[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624162":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":54,"collaborators":10,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":10,"enrollmentInfo":66,"targetDuration":10,"studyType":69,"phases":10,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":88},{"fullName":5,"class":6},"Chiesi Farmaceutici S.p.A.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Trimbow",null,"Adult patients with COPD treated with triple combination Beclometasone Diproprionate\u002FFormoterol Fumarate\u002FGlycopyrronium Bromide (BDP\u002FFF\u002FGB) as per local clinical practice",[13],"Drug: BDP\u002FFF\u002FGB (100ug\u002F6ug\u002F12.5ug)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","BDP\u002FFF\u002FGB (100ug\u002F6ug\u002F12.5ug)","Fixed combination of Inhaled Corticosteroid (ICS) \u002F Long-acting β2-agonist (LABA) \u002F long-acting muscarinic antagonist (LAMA) that contains Beclometasone dipropionate (BDP), Formoterol fumarate (FF) and Glycopyrronium bromide(GB)",[9],[9],[22],{"name":23,"affiliation":24,"role":25},"ROBERTO STIRBULOV, PhD, MD","Faculdade de Ciências Médicas da Santa Casa de São Paulo (FCMSCSP)","STUDY_CHAIR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":10,"email":31},"ISMAEL PRETTO SAUTER","CONTACT","+551130952359 \u002F +5511976281117","Ismael.sauter@chiesi.com",{"name":33,"role":29,"phone":34,"phoneExt":10,"email":35},"Medical Information Chiesi","0800 110 45 25","cientifico@chiesi.com",[37],{"facility":38,"status":39,"city":40,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Santa Casa de Misericórdia de São Paulo","RECRUITING","São Paulo","01221-020","Brazil","BR",{"type":45,"coordinates":46},"Point",[47,48],-46.63611,-23.5475,{"lat":48,"lon":47},[51],{"name":52,"role":29,"phone":10,"phoneExt":10,"email":53},"José Eduardo Cançado, PhD","educancado@uol.com.br",{"type":55,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100624162","real-world-effectiveness-of-a-triple-combination-bdpffgb-extrafine-in-a-single-pressurised-metered-dose-inhaler-in-brazilian-copd-patients-100624162",false,"NCT07406048","Real-World Effectiveness of a Triple Combination BDP\u002FFF\u002FGB Extrafine in a Single Pressurised Metered Dose Inhaler in Brazilian COPD Patients","A Real-World Study Evaluates the Clinical Characteristics and Effectiveness of COPD Patients Treated With the Triple Combination Beclometasone Diproprionate\u002FFormoterol Fumarate\u002FGlycopyrronium Bromide (BDP\u002FFF\u002FGB) in a Single Pressurised Metered Dose Inhaler (Trimbow® pMDI) in Brazil","RETRIBUTE","Inclusion Criteria:\n\n* Male and Female patients ≥ 40 years old at the time of BDP\u002FFF\u002FGB initiation\n* Patients with documented diagnosis of severe or very severe COPD prior to BDP\u002FFF\u002FGB initiation\n* Patients with CAT total score ≥ 10 at baseline (at the time of BDP\u002FFF\u002FGB initiation or within the 12 months before treatment initiation\\*) \\*If no CAT total score is available on BDP\u002FFF\u002FGB initiation date)\n* Patients with at least ≥ 1 COPD exacerbation within the previous 12 months before enrollment.\n* Patients who started treatment with BDP\u002FFF\u002FGB within 3-months before signing the Informed Consent Form (ICF), or on the date of the ICF signature according to Trimbow® Summary of Product Characteristics (SmPC)\n* Patients who are willing and able to give their written consent to participate in the study\n\nExclusion Criteria:\n\n\\- Patient known to be participating in any interventional study during the study period and in the 3 months prior to BDP\u002FFF\u002FGB initiation.","ALL","40 Years",{"count":67,"type":68},396,"ESTIMATED","OBSERVATIONAL","This multicenter, retrospective-prospective, cohort study aims to evaluate the effectiveness and safety of Extra-fine Beclometasone Diproprionate\u002FFormoterol Fumarate\u002FGlycopyrronium Bromide (EF-BDP\u002FFF\u002FGB) therapy in adults with severe or very severe COPD in Brazil. Around 400 patients will be enrolled across approximately 15 sites. Eligible patients must have started treatment on the day of enrollment or up to three months before enrollment. Data will be collected both retrospectively and prospectively, with baseline information covering up to 12 months before treatment initiation. All assessments will occur during routine medical visits, with follow-up expected at approximately 3 ± 1 month and 6 months ± 2 months. The medication Trimbow® will not be provided as part of the study and must be prescribed and used according to the institution's standard clinical practice, regardless of participation in the study.",[72],"COPD (Chronic Obstructive Pulmonary Disease)",[74,75,76,9,77],"COPD","Real-world evidence","extra-fine particule","Fixed Triple Therapy","2026-04-14",{"date":80,"type":81},"2026-04-17","ACTUAL",{"date":83,"type":81},"2026-04-01",{"date":85,"type":68},"2027-06-30",{"name":87,"class":6},"Chiesi Farmaceutica Ltda.",1]