Trial Outcomes & Findings for Infectious Pathogens in Acute Respiratory Illness in Adults and Elderly (NCT NCT01360398)
NCT ID: NCT01360398
Last Updated: 2019-02-15
Results Overview
An Acute Exacerbation in a COPD patient is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough, and/or sputum production and beyond normal day to day variations, that is acute in onset and may warrant a change in regular medication in a patient with underlying COPD The Means and Confidence Intervals (CI) were estimated using the Negative Binomial model taking into account time to follow up. Estimated exacerbations were presented as mean number of exacerbations per (/) subject/ year.
COMPLETED
NA
127 participants
During year 1
2019-02-15
Participant Flow
Participant milestones
| Measure |
Total Group
Chronic Obstructive Pulmonary Disease \[COPD\] diagnosed male and female patients between 40 and 85 years of age, recruited among the patients of the Southampton General Hospital and referring practices, enrolled to generate additional data for further exploration of COPD determinants and the contribution of infectious pathogens to Acute Exacerbation of COPD (AECOPD).
|
|---|---|
|
Overall Study
STARTED
|
127
|
|
Overall Study
COMPLETED
|
105
|
|
Overall Study
NOT COMPLETED
|
22
|
Reasons for withdrawal
| Measure |
Total Group
Chronic Obstructive Pulmonary Disease \[COPD\] diagnosed male and female patients between 40 and 85 years of age, recruited among the patients of the Southampton General Hospital and referring practices, enrolled to generate additional data for further exploration of COPD determinants and the contribution of infectious pathogens to Acute Exacerbation of COPD (AECOPD).
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
14
|
|
Overall Study
Other
|
7
|
|
Overall Study
Migrated/moved from study area
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Total Group
n=127 Participants
Chronic Obstructive Pulmonary Disease \[COPD\] diagnosed male and female patients between 40 and 85 years of age, recruited among the patients of the Southampton General Hospital and referring practices, enrolled to generate additional data for further exploration of COPD determinants and the contribution of infectious pathogens to Acute Exacerbation of COPD (AECOPD).
|
|---|---|
|
Age, Continuous
|
66.8 Years
STANDARD_DEVIATION 8.6 • n=127 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=127 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=127 Participants
|
PRIMARY outcome
Timeframe: During year 1Population: The analyses of AECOPD were performed on the Full cohort, which included all subjects eligible for inclusion based on medical history and study specific procedures defined in the protocol and who completed at least the Day 0 visit.
An Acute Exacerbation in a COPD patient is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough, and/or sputum production and beyond normal day to day variations, that is acute in onset and may warrant a change in regular medication in a patient with underlying COPD The Means and Confidence Intervals (CI) were estimated using the Negative Binomial model taking into account time to follow up. Estimated exacerbations were presented as mean number of exacerbations per (/) subject/ year.
Outcome measures
| Measure |
Total Group
n=127 Participants
Chronic Obstructive Pulmonary Disease \[COPD\] diagnosed male and female patients between 40 and 85 years of age, recruited among the patients of the Southampton General Hospital and referring practices, enrolled to generate additional data for further exploration of COPD determinants and the contribution of infectious pathogens to Acute Exacerbation of COPD (AECOPD).
|
|---|---|
|
Mean Estimated Number of Acute Exacerbation of COPD (AECOPD)
|
3.04 AECOPD/subject/year
Interval 2.63 to 3.5
|
PRIMARY outcome
Timeframe: During Year 1Population: The analyses of AECOPD were performed on the Full cohort, which included all subjects eligible for inclusion based on medical history and study specific procedures defined in the protocol and who completed at least the Day 0 visit.
Bacterial pathogens assessed were: Haemophilus influenzae (Hi), Moraxella catarrhalis (Mcat), Steptococcus pneumoniae (Sp), Staphylococcus Aureus (Sta), Pseudomonas aeruginosa (Psa), any or other. For each bacteria, the means and CIs were estimated from Negative Binomial model taking into account the follow up time.Estimated exacerbations were presented as mean number of exacerbations/ subject/ year.
Outcome measures
| Measure |
Total Group
n=127 Participants
Chronic Obstructive Pulmonary Disease \[COPD\] diagnosed male and female patients between 40 and 85 years of age, recruited among the patients of the Southampton General Hospital and referring practices, enrolled to generate additional data for further exploration of COPD determinants and the contribution of infectious pathogens to Acute Exacerbation of COPD (AECOPD).
|
|---|---|
|
Mean Estimated Number of AECOPD With Sputum Containing Bacterial Pathogens
Any
|
1.59 AECOPD/subject/year
Interval 1.3 to 1.95
|
|
Mean Estimated Number of AECOPD With Sputum Containing Bacterial Pathogens
Hi
|
1.10 AECOPD/subject/year
Interval 0.84 to 1.43
|
|
Mean Estimated Number of AECOPD With Sputum Containing Bacterial Pathogens
Sta
|
0.16 AECOPD/subject/year
Interval 0.07 to 0.36
|
|
Mean Estimated Number of AECOPD With Sputum Containing Bacterial Pathogens
Psa
|
0.18 AECOPD/subject/year
Interval 0.09 to 0.35
|
|
Mean Estimated Number of AECOPD With Sputum Containing Bacterial Pathogens
Mcat
|
0.34 AECOPD/subject/year
Interval 0.24 to 0.48
|
|
Mean Estimated Number of AECOPD With Sputum Containing Bacterial Pathogens
Sp
|
0.39 AECOPD/subject/year
Interval 0.27 to 0.58
|
|
Mean Estimated Number of AECOPD With Sputum Containing Bacterial Pathogens
Other
|
0.01 AECOPD/subject/year
Interval 0.0 to 0.06
|
PRIMARY outcome
Timeframe: During Year 1Population: The analyses of AECOPD were performed on the Full cohort, which included all subjects eligible for inclusion based on medical history and study specific procedures defined in the protocol and who completed at least the Day 0 visit.
Bacterial pathogens assessed, by culture, were: Haemophilus influenzae (Hi), Moraxella catarrhalis (Mcat), Streptococcus pneumoniae (Sp), Staphylococcus aureus (Sta), Pseudomonas aeruginosa (Psa), any bacteria or other bacteria. Overall exacerbation rate is the average number of exacerbations for each subject during their time in the study.
Outcome measures
| Measure |
Total Group
n=127 Participants
Chronic Obstructive Pulmonary Disease \[COPD\] diagnosed male and female patients between 40 and 85 years of age, recruited among the patients of the Southampton General Hospital and referring practices, enrolled to generate additional data for further exploration of COPD determinants and the contribution of infectious pathogens to Acute Exacerbation of COPD (AECOPD).
|
|---|---|
|
Overall AECOPD Exacerbation Rate for Any and Specific Bacterial Pathogens in Sputum
Any Bacteria
|
1.48 AECOPD/subject
|
|
Overall AECOPD Exacerbation Rate for Any and Specific Bacterial Pathogens in Sputum
Hi
|
1.02 AECOPD/subject
|
|
Overall AECOPD Exacerbation Rate for Any and Specific Bacterial Pathogens in Sputum
Mcat
|
0.31 AECOPD/subject
|
|
Overall AECOPD Exacerbation Rate for Any and Specific Bacterial Pathogens in Sputum
Psa
|
0.17 AECOPD/subject
|
|
Overall AECOPD Exacerbation Rate for Any and Specific Bacterial Pathogens in Sputum
Sp
|
0.37 AECOPD/subject
|
|
Overall AECOPD Exacerbation Rate for Any and Specific Bacterial Pathogens in Sputum
Sta
|
0.14 AECOPD/subject
|
|
Overall AECOPD Exacerbation Rate for Any and Specific Bacterial Pathogens in Sputum
Other Bacteria
|
0.01 AECOPD/subject
|
SECONDARY outcome
Timeframe: During Year 1Population: The analyses of AECOPD were performed on the Full cohort, which included all subjects eligible for inclusion based on medical history and study specific procedures defined in the protocol and who completed at least the Day 0 visit.
Sputum samples were tested by bacterial species (any bacteria, Hi, Mcat, Sp, Sta, Psa and other bacteria), or overall and were obtained from culture at each visit (enrollment, any stable visit, any exacerbation visit, any mild exacerbation visit, any moderate exacerbation visit, any severe exacerbation visit). This endpoint presents results for any bacteria and Hi.
Outcome measures
| Measure |
Total Group
n=127 Participants
Chronic Obstructive Pulmonary Disease \[COPD\] diagnosed male and female patients between 40 and 85 years of age, recruited among the patients of the Southampton General Hospital and referring practices, enrolled to generate additional data for further exploration of COPD determinants and the contribution of infectious pathogens to Acute Exacerbation of COPD (AECOPD).
|
|---|---|
|
Number of Sputum Samples Positive for Specific Pathogens - Any Bacteria and Hi
Any Bacteria - any stable visit
|
466 sputum samples
|
|
Number of Sputum Samples Positive for Specific Pathogens - Any Bacteria and Hi
Any Bacteria - any moderate exacerbation visit
|
162 sputum samples
|
|
Number of Sputum Samples Positive for Specific Pathogens - Any Bacteria and Hi
Any Bacteria - any severe exacerbation visit
|
9 sputum samples
|
|
Number of Sputum Samples Positive for Specific Pathogens - Any Bacteria and Hi
Hi - enrollment
|
32 sputum samples
|
|
Number of Sputum Samples Positive for Specific Pathogens - Any Bacteria and Hi
Hi - any stable visit
|
287 sputum samples
|
|
Number of Sputum Samples Positive for Specific Pathogens - Any Bacteria and Hi
Hi - any mild exacerbation visit
|
11 sputum samples
|
|
Number of Sputum Samples Positive for Specific Pathogens - Any Bacteria and Hi
Hi - any severe exacerbation visit
|
7 sputum samples
|
|
Number of Sputum Samples Positive for Specific Pathogens - Any Bacteria and Hi
Any Bacteria - enrollment
|
57 sputum samples
|
|
Number of Sputum Samples Positive for Specific Pathogens - Any Bacteria and Hi
Any Bacteria - any exacerbation visit
|
188 sputum samples
|
|
Number of Sputum Samples Positive for Specific Pathogens - Any Bacteria and Hi
Any Bacteria - any mild exacerbation visit
|
17 sputum samples
|
|
Number of Sputum Samples Positive for Specific Pathogens - Any Bacteria and Hi
Hi - any exacerbation visit
|
129 sputum samples
|
|
Number of Sputum Samples Positive for Specific Pathogens - Any Bacteria and Hi
Hi - any moderate exacerbation visit
|
111 sputum samples
|
SECONDARY outcome
Timeframe: During Year 1Population: The analyses of AECOPD were performed on the Full cohort, which included all subjects eligible for inclusion based on medical history and study specific procedures defined in the protocol and who completed at least the Day 0 visit.
Sputum samples were tested by bacterial species (any bacteria, Hi, Mcat, Sp, Sta, Psa and other bacteria), or overall and were obtained from culture at each visit (enrollment, any stable visit, any exacerbation visit, any mild exacerbation visit, any moderate exacerbation visit, any severe exacerbation visit). This endpoint presents results for Mcat and Sp.
Outcome measures
| Measure |
Total Group
n=127 Participants
Chronic Obstructive Pulmonary Disease \[COPD\] diagnosed male and female patients between 40 and 85 years of age, recruited among the patients of the Southampton General Hospital and referring practices, enrolled to generate additional data for further exploration of COPD determinants and the contribution of infectious pathogens to Acute Exacerbation of COPD (AECOPD).
|
|---|---|
|
Number of Sputum Samples Positive for Specific Pathogens - Mcat and Sp
Mcat - enrollment
|
8 sputum samples
|
|
Number of Sputum Samples Positive for Specific Pathogens - Mcat and Sp
Mcat - any stable visit
|
50 sputum samples
|
|
Number of Sputum Samples Positive for Specific Pathogens - Mcat and Sp
Mcat - any mild exacerbation visit
|
1 sputum samples
|
|
Number of Sputum Samples Positive for Specific Pathogens - Mcat and Sp
Mcat - any moderate exacerbation visit
|
39 sputum samples
|
|
Number of Sputum Samples Positive for Specific Pathogens - Mcat and Sp
Sp - enrollment
|
19 sputum samples
|
|
Number of Sputum Samples Positive for Specific Pathogens - Mcat and Sp
Sp - any stable visit
|
177 sputum samples
|
|
Number of Sputum Samples Positive for Specific Pathogens - Mcat and Sp
Sp - any exacerbation visit
|
47 sputum samples
|
|
Number of Sputum Samples Positive for Specific Pathogens - Mcat and Sp
Sp - any mild exacerbation visit
|
6 sputum samples
|
|
Number of Sputum Samples Positive for Specific Pathogens - Mcat and Sp
Sp - any moderate exacerbation visit
|
37 sputum samples
|
|
Number of Sputum Samples Positive for Specific Pathogens - Mcat and Sp
Sp - any severe exacerbation visit
|
4 sputum samples
|
|
Number of Sputum Samples Positive for Specific Pathogens - Mcat and Sp
Mcat - any exacerbation visit
|
40 sputum samples
|
|
Number of Sputum Samples Positive for Specific Pathogens - Mcat and Sp
Mcat - any severe exacerbation visit
|
0 sputum samples
|
SECONDARY outcome
Timeframe: During Year 1Population: The analyses of AECOPD were performed on the Full cohort, which included all subjects eligible for inclusion based on medical history and study specific procedures defined in the protocol and who completed at least the Day 0 visit.
Sputum samples were tested by bacterial species (any bacteria, Hi, Mcat, Sp, Sta, Psa and other bacteria), or overall and were obtained from culture at each visit (enrollment, any stable visit, any exacerbation visit, any mild exacerbation visit, any moderate exacerbation visit, any severe exacerbation visit). This endpoint presents results for Sta, Psa and other bacteria.
Outcome measures
| Measure |
Total Group
n=127 Participants
Chronic Obstructive Pulmonary Disease \[COPD\] diagnosed male and female patients between 40 and 85 years of age, recruited among the patients of the Southampton General Hospital and referring practices, enrolled to generate additional data for further exploration of COPD determinants and the contribution of infectious pathogens to Acute Exacerbation of COPD (AECOPD).
|
|---|---|
|
Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria
Sta - enrollment
|
6 sputum samples
|
|
Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria
Sta - any stable visit
|
40 sputum samples
|
|
Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria
Sta - any exacerbation visit
|
18 sputum samples
|
|
Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria
Sta - any mild exacerbation visit
|
0 sputum samples
|
|
Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria
Sta - any moderate exacerbation visit
|
18 sputum samples
|
|
Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria
Sta - any severe exacerbation visit
|
0 sputum samples
|
|
Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria
Psa - enrollment
|
6 sputum samples
|
|
Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria
Psa - any stable visit
|
49 sputum samples
|
|
Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria
Psa - any exacerbation visit
|
21 sputum samples
|
|
Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria
Psa - any mild exacerbation visit
|
0 sputum samples
|
|
Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria
Psa - any moderate exacerbation visit
|
19 sputum samples
|
|
Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria
Psa - any severe exacerbation visit
|
2 sputum samples
|
|
Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria
Other bacteria - enrollment
|
2 sputum samples
|
|
Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria
Other bacteria - any stable visit
|
6 sputum samples
|
|
Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria
Other bacteria - any exacerbation visit
|
1 sputum samples
|
|
Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria
Other bacteria - any moderate exacerbation visit
|
0 sputum samples
|
|
Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria
Other bacteria - any mild exacerbation visit
|
1 sputum samples
|
|
Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria
Other bacteria - any severe exacerbation visit
|
0 sputum samples
|
SECONDARY outcome
Timeframe: During Year 1Population: The analyses of AECOPD were performed on the Full cohort, which included all subjects eligible for inclusion based on medical history and study specific procedures defined in the protocol and who completed at least the Day 0 visit.
The number of days between 2 consecutive exacerbations, as estimated by the investigator, was calculated only whenever the first exacerbation had an end date.
Outcome measures
| Measure |
Total Group
n=127 Participants
Chronic Obstructive Pulmonary Disease \[COPD\] diagnosed male and female patients between 40 and 85 years of age, recruited among the patients of the Southampton General Hospital and referring practices, enrolled to generate additional data for further exploration of COPD determinants and the contribution of infectious pathogens to Acute Exacerbation of COPD (AECOPD).
|
|---|---|
|
Mean Number of Days Between 2 Consecutive AECOPDs
|
55.5 Days
Standard Deviation 53.0
|
SECONDARY outcome
Timeframe: During Year 1Population: The analyses of AECOPD were performed on the Full cohort, which included all subjects eligible for inclusion based on medical history and study specific procedures defined in the protocol and who completed at least the Day 0 visit.
The exacerbations of chronic pulmonary disease tool version 1.0 (EXACT) is a validated self-administered instrument that evaluates the effects of pharmacologic treatment on acute exacerbations of COPD. Analyses of exacerbations in relation to morning or evening EXACT-PRO e-diaries were presented as follows: descriptive statistics on the EXACT daily scores tabulated at enrolment, at any stable and at any, mild, moderate or severe exacerbation visit. EXACT-PRO contains 14 questions with scores ranging from 0 to 4, where 0= best outcome while 4= worse outcome.
Outcome measures
| Measure |
Total Group
n=127 Participants
Chronic Obstructive Pulmonary Disease \[COPD\] diagnosed male and female patients between 40 and 85 years of age, recruited among the patients of the Southampton General Hospital and referring practices, enrolled to generate additional data for further exploration of COPD determinants and the contribution of infectious pathogens to Acute Exacerbation of COPD (AECOPD).
|
|---|---|
|
Change From Baseline EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) Scores at Enrollment and Any AECOPD Visit
Enrollment
|
0.0 COPD EXACT Score
Standard Deviation 0.00
|
|
Change From Baseline EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) Scores at Enrollment and Any AECOPD Visit
Any stable visit
|
-3.0 COPD EXACT Score
Standard Deviation 9.34
|
|
Change From Baseline EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) Scores at Enrollment and Any AECOPD Visit
Any onset of exacerbation visit
|
2.7 COPD EXACT Score
Standard Deviation 10.24
|
|
Change From Baseline EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) Scores at Enrollment and Any AECOPD Visit
Any onset of mild exacerbation visit
|
0.3 COPD EXACT Score
Standard Deviation 11.16
|
|
Change From Baseline EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) Scores at Enrollment and Any AECOPD Visit
Any onset of moderate exacerbation visit
|
2.9 COPD EXACT Score
Standard Deviation 10.30
|
|
Change From Baseline EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) Scores at Enrollment and Any AECOPD Visit
Any onset of severe exacerbation visit
|
2.3 COPD EXACT Score
Standard Deviation 5.58
|
SECONDARY outcome
Timeframe: During Year 1Population: The analyses of AECOPD were performed on the Full cohort, which included all subjects eligible for inclusion based on medical history and study specific procedures defined in the protocol and who completed at least the Day 0 visit.
The COPD assessment test (CAT) is a validated self-administered instrument designed to provide a simple and reliable measure of health status in COPD patients. Its properties have been shown to be similar to the St George's respiratory questionnaire (SGRQ). The CAT comprises 8 items and has a scoring range of 0-40, 0= most positive answer and 40= most negative answer. In this study, the subjects were to complete the CAT questionnaire every 3 months.
Outcome measures
| Measure |
Total Group
n=127 Participants
Chronic Obstructive Pulmonary Disease \[COPD\] diagnosed male and female patients between 40 and 85 years of age, recruited among the patients of the Southampton General Hospital and referring practices, enrolled to generate additional data for further exploration of COPD determinants and the contribution of infectious pathogens to Acute Exacerbation of COPD (AECOPD).
|
|---|---|
|
Change From Baseline COPD Assessment Test (CAT) Scores at Enrollment and Any AECOPD Visit
Enrollment
|
0.0 COPD CAT Score
Standard Deviation 0.00
|
|
Change From Baseline COPD Assessment Test (CAT) Scores at Enrollment and Any AECOPD Visit
Any stable visit
|
-0.9 COPD CAT Score
Standard Deviation 6.04
|
|
Change From Baseline COPD Assessment Test (CAT) Scores at Enrollment and Any AECOPD Visit
Any onset of exacerbation visit
|
4.1 COPD CAT Score
Standard Deviation 7.40
|
|
Change From Baseline COPD Assessment Test (CAT) Scores at Enrollment and Any AECOPD Visit
Any onset of mild exacerbation visit
|
0.3 COPD CAT Score
Standard Deviation 5.17
|
|
Change From Baseline COPD Assessment Test (CAT) Scores at Enrollment and Any AECOPD Visit
Any onset of moderate exacerbation visit
|
4.3 COPD CAT Score
Standard Deviation 7.43
|
|
Change From Baseline COPD Assessment Test (CAT) Scores at Enrollment and Any AECOPD Visit
Any onset of severe exacerbation visit
|
7.2 COPD CAT Score
Standard Deviation 8.14
|
SECONDARY outcome
Timeframe: During Year 1Population: The analyses of AECOPD were performed on the Full cohort, which included all subjects eligible for inclusion based on medical history and study specific procedures defined in the protocol and who completed at least the Day 0 visit.
The NEADL assessed (quarterly in the present study) the ease or difficulty in performing extended activities of daily living. The NEADL scale contains 22 items, each measured on a 4-point Likert scale. There are four dimensions: mobility (6 items); kitchen (5 items); domestic (5 items); leisure (6 items). These are summed producing a total score reflecting general functioning. Each of the 22 individual items had 2 possible scores (0 or 1). Therefore, the range of the NEADL score was 0 to 22. Lower scores indicate greater levels of disability while higher scores indicate greater independence.
Outcome measures
| Measure |
Total Group
n=127 Participants
Chronic Obstructive Pulmonary Disease \[COPD\] diagnosed male and female patients between 40 and 85 years of age, recruited among the patients of the Southampton General Hospital and referring practices, enrolled to generate additional data for further exploration of COPD determinants and the contribution of infectious pathogens to Acute Exacerbation of COPD (AECOPD).
|
|---|---|
|
Change From Baseline COPD Nottingham Extended Activities of Daily Living Scale (NEADL) Scores at Enrollment and Any AECOPD Visit
Enrolment
|
0.0 NEADL AECOPD scores
Standard Deviation 0.00
|
|
Change From Baseline COPD Nottingham Extended Activities of Daily Living Scale (NEADL) Scores at Enrollment and Any AECOPD Visit
Any stable visit
|
6.2 NEADL AECOPD scores
Standard Deviation 13.41
|
|
Change From Baseline COPD Nottingham Extended Activities of Daily Living Scale (NEADL) Scores at Enrollment and Any AECOPD Visit
Any onset of exacerbation visit
|
3.2 NEADL AECOPD scores
Standard Deviation 12.78
|
|
Change From Baseline COPD Nottingham Extended Activities of Daily Living Scale (NEADL) Scores at Enrollment and Any AECOPD Visit
Any onset of mild exacerbation visit
|
3.8 NEADL AECOPD scores
Standard Deviation 8.95
|
|
Change From Baseline COPD Nottingham Extended Activities of Daily Living Scale (NEADL) Scores at Enrollment and Any AECOPD Visit
Any onset of moderate exacerbation visit
|
3.3 NEADL AECOPD scores
Standard Deviation 13.18
|
|
Change From Baseline COPD Nottingham Extended Activities of Daily Living Scale (NEADL) Scores at Enrollment and Any AECOPD Visit
Any onset of severe exacerbation visit
|
0 NEADL AECOPD scores
Standard Deviation 11.16
|
SECONDARY outcome
Timeframe: During Year 1Population: The analyses of AECOPD were performed on the Full cohort, which included all subjects eligible for inclusion based on medical history and study specific procedures defined in the protocol and who completed at least the Day 0 visit.
The EQ-5D is an established measure of generic health outcome that provides a simple descriptive profile and a single index value that can be used in clinical and economic evaluation of healthcare and in population surveys. Its current format is 3-level and 5 dimensional (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The EQ-5D index was derived from the ratings recorded every 3 months for each of the five individual items (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The EQ-5D index was 0 (worst health state) to 100 (best health state). The negative numbers presented represent a decrease from baseline values and a worsening of health.
Outcome measures
| Measure |
Total Group
n=127 Participants
Chronic Obstructive Pulmonary Disease \[COPD\] diagnosed male and female patients between 40 and 85 years of age, recruited among the patients of the Southampton General Hospital and referring practices, enrolled to generate additional data for further exploration of COPD determinants and the contribution of infectious pathogens to Acute Exacerbation of COPD (AECOPD).
|
|---|---|
|
Change From Baseline COPD EQ-5D Index and Visual Analogue Scale (VAS) Scores at Enrollment and Any AECOPD Visit
Enrolment
|
0.0 EQ-5D AECOPD scores
Standard Deviation 0.00
|
|
Change From Baseline COPD EQ-5D Index and Visual Analogue Scale (VAS) Scores at Enrollment and Any AECOPD Visit
Any stable visit
|
-1.4 EQ-5D AECOPD scores
Standard Deviation 19.25
|
|
Change From Baseline COPD EQ-5D Index and Visual Analogue Scale (VAS) Scores at Enrollment and Any AECOPD Visit
Any onset of exacerbation visit
|
-14.8 EQ-5D AECOPD scores
Standard Deviation 20.88
|
|
Change From Baseline COPD EQ-5D Index and Visual Analogue Scale (VAS) Scores at Enrollment and Any AECOPD Visit
Any onset of mild exacerbation visit
|
-4.3 EQ-5D AECOPD scores
Standard Deviation 18.78
|
|
Change From Baseline COPD EQ-5D Index and Visual Analogue Scale (VAS) Scores at Enrollment and Any AECOPD Visit
Any onset of severe exacerbation visit
|
-16.9 EQ-5D AECOPD scores
Standard Deviation 28.42
|
|
Change From Baseline COPD EQ-5D Index and Visual Analogue Scale (VAS) Scores at Enrollment and Any AECOPD Visit
Any onset of moderate exacerbation visit
|
-15.8 EQ-5D AECOPD scores
Standard Deviation 20.44
|
SECONDARY outcome
Timeframe: During Year 1Population: The analyses of AECOPD were performed on the Full cohort, which included all subjects eligible for inclusion based on medical history and study specific procedures defined in the protocol and who completed at least the Day 0 visit.
AECOPD health care type included: general practitioners (other than the study doctor), pneumologists, other specialists, hospital emergency department, home care nurses, pulmonary rehabilitation programs and/or nutrition advices.
Outcome measures
| Measure |
Total Group
n=108 Participants
Chronic Obstructive Pulmonary Disease \[COPD\] diagnosed male and female patients between 40 and 85 years of age, recruited among the patients of the Southampton General Hospital and referring practices, enrolled to generate additional data for further exploration of COPD determinants and the contribution of infectious pathogens to Acute Exacerbation of COPD (AECOPD).
|
|---|---|
|
Number of Subjects Receiving Various Health Care Types During AECOPD
General practitioner - Negative
|
82 Participants
|
|
Number of Subjects Receiving Various Health Care Types During AECOPD
General practitioner - Positive
|
26 Participants
|
|
Number of Subjects Receiving Various Health Care Types During AECOPD
Pneumologist - Negative
|
104 Participants
|
|
Number of Subjects Receiving Various Health Care Types During AECOPD
Pneumologist - Positive
|
4 Participants
|
|
Number of Subjects Receiving Various Health Care Types During AECOPD
Other specialist - Negative
|
103 Participants
|
|
Number of Subjects Receiving Various Health Care Types During AECOPD
Other specialist - Positive
|
5 Participants
|
|
Number of Subjects Receiving Various Health Care Types During AECOPD
Emergency department at the hospital - Negative
|
96 Participants
|
|
Number of Subjects Receiving Various Health Care Types During AECOPD
Emergency department at the hospital - Positive
|
12 Participants
|
|
Number of Subjects Receiving Various Health Care Types During AECOPD
Nurse home care - Negative
|
108 Participants
|
|
Number of Subjects Receiving Various Health Care Types During AECOPD
Pulmonary rehabilitation program - Negative
|
98 Participants
|
|
Number of Subjects Receiving Various Health Care Types During AECOPD
Pulmonary rehabilitation program - Positive
|
10 Participants
|
|
Number of Subjects Receiving Various Health Care Types During AECOPD
Nutrition Advice - Negative
|
107 Participants
|
|
Number of Subjects Receiving Various Health Care Types During AECOPD
Nutrition Advice - Positive
|
1 Participants
|
SECONDARY outcome
Timeframe: During Year 1Population: The analyses of AECOPD were performed on the Full cohort, which included all subjects eligible for inclusion based on medical history and study specific procedures defined in the protocol and who completed at least the Day 0 visit.
Serious adverse events (SAEs) include medical occur-rences that result in death, are life threatening, require hospitali-zation or prolongation of hospitalization or result in disabil-ity/incapacity.
Outcome measures
| Measure |
Total Group
n=127 Participants
Chronic Obstructive Pulmonary Disease \[COPD\] diagnosed male and female patients between 40 and 85 years of age, recruited among the patients of the Southampton General Hospital and referring practices, enrolled to generate additional data for further exploration of COPD determinants and the contribution of infectious pathogens to Acute Exacerbation of COPD (AECOPD).
|
|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs) Possibly Related/Linked to Withdrawal
|
0 Participants
|
SECONDARY outcome
Timeframe: During Year 1Population: The analyses of AECOPD were performed on the Full cohort, which included all subjects eligible for inclusion based on medical history and study specific procedures defined in the protocol and who completed at least the Day 0 visit.
Bacterial pathogens assessed, by PCR assay were: Hi, Mcat, Sp, Sta, Psa, Streptococcus pyogenes (Spyo) and any bacteria.
Outcome measures
| Measure |
Total Group
n=127 Participants
Chronic Obstructive Pulmonary Disease \[COPD\] diagnosed male and female patients between 40 and 85 years of age, recruited among the patients of the Southampton General Hospital and referring practices, enrolled to generate additional data for further exploration of COPD determinants and the contribution of infectious pathogens to Acute Exacerbation of COPD (AECOPD).
|
|---|---|
|
AECOPD Rate With Overall and Specific Bacterial Pathogens in Sputum , by Polymerase Chain Reaction (PCR) Assay
Any Bacteria
|
1.61 AECOPD/subject
|
|
AECOPD Rate With Overall and Specific Bacterial Pathogens in Sputum , by Polymerase Chain Reaction (PCR) Assay
Hi
|
1.30 AECOPD/subject
|
|
AECOPD Rate With Overall and Specific Bacterial Pathogens in Sputum , by Polymerase Chain Reaction (PCR) Assay
Mcat
|
0.47 AECOPD/subject
|
|
AECOPD Rate With Overall and Specific Bacterial Pathogens in Sputum , by Polymerase Chain Reaction (PCR) Assay
Sp
|
0.20 AECOPD/subject
|
|
AECOPD Rate With Overall and Specific Bacterial Pathogens in Sputum , by Polymerase Chain Reaction (PCR) Assay
Sta
|
0.09 AECOPD/subject
|
|
AECOPD Rate With Overall and Specific Bacterial Pathogens in Sputum , by Polymerase Chain Reaction (PCR) Assay
Psa
|
0.14 AECOPD/subject
|
|
AECOPD Rate With Overall and Specific Bacterial Pathogens in Sputum , by Polymerase Chain Reaction (PCR) Assay
Spyo
|
0.00 AECOPD/subject
|
SECONDARY outcome
Timeframe: During Year 1Population: The analyses of AECOPD were performed on the Full cohort, which included all subjects eligible for inclusion based on medical history and study specific procedures defined in the protocol and who completed at least the Day 0 visit.
Viral pathogens assessed were: respiratory syncytial virus (RSV), parainfluenza virus (PIV), entero rhinovirus (ENV), human metapneumovirus (HMP), influenza virus (INV), adenovirus (ADV), coronavirus (CRV), human bocavirus (HBoV) and any virus.
Outcome measures
| Measure |
Total Group
n=127 Participants
Chronic Obstructive Pulmonary Disease \[COPD\] diagnosed male and female patients between 40 and 85 years of age, recruited among the patients of the Southampton General Hospital and referring practices, enrolled to generate additional data for further exploration of COPD determinants and the contribution of infectious pathogens to Acute Exacerbation of COPD (AECOPD).
|
|---|---|
|
AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
Any virus
|
0.99 AECOPD/subject
|
|
AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
RSV
|
0.02 AECOPD/subject
|
|
AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
PIV
|
0.05 AECOPD/subject
|
|
AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
ENV
|
0.63 AECOPD/subject
|
|
AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
HMP
|
0.05 AECOPD/subject
|
|
AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
INV
|
0.06 AECOPD/subject
|
|
AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
ADV
|
0.02 AECOPD/subject
|
|
AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
CRV
|
0.17 AECOPD/subject
|
|
AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
HBoV
|
0.02 AECOPD/subject
|
SECONDARY outcome
Timeframe: During Year 1Population: The analyses of AECOPD were performed on the Full cohort, which included all subjects eligible for inclusion based on medical history and study specific procedures defined in the protocol and who completed at least the Day 0 visit.
Viral pathogens assessed were: respiratory syncytial virus (RSV), parainfluenza virus (PIV), entero rhinovirus (ENV), human metapneumovirus (HMP), influenza virus (INV), adenovirus (ADV), coronavirus (CRV), human bocavirus (HBoV) and any virus. Mild exacerbations were defined as worsening symptoms of COPD that were self-managed by the patient.
Outcome measures
| Measure |
Total Group
n=127 Participants
Chronic Obstructive Pulmonary Disease \[COPD\] diagnosed male and female patients between 40 and 85 years of age, recruited among the patients of the Southampton General Hospital and referring practices, enrolled to generate additional data for further exploration of COPD determinants and the contribution of infectious pathogens to Acute Exacerbation of COPD (AECOPD).
|
|---|---|
|
Mild-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
Any Virus
|
0.08 AECOPD/subject
|
|
Mild-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
RSV
|
0.00 AECOPD/subject
|
|
Mild-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
PIV
|
0.02 AECOPD/subject
|
|
Mild-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
ENV
|
0.05 AECOPD/subject
|
|
Mild-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
HMP
|
0.00 AECOPD/subject
|
|
Mild-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
INV
|
0.00 AECOPD/subject
|
|
Mild-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
ADV
|
0.00 AECOPD/subject
|
|
Mild-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
CRV
|
0.02 AECOPD/subject
|
|
Mild-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
HBoV
|
0.00 AECOPD/subject
|
SECONDARY outcome
Timeframe: During Year 1Population: The analyses of AECOPD were performed on the Full cohort, which included all subjects eligible for inclusion based on medical history and study specific procedures defined in the protocol and who completed at least the Day 0 visit.
Viral pathogens assessed were: respiratory syncytial virus (RSV), parainfluenza virus (PIV), entero rhinovirus (ENV), human metapneumovirus (HMP), influenza virus (INV), adenovirus (ADV), coronavirus (CRV), human bocavirus (HBoV) and any virus. Moderate exacerbations were defined as worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics.
Outcome measures
| Measure |
Total Group
n=127 Participants
Chronic Obstructive Pulmonary Disease \[COPD\] diagnosed male and female patients between 40 and 85 years of age, recruited among the patients of the Southampton General Hospital and referring practices, enrolled to generate additional data for further exploration of COPD determinants and the contribution of infectious pathogens to Acute Exacerbation of COPD (AECOPD).
|
|---|---|
|
Moderate-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
Any Virus
|
0.85 AECOPD/subject
|
|
Moderate-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
RSV
|
0.02 AECOPD/subject
|
|
Moderate-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
PIV
|
0.03 AECOPD/subject
|
|
Moderate-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
ENV
|
0.54 AECOPD/subject
|
|
Moderate-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
HMP
|
0.04 AECOPD/subject
|
|
Moderate-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
INV
|
0.06 AECOPD/subject
|
|
Moderate-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
ADV
|
0.02 AECOPD/subject
|
|
Moderate-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
CRV
|
0.14 AECOPD/subject
|
|
Moderate-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
HBoV
|
0.02 AECOPD/subject
|
SECONDARY outcome
Timeframe: During Year 1Population: The analyses of AECOPD were performed on the Full cohort, which included all subjects eligible for inclusion based on medical history and study specific procedures defined in the protocol and who completed at least the Day 0 visit.
Viral pathogens assessed were: respiratory syncytial virus (RSV), parainfluenza virus (PIV), entero rhinovirus (ENV), human metapneumovirus (HMP), influenza virus (INV), adenovirus (ADV), coronavirus (CRV), human bocavirus (HBoV) and any virus. Severe exacerbations were defined as worsening symptoms of COPD that required treatment with in-patient hospitalisation or home care intervention.
Outcome measures
| Measure |
Total Group
n=127 Participants
Chronic Obstructive Pulmonary Disease \[COPD\] diagnosed male and female patients between 40 and 85 years of age, recruited among the patients of the Southampton General Hospital and referring practices, enrolled to generate additional data for further exploration of COPD determinants and the contribution of infectious pathogens to Acute Exacerbation of COPD (AECOPD).
|
|---|---|
|
Severe-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
Any Virus
|
0.06 AECOPD/subject
|
|
Severe-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
RSV
|
0.00 AECOPD/subject
|
|
Severe-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
PIV
|
0.00 AECOPD/subject
|
|
Severe-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
ENV
|
0.04 AECOPD/subject
|
|
Severe-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
HMP
|
0.01 AECOPD/subject
|
|
Severe-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
INV
|
0.01 AECOPD/subject
|
|
Severe-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
ADV
|
0.00 AECOPD/subject
|
|
Severe-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
CRV
|
0.01 AECOPD/subject
|
|
Severe-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
HBoV
|
0.00 AECOPD/subject
|
SECONDARY outcome
Timeframe: During Year 1Population: The analyses of AECOPD were performed on the Full cohort, which included all subjects eligible for inclusion based on medical history and study specific procedures defined in the protocol and who completed at least the Day 0 visit.
An Acute Exacerbation in a COPD patient is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough, and/or sputum production and beyond normal day to day variations, that is acute in onset and may warrant a change in regular medication in a patient with underlying COPD. AECOPD severity was assessed as: any, mild, moderate and severe. Any = any COPD symptom regardless of severity. Mild = Worsening symptoms of COPD that are self-managed by the patient. Moderate = Worsening symptoms of COPD that require treatment with oral corticosteroids and/or antibiotics. Severe = Worsening symptoms of COPD that require treatment with in-patient hospitalisation or home care intervention.
Outcome measures
| Measure |
Total Group
n=127 Participants
Chronic Obstructive Pulmonary Disease \[COPD\] diagnosed male and female patients between 40 and 85 years of age, recruited among the patients of the Southampton General Hospital and referring practices, enrolled to generate additional data for further exploration of COPD determinants and the contribution of infectious pathogens to Acute Exacerbation of COPD (AECOPD).
|
|---|---|
|
AECOPD Rate With Overall and Specific Bacterial Pathogens in Sputum by Severity
Any AECOPD
|
1.48 AECOPD/subject
|
|
AECOPD Rate With Overall and Specific Bacterial Pathogens in Sputum by Severity
Mild AECOPD
|
0.13 AECOPD/subject
|
|
AECOPD Rate With Overall and Specific Bacterial Pathogens in Sputum by Severity
Moderate AECOPD
|
1.28 AECOPD/subject
|
|
AECOPD Rate With Overall and Specific Bacterial Pathogens in Sputum by Severity
Severe AECOPD
|
0.07 AECOPD/subject
|
Adverse Events
Total Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER