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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
480 Biomedical Sinus Drug Depot
Scientific title
An Exploratory Safety Study of 480 Biomedical Sinus Drug Depot in Adult Subjects With Chronic Sinusitis
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Sinusitis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Study type
Description of intervention(s) / exposure
Treatment: Drugs - 480 Mometasone Furoate Sinus Drug Depot

Experimental: 480 Mometasone Furoate Sinus Drug Depot - 480 Mometasone Furoate Sinus Drug Depot

Treatment: Drugs: 480 Mometasone Furoate Sinus Drug Depot
Management of Chronic Sinusitis

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Product related serious adverse events from baseline visit to 4 weeks post procedure
Timepoint [1] 0 0
4 weeks post procedure
Secondary outcome [1] 0 0
Plasma Mometasone Furoate concentration level from pre-treatment to end of treatment
Timepoint [1] 0 0
Up to 24 weeks

Key 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
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key 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

- 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.

Study design
Purpose of the study
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Queen Elizabeth Hospital - Adelaide
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [3] 0 0
Monash Medical Center - Melbourne
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0

Funding & Sponsors
Primary sponsor type
480 Biomedical, Inc.

Ethics approval
Ethics application status

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 website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications