[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100530811":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":25,"centralContacts":29,"locations":38,"responsibleParty":133,"collaborators":136,"id":146,"slug":147,"hasResults":148,"nctId":149,"briefTitle":150,"officialTitle":150,"acronym":10,"eligibilityCriteria":151,"healthyVolunteers":148,"sex":152,"minAge":153,"maxAge":154,"enrollmentInfo":155,"targetDuration":10,"studyType":158,"phases":10,"briefSummary":159,"conditions":160,"keywords":166,"overallStatus":41,"whyStopped":10,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":178},{"fullName":5,"class":6},"University of California, Los Angeles","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"HEMT Group",null,"Children with CF planning to start ivacaftor or elexacaftor\u002Ftezacaftor\u002Fivacaftor CFTR modulator therapy. Participants from the non-HEMT group of this study may enroll into the HEMT cohort if they become eligible for these CFTR modulator therapies and plan to start them.",[13],"Drug: Ivacaftor or elexacaftor\u002Ftezacaftor\u002Fivacaftor",{"label":15,"type":10,"description":16,"interventionNames":10},"Non-HEMT\u002FControl Group","Children with CF not on ivacaftor or elexacaftor\u002Ftezacaftor\u002Fivacaftor CFTR modulator therapy.",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","Ivacaftor or elexacaftor\u002Ftezacaftor\u002Fivacaftor","HEMT's are prescribed at the discretion of the treating physician and is not dictated by the principal investigator of this study.",[9],[24],"Kalydeco or Trikafta; Vertex (VX)-770 or VX-445\u002FVX-661\u002FVX-770",[26],{"name":27,"affiliation":5,"role":28},"Daniel M Beswick, MD","PRINCIPAL_INVESTIGATOR",[30,34],{"name":27,"role":31,"phone":32,"phoneExt":10,"email":33},"CONTACT","310-206-8457","dbeswick@mednet.ucla.edu",{"name":35,"role":31,"phone":36,"phoneExt":10,"email":37},"Marlene Florian","424-946-5862","mflorian@mednet.ucla.edu",[39,58,73,88,103,118],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Children's Hospital Colorado","RECRUITING","Aurora","Colorado","80045","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-104.83192,39.72943,{"lat":51,"lon":50},[54,56],{"name":55,"role":31,"phone":10,"phoneExt":10,"email":10},"Edith Zemanick, MD",{"name":57,"role":31,"phone":10,"phoneExt":10,"email":10},"Mary Cross",{"facility":59,"status":41,"city":60,"state":61,"zip":62,"country":45,"countryCode":46,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"University of Iowa","Iowa City","Iowa","52242",{"type":48,"coordinates":64},[65,66],-91.53017,41.66113,{"lat":66,"lon":65},[69,71],{"name":70,"role":31,"phone":10,"phoneExt":10,"email":10},"Sean B Fain, PhD",{"name":72,"role":31,"phone":10,"phoneExt":10,"email":10},"Mary Teresi",{"facility":74,"status":41,"city":75,"state":76,"zip":77,"country":45,"countryCode":46,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"University of Kansas Medical Center","Kansas City","Kansas","66160",{"type":48,"coordinates":79},[80,81],-94.62746,39.11417,{"lat":81,"lon":80},[84,86],{"name":85,"role":31,"phone":10,"phoneExt":10,"email":10},"Michael Lewis, MD",{"name":87,"role":31,"phone":10,"phoneExt":10,"email":10},"Larry Scott",{"facility":89,"status":41,"city":90,"state":91,"zip":92,"country":45,"countryCode":46,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Cincinnati Children's Hospital Medical Center","Cincinnati","Ohio","45229-3039",{"type":48,"coordinates":94},[95,96],-84.51439,39.12711,{"lat":96,"lon":95},[99,101],{"name":100,"role":31,"phone":10,"phoneExt":10,"email":10},"Jason Woods, PhD",{"name":102,"role":31,"phone":10,"phoneExt":10,"email":10},"Priyanka Desirazu",{"facility":104,"status":41,"city":105,"state":106,"zip":107,"country":45,"countryCode":46,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"University of Vermont","Colchester","Vermont","05446",{"type":48,"coordinates":109},[110,111],-73.14791,44.54394,{"lat":111,"lon":110},[114,116],{"name":115,"role":31,"phone":10,"phoneExt":10,"email":10},"Jillian S Sullivan, MD",{"name":117,"role":31,"phone":10,"phoneExt":10,"email":10},"Julie Sweet",{"facility":119,"status":41,"city":120,"state":121,"zip":122,"country":45,"countryCode":46,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"University of Virginia","Charlottesville","Virginia","22903",{"type":48,"coordinates":124},[125,126],-78.47668,38.02931,{"lat":126,"lon":125},[129,131],{"name":130,"role":31,"phone":10,"phoneExt":10,"email":10},"Jaime Mata, MS, PhD",{"name":132,"role":31,"phone":10,"phoneExt":10,"email":10},"Roselove N Nunoo-Asare",{"type":28,"investigatorFullName":134,"investigatorTitle":135,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Daniel M. Beswick","MD; Associate Professor-in-Residence; Associate Residency Program Director; Co-Chair, Equity, Diversity, and Inclusion Committee Department of Head and Neck Surgery",[137,138,140,141,142,143,145],{"name":74,"class":6},{"name":139,"class":6},"Children's Hospital Medical Center, Cincinnati",{"name":59,"class":6},{"name":119,"class":6},{"name":104,"class":6},{"name":144,"class":6},"University of North Carolina, Chapel Hill",{"name":40,"class":6},"100530811","sinus-disease-in-young-children-with-cystic-fibrosis-100530811",false,"NCT06191640","Sinus Disease in Young Children With Cystic Fibrosis","Inclusion Criteria:\n\nHEMT Group:\n\n* Children with documentation of a CF diagnosis\n* Age 2-8 years old at first study visit\n* CFTR mutation consistent with FDA labeled indication of highly effective modulator therapy (ivacaftor or elexacaftor\u002Ftezacaftor\u002Fivacaftor)\n* Clinician intent to prescribe ivacaftor or ETI so that enrollment is before start of HEMT\n\nNon-HEMT\u002FControl Group:\n\n* Children with documentation of a CF diagnosis\n* Age 2-8 years at first study visit\n* Ineligible for highly effective modulator therapy (ivacaftor or elexacaftor\u002Ftezacaftor\u002Fivacaftor) based on CFTR mutation or clinical decision not to initiate HEMT if eligible\n\nExclusion Criteria:\n\nFor Both Groups:\n\n* Use of an investigational drug within 28 days prior to the first study visit\n* Use of ivacaftor or elexacaftor\u002Ftezacaftor\u002Fivacaftor within the 180 days prior to and including the first study visit\n* Use of chronic oral corticosteroids within the 28 days prior to and including the first study visit.\n* Sinus surgery within 180 days prior to the first study visit","ALL","2 Years","8 Years",{"count":156,"type":157},80,"ESTIMATED","OBSERVATIONAL","This is a prospective, observational study examining the impact of highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators on chronic rhinosinusitis (CRS) and olfactory dysfunction (OD) in young children with cystic fibrosis (YCwCF). This study involves two groups: children 2-8 years old, inclusive at initial visit, receiving highly effective modulator therapy (HEMT), and a control group of children 2-8 years old, inclusive at initial visit, not receiving HEMT. Outcomes will include sinus magnetic resonance imaging (MRI) scans, olfactory tests, and quality of life surveys obtained over a two-year period.",[161,162,163,164,165],"Cystic Fibrosis in Children","Cystic Fibrosis","Chronic Rhinosinusitis (Diagnosis)","Olfactory Disorder","Olfactory Impairment",[162,167,168],"Chronic Rhinosinusitis","Olfactory Dysfunction","2026-05-06",{"date":171,"type":172},"2026-05-11","ACTUAL",{"date":174,"type":172},"2023-04-12",{"date":176,"type":157},"2029-06-30",{"name":5,"class":6},6]