[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100319523":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":42,"responsibleParty":58,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":31,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":31,"enrollmentInfo":74,"targetDuration":31,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":31,"overallStatus":44,"whyStopped":31,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"University of Alabama at Birmingham","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"standard of care treatment + ivacaftor","EXPERIMENTAL","topical nasal steroid spray and culture-directed antibiotics + ivacaftor 150 mg tablet",[13,14],"Drug: Ivacaftor","Drug: standard of care treatment",{"label":16,"type":17,"description":18,"interventionNames":19},"standard of care treatment","PLACEBO_COMPARATOR","topical nasal steroid spray and culture-directed antibiotics",[14],[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Ivacaftor","150 mg tablet PO BID x 14 days",[9],[27],"Kalydeco",{"type":22,"name":16,"description":29,"armGroupLabels":30,"otherNames":31},"topical nasal steroid spray and culture-directed antibiotics x 14 days",[16,9],null,[33],{"name":34,"affiliation":5,"role":35},"Bradford Woodworth, MD","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":31,"email":41},"Norma Miller, RN","CONTACT","(205) 975-6169","ncmiller@uabmc.edu",[43],{"facility":5,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"RECRUITING","Birmingham","Alabama","35233","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-86.80249,33.52066,{"lat":54,"lon":53},[57],{"name":38,"role":39,"phone":40,"phoneExt":31,"email":41},{"type":35,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Brad Woodworth, MD","Principal Investigator",[62],{"name":63,"class":64},"National Heart, Lung, and Blood Institute (NHLBI)","NIH","100319523","early-phase-1-ivacaftor-for-acquired-cftr-dysfunction-in-chronic-rhinosinusitis-100319523",false,"NCT03439865","Ivacaftor for Acquired CFTR Dysfunction in Chronic Rhinosinusitis","Ivacaftor for Acquired CFTR Dysfunction in Chronic Rhinosinusitis (Randomized Pilot Study Utilizing Ivacaftor for the Treatment of Refractory Gram-Negative Bacterial CRS)","Inclusion Criteria:\n\n* 18 years of age\n* Patient has provided informed consent\n* Diagnosis of CRS made by one of the investigators\n* Standard of care CT scan with definitive demonstration of isolated or diffuse mucosal thickening, bone changes, and air fluid levels, obtained within 30 days of treatment\n* Positive culture of at least one gram negative bacteria (e.g. Pseudomonas, E. coli, Steenotrophomonas) within 30 days prior to testing\n* Previous surgery with (at least) exposed maxillary and ethmoid sinuses\n* Ability to perform EDSPD testing such that nasal cavity space and sinus openings are sufficient for catheter placement\n* Negative pregnancy test for females of childbearing potential within 72 hours of testing and start of study treatment\n\nExclusion Criteria:\n\n* \\\u003C 18 years of age\n* Acute illness other than sinusitis within 2 weeks before start of study treatment that, in the opinion of the investigator, would preclude participation\n* Currently taking medications that are moderate or strong CP3A inhibitors\n* History of asthma attack requiring emergency room visit or treatment with oral steroids within 2 months prior to study treatment\n* History of solid organ or hematological transplantation\n* History of known immunodeficiency, autoimmune or granulomatous disorder\n* Serum creatinine \\> 1.5x upper normal limit\n* Abnormal liver function, as defined by serum AST \\> 2x upper normal limit, serum ALT \\> 2x upper normal limit, Alkaline phosphatase \\> 2x upper normal limit, Total bilirubin \\> 2x upper normal limit\n* Women who are pregnant or breastfeeding","ALL","18 Years",{"count":75,"type":76},20,"ESTIMATED","INTERVENTIONAL",[79],"EARLY_PHASE1","The purpose of this pilot study is to explore wither ivacaftor in refractory CRS patients will demonstrate safety and tolerability; restore CFTR-mediated Cl- secretions as measured by EDSPD testing; produce detectable improvements in validated measures of CRS including the SNOT-22 questionnaire, Lund-MacKay CT scan grading, and Lund-Kennedy endoscopic scores; and provide beneficial effects on readily measured markers of sinonasal inflammation and infection (IP-10, IL-8, and Pseudomonas CFUs).",[82],"Chronic Rhinosinusitis (Diagnosis)","2026-04-17",{"date":85,"type":86},"2026-04-22","ACTUAL",{"date":88,"type":86},"2019-05-02",{"date":90,"type":76},"2027-05-01",{"name":5,"class":6},1]