480 Biomedical Sinus Drug Depot
An Exploratory Safety Study of 480 Biomedical Sinus Drug Depot in Adult Subjects With Chronic Sinusitis
1 other identifier
interventional
20
2 countries
4
Brief Summary
This is a Phase I, exploratory safety study of the 480 Biomedical Mometasone Furoate Sinus Drug Depot in adult subjects with chronic sinusitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2017
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2016
CompletedFirst Posted
Study publicly available on registry
November 18, 2016
CompletedStudy Start
First participant enrolled
June 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 19, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 18, 2018
CompletedAugust 25, 2021
June 1, 2017
7 months
November 14, 2016
August 20, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Product related serious adverse events from baseline visit to 4 weeks post procedure
4 weeks post procedure
Secondary Outcomes (1)
Plasma Mometasone Furoate concentration level from pre-treatment to end of treatment
Up to 24 weeks
Study Arms (1)
480 Mometasone Furoate Sinus Drug Depot
EXPERIMENTAL480 Mometasone Furoate Sinus Drug Depot
Interventions
Management of Chronic Sinusitis
Eligibility Criteria
You may qualify if:
- Diagnosis of CS.
- Female study subjects of child-bearing potential must have a negative pregnancy test and must agree to not become pregnant during the course of the study.
- The study subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the ethics committee of the respective clinical site.
- The study subject agrees to comply with all study requirements
You may not qualify if:
- Known history of intolerance to corticosteroids.
- Oral-steroid dependent condition.
- Having had corticosteroids with potential systemic effect (e.g., oral, parenteral, or high dose topical) 1 month prior to screening visit.
- Subjects with acute or chronic intracranial or orbital complications of chronic rhinosinusitis (e.g., brain abscess, related problems with eyes or central nervous system).
- Known history of hypothalamic pituitary adrenal (HPA) axial dysfunction or having morning serum cortisol level at screening outside of normal range.
- Previous pituitary or adrenal surgery.
- History or diagnosis (in either eye) of glaucoma, ocular hypertension, or cataracts.
- Recent participation in another clinical trial within 1 month of screening visit.
- Subjects currently participating in an investigational drug or device study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
The Queen Elizabeth Hospital
Adelaide, Australia
Royal Brisbane and Women's Hospital
Brisbane, Australia
Monash Medical Center
Melbourne, Australia
University of Auckland
Auckland, New Zealand
Related Publications (1)
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.
PMID: 30645028DERIVED
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2016
First Posted
November 18, 2016
Study Start
June 6, 2017
Primary Completion
December 19, 2017
Study Completion
May 18, 2018
Last Updated
August 25, 2021
Record last verified: 2017-06