[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636800":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":37,"studyPopulation":38,"armGroups":39,"interventions":33,"overallOfficials":33,"centralContacts":46,"locations":52,"responsibleParty":132,"collaborators":33,"id":134,"slug":135,"hasResults":136,"nctId":137,"briefTitle":138,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":136,"sex":141,"minAge":33,"maxAge":33,"enrollmentInfo":142,"targetDuration":33,"studyType":145,"phases":33,"briefSummary":146,"conditions":147,"keywords":33,"overallStatus":66,"whyStopped":33,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":33},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"Incidence proportion of Adverse Events (AEs)\u002FAdverse Drug Reactions (ADRs)","All AEs\u002FADRs will be presented as the number of patients with an outcome of interest, the incidence proportion percentages, and the number of events, the corresponding Clopper-Pearson's two-sided 95% exact confidence interval (CI), and the number of events.","24 weeks",{"measure":14,"description":15,"timeFrame":12},"Incidence proportion of Serious AEs (SAEs)\u002FSerious ADRs (SADRs)","SAEs\u002FSADRs will be presented as the number of patients with an outcome of interest, the incidence proportion percentages, and the number of events, the corresponding Clopper-Pearson's two-sided 95% exact confidence interval (CI), and the number of events.",{"measure":17,"description":18,"timeFrame":12},"Incidence proportion of Unexpected AEs\u002FUnexpected ADRs","Unexpected AEs\u002FADRs will be presented as the number of patients with an outcome of interest, the incidence proportion percentages, and the number of events, the corresponding Clopper-Pearson's two-sided 95% exact confidence interval (CI), and the number of events.",{"measure":20,"description":21,"timeFrame":12},"Incidence proportion of Unexpected SAEs\u002FUnexpected SADRs","Unexpected SAEs\u002FSADRs, will be presented as the number of patients with an outcome of interest, the incidence proportion percentages, and the number of events, the corresponding Clopper-Pearson's two-sided 95% exact confidence interval (CI), and the number of events.",[23,27,30],{"measure":24,"description":25,"timeFrame":26},"Describe changes in clinical outcomes from baseline to week 12 and 24 in patients with COPD receiving Breztri under the approved indication(s) in Korea","Change from baseline to week 12 and 24(within a window of ±6 weeks) in predose Forced Expiratory Volume in 1 second (FEV₁) FEV₁ represents the volume of air forcibly exhaled in the first second of a forced expiratory maneuver, measured in milliliters (mL). Improvement indicates enhanced lung function.","12 and 24 weeks",{"measure":28,"description":29,"timeFrame":26},"Change from baseline to week 12 and 24 in COPD Assessment Test (CAT) score","Change from baseline to week 12 and 24(within a window of ±6 weeks) in COPD Assessment Test (CAT) score The CAT is an 8-item questionnaire assessing the impact of COPD symptoms on health status. Scores range from 0 (best) to 40 (worst), with lower scores indicating better health status.",{"measure":31,"description":32,"timeFrame":26},"Describe changes in clinical outcomes from baseline to week 12 and 24 in patient with asthma receiving Breztri under the approved indication(s) in Korea","Change from baseline to week 12 and 24(within a window of ±4 weeks) in investigator assessed asthma control\n\nAsthma control assessed by the study investigator according to GINA guidelines:\n\n\"Well controlled\", \"Partly controlled\", and \"Uncontrolled\".",null,{"allocation":33,"interventionModel":33,"interventionModelDescription":33,"primaryPurpose":33,"observationalModel":35,"timePerspective":36,"maskingInfo":33},"COHORT","PROSPECTIVE","This is an open-label, primary data collection, single-arm, multicentre, observational study. Eligible patients who initiate treatment with Breztri according to approved indications will be enrolled after obtaining informed consent. All patients treated (minimum 600 patients required) with Breztri in accordance with the local prescribing information are eligible for enrolment in this study. Initiation or continuation of Breztri prescription and patient enrolment will depend on physicians' medical decisions as per routine clinical practice. Approximately 30 study sites are expected to participate in this study.\n\nAs this study will be performed under clinical practice, the investigator may prescribe any other concomitant medications that are necessary for the patient as locally approved.\n\nThe total number of visits and the visit time will be determined at the discretion of the investigator based on the patient's condition.\n\nPatients will be observed for up to 24 weeks. Follow-up will begin on the date of the first administration of Breztri (index date). However, if a patient is found to meet any of the exclusion criteria after enrolment, no additional follow-up (including the 30-day safety follow-up) will be conducted.\n\nThe primary objective of this study is to characterize the safety profile separately in patients with COPD and in patients with asthma receiving Breztri under the approved indication(s) in Korea over a 24-week follow-up period, or until the end of treatment (EoT) if discontinued earlier.\n\nThe secondary objective of this study is to describe changes in clinical outcomes from baseline to week 12 and week 24, separately in patients with COPD and in patients with asthma receiving Breztri under the approved indication(s) in Korea.\n\nThe exploratory objective of this study is to identify patients' baseline characteristics that might be associated with safety and clinical outcomes separately in patients with COPD and in patients with asthma receiving Breztri under the approved indication(s) in Korean patients.","Patients newly initiating treatment with Breztri in accordance with the local prescribing information will be enrolled.",[40,43],{"label":41,"type":33,"description":42,"interventionNames":33},"Chronic obstructive pulmonary disease","Patients who have been diagnosed with COPD",{"label":44,"type":33,"description":45,"interventionNames":33},"Asthma","Patients who have been diagnosed with asthma",[47],{"name":48,"role":49,"phone":50,"phoneExt":33,"email":51},"AstraZeneca Clinical Study Information Center","CONTACT","1-877-240-9479","information.center@astrazeneca.com",[53,65,74,82,90,98,106,111,119,124],{"facility":54,"status":55,"city":56,"state":33,"zip":57,"country":58,"countryCode":33,"cosmosGeoPoint":59,"geoPoint":64,"contacts":33},"Research Site","NOT_YET_RECRUITING","Chuncheon","24289","South Korea",{"type":60,"coordinates":61},"Point",[62,63],127.73417,37.87472,{"lat":63,"lon":62},{"facility":54,"status":66,"city":67,"state":33,"zip":68,"country":58,"countryCode":33,"cosmosGeoPoint":69,"geoPoint":73,"contacts":33},"RECRUITING","Daegu","41931",{"type":60,"coordinates":70},[71,72],128.59111,35.87028,{"lat":72,"lon":71},{"facility":54,"status":55,"city":75,"state":33,"zip":76,"country":58,"countryCode":33,"cosmosGeoPoint":77,"geoPoint":81,"contacts":33},"Goyang-si","10380",{"type":60,"coordinates":78},[79,80],126.835,37.65639,{"lat":80,"lon":79},{"facility":54,"status":55,"city":83,"state":33,"zip":84,"country":58,"countryCode":33,"cosmosGeoPoint":85,"geoPoint":89,"contacts":33},"Gwangmyeong","14353",{"type":60,"coordinates":86},[87,88],126.86639,37.47722,{"lat":88,"lon":87},{"facility":54,"status":55,"city":91,"state":33,"zip":92,"country":58,"countryCode":33,"cosmosGeoPoint":93,"geoPoint":97,"contacts":33},"Jinju","52727",{"type":60,"coordinates":94},[95,96],128.08472,35.19278,{"lat":96,"lon":95},{"facility":54,"status":66,"city":99,"state":33,"zip":100,"country":58,"countryCode":33,"cosmosGeoPoint":101,"geoPoint":105,"contacts":33},"Seongnam-si","13590",{"type":60,"coordinates":102},[103,104],127.13778,37.43861,{"lat":104,"lon":103},{"facility":54,"status":55,"city":99,"state":33,"zip":107,"country":58,"countryCode":33,"cosmosGeoPoint":108,"geoPoint":110,"contacts":33},"13620",{"type":60,"coordinates":109},[103,104],{"lat":104,"lon":103},{"facility":54,"status":66,"city":112,"state":33,"zip":113,"country":58,"countryCode":33,"cosmosGeoPoint":114,"geoPoint":118,"contacts":33},"Seoul","4401",{"type":60,"coordinates":115},[116,117],126.9784,37.566,{"lat":117,"lon":116},{"facility":54,"status":55,"city":112,"state":33,"zip":120,"country":58,"countryCode":33,"cosmosGeoPoint":121,"geoPoint":123,"contacts":33},"6973",{"type":60,"coordinates":122},[116,117],{"lat":117,"lon":116},{"facility":54,"status":66,"city":125,"state":33,"zip":126,"country":58,"countryCode":33,"cosmosGeoPoint":127,"geoPoint":131,"contacts":33},"Wŏnju","26426",{"type":60,"coordinates":128},[129,130],127.94528,37.35139,{"lat":130,"lon":129},{"type":133,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100636800","breztri-regulatory-post-marketing-surveillance-in-korea-100636800",false,"NCT07570394","BREZTRI REGULATORY POST MARKETING SURVEILLANCE IN KOREA","Breztri rPMS","Inclusion Criteria:\n\n1. Patients who have been diagnosed with COPD or asthma.\n2. Patients who have newly initiated treatment with Breztri according to the approved label in Korea\n3. Provision of signed and dated written informed consent by the patient or legally acceptable representative\n\nExclusion Criteria:\n\n1. Other off-label indications outside of the locally approved prescribing information\n2. Pregnant and\u002For breast feeding\n3. Current participation in any interventional trial","ALL",{"count":143,"type":144},600,"ESTIMATED","OBSERVATIONAL","As part of a post-approval commitment requested by the Ministry of Food and Drug Safety (MFDS), this open-label, single-arm, multicentre, observational Post-Marketing Surveillance (PMS) study aims to characterize the safety profile of Breztri in real-world clinical practice settings, either confirming known safety outcomes or identifying previously unsuspected adverse drug reactions. The study will also evaluate effectiveness of Breztri in real-world clinical practice settings, generating essential clinical evidence from a broader and more diverse Korean patient population representative of daily medical practice.",[148,44],"Chronic Obstructive Pulmonary Disease (COPD)","2026-09-22",{"date":151,"type":152},"2026-09-23","ACTUAL",{"date":154,"type":152},"2026-09-17",{"date":156,"type":144},"2027-07-31",{"name":5,"class":6},10]