480 Biomedical Sinus Drug Depot

August 20, 2021 updated by: Lyra Therapeutics

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia
        • The Queen Elizabeth Hospital
      • Brisbane, Australia
        • Royal Brisbane and Women's Hospital
      • Melbourne, Australia
        • Monash Medical Center
  • New Zealand
      • Auckland, New Zealand
        • University of Auckland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 480 Mometasone Furoate Sinus Drug Depot
Drug: 480 Mometasone Furoate Sinus Drug Depot
Management of Chronic Sinusitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Product related serious adverse events from baseline visit to 4 weeks post procedure
Time Frame: 4 weeks post procedure
4 weeks post procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma Mometasone Furoate concentration level from pre-treatment to end of treatment
Time Frame: Up to 24 weeks
Up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lyra Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2017

Primary Completion (Actual)

December 19, 2017

Study Completion (Actual)

May 18, 2018

Study Registration Dates

First Submitted

November 14, 2016

First Submitted That Met QC Criteria

November 16, 2016

First Posted (Estimate)

November 18, 2016

Study Record Updates

Last Update Posted (Actual)

August 25, 2021

Last Update Submitted That Met QC Criteria

August 20, 2021

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 480MFSDD2016-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Sinusitis

Clinical Trials on 480 Mometasone Furoate Sinus Drug Depot

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe