[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100507093":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":20,"centralContacts":26,"locations":32,"responsibleParty":73,"collaborators":20,"id":75,"slug":20,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":20,"eligibilityCriteria":79,"healthyVolunteers":76,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":20,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":20,"overallStatus":35,"whyStopped":20,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Oticara Australia PTY LTD","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Betamethasone Dipropionate Nasal Cream 0.0644% Treatment","EXPERIMENTAL","Betamethasone Dipropionate Nasal Cream 0.0644% is applied topically to the inflamed tissue of the sinus using a pre-filled syringe and applicator under the guidance of an endoscope. Up to 5g on each side of the sinus (10g in total).",[13,14],"Drug: Betamethasone Dipropionate Nasal Cream 0.0644%","Device: Pre-filled syringe and applicator device",[16,21],{"type":17,"name":18,"description":11,"armGroupLabels":19,"otherNames":20},"DRUG","Betamethasone Dipropionate Nasal Cream 0.0644%",[9],null,{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":20},"DEVICE","Pre-filled syringe and applicator device","Cream is pre-filled to a syringe and applicator device to facilitate the topical application direct to the sinus under endoscopic guidance.",[9],[27],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Oticara Clinical","CONTACT","+1 279-217-0054","contact@oticara.com",[33,46,55,64],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":20},"Oticara Investigational Site","RECRUITING","Sydney","New South Wales","2153","Australia",{"type":41,"coordinates":42},"Point",[43,44],151.20732,-33.86785,{"lat":44,"lon":43},{"facility":34,"status":35,"city":47,"state":48,"zip":49,"country":39,"cosmosGeoPoint":50,"geoPoint":54,"contacts":20},"Brisbane","Queensland","4029",{"type":41,"coordinates":51},[52,53],153.02809,-27.46794,{"lat":53,"lon":52},{"facility":34,"status":35,"city":56,"state":57,"zip":58,"country":39,"cosmosGeoPoint":59,"geoPoint":63,"contacts":20},"Adelaide","South Australia","5042",{"type":41,"coordinates":60},[61,62],138.59863,-34.92866,{"lat":62,"lon":61},{"facility":34,"status":35,"city":65,"state":66,"zip":67,"country":39,"cosmosGeoPoint":68,"geoPoint":72,"contacts":20},"Perth","Western Australia","6163",{"type":41,"coordinates":69},[70,71],115.8614,-31.95224,{"lat":71,"lon":70},{"type":74,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100507093",false,"NCT05882903","The Effect of Intra-sinus Application of Betamethasone Dipropionate Nasal Cream on Patients with Chronic Rhinosinusitis Post Functional Endoscopic Sinus Surgery (FESS)","Inclusion Criteria:\n\n* Adult patients with a clinically confirmed diagnosis of CRS by an otolaryngologist (ENT) undergoing maximal medical therapy as part of their standard of care.\n* Having undergone functional endoscopic sinus surgery (FESS) at least 6 months prior to enrolment.\n* For each nostril, an endoscopic nasal polyp score of 0, 1, or 2 out of a maximum score of - (where 0= No polyps, 1= small polyps in the middle meatus not reaching below the inferior border of the middle turbinate , 2= nasal polyps reaching below the border of the middle turbinate, 3= large nasal polyps reaching the lower border of the inferior turbinate or nasal polyps medial to the middle turbinate, 4= large nasal polyps causing almost complete obstruction of the inferior nasal cavity) (Gevaert et al, 2023).\n* Visible middle turbinates and access to the ethmoid sinuses for dosing as established via endoscopic examination.\n* Participants must have a \\> 2 on the disease severity visual analogue scale (VAS) at screening and pre-treatment.\n* Body weight: A minimum body weight \\>=40 kilograms (kg) and a BMI of ≤ 39 at the screening visit.\n* Individuals of childbearing potential must use adequate birth control methods and not plan to get pregnant during the study.\n* Informed consent: Willingness to give written informed consent and willingness to participate in and comply with the study.\n* Age ≥18 but \\\u003C80 years.\n\nExclusion Criteria:\n\n* Subjects with known hypersensitivity or contraindications to betamethasone dipropionate, mometasone, or topical anaesthesia.\n* Subjects with sino-nasal abnormalities, disease, or implanted devices that prevents the application of the therapy.\n* Previous enrolment in this study.\n* Subjects currently receiving systemic corticosteroid or have received systemic corticosteroid in the prior 4 weeks or receiving biologic therapy.\n* Subjects with a history of glaucoma or cataracts or have an abnormal intraocular pressure (IOP) at screening or pre-treatment (abnormal IOP is defined as greater than 21 mm Hg).\n* Subjects with acute sinusitis.\n* Subjects with known immunodeficiency.\n* Subjects with diabetes (Type 1).\n* Subjects with cystic fibrosis.\n* Pregnant subjects or subjects trying to get pregnant or currently lactating as the effect on human pregnancy is unknown.\n* Subjects who are unable to give an informed consent because of mental illness, dementia or communication difficulties.\n* Subjects with a Cushing's disease diagnosis within the previous 12 months.\n* Severe septal deviation and or previous total resection of the middle turbinate.\n* Any lab abnormality or underlying medical condition which, in the Investigator's opinion, should exclude the participant.\n* Subjects who are unlikely to comply with study procedures, restrictions and requirements as determined by the investigator.","ALL","18 Years","80 Years",{"count":84,"type":85},24,"ESTIMATED","INTERVENTIONAL",[88],"PHASE2","To assess the safety and efficacy of one (single) application of Betamethasone Dipropionate Nasal Cream (BMDP CREAM) onto the sinus mucosa.",[91],"Chronic Rhinosinusitis (Diagnosis)","2024-11-10",{"date":94,"type":95},"2024-11-12","ACTUAL",{"date":97,"type":95},"2023-08-17",{"date":99,"type":85},"2025-06-01",{"name":5,"class":6},4]