[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Oticara Australia PTY LTD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":40},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"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":19,"type":20},24,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","To assess the safety and efficacy of one (single) application of Betamethasone Dipropionate Nasal Cream (BMDP CREAM) onto the sinus mucosa.",[26],"Chronic Rhinosinusitis (Diagnosis)","RECRUITING","2024-11-10",{"date":30,"type":31},"2024-11-12","ACTUAL",{"date":33,"type":31},"2023-08-17",{"date":35,"type":20},"2025-06-01",{"name":37,"class":38},"Oticara Australia PTY LTD","INDUSTRY",4,""]