[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621584":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":11,"locations":10,"responsibleParty":17,"collaborators":21,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":37,"acronym":38,"eligibilityCriteria":39,"healthyVolunteers":34,"sex":40,"minAge":41,"maxAge":10,"enrollmentInfo":42,"targetDuration":45,"studyType":46,"phases":10,"briefSummary":47,"conditions":48,"keywords":50,"overallStatus":59,"whyStopped":10,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":10},{"fullName":5,"class":6},"University Hospital, Ioannina","OTHER",[8],{"label":9,"type":10,"description":10,"interventionNames":10},"Males and females out-patients aged ≥18 years with uncontrolled asthma on ICS\u002FLABA treatment",null,[12],{"name":13,"role":14,"phone":15,"phoneExt":10,"email":16},"Konstantinos Kostikas, Professor","CONTACT","+302651007536","ktkostikas@uoi.gr",{"type":18,"investigatorFullName":19,"investigatorTitle":20,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Konstantinos Kostikas","Professor and Head Respiratory Medicine, University of Ioannina, Greece",[22,24,26,28,30],{"name":23,"class":6},"Attikon Hospital",{"name":25,"class":6},"424 General Military Hospital",{"name":27,"class":6},"George Papanicolaou Hospital",{"name":29,"class":6},"University Hospital of Patras",{"name":31,"class":6},"University Hospital, Alexandroupolis","100621584","measuring-small-airways-disease-improvement-after-step-up-to-extrafine-triple-or-high-dose-icslaba-in-patients-uncontrolled-on-medium-dose-icslaba-exploring-t2-inflammation-100621584",false,"NCT07372521","Measuring Small-Airways Disease Improvement After Step-up to Extrafine TRIple or High-dose ICS\u002FLABA in Patients Uncontrolled on Medium Dose ICS\u002FLABA eXploring T2 Inflammation","Measuring Small-Airways Disease Improvement After Step-up to Extrafine TRIple or High-dose ICS\u002FLABA in Patients Uncontrolled on Medium Dose ICS\u002FLABA eXploring T2 Inflammation: The MATRIX Real-life Observational Study","MATRIX","Inclusion Criteria:\n\n* Males and females out-patients aged ≥18 years providing written informed consent. \\[Note: Females are eligible if they are of non-childbearing potential or, if they are of childbearing potential, using or are willing to use appropriate contraceptive measures.\\]\n* Physician-diagnosed asthma for at least 6 months\n* Patients with uncontrolled asthma (ACT\\\u003C20 or ACQ-5\\>1.5) on stable treatment with medium dose ICS\u002FLABA for at least 12 weeks and with good adherence to treatment.\n* Evidence of SAD as expressed by FEF25-75% \\\u003C60% in spirometry.\n* Ability to be trained to use properly a pMDI inhaler (with or without spacer as per physician's judgement).\n* Documented decision in the patient's medical file for the (high-dose ICS regimen or medium dose efSITT) before the patient gets informed about his\u002Fher potential participation in the study.\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Patients who have experienced a severe asthma exacerbation (i.e. receiving OCS for at least 3 days and\u002For antibiotics or need for hospitalisation) in the 4 weeks prior to the screening visit.\n* Refusal or inability to give informed consent.\n* Patients with COPD or other respiratory disease, e.g. bronchiectasis, cystic fibrosis, interstitial lung diseases or any other clinically or functionally significant lung disorder, cancer (except localized carcinomas), or other clinically significant comorbidities that may affect the outcomes measured.\n* Long-term oxygen therapy at home.\n* Pregnancy or lactation or planned pregnancy.\n* Patients with a history of hypersensitivity or contraindications to any of the components of the study drug.\n* Participation in interventional study within 30 days prior to enrolment or at least two half-life times of an investigational drug.\n* Patient inability or incompliance to follow physician's instructions concerning treatment or study visits or unreliability, according to the physician evaluation.","ALL","18 Years",{"count":43,"type":44},130,"ESTIMATED","52 Weeks","OBSERVATIONAL","The goal of this observational study is to investigate the change in small airway function through the R5-R19 index in oscillometry at 12 weeks in adults with asthma.\n\nThe main question it aims to answer is: How can small airways dysfunction as evaluated by the oscillometry measure R5-19 be improved at 12 weeks, using 2 treatment arms (high-dose ICS regimen or medium dose efSITT)?\n\nResearchers will compare the efficacy of either (1) high-dose ICS combinations (high-dose extrafine BDP\u002FFF or high-dose efSITT BDP\u002FFF\u002FG) or (2) medium-dose efSITT (BDP\u002FFF\u002FG) to determine whether there is an improvement in small airways dysfunction and better asthma control in patients who are uncontrolled on medium-dose ICS\u002FLABA.\n\nParticipants will take as drugs the Trimbow (BDP\u002FFF\u002FG) medium (100\u002F6\u002F10 μg) or high (200\u002F6\u002F10 μg) strengths or Foster (BDP\u002FFF) high strength (200\u002F6 μg); Visit the clinic three times with an one optional follow up visit, at the start (Visit 1: baseline), at 4 weeks (Visit 2), at 12 weeks (Visit 3) and the optional visit at 52 weeks (Visit 4).",[49],"Asthma",[49,51,52,53,54,55,56,57,58],"Clinical Trials, Phase IV as Topic","Drug Therapy, Combination","LABA","LAMA","ICS","Oscillometry","Respiratory Function Tests","FeNO","NOT_YET_RECRUITING","2026-01-30",{"date":62,"type":63},"2026-02-03","ACTUAL",{"date":65,"type":44},"2026-01-19",{"date":67,"type":44},"2028-01-31",{"name":5,"class":6}]