 participants
4.7
(2.3 to 8.2)
Enterovirus, Any stable visit Number Analyzed 195 participants
0.6
(0.1 to 1.4)
Enterovirus, Any AECOPD visit Number Analyzed 88 participants
0
(0.0 to 1.9)
HRV, Any stable visit Number Analyzed 195 participants
8.1
(6.0 to 10.6)
HRV, Any AECOPD visit Number Analyzed 88 participants
16.6
(11.8 to 22.3)
Metapneumovirus, Any stable visit Number Analyzed 195 participants
0
(0.0 to 0.7)
Metapneumovirus, Any AECOPD visit Number Analyzed 88 participants
0
(0.0 to 1.9)
Influenza virus, Any stable visit Number Analyzed 195 participants
0.7
(0.2 to 1.7)
Influenza virus, Any AECOPD visit Number Analyzed 88 participants
8.2
(4.9 to 12.7)
Adenovirus, Any stable visit Number Analyzed 195 participants
2
(1.1 to 3.4)
Adenovirus, Any AECOPD visit Number Analyzed 88 participants
4.1
(1.9 to 7.6)
Bocavirus, Any stable visit Number Analyzed 195 participants
0.2
(0.0 to 0.8)
Bocavirus, Any AECOPD visit Number Analyzed 88 participants
0
(0.0 to 1.9)
Coronavirus, Any stable visit Number Analyzed 195 participants
2.6
(1.5 to 4.1)
Coronavirus, Any AECOPD visit Number Analyzed 88 participants
5.7
(3.0 to 9.5)
3.Secondary Outcome
Title Percentage of Sputum Samples Positive for Bacterial Pathogens in Stable COPD Patients and During AECOPDs, as Identified by PCR
Hide Description 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 scheduled study visit for which the investigator confirms that the subject is stable / has recovered from a previous exacerbation.
Time Frame Over the course of one year from the study start (Month 0 to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Full Analysis Set which included all screened subjects who were enrolled except for those subjects who discontinued the study at Month 0 visit.
Arm/Group Title Total Group
Hide Arm/Group Description:
Moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) patients with at least 1 documented moderate or severe Acute exacerbation of COPD (AECOPD) in the year before enrolment and for whom sputum and blood samples are collected during specified visits.
Overall Number of Participants Analyzed 195
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of sputum samples
Any, Any stable visit Number Analyzed 195 participants
67
(63.0 to 70.9)
Any, Any AECOPD visit Number Analyzed 88 participants
74.7
(68.3 to 80.5)
H. influenzae, Any stable visit Number Analyzed 195 participants
42.9
(38.7 to 47.0)
H. influenzae, Any AECOPD visit Number Analyzed 88 participants
39.7
(33.0 to 46.7)
M. catarrhalis, Any stable visit Number Analyzed 195 participants
13.7
(11.0 to 16.8)
M. catarrhalis, Any AECOPD visit Number Analyzed 88 participants
26.8
(20.9 to 33.3)
S. pneumoniae, Any stable visit Number Analyzed 195 participants
16.8
(13.9 to 20.1)
S. pneumoniae, Any AECOPD visit Number Analyzed 88 participants
19.1
(14.0 to 25.0)
S. aureus, Any stable visit Number Analyzed 195 participants
10.6
(8.2 to 13.4)
S. aureus, Any AECOPD visit Number Analyzed 88 participants
9.3
(5.7 to 13.9)
P. aeruginosa, Any stable visit Number Analyzed 195 participants
16.3
(13.4 to 19.6)
P. aeruginosa, Any AECOPD visit Number Analyzed 88 participants
16.5
(11.7 to 22.1)
S. pyogenes, Any stable visit Number Analyzed 195 participants
0.4
(0.1 to 1.1)
S. pyogenes, Any AECOPD visit Number Analyzed 88 participants
1
(0.2 to 3.1)
4.Secondary Outcome
Title 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 Visit
Hide Description 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
Time Frame Over the course of one year from the study start (Month 0 to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the sputum samples taken from Full Analysis Set which included all screened subjects who were enrolled except for those subjects who discontinued the study at Month 0 visit.
Arm/Group Title Total Group
Hide Arm/Group Description:
Moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) patients with at least 1 documented moderate or severe Acute exacerbation of COPD (AECOPD) in the year before enrolment and for whom sputum and blood samples are collected during specified visits.
Overall Number of Participants Analyzed 197
Overall Number of Units Analyzed
Type of Units Analyzed: Sputum samples
 740
Count of Units
Unit of Measure: Sputum samples
H. influenzae, Culture No, PCR No
425
  57.4%
H. influenzae, Culture No, PCR Yes
260
  35.1%
H. influenzae, Culture Yes, PCR No
4
   0.5%
H. influenzae, Culture Yes, PCR Yes
51
   6.9%
M. catarrhalis, Culture No, PCR No
613
  82.8%
M. catarrhalis, Culture No, PCR Yes
115
  15.5%
M. catarrhalis, Culture Yes, PCR No
0
   0.0%
M. catarrhalis, Culture Yes, PCR Yes
12
   1.6%
S. pneumoniae, Culture No, PCR No
610
  82.4%
S. pneumoniae, Culture No, PCR Yes
111
  15.0%
S. pneumoniae, Culture Yes, PCR No
1
   0.1%
S. pneumoniae, Culture Yes, PCR Yes
18
   2.4%
S. aureus, Culture No, PCR No
655
  88.5%
S. aureus, Culture No, PCR Yes
62
   8.4%
S. aureus, Culture Yes, PCR No
9
   1.2%
S. aureus, Culture Yes, PCR Yes
14
   1.9%
P. aeruginosa, Culture No, PCR No
599
  80.9%
P. aeruginosa, Culture No, PCR Yes
67
   9.1%
P. aeruginosa, Culture Yes, PCR No
20
   2.7%
P. aeruginosa, Culture Yes, PCR Yes
54
   7.3%
5.Secondary Outcome
Title 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) Grade
Hide Description 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.
Time Frame Over the course of one year from the study start (Month 0 to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the sputum samples taken from Full Analysis Set which included all screened subjects who were enrolled except for those subjects who discontinued the study at Month 0 visit.
Arm/Group Title Total Group
Hide Arm/Group Description:
Moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) patients with at least 1 documented moderate or severe Acute exacerbation of COPD (AECOPD) in the year before enrolment and for whom sputum and blood samples are collected during specified visits.
Overall Number of Participants Analyzed 197
Overall Number of Units Analyzed
Type of Units Analyzed: Sputum samples
 280
Count of Units
Unit of Measure: Sputum samples
Any, GOLD 2 Number Analyzed 224 Sputum samples
150
  67.0%
Any, GOLD 3 Number Analyzed 280 Sputum samples
217
  77.5%
Any, GOLD 4 Number Analyzed 50 Sputum samples
44
  88.0%
Hi, GOLD 2 Number Analyzed 13 Sputum samples
12
  92.3%
Hi, GOLD 3 Number Analyzed 21 Sputum samples
20
  95.2%
Hi, GOLD 4 Number Analyzed 3 Sputum samples
3
 100.0%
NTHi, GOLD 2 Number Analyzed 13 Sputum samples
12
  92.3%
NTHi, GOLD 3 Number Analyzed 21 Sputum samples
20
  95.2%
NTHi, GOLD 4 Number Analyzed 3 Sputum samples
3
 100.0%
Non-Hi, GOLD 2 Number Analyzed 13 Sputum samples
1
   7.7%
Non-Hi, GOLD 3 Number Analyzed 21 Sputum samples
1
   4.8%
Non-Hi, GOLD 4 Number Analyzed 3 Sputum samples
0
   0.0%
M. catarrhalis, GOLD 2 Number Analyzed 224 Sputum samples
0
   0.0%
M. catarrhalis, GOLD 3 Number Analyzed 280 Sputum samples
5
   1.8%
M. catarrhalis, GOLD 4 Number Analyzed 50 Sputum samples
0
   0.0%
S. pneumoniae, GOLD 2 Number Analyzed 224 Sputum samples
4
   1.8%
S. pneumoniae, GOLD 3 Number Analyzed 280 Sputum samples
10
   3.6%
S. pneumoniae, GOLD 4 Number Analyzed 50 Sputum samples
0
   0.0%
S. aureus, GOLD 2 Number Analyzed 224 Sputum samples
7
   3.1%
S. aureus, GOLD 3 Number Analyzed 280 Sputum samples
6
   2.1%
S. aureus, GOLD 4 Number Analyzed 50 Sputum samples
4
   8.0%
P. aeruginosa, GOLD 2 Number Analyzed 224 Sputum samples
14
   6.3%
P. aeruginosa, GOLD 3 Number Analyzed 280 Sputum samples
24
   8.6%
P. aeruginosa, GOLD 4 Number Analyzed 50 Sputum samples
9
  18.0%
K. pneumoniae, GOLD 2 Number Analyzed 224 Sputum samples
70
  31.3%
K. pneumoniae, GOLD 3 Number Analyzed 280 Sputum samples
60
  21.4%
K. pneumoniae, GOLD 4 Number Analyzed 50 Sputum samples
16
  32.0%
A. baumannii, GOLD 2 Number Analyzed 224 Sputum samples
2
   0.9%
A. baumannii, GOLD 3 Number Analyzed 279 Sputum samples
9
   3.2%
A. baumannii, GOLD 4 Number Analyzed 50 Sputum samples
1
   2.0%
Other bacteria, GOLD 2 Number Analyzed 224 Sputum samples
87
  38.8%
Other bacteria, GOLD 3 Number Analyzed 280 Sputum samples
149
  53.2%
Other bacteria, GOLD 4 Number Analyzed 50 Sputum samples
28
  56.0%
6.Secondary Outcome
Title Number of Sputum Samples Positive for Bacterial Pathogens (Overall and by Species) in Stable COPD Patients, as Identified by PCR, and Classified by GOLD Grade
Hide Description 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.
Time Frame Over the course of one year from the study start (Month 0 to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the sputum samples taken from Full Analysis Set which included all screened subjects who were enrolled except for those subjects who discontinued the study at Month 0 visit.
Arm/Group Title Total Group
Hide Arm/Group Description:
Moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) patients with at least 1 documented moderate or severe Acute exacerbation of COPD (AECOPD) in the year before enrolment and for whom sputum and blood samples are collected during specified visits.
Overall Number of Participants Analyzed 197
Overall Number of Units Analyzed
Type of Units Analyzed: Sputum samples
 277
Count of Units
Unit of Measure: Sputum samples
Any, GOLD 2 Number Analyzed 221 Sputum samples
146
  66.1%
Any, GOLD 3 Number Analyzed 277 Sputum samples
184
  66.4%
Any, GOLD 4 Number Analyzed 48 Sputum samples
36
  75.0%
H. influenzae, GOLD 2 Number Analyzed 221 Sputum samples
95
  43.0%
H. influenzae, GOLD 3 Number Analyzed 277 Sputum samples
120
  43.3%
H. influenzae, GOLD 4 Number Analyzed 48 Sputum samples
19
  39.6%
M. catarrhalis, GOLD 2 Number Analyzed 221 Sputum samples
30
  13.6%
M. catarrhalis, GOLD 3 Number Analyzed 277 Sputum samples
42
  15.2%
M. catarrhalis, GOLD 4 Number Analyzed 48 Sputum samples
3
   6.3%
S. pneumoniae, GOLD 2 Number Analyzed 221 Sputum samples
39
  17.6%
S. pneumoniae, GOLD 3 Number Analyzed 277 Sputum samples
47
  17.0%
S. pneumoniae, GOLD 4 Number Analyzed 48 Sputum samples
6
  12.5%
S. aureus, GOLD 2 Number Analyzed 221 Sputum samples
33
  14.9%
S. aureus, GOLD 3 Number Analyzed 277 Sputum samples
20
   7.2%
S. aureus, GOLD 4 Number Analyzed 48 Sputum samples
5
  10.4%
P. aeruginosa, GOLD 2 Number Analyzed 221 Sputum samples
33
  14.9%
P. aeruginosa, GOLD 3 Number Analyzed 277 Sputum samples
44
  15.9%
P. aeruginosa, GOLD 4 Number Analyzed 48 Sputum samples
12
  25.0%
S. pyogenes, GOLD 2 Number Analyzed 221 Sputum samples
1
   0.5%
S. pyogenes, GOLD 3 Number Analyzed 277 Sputum samples
1
   0.4%
S. pyogenes, GOLD 4 Number Analyzed 48 Sputum samples
0
   0.0%
7.Secondary Outcome
Title Number of Sputum Samples Positive for Viral Pathogens (Overall and by Species) in Stable COPD Patients, as Identified by PCR, and Classified by GOLD Grade
Hide Description 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.
Time Frame Over the course of one year from the study start (Month 0 to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the sputum samples taken from Full Analysis Set which included all screened subjects who were enrolled except for those subjects who discontinued the study at Month 0 visit.
Arm/Group Title Total Group
Hide Arm/Group Description:
Moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) patients with at least 1 documented moderate or severe Acute exacerbation of COPD (AECOPD) in the year before enrolment and for whom sputum and blood samples are collected during specified visits.
Overall Number of Participants Analyzed 197
Overall Number of Units Analyzed
Type of Units Analyzed: Sputum samples
 277
Count of Units
Unit of Measure: Sputum samples
Any, GOLD 2 Number Analyzed 221 Sputum samples
25
  11.3%
Any, GOLD 3 Number Analyzed 277 Sputum samples
52
  18.8%
Any, GOLD 4 Number Analyzed 48 Sputum samples
5
  10.4%
RSV, GOLD 2 Number Analyzed 221 Sputum samples
1
   0.5%
RSV, GOLD 3 Number Analyzed 277 Sputum samples
3
   1.1%
RSV, GOLD 4 Number Analyzed 48 Sputum samples
1
   2.1%
Parainfluenza virus, GOLD 2 Number Analyzed 221 Sputum samples
1
   0.5%
Parainfluenza virus, GOLD 3 Number Analyzed 276 Sputum samples
3
   1.1%
Parainfluenza virus, GOLD 4 Number Analyzed 48 Sputum samples
0
   0.0%
Enterovirus, GOLD 2 Number Analyzed 221 Sputum samples
0
   0.0%
Enterovirus, GOLD 3 Number Analyzed 276 Sputum samples
3
   1.1%
Enterovirus, GOLD 4 Number Analyzed 48 Sputum samples
0
   0.0%
HRV, GOLD 2 Number Analyzed 221 Sputum samples
14
   6.3%
HRV, GOLD 3 Number Analyzed 277 Sputum samples
27
   9.7%
HRV, GOLD 4 Number Analyzed 48 Sputum samples
3
   6.3%
Metapneumovirus, GOLD 2 Number Analyzed 221 Sputum samples
0
   0.0%
Metapneumovirus, GOLD 3 Number Analyzed 276 Sputum samples
0
   0.0%
Metapneumovirus, GOLD 4 Number Analyzed 48 Sputum samples
0
   0.0%
Influenza virus, GOLD 2 Number Analyzed 221 Sputum samples
1
   0.5%
Influenza virus, GOLD 3 Number Analyzed 277 Sputum samples
3
   1.1%
Influenza virus, GOLD 4 Number Analyzed 48 Sputum samples
0
   0.0%
Adenovirus, GOLD 2 Number Analyzed 221 Sputum samples
6
   2.7%
Adenovirus, GOLD 3 Number Analyzed 276 Sputum samples
5
   1.8%
Adenovirus, GOLD 4 Number Analyzed 48 Sputum samples
0
   0.0%
Bocavirus, GOLD 2 Number Analyzed 221 Sputum samples
0
   0.0%
Bocavirus, GOLD 3 Number Analyzed 277 Sputum samples
1
   0.4%
Bocavirus, GOLD 4 Number Analyzed 48 Sputum samples
0
   0.0%
Coronavirus, GOLD 2 Number Analyzed 221 Sputum samples
2
   0.9%
Coronavirus, GOLD 3 Number Analyzed 277 Sputum samples
11
   4.0%
Coronavirus, GOLD 4 Number Analyzed 48 Sputum samples
1
   2.1%
8.Secondary Outcome
Title 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 AECOPD
Hide Description 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.
Time Frame Over the course of one year from the study start (Month 0 to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the sputum samples taken from Full Analysis Set which included all screened subjects who were enrolled except for those subjects who discontinued the study at Month 0 visit.
Arm/Group Title Total Group
Hide Arm/Group Description:
Moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) patients with at least 1 documented moderate or severe Acute exacerbation of COPD (AECOPD) in the year before enrolment and for whom sputum and blood samples are collected during specified visits.
Overall Number of Participants Analyzed 88
Overall Number of Units Analyzed
Type of Units Analyzed: Sputum samples
 209
Count of Units
Unit of Measure: Sputum samples
Any, Mild AECOPD Number Analyzed 15 Sputum samples
9
  60.0%
Any, Moderate AECOPD Number Analyzed 171 Sputum samples
138
  80.7%
Any, Severe AECOPD Number Analyzed 23 Sputum samples
16
  69.6%
Hi, Mild AECOPD Number Analyzed 3 Sputum samples
3
 100.0%
Hi, Moderate AECOPD Number Analyzed 12 Sputum samples
11
  91.7%
Hi, Severe AECOPD Number Analyzed 2 Sputum samples
2
 100.0%
NTHi, Mild AECOPD Number Analyzed 3 Sputum samples
3
 100.0%
NTHi, Moderate AECOPD Number Analyzed 12 Sputum samples
11
  91.7%
NTHi, Severe AECOPD Number Analyzed 2 Sputum samples
2
 100.0%
Non-Hi, Mild AECOPD Number Analyzed 3 Sputum samples
0
   0.0%
Non-Hi, Moderate AECOPD Number Analyzed 12 Sputum samples
1
   8.3%
Non-Hi, Severe AECOPD Number Analyzed 2 Sputum samples
0
   0.0%
M. catarrhalis, Mild AECOPD Number Analyzed 15 Sputum samples
0
   0.0%
M. catarrhalis, Moderate AECOPD Number Analyzed 171 Sputum samples
6
   3.5%
M. catarrhalis, Severe AECOPD Number Analyzed 23 Sputum samples
1
   4.3%
S. pneumoniae, Mild AECOPD Number Analyzed 15 Sputum samples
0
   0.0%
S. pneumoniae, Moderate AECOPD Number Analyzed 171 Sputum samples
5
   2.9%
S. pneumoniae, Severe AECOPD Number Analyzed 23 Sputum samples
0
   0.0%
S. aureus, Mild AECOPD Number Analyzed 15 Sputum samples
0
   0.0%
S. aureus, Moderate AECOPD Number Analyzed 171 Sputum samples
5
   2.9%
S. aureus, Severe AECOPD Number Analyzed 23 Sputum samples
2
   8.7%
P. aeruginosa, Mild AECOPD Number Analyzed 15 Sputum samples
1
   6.7%
P. aeruginosa, Moderate AECOPD Number Analyzed 171 Sputum samples
26
  15.2%
P. aeruginosa, Severe AECOPD Number Analyzed 23 Sputum samples
3
  13.0%
K. pneumoniae, Mild AECOPD Number Analyzed 15 Sputum samples
4
  26.7%
K. pneumoniae, Moderate AECOPD Number Analyzed 171 Sputum samples
43
  25.1%
K. pneumoniae, Severe AECOPD Number Analyzed 23 Sputum samples
5
  21.7%
A. baumannii, Mild AECOPD Number Analyzed 15 Sputum samples
1
   6.7%
A. baumannii, Moderate AECOPD Number Analyzed 171 Sputum samples
8
   4.7%
A. baumannii, Severe AECOPD Number Analyzed 23 Sputum samples
0
   0.0%
Other bacteria, Mild AECOPD Number Analyzed 15 Sputum samples
4
  26.7%
Other bacteria, Moderate AECOPD Number Analyzed 171 Sputum samples
84
  49.1%
Other bacteria, Severe AECOPD Number Analyzed 23 Sputum samples
6
  26.1%
9.Secondary Outcome
Title Number of Sputum Samples Positive for Bacterial Pathogens (Overall and by Species) in AECOPD Patients, as Identified by PCR, and Classified by Severity of AECOPD
Hide Description 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.
Time Frame Over the course of one year from the study start (Month 0 to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the sputum samples taken from Full Analysis Set which included all screened subjects who were enrolled except for those subjects who discontinued the study at Month 0 visit.
Arm/Group Title Total Group
Hide Arm/Group Description:
Moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) patients with at least 1 documented moderate or severe Acute exacerbation of COPD (AECOPD) in the year before enrolment and for whom sputum and blood samples are collected during specified visits.
Overall Number of Participants Analyzed 88
Overall Number of Units Analyzed
Type of Units Analyzed: Sputum samples
 194
Count of Units
Unit of Measure: Sputum samples
Any, Mild AECOPD Number Analyzed 15 Sputum samples
13
  86.7%
Any, Moderate AECOPD Number Analyzed 157 Sputum samples
117
  74.5%
Any, Severe AECOPD Number Analyzed 22 Sputum samples
15
  68.2%
H. influenzae, Mild AECOPD Number Analyzed 15 Sputum samples
10
  66.7%
H. influenzae, Moderate AECOPD Number Analyzed 157 Sputum samples
62
  39.5%
H. influenzae, Severe AECOPD Number Analyzed 22 Sputum samples
5
  22.7%
M. catarrhalis, Mild AECOPD Number Analyzed 15 Sputum samples
3
  20.0%
M. catarrhalis, Moderate AECOPD Number Analyzed 157 Sputum samples
44
  28.0%
M. catarrhalis, Severe AECOPD Number Analyzed 22 Sputum samples
5
  22.7%
S. pneumoniae, Mild AECOPD Number Analyzed 15 Sputum samples
1
   6.7%
S. pneumoniae, Moderate AECOPD Number Analyzed 157 Sputum samples
32
  20.4%
S. pneumoniae, Severe AECOPD Number Analyzed 22 Sputum samples
4
  18.2%
S. aureus, Mild AECOPD Number Analyzed 15 Sputum samples
1
   6.7%
S. aureus, Moderate AECOPD Number Analyzed 157 Sputum samples
15
   9.6%
S. aureus, Severe AECOPD Number Analyzed 22 Sputum samples
2
   9.1%
P. aeruginosa, Mild AECOPD Number Analyzed 15 Sputum samples
2
  13.3%
P. aeruginosa, Moderate AECOPD Number Analyzed 157 Sputum samples
24
  15.3%
P. aeruginosa, Severe AECOPD Number Analyzed 22 Sputum samples
6
  27.3%
S. pyogenes, Mild AECOPD Number Analyzed 15 Sputum samples
0
   0.0%
S. pyogenes, Moderate AECOPD Number Analyzed 157 Sputum samples
2
   1.3%
S. pyogenes, Severe AECOPD Number Analyzed 22 Sputum samples
0
   0.0%
10.Secondary Outcome
Title Number of Sputum Samples Positive for Viral Pathogens (Overall and by Species) in AECOPD Patients, as Identified by PCR, and Classified by Severity of AECOPD
Hide Description 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.
Time Frame Over the course of one year from the study start (Month 0 to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the sputum samples taken from Full Analysis Set which included all screened subjects who were enrolled except for those subjects who discontinued the study at Month 0 visit.
Arm/Group Title Total Group
Hide Arm/Group Description:
Moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) patients with at least 1 documented moderate or severe Acute exacerbation of COPD (AECOPD) in the year before enrolment and for whom sputum and blood samples are collected during specified visits.
Overall Number of Participants Analyzed 88
Overall Number of Units Analyzed
Type of Units Analyzed: Sputum samples
 194
Count of Units
Unit of Measure: Sputum samples
Any, Mild AECOPD Number Analyzed 15 Sputum samples
6
  40.0%
Any, Moderate AECOPD Number Analyzed 157 Sputum samples
56
  35.7%
Any, Severe AECOPD Number Analyzed 22 Sputum samples
7
  31.8%
RSV, Mild AECOPD Number Analyzed 15 Sputum samples
1
   6.7%
RSV, Moderate AECOPD Number Analyzed 157 Sputum samples
1
   0.6%
RSV, Severe AECOPD Number Analyzed 22 Sputum samples
0
   0.0%
Parainfluenza virus, Mild AECOPD Number Analyzed 15 Sputum samples
1
   6.7%
Parainfluenza virus, Moderate AECOPD Number Analyzed 156 Sputum samples
6
   3.8%
Parainfluenza virus, Severe AECOPD Number Analyzed 22 Sputum samples
2
   9.1%
Enterovirus, Mild AECOPD Number Analyzed 15 Sputum samples
0
   0.0%
Enterovirus, Moderate AECOPD Number Analyzed 156 Sputum samples
0
   0.0%
Enterovirus, Severe AECOPD Number Analyzed 22 Sputum samples
0
   0.0%
HRV, Mild AECOPD Number Analyzed 15 Sputum samples
3
  20.0%
HRV, Moderate AECOPD Number Analyzed 157 Sputum samples
26
  16.6%
HRV, Severe AECOPD Number Analyzed 22 Sputum samples
3
  13.6%
Metapneumovirus, Mild AECOPD Number Analyzed 15 Sputum samples
0
   0.0%
Metapneumovirus, Moderate AECOPD Number Analyzed 156 Sputum samples
0
   0.0%
Metapneumovirus, Severe AECOPD Number Analyzed 22 Sputum samples
0
   0.0%
Influenza virus, Mild AECOPD Number Analyzed 15 Sputum samples
1
   6.7%
Influenza virus, Moderate AECOPD Number Analyzed 157 Sputum samples
14
   8.9%
Influenza virus, Severe AECOPD Number Analyzed 22 Sputum samples
1
   4.5%
Adenovirus, Mild AECOPD Number Analyzed 15 Sputum samples
0
   0.0%
Adenovirus, Moderate AECOPD Number Analyzed 156 Sputum samples
7
   4.5%
Adenovirus, Severe AECOPD Number Analyzed 22 Sputum samples
1
   4.5%
Bocavirus, Mild AECOPD Number Analyzed 15 Sputum samples
0
   0.0%
Bocavirus, Moderate AECOPD Number Analyzed 157 Sputum samples
0
   0.0%
Bocavirus, Severe AECOPD Number Analyzed 22 Sputum samples
0
   0.0%
Coronavirus, Mild AECOPD Number Analyzed 15 Sputum samples
1
   6.7%
Coronavirus, Moderate AECOPD Number Analyzed 157 Sputum samples
9
   5.7%
Coronavirus, Severe AECOPD Number Analyzed 22 Sputum samples
1
   4.5%
11.Secondary Outcome
Title Incidence Rate (Per Subject Per Year) of Confirmed and Confirmed Plus Potential AECOPDs, Overall and by GOLD Grade
Hide Description 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 which no medical records are available.
Time Frame Over the course of one year from the study start (Month 0 to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Full Analysis Set which included all screened subjects who were enrolled except for those subjects who discontinued the study at Month 0 visit.
Arm/Group Title Total Group
Hide Arm/Group Description:
Moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) patients with at least 1 documented moderate or severe Acute exacerbation of COPD (AECOPD) in the year before enrolment and for whom sputum and blood samples are collected during specified visits.
Overall Number of Participants Analyzed 197
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: AECOPDs per person-year
Total, Confirmed AECOPDs Number Analyzed 197 participants
1.27
(1.04 to 1.54)
GOLD 2, Confirmed AECOPDs Number Analyzed 79 participants
0.78
(0.54 to 1.14)
GOLD 3, Confirmed AECOPDs Number Analyzed 99 participants
1.51
(1.17 to 1.94)
GOLD 4, Confirmed AECOPDs Number Analyzed 19 participants
1.99
(1.37 to 2.89)
Total, Confirmed AECOPDs plus potential AECOPDs Number Analyzed 197 participants
1.3
(1.07 to 1.58)
GOLD 2, Confirmed AECOPDs plus potential AECOPDs Number Analyzed 79 participants
0.81
(0.56 to 1.16)
GOLD 3, Confirmed AECOPDs plus potential AECOPDs Number Analyzed 99 participants
1.56
(1.20 to 2.01)
GOLD 4, Confirmed AECOPDs plus potential AECOPDs Number Analyzed 19 participants
1.99
(1.37 to 2.89)
12.Secondary Outcome
Title Number of Subjects With AECOPDs, Classified by Number of Exacerbations and by Severity of AECOPD
Hide Description 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.
Time Frame Over the course of one year from the study start (Month 0 to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Full Analysis Set which included all screened subjects who were enrolled except for those subjects who discontinued the study at Month 0 visit.
Arm/Group Title Total Group
Hide Arm/Group Description:
Moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) patients with at least 1 documented moderate or severe Acute exacerbation of COPD (AECOPD) in the year before enrolment and for whom sputum and blood samples are collected during specified visits.
Overall Number of Participants Analyzed 197
Measure Type: Count of Participants
Unit of Measure: Participants
Mild AECOPD, 0
181
  91.9%
Moderate AECOPD, 0
115
  58.4%
Severe AECOPD, 0
168
  85.3%
Mild AECOPD, 1
12
   6.1%
Moderate AECOPD, 1
38
  19.3%
Severe AECOPD, 1
21
  10.7%
Mild AECOPD, 2
3
   1.5%
Moderate AECOPD, 2
15
   7.6%
Severe AECOPD, 2
7
   3.6%
Mild AECOPD, 3
1
   0.5%
Moderate AECOPD, 3
11
   5.6%
Severe AECOPD, 3
0
   0.0%
Mild AECOPD, 4
0
   0.0%
Moderate AECOPD, 4
7
   3.6%
Severe AECOPD, 4
1
   0.5%
Mild AECOPD, >4
0
   0.0%
Moderate AECOPD, >4
11
   5.6%
Severe AECOPD, >4
0
   0.0%
13.Secondary Outcome
Title Number of Subjects With AECOPDs, Classified by Number of Exacerbations and by GOLD Grade
Hide Description 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.
Time Frame Over the course of one year from the study start (Month 0 to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Full Analysis Set which included all screened subjects who were enrolled except for those subjects who discontinued the study at Month 0 visit.
Arm/Group Title Total Group
Hide Arm/Group Description:
Moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) patients with at least 1 documented moderate or severe Acute exacerbation of COPD (AECOPD) in the year before enrolment and for whom sputum and blood samples are collected during specified visits.
Overall Number of Participants Analyzed 99
Measure Type: Count of Participants
Unit of Measure: Participants
GOLD 2, 0 Number Analyzed 79 participants
48
  60.8%
GOLD 2, 1 Number Analyzed 79 participants
17
  21.5%
GOLD 2, 2 Number Analyzed 79 participants
6
   7.6%
GOLD 2, 3 Number Analyzed 79 participants
4
   5.1%
GOLD 2, 4 Number Analyzed 79 participants
1
   1.3%
GOLD 2, >4 Number Analyzed 79 participants
3
   3.8%
GOLD 3, 0 Number Analyzed 99 participants
42
  42.4%
GOLD 3, 1 Number Analyzed 99 participants
15
  15.2%
GOLD 3, 2 Number Analyzed 99 participants
21
  21.2%
GOLD 3, 3 Number Analyzed 99 participants
5
   5.1%
GOLD 3, 4 Number Analyzed 99 participants
7
   7.1%
GOLD 3, >4 Number Analyzed 99 participants
9
   9.1%
GOLD 4, 0 Number Analyzed 19 participants
3
  15.8%
GOLD 4, 1 Number Analyzed 19 participants
6
  31.6%
GOLD 4, 2 Number Analyzed 19 participants
5
  26.3%
GOLD 4, 3 Number Analyzed 19 participants
0
   0.0%
GOLD 4, 4 Number Analyzed 19 participants
4
  21.1%
GOLD 4, >4 Number Analyzed 19 participants
1
   5.3%
14.Secondary Outcome
Title Number of Days of AECOPD Episodes, Overall and by AECOPD Severity
Hide Description Descriptive statistics (mean, standard deviation) on the number of days of AECOPD episodes are presented, overall and by AECOPD severity.
Time Frame Over the course of one year from the study start (Month 0 to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Full Analysis Set which included all screened subjects who were enrolled except for those subjects who discontinued the study at Month 0 visit.
Arm/Group Title Total Group
Hide Arm/Group Description:
Moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) patients with at least 1 documented moderate or severe Acute exacerbation of COPD (AECOPD) in the year before enrolment and for whom sputum and blood samples are collected during specified visits.
Overall Number of Participants Analyzed 227
Mean (Standard Deviation)
Unit of Measure: Days
Any Severity Number Analyzed 227 participants
14.3  (9.0)
Mild Number Analyzed 21 participants
20.3  (11.1)
Moderate Number Analyzed 182 participants
12.6  (6.3)
Severe Number Analyzed 24 participants
21.5  (16.5)
15.Secondary Outcome
Title COPD Assessment Test (CAT) Score in Stable COPD Patients
Hide Description The CAT is a patient-completed instrument to assess the heath-related quality of life (HRQOL) and symptom burden in patients with COPD. Descriptive statistics (mean, standard deviation) on the CAT scores are tabulated at each stable visit. The CAT index is derived as the sum of the ratings recorded for each of the eight individual items. Each of these items has 6 possible scores (0, 1, 2, 3, 4 or 5), leading to a range of 0 (best score) to 40 (worst score) for CAT score.
Time Frame At Month 0, Month 6 and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Full Analysis Set which included all screened subjects who were enrolled except for those subjects who discontinued the study at Month 0 visit.
Arm/Group Title Total Group
Hide Arm/Group Description:
Moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) patients with at least 1 documented moderate or severe Acute exacerbation of COPD (AECOPD) in the year before enrolment and for whom sputum and blood samples are collected during specified visits.
Overall Number of Participants Analyzed 197
Mean (Standard Deviation)
Unit of Measure: Units on the CAT scale
Month 0 Number Analyzed 197 participants
11.78  (5.56)
Month 6 Number Analyzed 186 participants
12.56  (6.08)
Month 12 Number Analyzed 181 participants
13.71  (6.53)
16.Secondary Outcome
Title CAT Score by Frequency of Exacerbations
Hide Description The CAT is a patient-completed instrument to assess the HRQOL and symptom burden in patients with COPD. Descriptive statistics (mean, standard deviation) on the CAT scores are tabulated by frequency of exacerbations). The CAT index is derived as the sum of the ratings recorded for each of the eight individual items. Each of these items has 6 possible scores (0, 1, 2, 3, 4 or 5), leading to a range of 0 (best score) to 40 (worst score) for CAT score.
Time Frame Over the course of one year from the study start: (Month 0 to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Full Analysis Set which included all screened subjects who were enrolled except for those subjects who discontinued the study at Month 0 visit.
Arm/Group Title Total Group
Hide Arm/Group Description:
Moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) patients with at least 1 documented moderate or severe Acute exacerbation of COPD (AECOPD) in the year before enrolment and for whom sputum and blood samples are collected during specified visits.
Overall Number of Participants Analyzed 41
Mean (Standard Deviation)
Unit of Measure: Units on the CAT scale
1 exacerbation Number Analyzed 38 participants
2.05  (5.62)
2 or 3 exacerbations Number Analyzed 41 participants
3.08  (5.01)
>3 exacerbations Number Analyzed 25 participants
3.79  (4.84)
17.Secondary Outcome
Title St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Score in Stable COPD Patients
Hide Description The SGRQ-C is designed to assess HRQOL and current health of the patients. Descriptive statistics (mean, standard deviation) on the SGRQ-C scores are tabulated at each stable visit. The SGRQ-C total score is derived as the weighted sum of the forty individual items leading to a range of 0 (best score) to 100 (worst score) as detailed in the reference manual [St George's Respiratory Questionnaire for COPD patients, version 1.3, 2016].
Time Frame At Month 0, Month 6 and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Full Analysis Set which included all screened subjects who were enrolled except for those subjects who discontinued the study at Month 0 visit.
Arm/Group Title Total Group
Hide Arm/Group Description:
Moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) patients with at least 1 documented moderate or severe Acute exacerbation of COPD (AECOPD) in the year before enrolment and for whom sputum and blood samples are collected during specified visits.
Overall Number of Participants Analyzed 197
Mean (Standard Deviation)
Unit of Measure: Units on the SGRQ-C scale
Month 0 Number Analyzed 197 participants
35.22  (17.21)
Month 6 Number Analyzed 184 participants
34.38  (16.52)
Month 12 Number Analyzed 178 participants
35.1  (17.86)
18.Secondary Outcome
Title Post-bronchodilator FEV1 Percentage of Predicted Normal Value in Stable COPD Patients
Hide Description Summary statistics (mean, standard deviation) on post bronchodilator FEV1% of predicted normal value is tabulated at enrolment and final visit.
Time Frame At Pre-Month 0 (screening visit) and Month 12.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Full Analysis Set which included all screened subjects who were enrolled except for those subjects who discontinued the study at Month 0 visit.
Arm/Group Title Total Group
Hide Arm/Group Description:
Moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) patients with at least 1 documented moderate or severe Acute exacerbation of COPD (AECOPD) in the year before enrolment and for whom sputum and blood samples are collected during specified visits.
Overall Number of Participants Analyzed 197
Mean (Standard Deviation)
Unit of Measure: Percentage of FEV1
Pre-Month 0 47.83  (13.94)
Month 12 46.93  (14.93)
19.Secondary Outcome
Title Number of Patients With Healthcare Utilisation During Stable Periods
Hide Description Healthcare utilization includes all unscheduled visits to a physician office, visits to urgent care, visits to emergency department, and hospitalizations. The impact of AECOPD on healthcare utilization is assessed during the stable periods. Hospitalizations that were associated with the disease being studied were not collected as Adverse Events (AEs) or as serious AEs (SAEs) as per protocol.
Time Frame Over the course of one year from the study start (Month 0 to Month 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the Full Analysis Set which included all screened subjects who were enrolled except for those subjects who discontinued the study at Month 0 visit.
Arm/Group Title Total Group
Hide Arm/Group Description:
Moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) patients with at least 1 documented moderate or severe Acute exacerbation of COPD (AECOPD) in the year before enrolment and for whom sputum and blood samples are collected during specified visits.
Overall Number of Participants Analyzed 197
Measure Type: Count of Participants
Unit of Measure: Participants
Physician's office consultations
135
  68.5%
Urgent care
4
   2.0%
Emergency department
20
  10.2%
Hospitalization
26
  13.2%
20.Secondary Outcome
Title Number of Patients With Healthcare Utilisation During Exacerbation Periods
Hide Description Healthcare utilization includes all unscheduled visits to a physician office, visits to urgent care, visits to emergency department, and hospitalizations. The impact of AECOPD on healthcare utilization is assessed during exacerbation periods. Hospitalizations that were associated with the disease being studied were not collected as AEs or as SAEs as per protocol.
Time Frame Over the course of one year from the study start (Month 0 to Month 12)
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Hide Analysis Population Description
Analysis was performed on the Full Analysis Set which included all screened subjects who were enrolled except for those subjects who discontinued the study at Month 0 visit.
Arm/Group Title Total Group
Hide Arm/Group Description:
Moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) patients with at least 1 documented moderate or severe Acute exacerbation of COPD (AECOPD) in the year before enrolment and for whom sputum and blood samples are collected during specified visits.
Overall Number of Participants Analyzed 104
Measure Type: Count of Participants
Unit of Measure: Participants
Physician's office consultations
48
  46.2%
Urgent care
2
   1.9%
Emergency department
13
  12.5%
Hospitalization
20
  19.2%
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.
Adverse Event Reporting Description In the Participant flow section, there are 2 participants reported with "adverse event" reason for not completed: 1 was for SAE described in the Serious Adverse Events section below, and the other one was for a SAE not related to study procedure, and hence, no information (System Organ Class & Preferred Term) was collected, as per protocol, for this SAE. Hospitalizations that were associated with the disease being studied were not collected as AEs or as SAEs as per protocol.
 
Arm/Group Title Total Group
Hide Arm/Group Description Moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) patients with at least 1 documented moderate or severe Acute exacerbation of COPD (AECOPD) in the year before enrolment and for whom sputum and blood samples are collected during specified visits.
All-Cause Mortality
Total Group
Affected / at Risk (%)
Total   2/197 (1.02%)    
Hide Serious Adverse Events
Total Group
Affected / at Risk (%) # Events
Total   1/197 (0.51%)    
Infections and infestations   
Pneumonia necrotizing † 1  1/197 (0.51%)  1
1
Term from vocabulary, MedDRA Version 23.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Total Group
Affected / at Risk (%) # Events
Total   1/197 (0.51%)    
Respiratory, thoracic and mediastinal disorders   
Cough † 1  1/197 (0.51%)  1
1
Term from vocabulary, MedDRA Version 23.1
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
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Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
EMail: GSKClinicalSupportHD@gsk.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03151395    
Other Study ID Numbers: 201112
First Submitted: May 5, 2017
First Posted: May 12, 2017
Results First Submitted: March 26, 2021
Results First Posted: June 14, 2021
Last Update Posted: June 14, 2021