480 Biomedical Sinus Drug Depot

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02967731
Recruitment Status : Active, not recruiting
First Posted : November 18, 2016
Last Update Posted : January 3, 2018
Information provided by (Responsible Party):
480 Biomedical, Inc.

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.

Condition or disease Intervention/treatment Phase
Chronic Sinusitis Drug: 480 Mometasone Furoate Sinus Drug Depot Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Exploratory Safety Study of 480 Biomedical Sinus Drug Depot in Adult Subjects With Chronic Sinusitis
Actual Study Start Date : June 6, 2017
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis

Arm Intervention/treatment
Experimental: 480 Mometasone Furoate Sinus Drug Depot
480 Mometasone Furoate Sinus Drug Depot
Drug: 480 Mometasone Furoate Sinus Drug Depot
Management of Chronic Sinusitis

Primary Outcome Measures :
  1. Product related serious adverse events from baseline visit to 4 weeks post procedure [ Time Frame: 4 weeks post procedure ]

Secondary Outcome Measures :
  1. Plasma Mometasone Furoate concentration level from pre-treatment to end of treatment [ Time Frame: Up to 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02967731

The Queen Elizabeth Hospital
Adelaide, Australia
Royal Brisbane and Women's Hospital
Brisbane, Australia
Monash Medical Center
Melbourne, Australia
New Zealand
University of Auckland
Auckland, New Zealand
Sponsors and Collaborators
480 Biomedical, Inc.

Responsible Party: 480 Biomedical, Inc. Identifier: NCT02967731     History of Changes
Other Study ID Numbers: 480MFSDD2016-001
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents