[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634999":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":43,"responsibleParty":63,"collaborators":26,"id":65,"slug":26,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":26,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":89,"whyStopped":26,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Chiesi Farmaceutici S.p.A.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CHF 5993 pMDI HFA-152a","EXPERIMENTAL","Experimental: CHF 5993 pMDI HFA-152a; Fixed combination of beclometasone dipropionate (BDP) 100 μg+formoterol fumarate(FF) 6 μg+glycopyrronium bromide(GB) 12.5 μg, via pressurised metered dose inhaler(pMDI) with HFA-152a propellant.",[13],"Drug: Experimental: Participant Group CHF 5993 pMDI HFA-152a",{"label":15,"type":16,"description":17,"interventionNames":18},"CHF 1535 pMDI HFA-134a","ACTIVE_COMPARATOR","Comparator: CHF 1535 pMDI HFA-134a Fixed combination of BDP 100 μg+FF 6 μg, via pMDI with HFA-134a propellant.",[19],"Other: Active Comparator: CHF 1535 100\u002F6 μg pMDI HFA-134a",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Experimental: Participant Group CHF 5993 pMDI HFA-152a","total daily dose of BDP\u002FFF\u002FGB:400\u002F24\u002F50 μg\n\nAdministration:\n\nTwo (2) inhalations twice daily(BID) (i.e., 2 inhalations in the morning and 2 inhalations in the evening), total daily dose of BDP\u002FFF\u002FGB: 400\u002F24\u002F50 μg (subjects used to inhaling their asthma pMDI medications with a spacer should continue using the spacer AeroChamber Plus Flow Vu AntiStaticTM to take the pMDI study treatments)",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"OTHER","Active Comparator: CHF 1535 100\u002F6 μg pMDI HFA-134a","total daily dose of BDP\u002FFF: 400\u002F24 μg\n\nAdministration:\n\nTwo (2) inhalations BID (i.e., 2 inhalations in the morning and 2 inhalations in the evening), total daily dose of BDP\u002FFF: 400\u002F24 μg (subjects used to inhaling their asthma pMDI medications with a spacer should continue using the spacer AeroChamber Plus Flow Vu Anti-StaticTM to take the pMDI study treatments).",[15],[33],{"name":34,"affiliation":35,"role":36},"Chen Wang Academician, Principal Investigator","China-Japan Friendship Hospital","PRINCIPAL_INVESTIGATOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":26,"email":42},"Clinical Trial INFO Chiesi Farmaceutici S.p.A.","CONTACT","+ 39 0521 2791","clinicaltrials_info@chiesi.com",[44,59],{"facility":35,"status":26,"city":45,"state":46,"zip":26,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Beijing","Chaoyang District","China","CN",{"type":50,"coordinates":51},"Point",[52,53],116.39723,39.9075,{"lat":53,"lon":52},[56],{"name":57,"role":40,"phone":58,"phoneExt":26,"email":26},"Chen Wang, Academician","+86 -10 -84205288",{"facility":35,"status":26,"city":45,"state":46,"zip":26,"country":47,"countryCode":48,"cosmosGeoPoint":60,"geoPoint":62,"contacts":26},{"type":50,"coordinates":61},[52,53],{"lat":53,"lon":52},{"type":64,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100634999",false,"NCT07546981","Efficacy and Safety of CHF 5993 100\u002F6\u002F12.5 μg HFA-152a pMDI in Patients With Asthma Uncontrolled on Medium Doses of Inhaled Corticosteroids in Combination With Long-acting ß2-agonists","A 24 Week, Randomised, Double Blind, Multicentre, Active Controlled, 2-arm, Parallel Group Trial Comparing Efficacy and Safety of CHF 5993 100\u002F6\u002F12.5 μg HFA-152a pMDI (Fixed Combination of Extrafine Beclometasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrronium Bromide) to CHF 1535 100\u002F6 μg HFA-134a pMDI (Fixed Combination of Extrafine Beclometasone Dipropionate Plus Formoterol Fumarate) in Patients With Asthma Uncontrolled on Medium Doses of Inhaled Corticosteroids in Combination With Long-acting ß2-agonists","TRICHECO","Inclusion Criteria:\n\n* Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the study:\n\n  1. Subjects must provide written informed consent prior to any study-related procedures;\n  2. Subjects must be male or female Chinese aged ≥18 and\n\n     ≤75 years;\n  3. Subjects must have a documented history of asthma for at least 1 year and asthma must have been diagnosed before the subject's age of 40;\n  4. Subjects must have uncontrolled asthma, receiving double therapy only on medium doses of ICS in combination with LABA at a stable dose for at least 4 weeks prior to screening;\n  5. Subjects must have a pre-bronchodilator FEV1 \\\u003C80% of their predicted normal value, after appropriate wash out from bronchodilators at the screening visit.\n  6. Subjects must have a positive response to a reversibility test at screening.\n  7. Subjects must have uncontrolled asthma evidenced by a score at the ACQ-7 ≥1.5 (this criterion must be met at screening and at randomisation).\n\n     Exclusion Criteria:\n* Subjects meeting any of the following criteria will be excluded from study enrolment:\n\n  1. Subjects who have a history of near fatal asthma or of a past hospitalisation for status asthmaticus or severe asthma exacerbation which, in the judgement of the Investigator, may place the subject at undue risk;\n  2. Subjects who have undergone hospitalisation, emergency room visit or use of systemic corticosteroids for an asthma exacerbation in the 4 weeks prior to the screening visit or during the run-in period;\n  3. Subjects with any asthma exacerbation or respiratory tract infection in the 4 weeks prior to the screening visit or during run-in period;\n  4. Subjects with any change in dose, schedule or formulation of the combination ICS+LABA in the 4 weeks prior to the screening visit;\n  5. Subjects who have used systemic corticosteroid medication in the 4 weeks prior to screening or slow-release corticosteroids in the 12 weeks prior to screening;\n  6. Subjects who have a history of a diagnosis of chronic obstructive pulmonary disease (COPD) (according to the Global Initiative for Chronic Obstructive Lung Disease \\[GOLD\\] document), cystic fibrosis, bronchiectasis or alpha- 1 antitrypsin deficiency or any other significant lung disease which may interfere with study evaluations;\n  7. Subjects who are current smokers; ex-smokers with total cumulative exposure ≥10 pack-years; having stopped smoking 1 year or less prior to the screening visit;\n  8. Subjects who are treated with monoclonal antibodies (e.g., anti-immunoglobulin (Ig)E or anti-IgG antibodies) or biological drugs;\n  9. Subjects who have received an investigational drug within 2 months or six half-lives (whichever is greater) prior to the screening visit, or have been previously randomised in this study, or are currently participating in another clinical study.","ALL","18 Years","75 Years",{"count":76,"type":77},554,"ESTIMATED","INTERVENTIONAL",[80],"PHASE3","This is a study comparing CHF 5993 pMDI HFA-152a with CHF 1535 pMDI HFA-134a in Chinese patients with asthma uncontrolled on medium doses of ICS+LABA.",[83],"Asthma",[85,86,87,88,47],"Uncontrolled asthma","Triple therapy","HFA-152a","Pressurized metered-dose inhaler","NOT_YET_RECRUITING","2026-04-16",{"date":92,"type":93},"2026-04-23","ACTUAL",{"date":95,"type":77},"2026-05",{"date":97,"type":77},"2028-10-17",{"name":5,"class":6},2]