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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02967731




Registration number
NCT02967731
Ethics application status
Date submitted
14/11/2016
Date registered
18/11/2016
Date last updated
25/08/2021

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
480MFSDD2016-001
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

Intervention/exposure
Study type
Interventional
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

Outcomes
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

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/06/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/05/2018
Sample size
Target
Accrual to date
Final
20
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
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Lyra Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
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
https://clinicaltrials.gov/ct2/show/NCT02967731
Trial related presentations / publications
Public notes

Contacts
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02967731