{ "FullStudy":{ "Rank":217818, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01516437", "OrgStudyIdInfo":{ "OrgStudyId":"116021" }, "Organization":{ "OrgFullName":"GlaxoSmithKline", "OrgClass":"INDUSTRY" }, "BriefTitle":"A Study to Assess Immunity to Specific Microbial Antigens in Healthy Smokers and Non-smokers and in Subjects With Stable COPD", "OfficialTitle":"A Study to Assess Immunity to Specific Microbial Antigens in Healthy Smokers and Non-smokers and in Subjects With Stable Chronic Obstructive Pulmonary Disease (COPD) Aged Between 45-75 Years" }, "StatusModule":{ "StatusVerifiedDate":"April 2017", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"February 1, 2012", "StartDateType":"Actual" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"June 28, 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"December 20, 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 19, 2012", "StudyFirstSubmitQCDate":"January 19, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 24, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"January 10, 2017", "ResultsFirstSubmitQCDate":"January 16, 2017", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"March 7, 2017", "ResultsFirstPostDateType":"Actual" }, "LastUpdateSubmitDate":"April 12, 2017", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"May 17, 2017", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"GlaxoSmithKline", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{}, "DescriptionModule":{ "BriefSummary":"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." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Respiratory Disorders" ] }, "KeywordList":{ "Keyword":[ "Chronic Obstructive Pulmonary disease (COPD)" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Non-Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Basic Science", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"73", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"HNS Group", "ArmGroupType":"Experimental", "ArmGroupDescription":"Healthy non-smokers aged between 45-75 years", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Procedure: Blood collection", "Procedure: Swab collection" ] } },{ "ArmGroupLabel":"HS Group", "ArmGroupType":"Experimental", "ArmGroupDescription":"Healthy smokers aged between 45-75 years", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Procedure: Blood collection", "Procedure: Swab collection" ] } },{ "ArmGroupLabel":"FeCOPD Group", "ArmGroupType":"Experimental", "ArmGroupDescription":"COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Procedure: Blood collection", "Procedure: Swab collection", "Procedure: Sputum collection" ] } },{ "ArmGroupLabel":"NFeCOPD Group", "ArmGroupType":"Experimental", "ArmGroupDescription":"COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Procedure: Blood collection", "Procedure: Swab collection", "Procedure: Sputum collection" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Procedure", "InterventionName":"Blood collection", "InterventionDescription":"Blood collection at Day 0 (all subjects) and at Month 6 (COPD subjects) for the analysis of serology, cell-mediated immune response.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "FeCOPD Group", "HNS Group", "HS Group", "NFeCOPD Group" ] } },{ "InterventionType":"Procedure", "InterventionName":"Swab collection", "InterventionDescription":"Nasopharyngeal and oropharyngeal swabs collection at Day 0 (All subjects) and at exacerbation visits (COPD subjects).", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "FeCOPD Group", "HNS Group", "HS Group", "NFeCOPD Group" ] } },{ "InterventionType":"Procedure", "InterventionName":"Sputum collection", "InterventionDescription":"Sputum collection at Day 0 and at exacerbation visits (COPD subjects)", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "FeCOPD Group", "NFeCOPD Group" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Anti-protein D Antibody Concentrations", "PrimaryOutcomeDescription":"Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per millilitre (EU/mL)", "PrimaryOutcomeTimeFrame":"At Day 0" },{ "PrimaryOutcomeMeasure":"Anti-protein D Antibody Concentrations", "PrimaryOutcomeDescription":"Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL)", "PrimaryOutcomeTimeFrame":"At Month 6" },{ "PrimaryOutcomeMeasure":"Anti-Pneumococcal Histidine Triad D Antibody Concentrations", "PrimaryOutcomeDescription":"Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL)", "PrimaryOutcomeTimeFrame":"At Day 0" },{ "PrimaryOutcomeMeasure":"Anti-Pneumococcal Histidine Triad D Antibody Concentrations", "PrimaryOutcomeDescription":"Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL)", "PrimaryOutcomeTimeFrame":"At Month 6" },{ "PrimaryOutcomeMeasure":"Anti-pneumolysin Antibody Concentrations", "PrimaryOutcomeDescription":"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.", "PrimaryOutcomeTimeFrame":"At Day 0" },{ "PrimaryOutcomeMeasure":"Anti-pneumolysin Antibody Concentrations", "PrimaryOutcomeDescription":"Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL)", "PrimaryOutcomeTimeFrame":"At Month 6" },{ "PrimaryOutcomeMeasure":"Concentrations for Serum Protein-D Enzymatic Inhibition", "PrimaryOutcomeDescription":"Concentrations are presented as geometric mean concentrations (GMCs). The reference seropositivity cut-off value was ≥ 17.8%.", "PrimaryOutcomeTimeFrame":"At Day 0" },{ "PrimaryOutcomeMeasure":"Concentrations for Serum Protein-D Enzymatic Inhibition", "PrimaryOutcomeDescription":"Concentrations are presented as geometric mean concentrations (GMCs). The reference seropositivity cut-off value was ≥ 17.8%.", "PrimaryOutcomeTimeFrame":"At Month 6" },{ "PrimaryOutcomeMeasure":"Number of Subjects With PD Enzymatic Inhibition Concentration Greater Than or Equal to (≥) 17.8%", "PrimaryOutcomeDescription":"Concentrations were expressed as geometric mean concentrations (GMCs)", "PrimaryOutcomeTimeFrame":"At Day 0" },{ "PrimaryOutcomeMeasure":"Number of Subjects With PD Enzymatic Inhibition Concentration Greater Than or Equal to (≥) 17.8%", "PrimaryOutcomeDescription":"Concentrations were expressed as geometric mean concentrations (GMCs)", "PrimaryOutcomeTimeFrame":"At Month 6" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"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", "SecondaryOutcomeTimeFrame":"At Day 0" },{ "SecondaryOutcomeMeasure":"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", "SecondaryOutcomeTimeFrame":"At Day 0" },{ "SecondaryOutcomeMeasure":"Number of Subjects With Positive Sputum - Culture Testing Results", "SecondaryOutcomeTimeFrame":"At Day 0" },{ "SecondaryOutcomeMeasure":"Number of Subjects With Positive Nasopharyngeal Swab - Culture Testing Results", "SecondaryOutcomeTimeFrame":"At Day 0" },{ "SecondaryOutcomeMeasure":"Number of Subjects With Positive Oropharyngeal Swab - Culture Testing Results", "SecondaryOutcomeTimeFrame":"At Day 0" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nHealthy subjects (smokers and non-smokers)\n\nSubjects who the investigator believes can and will comply with the requirements of the protocol.\nA male or female between, and including 45 and 75 years of age at the time of consent.\nWritten informed consent obtained from the subject.\nBaseline 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.\nFree of obvious health problems as established by medical history and clinical examination before entering into the study.\nNon-smokers: subjects who never smoked OR\nSmokers: current smoker having a smoking history ≥ 10 pack-years.\n\nCOPD subjects (frequent and non-frequent exacerbators)\n\nSubjects who the investigator believes can and will comply with the requirements of the protocol.\nA male or female between, and including 45 and 75 years of age at the time of consent.\nWritten informed consent obtained from the subject.\nBaseline post-bronchodilator FEV1 < 80% and >30% of predicted normal values and baseline post-bronchodilator FEV1/FVC < 70% of predicted normal values.\nCurrent or former smoker having a smoking history of ≥ 10 pack-years.\nDocumented history of ≥ one exacerbation within 365 days prior to the screening visit that required treatment with systemic corticosteroids or resulted in hospitalization.\n\nExclusion Criteria:\n\nHealthy subjects (smokers and non-smokers)\n\nUse of any investigational or non-registered product within 30 days prior to Screening Visit or planned use during the study.\nConcurrently participating in another clinical study in which the subject has been or will be exposed to an investigational or a non-investigational product.\nAny known clinically significant anaemia or any other condition as per medical records that would preclude the drawing of blood as described in the protocol.\nReceipt of any vaccine within 30 days preceding blood sampling.\nPrevious vaccination with any NTHi vaccine.\nChronic administration of immunosuppressants or other immune-modifying drugs within 180 days prior to screening visit. Topical steroids are allowed.\nAny confirmed or suspected immunosuppressive or immunodeficient condition including human immunodeficiency virus (HIV) infection, based on medical history and physical examination.\nSerious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination.\nAny known respiratory disorders.\nAcute disease and/or fever at the time of the Screening Visit or Visit 1, as applicable\nReceipt of immunoglobulins and/or any blood products within 90 days prior to Screening Visit.\nReceipt of interferon within 90 days prior to Screening Visit.\nHistory of malignancy.\nSubjects with a history of, or current, alcohol or substance abuse.\nKnown history of immune-mediated disorder.\nRecent use of antibiotics or antiviral drug within 30 days prior to Screening Visit.\nPregnant female.\nOther conditions that the investigator judges may interfere with study findings.\n\nCOPD subjects (frequent and non-frequent exacerbators)\n\nUse 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.\nConcurrently 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.\nAny known clinically significant anaemia or any other condition as per medical records that would preclude the drawing of blood as described in the protocol.\nReceipt of any vaccine within 30 days preceding blood sampling.\nPrevious vaccination with any NTHi vaccine.\nAny confirmed or suspected immunosuppressive or immunodeficient condition including human immunodeficiency virus (HIV) infection, based on medical history and physical examination.\nSerious, uncontrolled disease likely to interfere with the study findings.\nAcute disease and/or fever at the time of the Screening Visit or Visit 1, as applicable\nReceipt of immunoglobulins and/or any blood products within 90 days prior to Screening Visit.\nReceipt of interferon within 90 days prior to Screening Visit.\nHistory of malignancy.\nSubjects with a history of, or current, alcohol or substance abuse.\nKnown history of immune-mediated disease other than COPD.\nRecent use of antibiotics or antiviral drug within 30 days prior to Screening Visit.\nSubject 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.\nChronic administration of immunosuppressants or other immune-modifying drugs within 180 days preceding screening visit.\nSubjects with very severe COPD, GOLD stage IV.\nPrimary diagnosis of asthma.\nOther respiratory disorders such as sarcoidosis, tuberculosis, lung cancer, lung fibrosis, cystic fibrosis.\nA known diagnosis of α-1 antitrypsin deficiency as underlying cause of COPD.\nHistory of lung surgery.\nPregnant female.\nOther conditions that the investigator judges may interfere with study findings.", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"All", "MinimumAge":"45 Years", "MaximumAge":"75 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"GSK Clinical Trials", "OverallOfficialAffiliation":"GlaxoSmithKline", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"GSK Investigational Site", "LocationCity":"Brussels", "LocationZip":"1000", "LocationCountry":"Belgium" },{ "LocationFacility":"GSK Investigational Site", "LocationCity":"Gent", "LocationZip":"9000", "LocationCountry":"Belgium" },{ "LocationFacility":"GSK Investigational Site", "LocationCity":"Liège", "LocationZip":"4000", "LocationCountry":"Belgium" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"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.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"HNS Group", "FlowGroupDescription":"Healthy non-smokers aged between 45-75 years" },{ "FlowGroupId":"FG001", "FlowGroupTitle":"HS Group", "FlowGroupDescription":"Healthy smokers aged between 45-75 years" },{ "FlowGroupId":"FG002", "FlowGroupTitle":"FeCOPD Group", "FlowGroupDescription":"COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years" },{ "FlowGroupId":"FG003", "FlowGroupTitle":"NFeCOPD Group", "FlowGroupDescription":"COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"24" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"24" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"15" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"7" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"24" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"24" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"14" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"6" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"1" },{ "FlowAchievementGroupId":"FG003", "FlowAchievementNumSubjects":"1" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Reason not specified", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG003", "FlowReasonNumSubjects":"1" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"HNS Group", "BaselineGroupDescription":"Healthy non-smokers aged between 45-75 years" },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"HS Group", "BaselineGroupDescription":"Healthy smokers aged between 45-75 years" },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"FeCOPD Group", "BaselineGroupDescription":"COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years" },{ "BaselineGroupId":"BG003", "BaselineGroupTitle":"NFeCOPD Group", "BaselineGroupDescription":"COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years" },{ "BaselineGroupId":"BG004", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"24" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"24" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"15" },{ "BaselineDenomCountGroupId":"BG003", "BaselineDenomCountValue":"7" },{ "BaselineDenomCountGroupId":"BG004", "BaselineDenomCountValue":"70" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"Years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"60", "BaselineMeasurementSpread":"10.10" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"57.8", "BaselineMeasurementSpread":"8.45" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"64.1", "BaselineMeasurementSpread":"7.39" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"61.4", "BaselineMeasurementSpread":"6.75" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"60.26", "BaselineMeasurementSpread":"8.85" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"16" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"9" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"33" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"15" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"9" },{ "BaselineMeasurementGroupId":"BG003", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG004", "BaselineMeasurementValue":"37" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Anti-protein D Antibody Concentrations", "OutcomeMeasureDescription":"Concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per millilitre (EU/mL)", "OutcomeMeasurePopulationDescription":"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.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Geometric Mean", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"EU/mL", "OutcomeMeasureTimeFrame":"At Day 0", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"HNS Group", "OutcomeGroupDescription":"Healthy non-smokers aged between 45-75 years" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"HS Group", "OutcomeGroupDescription":"Healthy smokers aged between 45-75 years" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"FeCOPD Group", "OutcomeGroupDescription":"COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years" },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"NFeCOPD Group", "OutcomeGroupDescription":"COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"23" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"24" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"15" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"7" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"79.5", "OutcomeMeasurementLowerLimit":"50.2", "OutcomeMeasurementUpperLimit":"126.0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"66.9", "OutcomeMeasurementLowerLimit":"53.1", "OutcomeMeasurementUpperLimit":"84.3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"61.7", "OutcomeMeasurementLowerLimit":"48.3", "OutcomeMeasurementUpperLimit":"78.7" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"72.8", "OutcomeMeasurementLowerLimit":"40.1", "OutcomeMeasurementUpperLimit":"132.0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Anti-protein D Antibody Concentrations", "OutcomeMeasureDescription":"Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL)", "OutcomeMeasurePopulationDescription":"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.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Geometric Mean", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"EU/mL", "OutcomeMeasureTimeFrame":"At Month 6", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"FeCOPD Group", "OutcomeGroupDescription":"COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"NFeCOPD Group", "OutcomeGroupDescription":"COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"13" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"6" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"68.6", "OutcomeMeasurementLowerLimit":"50.2", "OutcomeMeasurementUpperLimit":"93.9" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"61.0", "OutcomeMeasurementLowerLimit":"36.6", "OutcomeMeasurementUpperLimit":"101.8" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Anti-Pneumococcal Histidine Triad D Antibody Concentrations", "OutcomeMeasureDescription":"Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL)", "OutcomeMeasurePopulationDescription":"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.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Geometric Mean", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"EU/mL", "OutcomeMeasureTimeFrame":"At Day 0", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"HNS Group", "OutcomeGroupDescription":"Healthy non-smokers aged between 45-75 years" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"HS Group", "OutcomeGroupDescription":"Healthy smokers aged between 45-75 years" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"FeCOPD Group", "OutcomeGroupDescription":"COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years" },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"NFeCOPD Group", "OutcomeGroupDescription":"COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"24" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"24" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"15" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"7" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3786.7", "OutcomeMeasurementLowerLimit":"2748.3", "OutcomeMeasurementUpperLimit":"5217.5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3400.7", "OutcomeMeasurementLowerLimit":"2445.3", "OutcomeMeasurementUpperLimit":"4729.4" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3323.9", "OutcomeMeasurementLowerLimit":"2128.8", "OutcomeMeasurementUpperLimit":"5190.1" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"2563.9", "OutcomeMeasurementLowerLimit":"840.5", "OutcomeMeasurementUpperLimit":"7821.6" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Anti-Pneumococcal Histidine Triad D Antibody Concentrations", "OutcomeMeasureDescription":"Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL)", "OutcomeMeasurePopulationDescription":"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.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Geometric Mean", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"EU/mL", "OutcomeMeasureTimeFrame":"At Month 6", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"FeCOPD Group", "OutcomeGroupDescription":"COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"NFeCOPD Group", "OutcomeGroupDescription":"COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"6" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2521.5", "OutcomeMeasurementLowerLimit":"1598.6", "OutcomeMeasurementUpperLimit":"3977.4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2160.1", "OutcomeMeasurementLowerLimit":"863.2", "OutcomeMeasurementUpperLimit":"5405.5" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Anti-pneumolysin Antibody Concentrations", "OutcomeMeasureDescription":"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.", "OutcomeMeasurePopulationDescription":"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 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exacerbators), aged between 45-75 years" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"24" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"24" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"15" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"7" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"3870.5", "OutcomeMeasurementLowerLimit":"2607.0", "OutcomeMeasurementUpperLimit":"5746.3" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3116.7", "OutcomeMeasurementLowerLimit":"2097.3", "OutcomeMeasurementUpperLimit":"4631.8" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2804.5", "OutcomeMeasurementLowerLimit":"1831.8", "OutcomeMeasurementUpperLimit":"4293.7" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"3898.7", "OutcomeMeasurementLowerLimit":"1437.4", "OutcomeMeasurementUpperLimit":"10574.5" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Anti-pneumolysin Antibody Concentrations", "OutcomeMeasureDescription":"Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EU/mL)", "OutcomeMeasurePopulationDescription":"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.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Geometric Mean", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"EU/mL", "OutcomeMeasureTimeFrame":"At Month 6", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"FeCOPD Group", "OutcomeGroupDescription":"COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"NFeCOPD Group", "OutcomeGroupDescription":"COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"6" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2275.6", 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The reference seropositivity cut-off value was ≥ 17.8%.", "OutcomeMeasurePopulationDescription":"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.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Geometric Mean", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"EU/mL", "OutcomeMeasureTimeFrame":"At Day 0", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"HNS Group", "OutcomeGroupDescription":"Healthy non-smokers aged between 45-75 years" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"HS Group", "OutcomeGroupDescription":"Healthy smokers aged between 45-75 years" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"FeCOPD Group", "OutcomeGroupDescription":"COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years" },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"NFeCOPD Group", "OutcomeGroupDescription":"COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"24" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"24" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"15" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"7" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"10.4", "OutcomeMeasurementLowerLimit":"8.9", "OutcomeMeasurementUpperLimit":"12.1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"9.3", "OutcomeMeasurementLowerLimit":"8.5", "OutcomeMeasurementUpperLimit":"10.0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"9.9", "OutcomeMeasurementLowerLimit":"8.4", "OutcomeMeasurementUpperLimit":"11.7" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"8.9", "OutcomeMeasurementLowerLimit":"8.9", "OutcomeMeasurementUpperLimit":"8.9" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Concentrations for Serum Protein-D Enzymatic Inhibition", "OutcomeMeasureDescription":"Concentrations are presented as geometric mean concentrations (GMCs). The reference seropositivity cut-off value was ≥ 17.8%.", "OutcomeMeasurePopulationDescription":"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.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Geometric Mean", "OutcomeMeasureDispersionType":"95% Confidence Interval", "OutcomeMeasureUnitOfMeasure":"EU/mL", "OutcomeMeasureTimeFrame":"At Month 6", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"FeCOPD Group", "OutcomeGroupDescription":"COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"NFeCOPD Group", "OutcomeGroupDescription":"COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"14" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"6" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"9.4", "OutcomeMeasurementLowerLimit":"8.4", "OutcomeMeasurementUpperLimit":"10.4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"8.9", "OutcomeMeasurementLowerLimit":"8.9", "OutcomeMeasurementUpperLimit":"8.9" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Number of Subjects With PD Enzymatic Inhibition Concentration Greater Than or Equal to (≥) 17.8%", "OutcomeMeasureDescription":"Concentrations were expressed as geometric mean concentrations (GMCs)", "OutcomeMeasurePopulationDescription":"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.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Subjects", "OutcomeMeasureTimeFrame":"At Day 0", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"HNS Group", "OutcomeGroupDescription":"Healthy non-smokers aged between 45-75 years" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"HS Group", "OutcomeGroupDescription":"Healthy smokers aged between 45-75 years" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"FeCOPD Group", "OutcomeGroupDescription":"COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years" },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"NFeCOPD Group", "OutcomeGroupDescription":"COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"24" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"24" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"15" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"7" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Number of Subjects With PD Enzymatic Inhibition Concentration Greater Than or Equal to (≥) 17.8%", "OutcomeMeasureDescription":"Concentrations were expressed as geometric mean concentrations (GMCs)", "OutcomeMeasurePopulationDescription":"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.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Subjects", "OutcomeMeasureTimeFrame":"At Month 6", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"FeCOPD Group", "OutcomeGroupDescription":"COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged 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"OutcomeGroupDescription":"COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years" },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"NFeCOPD Group", "OutcomeGroupDescription":"COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"24" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"24" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"15" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"7" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"159.6", "OutcomeMeasurementSpread":"67.29" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"163.5", "OutcomeMeasurementSpread":"87.11" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"173.9", "OutcomeMeasurementSpread":"89.69" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"170.1", "OutcomeMeasurementSpread":"88.96" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"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", "OutcomeMeasurePopulationDescription":"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.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"T cells/million cells", "OutcomeMeasureTimeFrame":"At Day 0", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"HNS Group", "OutcomeGroupDescription":"Healthy non-smokers aged between 45-75 years" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"HS Group", "OutcomeGroupDescription":"Healthy smokers aged between 45-75 years" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"FeCOPD Group", "OutcomeGroupDescription":"COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years" },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"NFeCOPD Group", "OutcomeGroupDescription":"COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"24" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"24" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"15" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"7" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"97.9", "OutcomeMeasurementSpread":"56.74" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"125.2", "OutcomeMeasurementSpread":"73.93" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"125.2", "OutcomeMeasurementSpread":"44.12" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"161.3", "OutcomeMeasurementSpread":"43.72" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Subjects With Positive Sputum - Culture Testing Results", "OutcomeMeasurePopulationDescription":"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.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Subjects", "OutcomeMeasureTimeFrame":"At Day 0", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"FeCOPD Group", "OutcomeGroupDescription":"COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"NFeCOPD Group", "OutcomeGroupDescription":"COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"15" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"7" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Any bacteria", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"9" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"Streptococcus pneumoniae", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Haemophilus influenzae", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"Moraxella catarrhalis", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Staphylococcus aureus", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Pseudomonas aeruginosa", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Other bacteria", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Subjects With Positive Nasopharyngeal Swab - Culture Testing Results", "OutcomeMeasurePopulationDescription":"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.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Subjects", "OutcomeMeasureTimeFrame":"At Day 0", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"HNS Group", "OutcomeGroupDescription":"Healthy non-smokers aged between 45-75 years" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"HS Group", "OutcomeGroupDescription":"Healthy smokers aged between 45-75 years" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"FeCOPD Group", "OutcomeGroupDescription":"COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years" },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"NFeCOPD Group", "OutcomeGroupDescription":"COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"24" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"24" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"15" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"7" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Any bacteria", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Streptococcus pneumoniae", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Haemophilus influenzae", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Moxarella catarrhalis", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Staphylococcus aureus", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Pseudomonas aeruginosa", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Other bacteria", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Number of Subjects With Positive Oropharyngeal Swab - Culture Testing Results", "OutcomeMeasurePopulationDescription":"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.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Subjects", "OutcomeMeasureTimeFrame":"At Day 0", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"HNS Group", "OutcomeGroupDescription":"Healthy non-smokers aged between 45-75 years" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"HS Group", "OutcomeGroupDescription":"Healthy smokers aged between 45-75 years" },{ "OutcomeGroupId":"OG002", "OutcomeGroupTitle":"FeCOPD Group", "OutcomeGroupDescription":"COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years" },{ "OutcomeGroupId":"OG003", "OutcomeGroupTitle":"NFeCOPD Group", "OutcomeGroupDescription":"COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"24" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"24" },{ "OutcomeDenomCountGroupId":"OG002", "OutcomeDenomCountValue":"15" },{ "OutcomeDenomCountGroupId":"OG003", "OutcomeDenomCountValue":"7" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Any bacteria", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"5" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1" } ] } } ] } },{ "OutcomeClassTitle":"Streptococcus pneumoniae", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Haemophilus influenzae", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Moxarella catarrhalis", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Staphylococcus aureus", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"1" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Pseudomonas aeruginosa", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"0" } ] } } ] } },{ "OutcomeClassTitle":"Other bacteria", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"0" },{ "OutcomeMeasurementGroupId":"OG002", "OutcomeMeasurementValue":"4" },{ "OutcomeMeasurementGroupId":"OG003", "OutcomeMeasurementValue":"1" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"5", "EventsTimeFrame":"Serious Adverse Events (SAEs) up to Month 6.", "EventsDescription":"Non-serious/frequent adverse events were not collected in this study.", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"HNS Group", "EventGroupDescription":"Healthy non-smokers aged between 45-75 years", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"24", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"0" },{ "EventGroupId":"EG001", "EventGroupTitle":"HS Group", "EventGroupDescription":"Healthy smokers aged between 45-75 years", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"24", "EventGroupOtherNumAffected":"0", 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Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"24" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"24" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"15" },{ "SeriousEventStatsGroupId":"EG003", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"7" } ] } } ] } }, "MoreInfoModule":{ "CertainAgreement":{ "AgreementPISponsorEmployee":"No", "AgreementRestrictionType":"OTHER", "AgreementRestrictiveAgreement":"Yes", "AgreementOtherDetails":"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." }, "PointOfContact":{ "PointOfContactTitle":"GSK Response Center", "PointOfContactOrganization":"GlaxoSmithKline", "PointOfContactPhone":"866-435-7343" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000012120", "ConditionMeshTerm":"Respiration Disorders" },{ "ConditionMeshId":"D000012140", "ConditionMeshTerm":"Respiratory Tract Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M9751", "ConditionBrowseLeafName":"Lung Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13540", "ConditionBrowseLeafName":"Respiration Disorders", "ConditionBrowseLeafAsFound":"Respiratory Disorders", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M13560", "ConditionBrowseLeafName":"Respiratory Tract Diseases", "ConditionBrowseLeafAsFound":"Respiratory Disorders", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M9753", "ConditionBrowseLeafName":"Lung Diseases, Obstructive", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M22033", "ConditionBrowseLeafName":"Pulmonary Disease, Chronic Obstructive", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC08", "ConditionBrowseBranchName":"Respiratory Tract (Lung and Bronchial) Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }