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Completed

NCT Number: NCT02967731

480 Biomedical Sinus Drug Depot

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

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Key information

Conditions

Chronic Sinusitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Queen Elizabeth Hospital, Adelaide, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

480 Mometasone Furoate Sinus Drug Depot

Drug

Management of Chronic Sinusitis

Primary outcomes

  1. Product related serious adverse events from baseline visit to 4 weeks post procedure

    Time frame: 4 weeks post procedure

Secondary outcomes

  1. Plasma Mometasone Furoate concentration level from pre-treatment to end of treatment

    Time frame: Up to 24 weeks

Sponsors and collaborators

Lead sponsor

Lyra Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Nov 18, 2016
Registry last updated
Aug 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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