Back to results480 Biomedical Sinus Drug Depot
Primary Purpose
Chronic Sinusitis
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
480 Mometasone Furoate Sinus Drug Depot
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Sinusitis
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- The Queen Elizabeth Hospital
- Royal Brisbane and Women's Hospital
- Monash Medical Center
- University of Auckland
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
480 Mometasone Furoate Sinus Drug Depot
Arm Description
480 Mometasone Furoate Sinus Drug Depot
Outcomes
Primary Outcome Measures
Product related serious adverse events from baseline visit to 4 weeks post procedure
Secondary Outcome Measures
Plasma Mometasone Furoate concentration level from pre-treatment to end of treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02967731
Brief Title
480 Biomedical Sinus Drug Depot
Official Title
An Exploratory Safety Study of 480 Biomedical Sinus Drug Depot in Adult Subjects With Chronic Sinusitis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
June 6, 2017 (Actual)
Primary Completion Date
December 19, 2017 (Actual)
Study Completion Date
May 18, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lyra Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Sinusitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
480 Mometasone Furoate Sinus Drug Depot
Arm Type
Experimental
Arm Description
480 Mometasone Furoate Sinus Drug Depot
Intervention Type
Drug
Intervention Name(s)
480 Mometasone Furoate Sinus Drug Depot
Intervention Description
Management of Chronic Sinusitis
Primary Outcome Measure Information:
Title
Product related serious adverse events from baseline visit to 4 weeks post procedure
Time Frame
4 weeks post procedure
Secondary Outcome Measure Information:
Title
Plasma Mometasone Furoate concentration level from pre-treatment to end of treatment
Time Frame
Up to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Facility Information:
Facility Name
The Queen Elizabeth Hospital
City
Adelaide
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Brisbane
Country
Australia
Facility Name
Monash Medical Center
City
Melbourne
Country
Australia
Facility Name
University of Auckland
City
Auckland
Country
New Zealand
12. IPD Sharing Statement
Citations:
PubMed Identifier
30645028
Citation
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.
Results Reference
derived
Learn more about this trial
480 Biomedical Sinus Drug Depot
We'll reach out to this number within 24 hrs