[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100479672":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":19,"centralContacts":20,"locations":19,"responsibleParty":29,"collaborators":19,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":19,"eligibilityCriteria":39,"healthyVolunteers":35,"sex":40,"minAge":41,"maxAge":19,"enrollmentInfo":42,"targetDuration":19,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":19,"overallStatus":51,"whyStopped":19,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":19},{"fullName":5,"class":6},"Universitair Ziekenhuis Brussel","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"ETI","pwCF which are CFTR-modulator naive and pwCF previously treated with a CFTR-modulator (i.e. tezacaftor-ivacaftor or lumacaftor-ivacaftor) will undergo standard-of-care examinations as well as examinations in the context of this trial (i.e. CFQ-R, PHQ-9, GAD-7 and SNOT-22 questionnaires, fecal elastase measurement)",[12],"Diagnostic Test: CFQ-R questionnaire, SNOT-22 questionnaire, fecal elastase measurement",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"DIAGNOSTIC_TEST","CFQ-R questionnaire, SNOT-22 questionnaire, fecal elastase measurement","cf supra",[9],null,[21,26],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Stefanie Vincken, M.D.","CONTACT","+32 2 477 68 41","stefanie.vincken@uzbrussel.be",{"name":27,"role":23,"phone":24,"phoneExt":19,"email":28},"Eef Vanderhelst, M.D. Ph.D.","eef.vanderhelst@uzbrussel.be",{"type":30,"investigatorFullName":31,"investigatorTitle":32,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Stefanie Vincken","Medical doctor","100479672","real-world-efficacy-and-safety-of-cystic-fibrosis-transmembrane-conductance-regulator-cftr-modulator-therapy-in-adult-patients-with-cystic-fibrosis-cf-100479672",false,"NCT05526027","Real-world Efficacy and Safety of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Modulator Therapy in Adult Patients With Cystic Fibrosis (CF)","Real-world Efficacy and Safety of CFTR Modulator Therapy in Adult Patients With Cystic Fibrosis","Inclusion Criteria:\n\n* eligible for ETI (i.e. age above 18 years and CFTR genotype F508del\u002Fany) based on reimbursement criteria in Belgium\n\nExclusion Criteria:\n\n* inability to perform lung function testing","ALL","18 Years",{"count":43,"type":44},85,"ESTIMATED","INTERVENTIONAL",[47],"NA","In this trial real-world data on the safety (side effects and medication interactions) and efficacy (evolution of lung function testing, chronic bacterial airway infection, quality of life and endo- and exocrine pancreatic function) will be collected in adult people with cystic fibrosis (pwCF) eligible for elexacaftor-tezacaftor-ivacaftor (ETI) up until 2 years after the start of this therapy.",[50],"Cystic Fibrosis","UNKNOWN","2022-08-30",{"date":54,"type":55},"2022-09-02","ACTUAL",{"date":57,"type":44},"2022-09-01",{"date":59,"type":44},"2024-12-31",{"name":5,"class":6}]