Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-31 @ 9:26 AM
Study NCT ID:
NCT05220293
Status:
TERMINATED
Last Update Posted:
2024-05-02
First Post:
2022-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Eosinophilic Chronic Rhinosinusitis Utilizing Betamethasone Dipropionate Nasal Cream
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Single site study OT-007 re-opened as multi-site OT-007B study', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-30', 'studyFirstSubmitDate': '2022-01-21', 'studyFirstSubmitQcDate': '2022-01-21', 'lastUpdatePostDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in 4 cardinal symptoms score (4CSS) from Baseline to Week 3.', 'timeFrame': 'Baseline to Week 3', 'description': 'Participants score their 4-Cardinal Symptom score (4CSS) daily on a Likert scale of 0-5; where 0= no problem - 5= problem as bad as can be, higher scores indicate higher severity of symptoms.'}, {'measure': 'Change in Visual Analogue Scale (VAS) (0-10) evaluating global disease severity score from Baseline to Week 3.', 'timeFrame': 'Baseline to Week 3', 'description': 'Participants score their global disease severity assessment daily on a Visual Analogue Scale (VAS) (0-10), higher score indicating greater disease severity.'}, {'measure': 'Change in SNOT-22 Score from Baseline to Week 3.', 'timeFrame': 'Baseline to Week 3', 'description': 'Participants complete the SNOT-22 questionnaire at Baseline and Week 3,analysis will focus on the nasal and ear/facial subdomains. Higher scores indicate greater severity.'}, {'measure': 'Change in Modified Lund Mackay Postoperative Endoscopy Score from Baseline to Week 3.', 'timeFrame': 'Baseline to Week 3', 'description': 'Change in Modified Lund Mackay Postoperative Endoscopy Score is evaluated by experienced ENT at Baseline to Week 3.'}, {'measure': 'Overall Patient Global Impression of Change at Week 3.', 'timeFrame': 'Week 3', 'description': 'Patient Global Impression of Change (recorded on a Likert scale 1-7, where 1= very much improved - 7= very much worse) will be completed by the participant at Week 3.'}], 'secondaryOutcomes': [{'measure': 'BMDP Cream retention time on the sinus', 'timeFrame': 'Treatment visit to Week 3', 'description': 'Visual inspection of cream retention time on the sinus via endoscope.'}, {'measure': 'To assess the safety of one application of BMDP CREAM onto the sinus', 'timeFrame': 'Treatment visit to Week 3', 'description': 'Adverse event and intraocular pressure monitoring'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['eosinophilic Chronic Rhinosinusitis'], 'conditions': ['Chronic Rhinosinusitis (Diagnosis)']}, 'descriptionModule': {'briefSummary': 'This is an open-label, single dose, pilot study, to assess the efficacy and safety of Betamethasone Dipropionate Nasal Cream 0.0644% (equivalent to 0.05% Betamethasone) for the treatment of eosinophilic Chronic Rhinosinusitis (eCRS).', 'detailedDescription': 'In this open-label study, a single dose of the corticosteroid Betamethasone Dipropionate Nasal Cream 0.0644% (equivalent to 0.05% Betamethasone) will be administered under endoscopic guidance to the sinus mucosa of post-FESS patients whose eCRS condition is suboptimal under the current standard of care. The safety and benefits of this treatment will be monitored by patient-reported symptoms and visualization of the sinus mucosa.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with a clinically confirmed diagnosis of eCRS by a ENT undergoing maximal medical therapy as part of their standard of care.\n* Having undergone functional endoscopic sinus surgery at least 6 months prior to enrolment.\n* Participants with an endoscopic bilateral nasal polyp score of ≤5 out of a maximum score of 8\n* Score \\> 2 on disease severity visual analogue scale (VAS)\n* A minimum body weight \\>=40 kilograms (kg) at screening visit\n* Gender: Male or female (females of childbearing potential must use adequate birth control methods and not plan to get pregnant during the course of the study).\n* Informed consent: Willingness to give written informed consent and willingness to participate to and comply with the study.\n* Age ≥18 but \\<80 years.\n\nExclusion Criteria:\n\n* Subjects with known hypersensitivity or contraindications to Betamethasone Dipropionate, corticosteroids or topical anaesthesia.\n* Subjects with sino-nasal abnormalities, disease or implanted devices that prevent application of the therapy.\n* Previous enrolment in this study.\n* Subjects currently required systemic corticosteroid use or receiving biologic therapy as part of their disease management plan or who meet the PBS criteria for severe lower airway disease.\n* Subjects with history or current glaucoma or cataract or if they have abnormal IOP at screening or pre-treatment (abnormal IOP is defined as greater than 21 mm Hg).\n* Subjects with other conditions that could lead to elevated eosinophils such as Hypereosinophilic Syndromes, including Churg-Strauss Syndrome, or Eosinophilic Esophagitis.\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 currently lactating as the effect on human pregnancy is unknown.'}, 'identificationModule': {'nctId': 'NCT05220293', 'acronym': 'OT-007', 'briefTitle': 'Treatment of Eosinophilic Chronic Rhinosinusitis Utilizing Betamethasone Dipropionate Nasal Cream', 'organization': {'class': 'INDUSTRY', 'fullName': 'Oticara Australia PTY LTD'}, 'officialTitle': 'The Effect of Betamethasone Dipropionate on Patients With Eosinophilic Chronic Rhinosinusitis', 'orgStudyIdInfo': {'id': 'OT-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Betamethasone Dipropionate Nasal Cream 0.0644% Treatment', 'description': '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).', 'interventionNames': ['Drug: Betamethasone Dipropionate Nasal Cream 0.0644%', 'Device: Pre-filled syringe and applicator device']}], 'interventions': [{'name': 'Betamethasone Dipropionate Nasal Cream 0.0644%', 'type': 'DRUG', 'description': 'Betamethasone Dipropionate Nasal Cream 0.0644%, up to 5g per sinus.', 'armGroupLabels': ['Betamethasone Dipropionate Nasal Cream 0.0644% Treatment']}, {'name': 'Pre-filled syringe and applicator device', 'type': 'DEVICE', 'description': 'Cream is pre-filled to a syringe and applicator device to facilitate the topical application direct to the sinus under endoscopic guidance.', 'armGroupLabels': ['Betamethasone Dipropionate Nasal Cream 0.0644% Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2000', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Oticara Clinical Trial Site', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}], 'overallOfficials': [{'name': 'Oticara Clinical', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Oticara Australia PTY LTD'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is not a plan to make IPD available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oticara Australia PTY LTD', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}