[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644137":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":34,"locations":33,"responsibleParty":40,"collaborators":33,"id":42,"slug":33,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":43,"sex":49,"minAge":50,"maxAge":33,"enrollmentInfo":51,"targetDuration":33,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":64,"whyStopped":33,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":33},{"fullName":5,"class":6},"Chiesi Farmaceutici S.p.A.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"BDP\u002FFF\u002FGB","ACTIVE_COMPARATOR","Trimbow® 87\u002F5\u002F9 pMDI (BDP\u002FFF\u002FGB 100\u002F6\u002F12.5 µg) - 2 inhalations bid",[13],"Drug: Beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide (100\u002F6\u002F12.5 µg per actuation)",{"label":15,"type":10,"description":16,"interventionNames":17},"BDP\u002FFF","Foster® 200\u002F6 pMDI (BDP\u002FFF 200\u002F6 µg) - 2 inhalations bid",[18],"Drug: Foster® 200\u002F6 pMDI (BDP\u002FFF-200\u002F6 µg)",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide (100\u002F6\u002F12.5 µg per actuation)","Beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide BDP\u002FFF\u002FGB (100\u002F6\u002F12.5 µg per actuation) administered via pressurised metered-dose inhaler (pMDI) 2 inhalations bid (i.e. 2 inhalations in the morning and 2 inhalations in the evening) for a total of 12 months.",[9],[26],"Trimbow®",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Foster® 200\u002F6 pMDI (BDP\u002FFF-200\u002F6 µg)","Beclometasone dipropionate, formoterol fumarate (BDP\u002FFF-200\u002F6 µg) administered via pressurised metered-dose inhaler (pMDI) 2 inhalations bid (i.e. 2 inhalations in the morning and 2 inhalations in the evening) for a total of 12 months.",[15],[32],"Foster®",null,[35],{"name":36,"role":37,"phone":38,"phoneExt":33,"email":39},"Clinical Trial INFO Chiesi Farmaceutici S.p.A.","CONTACT","+39 0521 2791","clinicaltrials_info@chiesi.com",{"type":41,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100644137",false,"NCT07666490","BETRI-Prospective: Asthma Control in Single Inhaler ICS\u002FLABA\u002FLAMA (87\u002F5\u002F9 pMDI [BDP\u002FFF\u002FGB - 100\u002F6\u002F12.5 μg]) vs Single Inhaler ICS\u002FLABA (200\u002F6 pMDI [BDP\u002FFF - 200\u002F6 μg])","A Pragmatic, Phase IV, Randomized, Open-label, Multinational, Multicentre, 2-arm Parallel Group, Prospective Study Comparing Efficacy and Safety of Single Inhaler ICS\u002FLABA\u002FLAMA (Beclometasone\u002FFormoterol Fumarate\u002FGlycopyrronium Bromide [87\u002F5\u002F9 pMDI { BD\u002FFF\u002FGB -100\u002F6\u002F12.5 μg} ]) vs Single Inhaler ICS\u002FLABA (Beclometasone Dipropionate Plus Formoterol Fumarate [200\u002F6 pMDI { BD\u002FFF - 200\u002F6 μg} ]) in Asthma Subjects","BETRI","Inclusion Criteria:\n\n1 . Study participant's written informed consent obtained prior to any study related procedure.\n\n2\\. Male or female study participants aged ≥18 years old. 3. Physician confirmed documented asthma diagnosis as per current clinical practice.\n\n4\\. Stable asthma treatment prior randomisation: At least 3 months on any medium strength (MS) ICS\u002FLABA regular treatment.\n\n5\\. Poor asthma control at randomisation (ACQ-5 ≥1.5 and at least 1 exacerbation in the previous year).\n\n6\\. Women with childbearing potential (WOCBP) and with fertile male partners: they and\u002For their partner must be willing to use a highly effective birth control method from the signature of the informed consent and until the last visit.\n\n7\\. Study participants must have a cooperative attitude and the ability to be trained to use the patient app correctly, to be able to perform the required outcomes measurements (e.g. ePRO completion) and the ability to understand the risks involved.\n\nNote: Study participants with asthma diagnosis and no clinically relevant concurrent COPD diagnosis upon clinical judgement can be included. Study participants on maintenance and reliever therapy (MART) can be included if the ICS dosage does not exceed 400 µg\u002Fday of beclometasone or equivalent.\n\nExclusion Criteria: The presence of any of the following will exclude a study participant from study enrolment:\n\n1. Participation in another interventional clinical trial.\n2. Pregnant or breastfeeding women at the moment of enrolment.\n3. Other chronic respiratory disease: Lung Cancer, known alpha1-antitrypsin deficiency, active tuberculosis, clinically significant bronchiectasis, interstitial lung disease, pulmonary hypertension, or any other uncontrolled\u002Fclinically significant diseases (according to investigator's judgement).\n4. Contraindication for LAMA use.\n5. Study participants on biological therapies for asthma.\n6. For France only: Individuals under court protection (including protected adults) and individuals not affiliated to a social security system are excluded from participation in this study (Country\u002FRegion-Specific Differences - France), in accordance with Articles L.1121-6, L.1121-8, and L.1121-8-1 of the French Public Health Code.","ALL","18 Years",{"count":52,"type":53},644,"ESTIMATED","INTERVENTIONAL",[56],"PHASE4","This study will evaluate the effect of triple ICS\u002FLAMA\u002FLABA therapy with a BDP\u002FFF\u002FGB 100\u002F6\u002F12.5 µg on asthma control outcomes relative to ICS\u002FLABA therapy with BDP\u002FFF 200\u002F6 μg in a population with asthma poorly controlled.",[59],"Asthma",[61,62,63,9,15],"asthma control","adults","pragmatic study","NOT_YET_RECRUITING","2026-06-25",{"date":67,"type":68},"2026-06-29","ACTUAL",{"date":70,"type":53},"2026-06-12",{"date":72,"type":53},"2028-06-13",{"name":5,"class":6}]