[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100489386":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":21,"studyPopulation":22,"armGroups":23,"interventions":33,"overallOfficials":41,"centralContacts":46,"locations":52,"responsibleParty":69,"collaborators":17,"id":71,"slug":17,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":72,"sex":78,"minAge":79,"maxAge":17,"enrollmentInfo":80,"targetDuration":17,"studyType":83,"phases":17,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":55,"whyStopped":17,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Chiesi Farmaceutici S.p.A.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of Major Adverse Cardiovascular Events (MACE)","To assess the incidence of MACEs and compare it between fixed triple therapy BDP\u002FFF\u002FGB via DPI and pMDI formulation. MACEs will be defined as any of the following events:\n\n* Myocardial infarction\n* Stroke (ischemic and haemorrhagic stroke)\n* Hospitalization due to acute coronary syndrome\n* Hospitalization due to heart failure","Through study completion, up to 5 years",[14],{"measure":15,"description":16,"timeFrame":12},"Incidence of major cardiovascular and cerebrovascular events individually","To assess the incidence of each of the following events individually:\n\n* Myocardial infarction\n* Cerebrovascular disorders (ischemic and haemorrhagic stroke, transient ischemic attack)\n* Hospitalization due to acute coronary syndrome\n* Hospitalization due to heart failure\n* Arrhythmias (new-sustained supra-ventricular and sustained ventricular)\n* All-cause death",null,{"allocation":17,"interventionModel":17,"interventionModelDescription":17,"primaryPurpose":17,"observationalModel":19,"timePerspective":20,"maskingInfo":17},"COHORT","RETROSPECTIVE","Non-interventional, multi-country cohort study to assess the incidence of adverse cardiovascular and cerebrovascular events among patients with chronic obstructive pulmonary disease (COPD), exposed to inhaled fixed triple therapy BDP\u002FFF\u002FGB via DPI (drug of interest) or pMDI (comparator).\n\nThe study will be conducted based on secondary health data collected (as per clinical practice) retrospectively from seven different European data sources in the following countries: United Kingdom, Germany, The Netherlands, Denmark, Sweden, Norway and Finland.\n\nPatients in the two exposure groups of this Post Authorisation Safety Study (PASS) will be followed for the study outcomes from the start of the exposure until the first occurrence of end of treatment, switch to the other study drug, end of the study period, or censoring. The pre-defined hypothesis is that the DPI is not associated with different risks of the primary and secondary outcomes, compared with pMDI.","The study population will include patients diagnosed with COPD, aged 40 years or older. Eligible for inclusion will be patients with new use of single inhaler triple therapy BDP\u002FFF\u002FGB via DPI or pMDI and no use of any single or multi-inhaler triple therapy (including the study drugs) in the previous 90 days.\n\nThe source population includes patients who have at least one prescription\u002Fdispensation of BDP\u002FFF\u002FGB administered via DPI or pMDI during the study period.",[24,29],{"label":25,"type":17,"description":26,"interventionNames":27},"Fixed triple therapy BDP\u002FFF\u002FGB via DPI","COPD patients new users of fixed triple therapy BDP\u002FFF\u002FGB administered via DPI formulation according to local clinical practice",[28],"Other: Observational retrospective data collection",{"label":30,"type":17,"description":31,"interventionNames":32},"Fixed triple therapy BDP\u002FFF\u002FGB via pMDI","COPD patients new users of fixed triple therapy BDP\u002FFF\u002FGB administered via pMDI formulation according to local clinical practice",[28],[34],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"OTHER","Observational retrospective data collection","Observational retrospective data collection of the incidence of adverse cardiovascular and cerebrovascular outcomes",[25,30],[40],"No treatment given",[42],{"name":43,"affiliation":44,"role":45},"Fabian Hoti","IQVIA Pty Ltd","PRINCIPAL_INVESTIGATOR",[47],{"name":48,"role":49,"phone":50,"phoneExt":17,"email":51},"Clinical Trial Info","CONTACT","+3905212791","clinicaltrials_info@chiesi.com",[53],{"facility":54,"status":55,"city":56,"state":17,"zip":17,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":65},"Clinical Practice Research Datalink (CPRD)","RECRUITING","London","United Kingdom","UK",{"type":60,"coordinates":61},"Point",[62,63],-0.12574,51.50853,{"lat":63,"lon":62},[66],{"name":67,"role":49,"phone":17,"phoneExt":17,"email":68},"Enquiries CPRD","enquiries@cprd.com",{"type":70,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100489386",false,"NCT05652439","PASS to Assess Cardiovascular and Cerebrovascular Events in COPD Patients Initiating Fixed Triple Therapy (DPI or pMDI)","Multinational Database Cohort Study to Assess Adverse Cardiovascular and Cerebrovascular Outcomes in Patients With COPD Initiating a Fixed Triple Therapy Containing BDP, FF and GB Administered Via DPI Compared to pMDI","TRIBE","Inclusion Criteria:\n\n* Patients diagnosed with COPD\n* 40 years or older\n* Availability of baseline information for a minimum of 12 months before the index date\n* New users of single inhaler triple therapy BDP\u002FFF\u002FGB via DPI or pMDI\n\nExclusion Criteria:\n\n* Single or multi-inhaler triple therapy in the previous 90 days before the index date\n* Prescription of BDP\u002FFF\u002FGP administered via pMDI or DPI or any other single inhaler triple therapy in addition to a study drug on the index date.\n* Hospitalization due to cardiovascular causes in the previous 30 days before the index date.","ALL","40 Years",{"count":81,"type":82},25000,"ESTIMATED","OBSERVATIONAL","The aim of this Post Authorisation Safety Study (PASS) is to assess the incidence of adverse cardiovascular and cerebrovascular events in COPD patients who are new to inhaled fixed triple therapy (dual bronchodilator plus corticosteroid) administered via Dry Powder Inhaler (DPI) compared to new users of pressurized Metered Dose Inhaler (pMDI).\n\nData from clinical practice from different European data sources will be collected. The baseline hypothesis is that the DPI is not associated with different risks of the primary and secondary outcomes, compared with pMDI.",[86],"Chronic Obstructive Pulmonary Disease",[88,89,90,91],"retrospective","cardiovascular","cerebrovascular","triple therapy","2025-04-30",{"date":94,"type":95},"2025-05-04","ACTUAL",{"date":97,"type":95},"2022-12-02",{"date":99,"type":82},"2026-08",{"name":5,"class":6},1]