[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658965":3},{"organization":4,"outcomesModule":7,"designInfo":49,"detailedDescription":61,"studyPopulation":19,"armGroups":62,"interventions":73,"overallOfficials":83,"centralContacts":88,"locations":94,"responsibleParty":368,"collaborators":19,"id":370,"slug":371,"hasResults":372,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":376,"eligibilityCriteria":377,"healthyVolunteers":372,"sex":378,"minAge":379,"maxAge":380,"enrollmentInfo":381,"targetDuration":19,"studyType":384,"phases":385,"briefSummary":387,"conditions":388,"keywords":19,"overallStatus":390,"whyStopped":19,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":400},{"fullName":5,"class":6},"Chiesi Farmaceutici S.p.A.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":19},[9],{"measure":10,"description":11,"timeFrame":12},"Change from baseline in pre-dose Forced Expiratory Volume FEV1 in the first second (FEV1).","Population summary measure is the adjusted mean between treatment difference comparing CHF5993 BDP\u002FFF\u002FGB pMDI vs. Seretide® Evohaler® FP\u002FSLM pMDI in a Intent To Treat (ITT) Population to demonstrate the superiority of CHF5993 BDP\u002FFF\u002FGB pMDI compared to Seretide Evohaler FP\u002FSLM pMDI","Baseline (pre-dose on Week 0) and Week 26",[14,17,21,23,27,30,33,36,39,42,46],{"measure":15,"description":16,"timeFrame":12},"Change from baseline in 2h post-dose FEV1","Population summary measure is the adjusted mean between treatment difference comparing CHF5993 BDP\u002FFF\u002FGB pMDI vs. Seretide® Evohaler® FP\u002FSLM pMDI in ITT population to demonstrate the superiority of CHF5993 BDP\u002FFF\u002FGB pMDI compared to Seretide Evohaler FP\u002FSLM pMDI",{"measure":18,"description":19,"timeFrame":20},"Evaluation of Severe asthma exacerbations rate over the 52 weeks of treatment",null,"Over the 52 weeks of treatment",{"measure":22,"description":19,"timeFrame":20},"Time to first severe exacerbation during the entire 52 weeks of treatment",{"measure":24,"description":25,"timeFrame":26},"Change from baseline in the 7-item Asthma Control Questionnaire (ACQ-7) at Week 12, Week 26 and Week 52 during study visits (using centralized spirometry)","The 7-item Asthma Control Questionnaire (ACQ-7) score ranges from 0 to 6, with higher scores indicating worse asthma control.","Baseline (pre-dose on Week 0) and Week 12, Week 26, Week 52",{"measure":28,"description":29,"timeFrame":26},"Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) at Week 12, Week 26 and Week 52 during study visits","The Asthma Quality of Life Questionnaire (AQLQ) score ranges from 1 to 7, with higher scores indicating better asthma-related quality of life.",{"measure":31,"description":19,"timeFrame":32},"Change from baseline in pre-dose FEV1 at all clinical visits","Baseline (pre-dose on Week 0) and applicable clinical visits",{"measure":34,"description":19,"timeFrame":35},"Change from baseline in 2h post-dose FEV1 at all clinical visits","Baseline (pre-dose on Week 0) and all applicable clinical visits",{"measure":37,"description":19,"timeFrame":38},"Proportion of subjects classified as responders in terms of pre-dose FEV1 at Week 26 and Week 52 (i.e., subjects with change from baseline in pre-dose FEV1 ≥100 mL)","Baseline (pre-dose on Week 0) and Week 26, Week 52",{"measure":40,"description":19,"timeFrame":41},"Change from baseline in 48h post-dose morning FEV1 after the last intake of study treatment at Week 52","Week 52",{"measure":43,"description":44,"timeFrame":45},"Change from baseline in weekly 5-item Asthma Control Questionnaire (ACQ-5) over the 52 weeks of treatment (performed at home by the subject)","The 5-item Asthma Control Questionnaire (ACQ-5) score ranges from 0 to 6, with higher scores indicating worse asthma control.","Baseline (pre-dose on Week 0) and over the 52 weeks of treatment",{"measure":47,"description":19,"timeFrame":48},"Change from baseline in home spirometry parameters (e.g. FEV1, Forced Vital Capacity) over the 52 weeks of treatment (performed at home by the subject)","Baseline (pre-dose on Week 0) and Over the 52 weeks of treatment",{"allocation":50,"interventionModel":51,"interventionModelDescription":52,"primaryPurpose":53,"observationalModel":19,"timePerspective":19,"maskingInfo":54},"RANDOMIZED","PARALLEL","Double-blind multicenter, randomized, active-controlled, 2-arm, parallel-group","TREATMENT",{"masking":55,"maskingDescription":19,"whoMasked":56},"QUADRUPLE",[57,58,59,60],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Outpatients attending the hospital clinics\u002Fstudy centers will be recruited. Uncontrolled asthma adolescent subjects will be recruited. A total of 420 subjects will be randomized. The whole study will last approximately 52 weeks for each subject.",[63,68],{"label":64,"type":65,"description":19,"interventionNames":66},"Inhaler CHF5993 100\u002F6\u002F12,5μg pMDI","EXPERIMENTAL",[67],"Drug: CHF5993 100\u002F6\u002F12.5 μg pMDI HFA-152a",{"label":69,"type":70,"description":19,"interventionNames":71},"Seretide Evohaler FP\u002FSLM pMDI 125\u002F25μg","ACTIVE_COMPARATOR",[72],"Drug: Seretide Evohaler",[74,79],{"type":75,"name":76,"description":77,"armGroupLabels":78,"otherNames":19},"DRUG","CHF5993 100\u002F6\u002F12.5 μg pMDI HFA-152a","Drug: CHF5993 100\u002F6\u002F12.5 μg pMDI HFA-152a administered via Pressurized Metered Dose Inhaler (pMDI).\n\nActive ingredients: Beclomethasone Dipropionate (BDP)\u002F\u002FFormoterol Fumarate (FF) \u002FGlycopyrronium Bromide (GB) 100\u002F6\u002F12,5μg per actuation; Excipients: HFA-152a propellant.",[64],{"type":75,"name":80,"description":81,"armGroupLabels":82,"otherNames":19},"Seretide Evohaler","Drug: Seretide Evohaler administered via Pressurized Metered Dose Inhaler (pMDI).\n\nActive ingredients: Fluticasone Propionate (FP)\u002FSalmeterol Xinafoate (SLM) pMDI 125\u002F25μg per actuation; Excipients: HFA-134a propellant.",[69],[84],{"name":85,"affiliation":86,"role":87},"Stefan Zielen, MD","Institut für Atemwegserkrankungen Medaimun GmbH","PRINCIPAL_INVESTIGATOR",[89],{"name":90,"role":91,"phone":92,"phoneExt":19,"email":93},"Chiesi Clinical Trial Info","CONTACT","+39 0521 2791","clinicaltrials_info@chiesi.com",[95,109,120,131,142,155,166,177,188,199,210,218,229,240,251,262,273,286,297,305,316,327,338,346,357],{"facility":96,"status":19,"city":97,"state":19,"zip":19,"country":98,"countryCode":99,"cosmosGeoPoint":100,"geoPoint":105,"contacts":106},"Institute for Respiratory Diseases Medaimun GmbH","Frankfurt","Germany","DE",{"type":101,"coordinates":102},"Point",[103,104],10.53333,49.68333,{"lat":104,"lon":103},[107],{"name":108,"role":91,"phone":19,"phoneExt":19,"email":19},"Stefan Zielen",{"facility":110,"status":19,"city":111,"state":19,"zip":19,"country":98,"countryCode":99,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"Georg-August-Universität Göttingen","Göttingen",{"type":101,"coordinates":113},[114,115],9.93228,51.53443,{"lat":115,"lon":114},[118],{"name":119,"role":91,"phone":19,"phoneExt":19,"email":19},"Christiane Lex",{"facility":121,"status":19,"city":122,"state":19,"zip":19,"country":98,"countryCode":99,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"Universitätsklinikum Jena","Jena",{"type":101,"coordinates":124},[125,126],11.5899,50.92878,{"lat":126,"lon":125},[129],{"name":130,"role":91,"phone":19,"phoneExt":19,"email":19},"Michael Lorenz",{"facility":132,"status":19,"city":133,"state":19,"zip":19,"country":98,"countryCode":99,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"Centre for Congenital Heart Defects Stuttgart, Paediatric Intensive Care, Pulmonology and Allergology","Stuttgart",{"type":101,"coordinates":135},[136,137],9.17702,48.78232,{"lat":137,"lon":136},[140],{"name":141,"role":91,"phone":19,"phoneExt":19,"email":19},"Marcus Rose",{"facility":143,"status":19,"city":144,"state":19,"zip":19,"country":145,"countryCode":146,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"ASST Spedali Civili Brescia","Brescia","Italy","IT",{"type":101,"coordinates":148},[149,150],10.21472,45.53558,{"lat":150,"lon":149},[153],{"name":154,"role":91,"phone":19,"phoneExt":19,"email":19},"Laura Pini",{"facility":156,"status":19,"city":157,"state":19,"zip":19,"country":145,"countryCode":146,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"\"A. Perrino\" Hospital","Brindisi",{"type":101,"coordinates":159},[160,161],17.93607,40.63215,{"lat":161,"lon":160},[164],{"name":165,"role":91,"phone":19,"phoneExt":19,"email":19},"Aniello Meoli",{"facility":167,"status":19,"city":168,"state":19,"zip":19,"country":145,"countryCode":146,"cosmosGeoPoint":169,"geoPoint":173,"contacts":174},"Istituto Giannina Gaslini Pediatric Allergic Center,","Genoa",{"type":101,"coordinates":170},[171,172],8.94439,44.40478,{"lat":172,"lon":171},[175],{"name":176,"role":91,"phone":19,"phoneExt":19,"email":19},"Maria Angela Tosca",{"facility":178,"status":19,"city":179,"state":19,"zip":19,"country":145,"countryCode":146,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"University of Messina G. Martino Hospital, Allergy and Clinical Immunology Unit","Messina",{"type":101,"coordinates":181},[182,183],15.55256,38.19394,{"lat":183,"lon":182},[186],{"name":187,"role":91,"phone":19,"phoneExt":19,"email":19},"Luisa Riccardi",{"facility":189,"status":19,"city":190,"state":19,"zip":19,"country":145,"countryCode":146,"cosmosGeoPoint":191,"geoPoint":195,"contacts":196},"Buzzi Children Hospital","Milan",{"type":101,"coordinates":192},[193,194],9.18951,45.46427,{"lat":194,"lon":193},[197],{"name":198,"role":91,"phone":19,"phoneExt":19,"email":19},"Michele Ghezzi",{"facility":200,"status":19,"city":201,"state":19,"zip":19,"country":145,"countryCode":146,"cosmosGeoPoint":202,"geoPoint":206,"contacts":207},"Federico II University, Department of Translational Medical Sciences, Section of Pediatrics","Naples",{"type":101,"coordinates":203},[204,205],14.26811,40.85216,{"lat":205,"lon":204},[208],{"name":209,"role":91,"phone":19,"phoneExt":19,"email":19},"Melissa Borrelli",{"facility":211,"status":19,"city":201,"state":19,"zip":19,"country":145,"countryCode":146,"cosmosGeoPoint":212,"geoPoint":214,"contacts":215},"IPAS (Respiratory Diseases of Pediatric Interest) University of Campania 'Luigi Vanvitelli',",{"type":101,"coordinates":213},[204,205],{"lat":205,"lon":204},[216],{"name":217,"role":91,"phone":19,"phoneExt":19,"email":19},"Michele Miraglia del Giudice",{"facility":219,"status":19,"city":220,"state":19,"zip":19,"country":145,"countryCode":146,"cosmosGeoPoint":221,"geoPoint":225,"contacts":226},"University Hospital of Parma","Parma",{"type":101,"coordinates":222},[223,224],10.32618,44.79935,{"lat":224,"lon":223},[227],{"name":228,"role":91,"phone":19,"phoneExt":19,"email":19},"Susanna Maria Roberta Esposito",{"facility":230,"status":19,"city":231,"state":19,"zip":19,"country":145,"countryCode":146,"cosmosGeoPoint":232,"geoPoint":236,"contacts":237},"University Hospital of Pisa, Pediatrics Unit","Pisa",{"type":101,"coordinates":233},[234,235],10.4036,43.70853,{"lat":235,"lon":234},[238],{"name":239,"role":91,"phone":19,"phoneExt":19,"email":19},"Maria Elisa di Cicco",{"facility":241,"status":19,"city":242,"state":19,"zip":19,"country":145,"countryCode":146,"cosmosGeoPoint":243,"geoPoint":247,"contacts":248},"Fondazione Policlinico Universitario A. Gemelli IRCCS, Department of Woman and Child Health and Public Health","Roma",{"type":101,"coordinates":244},[245,246],11.10642,44.99364,{"lat":246,"lon":245},[249],{"name":250,"role":91,"phone":19,"phoneExt":19,"email":19},"Roberta Onesimo",{"facility":252,"status":19,"city":253,"state":19,"zip":19,"country":145,"countryCode":146,"cosmosGeoPoint":254,"geoPoint":258,"contacts":259},"Bambino Gesù Pediatric Hospital IRCCS, Allergy Division","Rome",{"type":101,"coordinates":255},[256,257],12.51133,41.89193,{"lat":257,"lon":256},[260],{"name":261,"role":91,"phone":19,"phoneExt":19,"email":19},"Alessandro Fiocchi",{"facility":263,"status":19,"city":264,"state":19,"zip":19,"country":145,"countryCode":146,"cosmosGeoPoint":265,"geoPoint":269,"contacts":270},"IRCCS Humanitas Research Hospital","Rozzano",{"type":101,"coordinates":266},[267,268],9.1559,45.38193,{"lat":268,"lon":267},[271],{"name":272,"role":91,"phone":19,"phoneExt":19,"email":19},"Enrico Heffler",{"facility":274,"status":19,"city":275,"state":19,"zip":19,"country":276,"countryCode":277,"cosmosGeoPoint":278,"geoPoint":282,"contacts":283},"Hospital Universitario Germans Trias","Badalona","Spain","ES",{"type":101,"coordinates":279},[280,281],2.24741,41.45004,{"lat":281,"lon":280},[284],{"name":285,"role":91,"phone":19,"phoneExt":19,"email":19},"Albert Roger Reig",{"facility":287,"status":19,"city":288,"state":19,"zip":19,"country":276,"countryCode":277,"cosmosGeoPoint":289,"geoPoint":293,"contacts":294},"Hospital Sant Joan de Deu","Barcelona",{"type":101,"coordinates":290},[291,292],2.15899,41.38879,{"lat":292,"lon":291},[295],{"name":296,"role":91,"phone":19,"phoneExt":19,"email":19},"Jaime Lozano Blasco",{"facility":298,"status":19,"city":288,"state":19,"zip":19,"country":276,"countryCode":277,"cosmosGeoPoint":299,"geoPoint":301,"contacts":302},"Vall d'Hebron University Hospital",{"type":101,"coordinates":300},[291,292],{"lat":292,"lon":291},[303],{"name":304,"role":91,"phone":19,"phoneExt":19,"email":19},"Teresa Garriga-Baraut",{"facility":306,"status":19,"city":307,"state":19,"zip":19,"country":276,"countryCode":277,"cosmosGeoPoint":308,"geoPoint":312,"contacts":313},"Hospital General Universitario Santa Lucia","Cartagena",{"type":101,"coordinates":309},[310,311],-0.98397,37.60197,{"lat":311,"lon":310},[314],{"name":315,"role":91,"phone":19,"phoneExt":19,"email":19},"Jose Valverde Molina",{"facility":317,"status":19,"city":318,"state":19,"zip":19,"country":276,"countryCode":277,"cosmosGeoPoint":319,"geoPoint":323,"contacts":324},"Hospital Universitario De Jerez Servicio de Pediatría","Jerez de la Frontera",{"type":101,"coordinates":320},[321,322],-6.13606,36.68645,{"lat":322,"lon":321},[325],{"name":326,"role":91,"phone":19,"phoneExt":19,"email":19},"David Gomez Pastrana",{"facility":328,"status":19,"city":329,"state":19,"zip":19,"country":276,"countryCode":277,"cosmosGeoPoint":330,"geoPoint":334,"contacts":335},"Hospital Universitario Infanta Leonor","Madrid",{"type":101,"coordinates":331},[332,333],-3.70256,40.4165,{"lat":333,"lon":332},[336],{"name":337,"role":91,"phone":19,"phoneExt":19,"email":19},"Maria Vazquez de la Torre Gaspar",{"facility":339,"status":19,"city":329,"state":19,"zip":19,"country":276,"countryCode":277,"cosmosGeoPoint":340,"geoPoint":342,"contacts":343},"Hospital Universitario Severo Ochoa",{"type":101,"coordinates":341},[332,333],{"lat":333,"lon":332},[344],{"name":345,"role":91,"phone":19,"phoneExt":19,"email":19},"Sergio Quevedo Teruel",{"facility":347,"status":19,"city":348,"state":19,"zip":19,"country":276,"countryCode":277,"cosmosGeoPoint":349,"geoPoint":353,"contacts":354},"Hospital Clínico Universitario de Santiago de Compostela","Santiago de Compostela",{"type":101,"coordinates":350},[351,352],-8.54569,42.88052,{"lat":352,"lon":351},[355],{"name":356,"role":91,"phone":19,"phoneExt":19,"email":19},"Carlos Garcia Magan",{"facility":358,"status":19,"city":359,"state":19,"zip":19,"country":276,"countryCode":277,"cosmosGeoPoint":360,"geoPoint":364,"contacts":365},"IMED Valencia","Valencia",{"type":101,"coordinates":361},[362,363],-0.37966,39.47391,{"lat":363,"lon":362},[366],{"name":367,"role":91,"phone":19,"phoneExt":19,"email":19},"Noelia Colomer Hernadez",{"type":369,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100658965","phase-3-safety-and-efficacy-comparison-between-chf5993-1006-125g-pmdi-to-seretide-evohaler-12525g-pmdi-in-adolescent-subjects-with-asthma-100658965",false,"NCT07858123","Safety and Efficacy Comparison Between CHF5993 100\u002F6 12.5µg pMDI to Seretide Evohaler 125\u002F25µg pMDI in Adolescent Subjects With Asthma","A 52-Week, Randomised, Double-Blind, Double-Dummy, Multinational, Multicenter, Active-Controlled, 2-Arm Parallel Group Study Comparing CHF5993 100\u002F6\u002F12.5 μg pMDI (Fixed Combination of Extrafine Beclomethasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrronium Bromide) to Seretide® Evohaler® 125\u002F25 μg pMDI (Fixed Combination of Fluticasone Propionate\u002FSalmeterol Xinafoate) in Adolescent Subjects With Uncontrolled Asthma on Medium Doses of Inhaled Corticosteroids in Combination With Long-Acting β2-Agonists","TRIADES","Inclusion Criteria:\n\n* Subject's written informed consent obtained prior to any study related procedure;\n* Male and female adolescent aged ≥ 12 and \\\u003C18 years;\n* Subject participating in the Pharmacokinetic(s) (PK) part of the study, body weight should be ≥ 30kg\n* A documented history of asthma for at least 6 months\n* Subjects in treatment with double therapy with medium doses of inhaled corticosteroids (ICS) in fixed or free combination with a long-acting β2-agonist (LABA) ( \\> 500-1000 μg daily dose Beclomethasone Dipropionate non-extrafine or estimated clinically comparable dose plus formoterol 24 µg\u002Fday or salmeterol 100 µg\u002Fday or vilanterol 25 µg\u002Fday) at a stable dose for at least 4 weeks prior to screening;\n* Subjects must have a cooperative attitude and the ability to be trained to use correctly the pMDI inhalers and e-Diary, to be able to read\u002Fwrite, to be able to perform the required outcomes measurements (e.g., technically acceptable spirometry, e-Diary completion) and the ability to understand the risks involved.\n* Subjects with a pre-Bronchodilator (BD) Forced Expiratory Volume in the first second (FEV1) ≤90% and ≥60% of their predicted normal value, after appropriate washout from BDs, at the Screening and Randomization Visits\n* Subjects with a positive response to a reversibility test at screening, defined as FEV1 ≥12% and ≥200 mL over baseline, 10 to 15 minutes (min) after inhaling 200-400 µg of salbutamol pMDI.\n* Subjects with uncontrolled asthma evidenced by an ACQ-7 total score ≥1.5 at screening;\n* A documented history of one or more asthma exacerbations requiring treatment with systemic corticosteroids (SCS) or emergency department visit or in-patient hospitalization in the previous 12 months;\n\nExclusion Criteria:\n\n* History of \"at risk\" asthma: history of near fatal asthma or of a past hospitalization for asthma in an intensive care unit which, in the judgement of the Investigator, may place the subject at undue risk;\n* Recent exacerbation or respiratory tract infection: hospitalization, emergency room admission or use of SCS for an asthma exacerbation or a documented diagnosis of lower respiratory tract infection that required antibiotics or an unresolved respiratory tract infection within 4 weeks prior to Screening Visit (V1) or during the run-in period;\n* Respiratory disorders other than asthma: this can include but is not limited to: α1-antitrypsin deficiency, active tuberculosis, bronchiectasis, cystic fibrosis, sarcoidosis, pulmonary hypertension and interstitial lung disease;\n* Current smokers (including e-cigarettes, vaping and hookah), or ex-smokers with a smoking history of ≥5 pack-years (pack-years = the number of cigarette packs per day times the number of years), or current use of inhaled or oral cannabis products. Ex-smokers must have stopped smoking ≥1 year (≥6 months for e-cigarettes);\n* Other severe acute or chronic medical (such as but not limited to thyrotoxicosis, diabetes mellitus, and untreated hypokalemia) or malignancy or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study;\n* Any change in dose, schedule or formulation of the combination ICS plus LABA in the 4 weeks prior to Screening Visit (V1)\n* Subjects using SCS medication in the 4 weeks or slow-release corticosteroids in the 12 weeks, prior to screening\n* Only for subjects included in the subset for PK assessment:\n\nVeins unsuitable for repeated venipuncture; Blood donation or blood loss (\\>450 mL) in the 4 weeks before randomization.","ALL","12 Years","17 Years",{"count":382,"type":383},700,"ESTIMATED","INTERVENTIONAL",[386],"PHASE3","The CLI-05993AA5-06 study is an interventional study designed to investigate the safety and efficacy of a new experimental drug called CHF5993 pMDI compared to the currently approved Seretide 125 Evohaler pMDI in adolescent patients with uncontrolled asthma.",[389],"Asthma","NOT_YET_RECRUITING","2026-10-02",{"date":393,"type":394},"2026-10-05","ACTUAL",{"date":396,"type":383},"2026-11-16",{"date":398,"type":383},"2030-06-26",{"name":5,"class":6},25]