[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100460443":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":45,"responsibleParty":115,"collaborators":118,"id":123,"slug":124,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":26,"eligibilityCriteria":129,"healthyVolunteers":130,"sex":131,"minAge":132,"maxAge":133,"enrollmentInfo":134,"targetDuration":26,"studyType":137,"phases":138,"briefSummary":140,"conditions":141,"keywords":143,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},{"fullName":5,"class":6},"Cedars-Sinai Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1 (Placebo)","PLACEBO_COMPARATOR","Arm 1 (placebo) will get placebo spray per day.",[13],"Other: Placebo Nasal Spray",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm 2 (EDS-FLU)","ACTIVE_COMPARATOR","Arm 2 (EDS-FLU) will get 744 mcg of fluticasone propionate per day.",[19],"Drug: Fluticasone Propionate 93 MCG\u002F1 ACTUATION Nasal Spray",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Fluticasone Propionate 93 MCG\u002F1 ACTUATION Nasal Spray","Patients will use two sprays in each nostril twice a day for 6 weeks and additional 6 weeks (open label).",[15],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo Nasal Spray","The Placebo is made of the following ingredients: Purified Water, Microcrystalline Cellulose RC-591, Dextrose, Anhydrous, EDTA Disodium Dihydrate, Benzalkonium Chloride Solution 50%, Polysorbate 80 (Tween 80, HP-LQ-(MH)), Sodium Hydroxide, and Hydrochloric Acid. Patients will use two sprays in each nostril twice a day",[9],[32],{"name":33,"affiliation":5,"role":34},"Arthur Wu, MD","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Missael Vasquez","CONTACT","424-315-2437","missael.vasquez@cshs.org",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"Laura Sarmiento, CCRP","3104234295","laura.sarmiento@cshs.org",[46,64,82,100],{"facility":5,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"RECRUITING","Los Angeles","California","90048","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-118.24368,34.05223,{"lat":57,"lon":56},[60,61,63],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"name":42,"role":38,"phone":62,"phoneExt":26,"email":44},"310-423-4295",{"name":33,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":65,"status":47,"city":66,"state":49,"zip":67,"country":51,"countryCode":52,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Sacramento Ear, Nose & Throat","Sacramento","95661",{"type":54,"coordinates":69},[70,71],-121.4944,38.58157,{"lat":71,"lon":70},[74,78,81],{"name":75,"role":38,"phone":76,"phoneExt":26,"email":77},"Rose Khalatyan","916-531-2788","rkhalatyan@davinciresearch.net",{"name":79,"role":38,"phone":26,"phoneExt":26,"email":80},"Randall A Ow, MD","row@sacent.com",{"name":79,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":83,"status":47,"city":84,"state":85,"zip":86,"country":51,"countryCode":52,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Indiana University","Indianapolis","Indiana","46202",{"type":54,"coordinates":88},[89,90],-86.15804,39.76838,{"lat":90,"lon":89},[93,96,99],{"name":94,"role":38,"phone":26,"phoneExt":26,"email":95},"Elisa Illing, MD","eilling@iu.edu",{"name":97,"role":38,"phone":26,"phoneExt":26,"email":98},"Joey Calcagno","jcalcagn@iu.edu",{"name":94,"role":34,"phone":26,"phoneExt":26,"email":26},{"facility":101,"status":47,"city":102,"state":103,"zip":104,"country":51,"countryCode":52,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Ochsner Health System","New Orleans","Louisiana","70121",{"type":54,"coordinates":106},[107,108],-90.07507,29.95465,{"lat":108,"lon":107},[111,114],{"name":112,"role":38,"phone":26,"phoneExt":26,"email":113},"Edward McCoul, MD","edward.mccoul@ochsner.org",{"name":112,"role":34,"phone":26,"phoneExt":26,"email":26},{"type":34,"investigatorFullName":116,"investigatorTitle":117,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Arthur Wu","Principal Investigator, MD",[119,121,122],{"name":65,"class":120},"UNKNOWN",{"name":101,"class":6},{"name":83,"class":6},"100460443","phase-2-effect-of-novel-exhalational-delivery-system-with-fluticasone-eds-flu-on-eustachian-tube-dysfunction-etd-100460443",false,"NCT05275686","Effect of Novel Exhalational Delivery System With Fluticasone (EDS-FLU) on Eustachian Tube Dysfunction (ETD)","Effect of Novel Exhalational Delivery System With Fluticasone (EDS-FLU) on Eustachian Tube Dysfunction (ETD) in a Multi-center, Double-Blinded, Placebo-controlled Trial","Inclusion Criteria:\n\n* Age greater than or equal to 18 years old, \\\u003C80 years old\n* Chronic Eustachian tube dysfunction defined as:\n\n  * Symptoms in one or both ears \\> 3 months AND\n  * ETDQ-7 score \\>14.5 AND\n  * Type B, C, or As tympanometry\n* Female subjects of childbearing potential must have a negative urine pregnancy test at screening and throughout the study duration.\n\nExclusion Criteria:\n\n* Age \\\u003C18 years old\n* Known history of otologic surgery (excluding myringotomy or myringotomy tubes)\n* Use of any additional intranasal medication\n* Tympanic membrane perforation\n* Adhesive otitis media\n* Cholesteatoma or significant retraction pocket\n* Middle ear effusion\n* Nasopharyngeal tumor\n* Any history of head and neck cancer\n* Any history of head and neck irradiation\n* Any history of temporomandibular disorder or prior surgery to the temporomandibular joint\n* Any medical condition that the investigator deems inappropriate for enrollment",true,"ALL","18 Years","80 Years",{"count":135,"type":136},80,"ESTIMATED","INTERVENTIONAL",[139],"PHASE2","Intranasal nasal steroid sprays are the mainstay of treatment for chronic Eustachian tube dysfunction despite having little supportive evidence in the literature. A novel, commercially available nasal spray delivery system is available now for fluticasone that improves its delivery to the nasopharynx. The hypothesis of this study is that fluticasone using the novel spray system is effective for Eustachian tube dysfunction (ETD).",[142],"Eustachian Tube Dysfunction",[142,144],"Fluticasone","2026-03-09",{"date":147,"type":148},"2026-03-11","ACTUAL",{"date":150,"type":148},"2022-04-20",{"date":152,"type":136},"2027-12-31",{"name":5,"class":6},4]