Respiratory Disorders
Conditions
Keywords
Chronic Obstructive Pulmonary disease (COPD)
Brief summary
The present study aims to assess the natural immunity to specific microbial antigens in healthy subjects and in subjects with stable COPD aged between 45-75 years.
Interventions
PROCEDUREBlood collection
Blood collection at Day 0 (all subjects) and at Month 6 (COPD subjects) for the analysis of serology, cell-mediated immune response.
PROCEDURESwab collection
Nasopharyngeal and oropharyngeal swabs collection at Day 0 (All subjects) and at exacerbation visits (COPD subjects).
PROCEDURESputum collection
Sputum collection at Day 0 and at exacerbation visits (COPD subjects)
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy subjects (smokers and non-smokers) * Subjects who the investigator believes can and will comply with the requirements of the protocol. * A male or female between, and including 45 and 75 years of age at the time of consent. * Written informed consent obtained from the subject. * Baseline post-bronchodilator Forced Expiratory Volume of air in one second (FEV1) \> 85% of predicted normal values and baseline post-bronchodilator FEV1/Forced expiratory Vital Capacity (FVC) \> 70% of predicted normal values. * Free of obvious health problems as established by medical history and clinical examination before entering into the study. * Non-smokers: subjects who never smoked OR * Smokers: current smoker having a smoking history ≥ 10 pack-years. COPD subjects (frequent and non-frequent exacerbators) * Subjects who the investigator believes can and will comply with the requirements of the protocol. * A male or female between, and including 45 and 75 years of age at the time of consent. * Written informed consent obtained from the subject. * Baseline post-bronchodilator FEV1 \< 80% and \>30% of predicted normal values and baseline post-bronchodilator FEV1/FVC \< 70% of predicted normal values. * Current or former smoker having a smoking history of ≥ 10 pack-years. * Documented history of ≥ one exacerbation within 365 days prior to the screening visit that required treatment with systemic corticosteroids or resulted in hospitalization.
Exclusion criteria
Healthy subjects (smokers and non-smokers) * Use of any investigational or non-registered product within 30 days prior to Screening Visit or planned use during the study. * Concurrently participating in another clinical study in which the subject has been or will be exposed to an investigational or a non-investigational product. * Any known clinically significant anaemia or any other condition as per medical records that would preclude the drawing of blood as described in the protocol. * Receipt of any vaccine within 30 days preceding blood sampling. * Previous vaccination with any NTHi vaccine. * Chronic administration of immunosuppressants or other immune-modifying drugs within 180 days prior to screening visit. Topical steroids are allowed. * Any confirmed or suspected immunosuppressive or immunodeficient condition including human immunodeficiency virus (HIV) infection, based on medical history and physical examination. * Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination. * Any known respiratory disorders. * Acute disease and/or fever at the time of the Screening Visit or Visit 1, as applicable * Receipt of immunoglobulins and/or any blood products within 90 days prior to Screening Visit. * Receipt of interferon within 90 days prior to Screening Visit. * History of malignancy. * Subjects with a history of, or current, alcohol or substance abuse. * Known history of immune-mediated disorder. * Recent use of antibiotics or antiviral drug within 30 days prior to Screening Visit. * Pregnant female. * Other conditions that the investigator judges may interfere with study findings. COPD subjects (frequent and non-frequent exacerbators) * Use of any investigational or non-registered product within 30 days prior to Screening Visit or planned use during the study. Use of investigational inhaled long acting muscarinic antagonists (LAMA), inhaled long acting beta agonists (LABA) or inhaled corticosteroids is allowed. * Concurrently participating in another clinical study in which the subject has been or will be exposed to an investigational or a non-investigational product. Subjects participating in clinical studies with investigational inhaled LAMA and/or LABA and/or inhaled corticosteroids can be enrolled. * Any known clinically significant anaemia or any other condition as per medical records that would preclude the drawing of blood as described in the protocol. * Receipt of any vaccine within 30 days preceding blood sampling. * Previous vaccination with any NTHi vaccine. * Any confirmed or suspected immunosuppressive or immunodeficient condition including human immunodeficiency virus (HIV) infection, based on medical history and physical examination. * Serious, uncontrolled disease likely to interfere with the study findings. * Acute disease and/or fever at the time of the Screening Visit or Visit 1, as applicable * Receipt of immunoglobulins and/or any blood products within 90 days prior to Screening Visit. * Receipt of interferon within 90 days prior to Screening Visit. * History of malignancy. * Subjects with a history of, or current, alcohol or substance abuse. * Known history of immune-mediated disease other than COPD. * Recent use of antibiotics or antiviral drug within 30 days prior to Screening Visit. * Subject who experienced COPD exacerbation which required antibiotic, systemic corticosteroid or hospitalisation and which did not resolve at least one month prior to Screening Visit and at least 30 days following the last dose of oral corticosteroids. * Chronic administration of immunosuppressants or other immune-modifying drugs within 180 days preceding screening visit. * Subjects with very severe COPD, GOLD stage IV. * Primary diagnosis of asthma. * Other respiratory disorders such as sarcoidosis, tuberculosis, lung cancer, lung fibrosis, cystic fibrosis. * A known diagnosis of α-1 antitrypsin deficiency as underlying cause of COPD. * History of lung surgery. * Pregnant female. * Other conditions that the investigator judges may interfere with study findings.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-Pneumococcal Histidine Triad D Antibody Concentrations | At Day 0 | Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL) |
| Anti-pneumolysin Antibody Concentrations | At Day 0 | The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0. |
| Concentrations for Serum Protein-D Enzymatic Inhibition | At Day 0 | Concentrations are presented as geometric mean concentrations (GMCs). The reference seropositivity cut-off value was ≥ 17.8%. |
| Number of Subjects With PD Enzymatic Inhibition Concentration Greater Than or Equal to (≥) 17.8% | At Day 0 | Concentrations were expressed as geometric mean concentrations (GMCs) |
| Anti-protein D Antibody Concentrations | At Day 0 | Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per millilitre (EU/mL) |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of Specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α), Interferon-γ (IFN-γ), IL-13 and IL-17 Upon in Vitro Stimulation | At Day 0 |
| Frequency of Specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α), Interferon-γ (IFN-γ), IL-13 and IL-17 Upon in Vitro Stimulation | At Day 0 |
| Number of Subjects With Positive Sputum - Culture Testing Results | At Day 0 |
| Number of Subjects With Positive Nasopharyngeal Swab - Culture Testing Results | At Day 0 |
| Number of Subjects With Positive Oropharyngeal Swab - Culture Testing Results | At Day 0 |
Countries
Belgium
Participant flow
Pre-assignment details
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms. 3 enrolled subjects did not receive subject allocations, and were excluded from the study prior to start.
Participants by arm
| Arm | Count |
|---|---|
| HNS Group Healthy non-smokers aged between 45-75 years | 24 |
| HS Group Healthy smokers aged between 45-75 years | 24 |
| FeCOPD Group COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years | 15 |
| NFeCOPD Group COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years | 7 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Reason not specified | 0 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | HNS Group | HS Group | FeCOPD Group | NFeCOPD Group | Total |
|---|---|---|---|---|---|
| Age, Continuous | 60 Years STANDARD_DEVIATION 10.1 | 57.8 Years STANDARD_DEVIATION 8.45 | 64.1 Years STANDARD_DEVIATION 7.39 | 61.4 Years STANDARD_DEVIATION 6.75 | 60.26 Years STANDARD_DEVIATION 8.85 |
| Sex: Female, Male Female | 16 Participants | 9 Participants | 6 Participants | 2 Participants | 33 Participants |
| Sex: Female, Male Male | 8 Participants | 15 Participants | 9 Participants | 5 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 | 1 / 15 | 0 / 7 |
Outcome results
Primary
Anti-Pneumococcal Histidine Triad D Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL)
Time frame: At Day 0
Population: The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| HNS Group | Anti-Pneumococcal Histidine Triad D Antibody Concentrations | 3786.7 EU/mL |
| HS Group | Anti-Pneumococcal Histidine Triad D Antibody Concentrations | 3400.7 EU/mL |
| FeCOPD Group | Anti-Pneumococcal Histidine Triad D Antibody Concentrations | 3323.9 EU/mL |
| NFeCOPD Group | Anti-Pneumococcal Histidine Triad D Antibody Concentrations | 2563.9 EU/mL |
Primary
Anti-Pneumococcal Histidine Triad D Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL)
Time frame: At Month 6
Population: The analysis was performed on the According-to-Protocol cohort at Month 6, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Month 6.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| HNS Group | Anti-Pneumococcal Histidine Triad D Antibody Concentrations | 2521.5 EU/mL |
| HS Group | Anti-Pneumococcal Histidine Triad D Antibody Concentrations | 2160.1 EU/mL |
Primary
Anti-pneumolysin Antibody Concentrations
The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.
Time frame: At Day 0
Population: The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| HNS Group | Anti-pneumolysin Antibody Concentrations | 3870.5 EU/mL |
| HS Group | Anti-pneumolysin Antibody Concentrations | 3116.7 EU/mL |
| FeCOPD Group | Anti-pneumolysin Antibody Concentrations | 2804.5 EU/mL |
| NFeCOPD Group | Anti-pneumolysin Antibody Concentrations | 3898.7 EU/mL |
Primary
Anti-pneumolysin Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL)
Time frame: At Month 6
Population: The analysis was performed on the According-to-Protocol cohort at Month 6, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Month 6.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| HNS Group | Anti-pneumolysin Antibody Concentrations | 2275.6 EU/mL |
| HS Group | Anti-pneumolysin Antibody Concentrations | 3222.3 EU/mL |
Primary
Anti-protein D Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL)
Time frame: At Month 6
Population: The analysis was performed on the According-to-Protocol cohort at Month 6, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Month 6.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| HNS Group | Anti-protein D Antibody Concentrations | 68.6 EU/mL |
| HS Group | Anti-protein D Antibody Concentrations | 61.0 EU/mL |
Primary
Anti-protein D Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per millilitre (EU/mL)
Time frame: At Day 0
Population: The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| HNS Group | Anti-protein D Antibody Concentrations | 79.5 EU/mL |
| HS Group | Anti-protein D Antibody Concentrations | 66.9 EU/mL |
| FeCOPD Group | Anti-protein D Antibody Concentrations | 61.7 EU/mL |
| NFeCOPD Group | Anti-protein D Antibody Concentrations | 72.8 EU/mL |
Primary
Concentrations for Serum Protein-D Enzymatic Inhibition
Concentrations are presented as geometric mean concentrations (GMCs). The reference seropositivity cut-off value was ≥ 17.8%.
Time frame: At Month 6
Population: The analysis was performed on the According-to-Protocol cohort at Month 6, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Month 6.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| HNS Group | Concentrations for Serum Protein-D Enzymatic Inhibition | 9.4 EU/mL |
| HS Group | Concentrations for Serum Protein-D Enzymatic Inhibition | 8.9 EU/mL |
Primary
Concentrations for Serum Protein-D Enzymatic Inhibition
Concentrations are presented as geometric mean concentrations (GMCs). The reference seropositivity cut-off value was ≥ 17.8%.
Time frame: At Day 0
Population: The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| HNS Group | Concentrations for Serum Protein-D Enzymatic Inhibition | 10.4 EU/mL |
| HS Group | Concentrations for Serum Protein-D Enzymatic Inhibition | 9.3 EU/mL |
| FeCOPD Group | Concentrations for Serum Protein-D Enzymatic Inhibition | 9.9 EU/mL |
| NFeCOPD Group | Concentrations for Serum Protein-D Enzymatic Inhibition | 8.9 EU/mL |
Primary
Number of Subjects With PD Enzymatic Inhibition Concentration Greater Than or Equal to (≥) 17.8%
Concentrations were expressed as geometric mean concentrations (GMCs)
Time frame: At Day 0
Population: The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HNS Group | Number of Subjects With PD Enzymatic Inhibition Concentration Greater Than or Equal to (≥) 17.8% | 4 Subjects |
| HS Group | Number of Subjects With PD Enzymatic Inhibition Concentration Greater Than or Equal to (≥) 17.8% | 1 Subjects |
| FeCOPD Group | Number of Subjects With PD Enzymatic Inhibition Concentration Greater Than or Equal to (≥) 17.8% | 2 Subjects |
| NFeCOPD Group | Number of Subjects With PD Enzymatic Inhibition Concentration Greater Than or Equal to (≥) 17.8% | 0 Subjects |
Primary
Number of Subjects With PD Enzymatic Inhibition Concentration Greater Than or Equal to (≥) 17.8%
Concentrations were expressed as geometric mean concentrations (GMCs)
Time frame: At Month 6
Population: The analysis was performed on the According-to-Protocol cohort at Month 6, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Month 6.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HNS Group | Number of Subjects With PD Enzymatic Inhibition Concentration Greater Than or Equal to (≥) 17.8% | 1 Subjects |
| HS Group | Number of Subjects With PD Enzymatic Inhibition Concentration Greater Than or Equal to (≥) 17.8% | 0 Subjects |
Secondary
Frequency of Specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α), Interferon-γ (IFN-γ), IL-13 and IL-17 Upon in Vitro Stimulation
Time frame: At Day 0
Population: The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HNS Group | Frequency of Specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α), Interferon-γ (IFN-γ), IL-13 and IL-17 Upon in Vitro Stimulation | 159.6 T cells/million cells | Standard Deviation 67.29 |
| HS Group | Frequency of Specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α), Interferon-γ (IFN-γ), IL-13 and IL-17 Upon in Vitro Stimulation | 163.5 T cells/million cells | Standard Deviation 87.11 |
| FeCOPD Group | Frequency of Specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α), Interferon-γ (IFN-γ), IL-13 and IL-17 Upon in Vitro Stimulation | 173.9 T cells/million cells | Standard Deviation 89.69 |
| NFeCOPD Group | Frequency of Specific Cluster of Differentiation 4+ (CD4+) T Cells Expressing at Least 2 Markers Among CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α), Interferon-γ (IFN-γ), IL-13 and IL-17 Upon in Vitro Stimulation | 170.1 T cells/million cells | Standard Deviation 88.96 |
Secondary
Frequency of Specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α), Interferon-γ (IFN-γ), IL-13 and IL-17 Upon in Vitro Stimulation
Time frame: At Day 0
Population: The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HNS Group | Frequency of Specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α), Interferon-γ (IFN-γ), IL-13 and IL-17 Upon in Vitro Stimulation | 97.9 T cells/million cells | Standard Deviation 56.74 |
| HS Group | Frequency of Specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α), Interferon-γ (IFN-γ), IL-13 and IL-17 Upon in Vitro Stimulation | 125.2 T cells/million cells | Standard Deviation 73.93 |
| FeCOPD Group | Frequency of Specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α), Interferon-γ (IFN-γ), IL-13 and IL-17 Upon in Vitro Stimulation | 125.2 T cells/million cells | Standard Deviation 44.12 |
| NFeCOPD Group | Frequency of Specific Cluster of Differentiation 8+ (CD8+) T Cells Expressing at Least 2 Markers Among CD 40 Ligand (CD40L), Interleukin 2 (IL-2), Tumor Necrosis Factor-α (TNF-α), Interferon-γ (IFN-γ), IL-13 and IL-17 Upon in Vitro Stimulation | 161.3 T cells/million cells | Standard Deviation 43.72 |
Secondary
Number of Subjects With Positive Nasopharyngeal Swab - Culture Testing Results
Time frame: At Day 0
Population: The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HNS Group | Number of Subjects With Positive Nasopharyngeal Swab - Culture Testing Results | Any bacteria | 4 Subjects |
| HNS Group | Number of Subjects With Positive Nasopharyngeal Swab - Culture Testing Results | Pseudomonas aeruginosa | 0 Subjects |
| HNS Group | Number of Subjects With Positive Nasopharyngeal Swab - Culture Testing Results | Staphylococcus aureus | 4 Subjects |
| HNS Group | Number of Subjects With Positive Nasopharyngeal Swab - Culture Testing Results | Streptococcus pneumoniae | 0 Subjects |
| HNS Group | Number of Subjects With Positive Nasopharyngeal Swab - Culture Testing Results | Other bacteria | 0 Subjects |
| HNS Group | Number of Subjects With Positive Nasopharyngeal Swab - Culture Testing Results | Haemophilus influenzae | 0 Subjects |
| HNS Group | Number of Subjects With Positive Nasopharyngeal Swab - Culture Testing Results | Moxarella catarrhalis | 0 Subjects |
| HS Group | Number of Subjects With Positive Nasopharyngeal Swab - Culture Testing Results | Pseudomonas aeruginosa | 0 Subjects |
| HS Group | Number of Subjects With Positive Nasopharyngeal Swab - Culture Testing Results | Moxarella catarrhalis | 0 Subjects |
| HS Group | Number of Subjects With Positive Nasopharyngeal Swab - Culture Testing Results | Haemophilus influenzae | 0 Subjects |
| HS Group | Number of Subjects With Positive Nasopharyngeal Swab - Culture Testing Results | Staphylococcus aureus | 0 Subjects |
| HS Group | Number of Subjects With Positive Nasopharyngeal Swab - Culture Testing Results | Other bacteria | 0 Subjects |
| HS Group | Number of Subjects With Positive Nasopharyngeal Swab - Culture Testing Results | Streptococcus pneumoniae | 1 Subjects |
| HS Group | Number of Subjects With Positive Nasopharyngeal Swab - Culture Testing Results | Any bacteria | 1 Subjects |
| FeCOPD Group | Number of Subjects With Positive Nasopharyngeal Swab - Culture Testing Results | Moxarella catarrhalis | 0 Subjects |
| FeCOPD Group | Number of Subjects With Positive Nasopharyngeal Swab - Culture Testing Results | Any bacteria | 4 Subjects |
| FeCOPD Group | Number of Subjects With Positive Nasopharyngeal Swab - Culture Testing Results | Streptococcus pneumoniae | 0 Subjects |
| FeCOPD Group | Number of Subjects With Positive Nasopharyngeal Swab - Culture Testing Results | Haemophilus influenzae | 0 Subjects |
| FeCOPD Group | Number of Subjects With Positive Nasopharyngeal Swab - Culture Testing Results | Staphylococcus aureus | 3 Subjects |
| FeCOPD Group | Number of Subjects With Positive Nasopharyngeal Swab - Culture Testing Results | Pseudomonas aeruginosa | 0 Subjects |
| FeCOPD Group | Number of Subjects With Positive Nasopharyngeal Swab - Culture Testing Results | Other bacteria | 1 Subjects |
| NFeCOPD Group | Number of Subjects With Positive Nasopharyngeal Swab - Culture Testing Results | Other bacteria | 0 Subjects |
| NFeCOPD Group | Number of Subjects With Positive Nasopharyngeal Swab - Culture Testing Results | Pseudomonas aeruginosa | 0 Subjects |
| NFeCOPD Group | Number of Subjects With Positive Nasopharyngeal Swab - Culture Testing Results | Streptococcus pneumoniae | 0 Subjects |
| NFeCOPD Group | Number of Subjects With Positive Nasopharyngeal Swab - Culture Testing Results | Any bacteria | 0 Subjects |
| NFeCOPD Group | Number of Subjects With Positive Nasopharyngeal Swab - Culture Testing Results | Staphylococcus aureus | 0 Subjects |
| NFeCOPD Group | Number of Subjects With Positive Nasopharyngeal Swab - Culture Testing Results | Moxarella catarrhalis | 0 Subjects |
| NFeCOPD Group | Number of Subjects With Positive Nasopharyngeal Swab - Culture Testing Results | Haemophilus influenzae | 0 Subjects |
Secondary
Number of Subjects With Positive Oropharyngeal Swab - Culture Testing Results
Time frame: At Day 0
Population: The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HNS Group | Number of Subjects With Positive Oropharyngeal Swab - Culture Testing Results | Any bacteria | 5 Subjects |
| HNS Group | Number of Subjects With Positive Oropharyngeal Swab - Culture Testing Results | Pseudomonas aeruginosa | 0 Subjects |
| HNS Group | Number of Subjects With Positive Oropharyngeal Swab - Culture Testing Results | Staphylococcus aureus | 1 Subjects |
| HNS Group | Number of Subjects With Positive Oropharyngeal Swab - Culture Testing Results | Streptococcus pneumoniae | 0 Subjects |
| HNS Group | Number of Subjects With Positive Oropharyngeal Swab - Culture Testing Results | Other bacteria | 2 Subjects |
| HNS Group | Number of Subjects With Positive Oropharyngeal Swab - Culture Testing Results | Haemophilus influenzae | 2 Subjects |
| HNS Group | Number of Subjects With Positive Oropharyngeal Swab - Culture Testing Results | Moxarella catarrhalis | 0 Subjects |
| HS Group | Number of Subjects With Positive Oropharyngeal Swab - Culture Testing Results | Pseudomonas aeruginosa | 0 Subjects |
| HS Group | Number of Subjects With Positive Oropharyngeal Swab - Culture Testing Results | Moxarella catarrhalis | 0 Subjects |
| HS Group | Number of Subjects With Positive Oropharyngeal Swab - Culture Testing Results | Haemophilus influenzae | 1 Subjects |
| HS Group | Number of Subjects With Positive Oropharyngeal Swab - Culture Testing Results | Staphylococcus aureus | 1 Subjects |
| HS Group | Number of Subjects With Positive Oropharyngeal Swab - Culture Testing Results | Other bacteria | 0 Subjects |
| HS Group | Number of Subjects With Positive Oropharyngeal Swab - Culture Testing Results | Streptococcus pneumoniae | 1 Subjects |
| HS Group | Number of Subjects With Positive Oropharyngeal Swab - Culture Testing Results | Any bacteria | 3 Subjects |
| FeCOPD Group | Number of Subjects With Positive Oropharyngeal Swab - Culture Testing Results | Moxarella catarrhalis | 0 Subjects |
| FeCOPD Group | Number of Subjects With Positive Oropharyngeal Swab - Culture Testing Results | Any bacteria | 5 Subjects |
| FeCOPD Group | Number of Subjects With Positive Oropharyngeal Swab - Culture Testing Results | Streptococcus pneumoniae | 0 Subjects |
| FeCOPD Group | Number of Subjects With Positive Oropharyngeal Swab - Culture Testing Results | Haemophilus influenzae | 2 Subjects |
| FeCOPD Group | Number of Subjects With Positive Oropharyngeal Swab - Culture Testing Results | Staphylococcus aureus | 1 Subjects |
| FeCOPD Group | Number of Subjects With Positive Oropharyngeal Swab - Culture Testing Results | Pseudomonas aeruginosa | 0 Subjects |
| FeCOPD Group | Number of Subjects With Positive Oropharyngeal Swab - Culture Testing Results | Other bacteria | 4 Subjects |
| NFeCOPD Group | Number of Subjects With Positive Oropharyngeal Swab - Culture Testing Results | Haemophilus influenzae | 0 Subjects |
| NFeCOPD Group | Number of Subjects With Positive Oropharyngeal Swab - Culture Testing Results | Other bacteria | 1 Subjects |
| NFeCOPD Group | Number of Subjects With Positive Oropharyngeal Swab - Culture Testing Results | Pseudomonas aeruginosa | 0 Subjects |
| NFeCOPD Group | Number of Subjects With Positive Oropharyngeal Swab - Culture Testing Results | Streptococcus pneumoniae | 0 Subjects |
| NFeCOPD Group | Number of Subjects With Positive Oropharyngeal Swab - Culture Testing Results | Any bacteria | 1 Subjects |
| NFeCOPD Group | Number of Subjects With Positive Oropharyngeal Swab - Culture Testing Results | Staphylococcus aureus | 0 Subjects |
| NFeCOPD Group | Number of Subjects With Positive Oropharyngeal Swab - Culture Testing Results | Moxarella catarrhalis | 0 Subjects |
Secondary
Number of Subjects With Positive Sputum - Culture Testing Results
Time frame: At Day 0
Population: The analysis was performed on the According-to-Protocol cohort at Day 0, which included all evaluable subjects for whom at least one assay results was available for the blood samples collected at Day 0.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HNS Group | Number of Subjects With Positive Sputum - Culture Testing Results | Haemophilus influenzae | 2 Subjects |
| HNS Group | Number of Subjects With Positive Sputum - Culture Testing Results | Staphylococcus aureus | 1 Subjects |
| HNS Group | Number of Subjects With Positive Sputum - Culture Testing Results | Streptococcus pneumoniae | 0 Subjects |
| HNS Group | Number of Subjects With Positive Sputum - Culture Testing Results | Pseudomonas aeruginosa | 0 Subjects |
| HNS Group | Number of Subjects With Positive Sputum - Culture Testing Results | Moraxella catarrhalis | 2 Subjects |
| HNS Group | Number of Subjects With Positive Sputum - Culture Testing Results | Other bacteria | 6 Subjects |
| HNS Group | Number of Subjects With Positive Sputum - Culture Testing Results | Any bacteria | 9 Subjects |
| HS Group | Number of Subjects With Positive Sputum - Culture Testing Results | Other bacteria | 0 Subjects |
| HS Group | Number of Subjects With Positive Sputum - Culture Testing Results | Any bacteria | 1 Subjects |
| HS Group | Number of Subjects With Positive Sputum - Culture Testing Results | Streptococcus pneumoniae | 0 Subjects |
| HS Group | Number of Subjects With Positive Sputum - Culture Testing Results | Haemophilus influenzae | 1 Subjects |
| HS Group | Number of Subjects With Positive Sputum - Culture Testing Results | Moraxella catarrhalis | 0 Subjects |
| HS Group | Number of Subjects With Positive Sputum - Culture Testing Results | Staphylococcus aureus | 0 Subjects |
| HS Group | Number of Subjects With Positive Sputum - Culture Testing Results | Pseudomonas aeruginosa | 0 Subjects |