480 Biomedical Sinus Drug Depot

Chronic Sinusitis Clinical Trial

Official title:

An Exploratory Safety Study of 480 Biomedical Sinus Drug Depot in Adult Subjects With Chronic Sinusitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02967731
• Other study ID #: 480MFSDD2016-001
• Status: Completed
• Phase: Phase 1
• Start date: June 6, 2017
• Est. completion date: May 18, 2018

Study information

• Verified date: June 2017
• Source: Lyra Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase I, exploratory safety study of the 480 Biomedical Mometasone Furoate Sinus Drug Depot in adult subjects with chronic sinusitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 18, 2018
• Est. primary completion date: December 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Sinusitis
• Sinusitis

Intervention

Drug:
• 480 Mometasone Furoate Sinus Drug Depot
Management of Chronic Sinusitis

Locations

Country	Name	City	State
Australia	The Queen Elizabeth Hospital	Adelaide
Australia	Royal Brisbane and Women's Hospital	Brisbane
Australia	Monash Medical Center	Melbourne
New Zealand	University of Auckland	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
Lyra Therapeutics

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Product related serious adverse events from baseline visit to 4 weeks post procedure		4 weeks post procedure
Secondary	Plasma Mometasone Furoate concentration level from pre-treatment to end of treatment		Up to 24 weeks