[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100507093":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":20,"centralContacts":26,"locations":32,"responsibleParty":74,"collaborators":20,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":20,"eligibilityCriteria":81,"healthyVolunteers":78,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":20,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":20,"overallStatus":35,"whyStopped":20,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"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",[33,47,56,65],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":20},"Oticara Investigational Site","RECRUITING","Sydney","New South Wales","2153","Australia","AU",{"type":42,"coordinates":43},"Point",[44,45],151.20732,-33.86785,{"lat":45,"lon":44},{"facility":34,"status":35,"city":48,"state":49,"zip":50,"country":39,"countryCode":40,"cosmosGeoPoint":51,"geoPoint":55,"contacts":20},"Brisbane","Queensland","4029",{"type":42,"coordinates":52},[53,54],153.02809,-27.46794,{"lat":54,"lon":53},{"facility":34,"status":35,"city":57,"state":58,"zip":59,"country":39,"countryCode":40,"cosmosGeoPoint":60,"geoPoint":64,"contacts":20},"Adelaide","South Australia","5042",{"type":42,"coordinates":61},[62,63],138.59863,-34.92866,{"lat":63,"lon":62},{"facility":34,"status":35,"city":66,"state":67,"zip":68,"country":39,"countryCode":40,"cosmosGeoPoint":69,"geoPoint":73,"contacts":20},"Perth","Western Australia","6163",{"type":42,"coordinates":70},[71,72],115.8614,-31.95224,{"lat":72,"lon":71},{"type":75,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100507093","phase-2-the-effect-of-intra-sinus-application-of-betamethasone-dipropionate-nasal-cream-on-patients-with-chronic-rhinosinusitis-post-functional-endoscopic-sinus-surgery-fess-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":86,"type":87},24,"ESTIMATED","INTERVENTIONAL",[90],"PHASE2","To assess the safety and efficacy of one (single) application of Betamethasone Dipropionate Nasal Cream (BMDP CREAM) onto the sinus mucosa.",[93],"Chronic Rhinosinusitis (Diagnosis)","2024-11-10",{"date":96,"type":97},"2024-11-12","ACTUAL",{"date":99,"type":97},"2023-08-17",{"date":101,"type":87},"2025-06-01",{"name":5,"class":6},4]