Chronic Sinusitis
Conditions
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.
Interventions
DRUG480 Mometasone Furoate Sinus Drug Depot
Management of Chronic Sinusitis
Sponsors
Lyra Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Product related serious adverse events from baseline visit to 4 weeks post procedure | 4 weeks post procedure |
Secondary
| Measure | Time frame |
|---|---|
| Plasma Mometasone Furoate concentration level from pre-treatment to end of treatment | Up to 24 weeks |
Countries
Australia, New Zealand
Outcome results
None listed