[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634999":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":43,"responsibleParty":66,"collaborators":26,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":26,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"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",[44,60],{"facility":35,"status":45,"city":46,"state":47,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"RECRUITING","Beijing","Chaoyang District","China","CN",{"type":51,"coordinates":52},"Point",[53,54],116.39723,39.9075,{"lat":54,"lon":53},[57],{"name":58,"role":40,"phone":59,"phoneExt":26,"email":26},"Chen Wang, Academician","+86 -10 -84205288",{"facility":35,"status":45,"city":46,"state":47,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":61,"geoPoint":63,"contacts":64},{"type":51,"coordinates":62},[53,54],{"lat":54,"lon":53},[65],{"name":58,"role":40,"phone":26,"phoneExt":26,"email":26},{"type":67,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100634999","phase-3-efficacy-and-safety-of-chf-5993-1006125-g-hfa-152a-pmdi-in-patients-with-asthma-uncontrolled-on-medium-doses-of-inhaled-corticosteroids-in-combination-with-long-acting-2-agonists-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":80,"type":81},554,"ESTIMATED","INTERVENTIONAL",[84],"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.",[87],"Asthma",[89,90,91,92,48],"Uncontrolled asthma","Triple therapy","HFA-152a","Pressurized metered-dose inhaler","2026-07-07",{"date":95,"type":96},"2026-07-08","ACTUAL",{"date":98,"type":96},"2026-06-26",{"date":100,"type":81},"2028-10-17",{"name":5,"class":6},2]