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This is a Phase I, exploratory safety study of the 480 Biomedical Mometasone Furoate Sinus Drug Depot in adult subjects with chronic sinusitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 480 Mometasone Furoate Sinus Drug Depot | Experimental | 480 Mometasone Furoate Sinus Drug Depot |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 480 Mometasone Furoate Sinus Drug Depot | Drug | Management of Chronic Sinusitis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Product related serious adverse events from baseline visit to 4 weeks post procedure | 4 weeks post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Mometasone Furoate concentration level from pre-treatment to end of treatment | Up to 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Queen Elizabeth Hospital | Adelaide | Australia | ||||
| Royal Brisbane and Women's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30645028 | Derived | Douglas RG, Psaltis AJ, Rimmer J, Kuruvilla T, Cervin A, Kuang Y. Phase 1 clinical study to assess the safety of a novel drug delivery system providing long-term topical steroid therapy for chronic rhinosinusitis. Int Forum Allergy Rhinol. 2019 Apr;9(4):378-387. doi: 10.1002/alr.22288. Epub 2019 Jan 15. |
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| Brisbane |
| Australia |
| Monash Medical Center | Melbourne | Australia |
| University of Auckland | Auckland | New Zealand |