Respiratory Disorders
Conditions
Keywords
pathogen, Chronic Obstructive Pulmonary Disease, Acute Exacerbations of Chronic Obstructive Pulmonary Disease, COPD, respiratory, AECOPD, exacerbation
Brief summary
The aim of this study is to generate epidemiological data to further explore determinants of Chronic Obstructive Pulmonary Disease (COPD) and the contribution of bacterial and viral pathogens to Acute Exacerbation of COPD (AECOPD) episodes.
Interventions
PROCEDUREBlood sample
Blood samples will be collected from all patients at enrolment, at follow-up visits, at exacerbation visits, and during the final visit.
PROCEDURESputum sample
Sputum will be collected from all patients at enrolment, at monthly follow-up visits, at exacerbation visits, and during the final visit. Sputum will be obtained by spontaneous expectoration or induced by stimulation according to standard methods.
PROCEDURENasopharyngeal swab
Nasopharyngeal swabs will be collected from all patients at enrolment and from a subcohort of 30 patients at monthly follow-up visits and at exacerbation visits during the first year.
PROCEDUREUrine sample
Urine samples will be taken at enrolment and exacerbation visits from all subjects and from the same subcohort of 30 patients providing nasopharyngeal swabs, at monthly follow-up visits during the first year.
PROCEDUREEnd tidal breath sample
Breath samples will be collected from all patients at enrolment, at follow-up visits (monthly), at exacerbation visits, and during the final visit.
OTHERData collection
Patient interview, diary cards review and questionnaires completion
OTHERTests
Urine pregnancy test, chest CT-scan, lung function testing and 6-min walk test
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Subjects who the investigator believes can and will comply with the requirements of the protocol. * Written informed consent obtained from the subject. * Male or female subjects between, and including, 40 and 85 years of age, at the time of consent. * Subjects with confirmed diagnosis of COPD with Forced Expiratory Volume of air expired in 1 second (FEV1) of \</=80% of predicted normal and FEV1/Forced expiratory Vital Capacity (FVC)\<0.7 * Subjects have moderate, severe, or very severe COPD, according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) staging. * Subjects have a current or prior history of \>/=10 pack-years of cigarette smoking. Former smokers are defined as those who have stopped smoking for at least 6 months. Number of pack years = (number of cigarettes per day/20) x number of years smoked. * Subjects present a documented history of \>/=1 exacerbation requiring antibiotics and/or oral corticosteroids or hospitalization in the previous 12 months.
Exclusion criteria
* Subject also has a confirmed diagnosis of asthma, cystic fibrosis, pneumonia risk factors or other respiratory disorders. * Subjects having undergone lung surgery. * Subject has a α-1 antitrypsin deficiency as underlying cause of COPD. * Subject who experienced a moderate or severe COPD exacerbation not resolved at least 1 month prior to enrolment visit and at least 30 days following the last dose of oral corticosteroids. * Subject using any antibacterial, antiviral or respiratory investigational drug or relevant vaccine up to 30 days prior to the enrolment visit. * Subject has other conditions that the principal investigator judges may interfere with the study findings. Women who are pregnant or lactating or are planning on becoming pregnant during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Estimated Number of Acute Exacerbation of COPD (AECOPD) | During year 1 | 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. |
| Mean Estimated Number of AECOPD With Sputum Containing Bacterial Pathogens | During Year 1 | 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. |
| Overall AECOPD Exacerbation Rate for Any and Specific Bacterial Pathogens in Sputum | During Year 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of Days Between 2 Consecutive AECOPDs | During Year 1 | The number of days between 2 consecutive exacerbations, as estimated by the investigator, was calculated only whenever the first exacerbation had an end date. |
| Number of Subjects With Serious Adverse Events (SAEs) Possibly Related/Linked to Withdrawal | During Year 1 | 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. |
| Change From Baseline EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) Scores at Enrollment and Any AECOPD Visit | During Year 1 | 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. |
| Change From Baseline COPD Assessment Test (CAT) Scores at Enrollment and Any AECOPD Visit | During Year 1 | 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. |
| Change From Baseline COPD Nottingham Extended Activities of Daily Living Scale (NEADL) Scores at Enrollment and Any AECOPD Visit | During Year 1 | 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. |
| Change From Baseline COPD EQ-5D Index and Visual Analogue Scale (VAS) Scores at Enrollment and Any AECOPD Visit | During Year 1 | 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. |
| Number of Sputum Samples Positive for Specific Pathogens - Any Bacteria and Hi | During Year 1 | 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. |
| AECOPD Rate With Overall and Specific Bacterial Pathogens in Sputum , by Polymerase Chain Reaction (PCR) Assay | During Year 1 | Bacterial pathogens assessed, by PCR assay were: Hi, Mcat, Sp, Sta, Psa, Streptococcus pyogenes (Spyo) and any bacteria. |
| AECOPD Rate With Overall and Specific Viral Pathogens in Sputum | During Year 1 | 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-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum | During Year 1 | 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. |
| Moderate-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum | During Year 1 | 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. |
| Severe-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum | During Year 1 | 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. |
| AECOPD Rate With Overall and Specific Bacterial Pathogens in Sputum by Severity | During Year 1 | 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. |
| Number of Subjects Receiving Various Health Care Types During AECOPD | During Year 1 | 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. |
| Number of Sputum Samples Positive for Specific Pathogens - Mcat and Sp | During Year 1 | 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. |
| Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria | During Year 1 | 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. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 127 |
| Total | 127 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Migrated/moved from study area | 1 |
| Overall Study | Other | 7 |
| Overall Study | Withdrawal by Subject | 14 |
Baseline characteristics
| Characteristic | Total Group | — |
|---|---|---|
| Age, Continuous | 66.8 Years STANDARD_DEVIATION 8.6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 59 Participants | — |
| Sex: Female, Male Male | 68 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 127 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 127 |
Outcome results
Primary
Mean Estimated Number of Acute Exacerbation of COPD (AECOPD)
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.
Time frame: During year 1
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Total Group | Mean Estimated Number of Acute Exacerbation of COPD (AECOPD) | 3.04 AECOPD/subject/year |
Primary
Mean Estimated Number of AECOPD With Sputum Containing Bacterial Pathogens
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.
Time frame: During Year 1
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Total Group | Mean Estimated Number of AECOPD With Sputum Containing Bacterial Pathogens | Any | 1.59 AECOPD/subject/year |
| Total Group | Mean Estimated Number of AECOPD With Sputum Containing Bacterial Pathogens | Hi | 1.10 AECOPD/subject/year |
| Total Group | Mean Estimated Number of AECOPD With Sputum Containing Bacterial Pathogens | Mcat | 0.34 AECOPD/subject/year |
| Total Group | Mean Estimated Number of AECOPD With Sputum Containing Bacterial Pathogens | Sp | 0.39 AECOPD/subject/year |
| Total Group | Mean Estimated Number of AECOPD With Sputum Containing Bacterial Pathogens | Sta | 0.16 AECOPD/subject/year |
| Total Group | Mean Estimated Number of AECOPD With Sputum Containing Bacterial Pathogens | Psa | 0.18 AECOPD/subject/year |
| Total Group | Mean Estimated Number of AECOPD With Sputum Containing Bacterial Pathogens | Other | 0.01 AECOPD/subject/year |
Primary
Overall AECOPD Exacerbation Rate for Any and Specific Bacterial Pathogens in Sputum
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.
Time frame: During Year 1
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total Group | Overall AECOPD Exacerbation Rate for Any and Specific Bacterial Pathogens in Sputum | Any Bacteria | 1.48 AECOPD/subject |
| Total Group | Overall AECOPD Exacerbation Rate for Any and Specific Bacterial Pathogens in Sputum | Hi | 1.02 AECOPD/subject |
| Total Group | Overall AECOPD Exacerbation Rate for Any and Specific Bacterial Pathogens in Sputum | Mcat | 0.31 AECOPD/subject |
| Total Group | Overall AECOPD Exacerbation Rate for Any and Specific Bacterial Pathogens in Sputum | Sp | 0.37 AECOPD/subject |
| Total Group | Overall AECOPD Exacerbation Rate for Any and Specific Bacterial Pathogens in Sputum | Sta | 0.14 AECOPD/subject |
| Total Group | Overall AECOPD Exacerbation Rate for Any and Specific Bacterial Pathogens in Sputum | Psa | 0.17 AECOPD/subject |
| Total Group | Overall AECOPD Exacerbation Rate for Any and Specific Bacterial Pathogens in Sputum | Other Bacteria | 0.01 AECOPD/subject |
Secondary
AECOPD Rate With Overall and Specific Bacterial Pathogens in Sputum , by Polymerase Chain Reaction (PCR) Assay
Bacterial pathogens assessed, by PCR assay were: Hi, Mcat, Sp, Sta, Psa, Streptococcus pyogenes (Spyo) and any bacteria.
Time frame: During Year 1
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total Group | AECOPD Rate With Overall and Specific Bacterial Pathogens in Sputum , by Polymerase Chain Reaction (PCR) Assay | Any Bacteria | 1.61 AECOPD/subject |
| Total Group | AECOPD Rate With Overall and Specific Bacterial Pathogens in Sputum , by Polymerase Chain Reaction (PCR) Assay | Hi | 1.30 AECOPD/subject |
| Total Group | AECOPD Rate With Overall and Specific Bacterial Pathogens in Sputum , by Polymerase Chain Reaction (PCR) Assay | Mcat | 0.47 AECOPD/subject |
| Total Group | AECOPD Rate With Overall and Specific Bacterial Pathogens in Sputum , by Polymerase Chain Reaction (PCR) Assay | Sp | 0.20 AECOPD/subject |
| Total Group | AECOPD Rate With Overall and Specific Bacterial Pathogens in Sputum , by Polymerase Chain Reaction (PCR) Assay | Sta | 0.09 AECOPD/subject |
| Total Group | AECOPD Rate With Overall and Specific Bacterial Pathogens in Sputum , by Polymerase Chain Reaction (PCR) Assay | Psa | 0.14 AECOPD/subject |
| Total Group | AECOPD Rate With Overall and Specific Bacterial Pathogens in Sputum , by Polymerase Chain Reaction (PCR) Assay | Spyo | 0.00 AECOPD/subject |
Secondary
AECOPD Rate With Overall and Specific Bacterial Pathogens in Sputum by Severity
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.
Time frame: During Year 1
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total Group | AECOPD Rate With Overall and Specific Bacterial Pathogens in Sputum by Severity | Any AECOPD | 1.48 AECOPD/subject |
| Total Group | AECOPD Rate With Overall and Specific Bacterial Pathogens in Sputum by Severity | Mild AECOPD | 0.13 AECOPD/subject |
| Total Group | AECOPD Rate With Overall and Specific Bacterial Pathogens in Sputum by Severity | Moderate AECOPD | 1.28 AECOPD/subject |
| Total Group | AECOPD Rate With Overall and Specific Bacterial Pathogens in Sputum by Severity | Severe AECOPD | 0.07 AECOPD/subject |
Secondary
AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
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.
Time frame: During Year 1
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total Group | AECOPD Rate With Overall and Specific Viral Pathogens in Sputum | Any virus | 0.99 AECOPD/subject |
| Total Group | AECOPD Rate With Overall and Specific Viral Pathogens in Sputum | RSV | 0.02 AECOPD/subject |
| Total Group | AECOPD Rate With Overall and Specific Viral Pathogens in Sputum | PIV | 0.05 AECOPD/subject |
| Total Group | AECOPD Rate With Overall and Specific Viral Pathogens in Sputum | ENV | 0.63 AECOPD/subject |
| Total Group | AECOPD Rate With Overall and Specific Viral Pathogens in Sputum | HMP | 0.05 AECOPD/subject |
| Total Group | AECOPD Rate With Overall and Specific Viral Pathogens in Sputum | INV | 0.06 AECOPD/subject |
| Total Group | AECOPD Rate With Overall and Specific Viral Pathogens in Sputum | ADV | 0.02 AECOPD/subject |
| Total Group | AECOPD Rate With Overall and Specific Viral Pathogens in Sputum | CRV | 0.17 AECOPD/subject |
| Total Group | AECOPD Rate With Overall and Specific Viral Pathogens in Sputum | HBoV | 0.02 AECOPD/subject |
Secondary
Change From Baseline COPD Assessment Test (CAT) Scores at Enrollment and Any AECOPD 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.
Time frame: During Year 1
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Group | Change From Baseline COPD Assessment Test (CAT) Scores at Enrollment and Any AECOPD Visit | Enrollment | 0.0 COPD CAT Score | Standard Deviation 0 |
| Total Group | 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 |
| Total Group | 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 7.4 |
| Total Group | 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 |
| Total Group | 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 |
| Total Group | 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
Change From Baseline COPD EQ-5D Index and Visual Analogue Scale (VAS) Scores at Enrollment and Any AECOPD 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.
Time frame: During Year 1
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Group | 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 |
| Total Group | 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 |
| Total Group | 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 |
| Total Group | 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 |
| Total Group | 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 |
| Total Group | 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 |
Secondary
Change From Baseline COPD Nottingham Extended Activities of Daily Living Scale (NEADL) Scores at Enrollment and Any AECOPD 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.
Time frame: During Year 1
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Group | 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 |
| Total Group | 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 |
| Total Group | 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 |
| Total Group | 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 |
| Total Group | 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 |
| Total Group | 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
Change From Baseline EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) Scores at Enrollment and Any AECOPD 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.
Time frame: During Year 1
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Total Group | 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 |
| Total Group | 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 |
| Total Group | 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 |
| Total Group | 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 |
| Total Group | 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 10.3 |
| Total Group | 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
Mean Number of Days Between 2 Consecutive AECOPDs
The number of days between 2 consecutive exacerbations, as estimated by the investigator, was calculated only whenever the first exacerbation had an end date.
Time frame: During Year 1
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Total Group | Mean Number of Days Between 2 Consecutive AECOPDs | 55.5 Days | Standard Deviation 53 |
Secondary
Mild-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
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.
Time frame: During Year 1
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total Group | Mild-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum | Any Virus | 0.08 AECOPD/subject |
| Total Group | Mild-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum | RSV | 0.00 AECOPD/subject |
| Total Group | Mild-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum | PIV | 0.02 AECOPD/subject |
| Total Group | Mild-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum | ENV | 0.05 AECOPD/subject |
| Total Group | Mild-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum | HMP | 0.00 AECOPD/subject |
| Total Group | Mild-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum | INV | 0.00 AECOPD/subject |
| Total Group | Mild-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum | ADV | 0.00 AECOPD/subject |
| Total Group | Mild-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum | CRV | 0.02 AECOPD/subject |
| Total Group | Mild-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum | HBoV | 0.00 AECOPD/subject |
Secondary
Moderate-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
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.
Time frame: During Year 1
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total Group | Moderate-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum | Any Virus | 0.85 AECOPD/subject |
| Total Group | Moderate-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum | RSV | 0.02 AECOPD/subject |
| Total Group | Moderate-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum | PIV | 0.03 AECOPD/subject |
| Total Group | Moderate-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum | ENV | 0.54 AECOPD/subject |
| Total Group | Moderate-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum | HMP | 0.04 AECOPD/subject |
| Total Group | Moderate-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum | INV | 0.06 AECOPD/subject |
| Total Group | Moderate-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum | ADV | 0.02 AECOPD/subject |
| Total Group | Moderate-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum | CRV | 0.14 AECOPD/subject |
| Total Group | Moderate-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum | HBoV | 0.02 AECOPD/subject |
Secondary
Number of Sputum Samples Positive for Specific Pathogens - Any Bacteria and Hi
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.
Time frame: During Year 1
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Any Bacteria and Hi | Any Bacteria - enrollment | 57 sputum samples |
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Any Bacteria and Hi | Any Bacteria - any stable visit | 466 sputum samples |
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Any Bacteria and Hi | Any Bacteria - any exacerbation visit | 188 sputum samples |
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Any Bacteria and Hi | Any Bacteria - any mild exacerbation visit | 17 sputum samples |
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Any Bacteria and Hi | Any Bacteria - any moderate exacerbation visit | 162 sputum samples |
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Any Bacteria and Hi | Any Bacteria - any severe exacerbation visit | 9 sputum samples |
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Any Bacteria and Hi | Hi - enrollment | 32 sputum samples |
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Any Bacteria and Hi | Hi - any stable visit | 287 sputum samples |
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Any Bacteria and Hi | Hi - any exacerbation visit | 129 sputum samples |
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Any Bacteria and Hi | Hi - any mild exacerbation visit | 11 sputum samples |
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Any Bacteria and Hi | Hi - any moderate exacerbation visit | 111 sputum samples |
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Any Bacteria and Hi | Hi - any severe exacerbation visit | 7 sputum samples |
Secondary
Number of Sputum Samples Positive for Specific Pathogens - Mcat and Sp
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.
Time frame: During Year 1
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Mcat and Sp | Mcat - enrollment | 8 sputum samples |
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Mcat and Sp | Mcat - any stable visit | 50 sputum samples |
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Mcat and Sp | Mcat - any exacerbation visit | 40 sputum samples |
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Mcat and Sp | Mcat - any mild exacerbation visit | 1 sputum samples |
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Mcat and Sp | Mcat - any moderate exacerbation visit | 39 sputum samples |
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Mcat and Sp | Mcat - any severe exacerbation visit | 0 sputum samples |
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Mcat and Sp | Sp - enrollment | 19 sputum samples |
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Mcat and Sp | Sp - any stable visit | 177 sputum samples |
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Mcat and Sp | Sp - any exacerbation visit | 47 sputum samples |
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Mcat and Sp | Sp - any mild exacerbation visit | 6 sputum samples |
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Mcat and Sp | Sp - any moderate exacerbation visit | 37 sputum samples |
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Mcat and Sp | Sp - any severe exacerbation visit | 4 sputum samples |
Secondary
Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria
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.
Time frame: During Year 1
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria | Other bacteria - any exacerbation visit | 1 sputum samples |
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria | Sta - enrollment | 6 sputum samples |
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria | Sta - any stable visit | 40 sputum samples |
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria | Sta - any exacerbation visit | 18 sputum samples |
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria | Sta - any mild exacerbation visit | 0 sputum samples |
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria | Sta - any moderate exacerbation visit | 18 sputum samples |
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria | Sta - any severe exacerbation visit | 0 sputum samples |
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria | Psa - enrollment | 6 sputum samples |
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria | Psa - any stable visit | 49 sputum samples |
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria | Psa - any exacerbation visit | 21 sputum samples |
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria | Psa - any mild exacerbation visit | 0 sputum samples |
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria | Psa - any moderate exacerbation visit | 19 sputum samples |
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria | Psa - any severe exacerbation visit | 2 sputum samples |
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria | Other bacteria - enrollment | 2 sputum samples |
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria | Other bacteria - any stable visit | 6 sputum samples |
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria | Other bacteria - any moderate exacerbation visit | 0 sputum samples |
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria | Other bacteria - any mild exacerbation visit | 1 sputum samples |
| Total Group | Number of Sputum Samples Positive for Specific Pathogens - Sta, Psa and Other Bacteria | Other bacteria - any severe exacerbation visit | 0 sputum samples |
Secondary
Number of Subjects Receiving Various Health Care Types During AECOPD
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.
Time frame: During Year 1
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Total Group | Number of Subjects Receiving Various Health Care Types During AECOPD | General practitioner - Negative | 82 Participants |
| Total Group | Number of Subjects Receiving Various Health Care Types During AECOPD | General practitioner - Positive | 26 Participants |
| Total Group | Number of Subjects Receiving Various Health Care Types During AECOPD | Pneumologist - Negative | 104 Participants |
| Total Group | Number of Subjects Receiving Various Health Care Types During AECOPD | Pneumologist - Positive | 4 Participants |
| Total Group | Number of Subjects Receiving Various Health Care Types During AECOPD | Other specialist - Negative | 103 Participants |
| Total Group | Number of Subjects Receiving Various Health Care Types During AECOPD | Other specialist - Positive | 5 Participants |
| Total Group | Number of Subjects Receiving Various Health Care Types During AECOPD | Emergency department at the hospital - Negative | 96 Participants |
| Total Group | Number of Subjects Receiving Various Health Care Types During AECOPD | Emergency department at the hospital - Positive | 12 Participants |
| Total Group | Number of Subjects Receiving Various Health Care Types During AECOPD | Nurse home care - Negative | 108 Participants |
| Total Group | Number of Subjects Receiving Various Health Care Types During AECOPD | Pulmonary rehabilitation program - Negative | 98 Participants |
| Total Group | Number of Subjects Receiving Various Health Care Types During AECOPD | Pulmonary rehabilitation program - Positive | 10 Participants |
| Total Group | Number of Subjects Receiving Various Health Care Types During AECOPD | Nutrition Advice - Negative | 107 Participants |
| Total Group | Number of Subjects Receiving Various Health Care Types During AECOPD | Nutrition Advice - Positive | 1 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs) Possibly Related/Linked to Withdrawal
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.
Time frame: During Year 1
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Total Group | Number of Subjects With Serious Adverse Events (SAEs) Possibly Related/Linked to Withdrawal | 0 Participants |
Secondary
Severe-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum
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.
Time frame: During Year 1
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Total Group | Severe-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum | ENV | 0.04 AECOPD/subject |
| Total Group | Severe-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum | Any Virus | 0.06 AECOPD/subject |
| Total Group | Severe-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum | RSV | 0.00 AECOPD/subject |
| Total Group | Severe-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum | PIV | 0.00 AECOPD/subject |
| Total Group | Severe-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum | HMP | 0.01 AECOPD/subject |
| Total Group | Severe-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum | INV | 0.01 AECOPD/subject |
| Total Group | Severe-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum | ADV | 0.00 AECOPD/subject |
| Total Group | Severe-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum | CRV | 0.01 AECOPD/subject |
| Total Group | Severe-AECOPD Rate With Overall and Specific Viral Pathogens in Sputum | HBoV | 0.00 AECOPD/subject |