480 Biomedical Sinus Drug Depot

Phase 1

Completed

• Conditions: Chronic Sinusitis
• Interventions: Drug: 480 Mometasone Furoate Sinus Drug Depot

• Registration Number: NCT02967731
• Lead Sponsor: Lyra Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-14
• Study First Submitted QC: 2016-11-16
• Study First Posted: 2016-11-18
• Status Verified: 2017-06
• Study Start: 2017-06-06
• Primary Completion: 2017-12-19
• Study Completion: 2018-05-18
• Last Update Submitted: 2021-08-20
• Last Update Posted: 2021-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
480 Mometasone Furoate Sinus Drug Depot	480 Mometasone Furoate Sinus Drug Depot	480 Mometasone Furoate Sinus Drug Depot

Primary Outcome Measures

Name	Time	Method
Product related serious adverse events from baseline visit to 4 weeks post procedure	4 weeks post procedure

Secondary Outcome Measures

Name	Time	Method
Plasma Mometasone Furoate concentration level from pre-treatment to end of treatment	Up to 24 weeks

Trial Locations

Locations (4)

University of Auckland; 🇳🇿 Auckland, New Zealand

Royal Brisbane and Women's Hospital; 🇦🇺 Brisbane, Australia

Monash Medical Center; 🇦🇺 Melbourne, Australia

The Queen Elizabeth Hospital; 🇦🇺 Adelaide, Australia