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480 Biomedical Sinus Drug Depot

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by 480 Biomedical, Inc.
Sponsor:
Information provided by (Responsible Party):
480 Biomedical, Inc.
ClinicalTrials.gov Identifier:
NCT02967731
First received: November 14, 2016
Last updated: June 8, 2017
Last verified: June 2017
  Purpose
This is a Phase I, exploratory safety study of the 480 Biomedical Mometasone Furoate Sinus Drug Depot in adult subjects with chronic sinusitis.

Condition Intervention Phase
Chronic Sinusitis Drug: 480 Mometasone Furoate Sinus Drug Depot Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by 480 Biomedical, Inc.:

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

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

Estimated Enrollment: 20
Actual Study Start Date: June 6, 2017
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 480 Mometasone Furoate Sinus Drug Depot
480 Mometasone Furoate Sinus Drug Depot
Drug: 480 Mometasone Furoate Sinus Drug Depot
Management of Chronic Sinusitis

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02967731

Contacts
Contact: Veronica Faughnan 617-393-4600 vfaughnan@480biomedical.com

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

Responsible Party: 480 Biomedical, Inc.
ClinicalTrials.gov Identifier: NCT02967731     History of Changes
Other Study ID Numbers: 480MFSDD2016-001
Study First Received: November 14, 2016
Last Updated: June 8, 2017

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

Additional relevant MeSH terms:
Sinusitis
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

ClinicalTrials.gov processed this record on August 18, 2017