480 Mometasone Furoate Sinus Drug Depot

Rhinosinusitis Clinical Trial

Official title:

Clinical Investigational Plan Title: An Exploratory Safety Study of 480 Biomedical Mometasone Furoate Sinus Drug Depot (MFSDD) in Adult Subjects With Chronic Sinusitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02942186
• Other study ID #: 480-MFSDD2016-001
• Status: Not yet recruiting
• Phase: Phase 1
• First received: October 20, 2016
• Last updated: October 20, 2016
• Start date: January 2017
• Est. completion date: January 2018

Study information

• Verified date: October 2016
• Source: 480 Biomedical, Inc.
• Contact: Veronica Faughnan
• Phone: 617-393-4600
• Email: vfaughnan[@]arsenalmedical.com
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationNew Zealand: Health and Disability Ethics Committees
• Study type: Interventional

Clinical Trial Summary

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

Description:

This is a prospective, multi-center, non-randomized, single arm open label clinical trial. The trial will enroll up to 20 patients in up to 10 sites in New Zealand and Australia.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 and older.

• Diagnosis of CS.

• Having had at least one trial of topical corticosteroid spray and saline spray/irrigation for a minimum of one month in the past.

• Ability to tolerate topical anesthesia.

• Female study subjects of child-bearing potential must not be pregnant 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.

• Subjects with previous sinonasal procedure except for a septoplasty more than a year ago or CT evidence/subject history of prior sinus surgery.

• Subjects with dental procedure/implant on maxillary dentition in the past 4 weeks.

• Subjects with nasal septal perforation.

• Subjects have had more than 1 episode of epistaxis with frank bleeding

• Previous pituitary or adrenal surgery.

• Subjects who have experienced an exacerbation of asthma seeking medical attention History or clinical evidence or suspicion of invasive fungal sinusitis

• Sensitivity to aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs).

• Recent participation in another clinical trial within 1 month of screening visit.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinosinusitis

Intervention

Drug:
• Mometasone Furoate
Steroid used to treat Chronic Sinusitis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
480 Biomedical, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Product related serious adverse events from baseline visit to 4 weeks post procedure		4 weeks post procedure	Yes
Secondary	Plasma Mometasone Furoate concentration level at pre-procedure, 1 hour post procedure, and 1, 4, 12 and 24 weeks post procedure.		Pre-procedure, 1 hour post procedure, and 1, 4, 12 and 24 weeks post procedure.	Yes