Adjunctive Treatment for Chronic Rhinosinusitis With Nasal Polyposis

NCT03607175 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: 1161972-3
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a research study to find out if an off-label use of carboxymethylcellulose foam (CMC), an absorbable nasal packing, combined with triamcinolone acetonide, a steroid, is more comfortable postoperatively for participants and is as effective in decreasing scarring, swelling and crusting after surgery than an FDA approved steroid eluting implant. Anticipated sample size will be 30. Study is an intrapatient control design. Subjects will be randomly assigned to receive CMC foam with triamcinolone in one nare and the steroid-eluting implant in the other. Participants will fill out preoperative and follow-up visit surveys at 7, 14, 30 and 90 days. Subjects at each visit will also have pictures taken of the nasal cavities to be scored for later analysis. Paired t-tests will be performed for analysis. Our primary objective is to demonstrate that triamcinolone-impregnated carboxymethylcellulose foam is noninferior to steroid-eluting implants in improving postoperative ethmoid inflammation, middle turbinate position, preventing intranasal synechiae and reducing polypoid change with objective measurement scales Our secondary objects include assessing the quality-of-life and nasal obstruction symptoms before and after functional endoscopic sinus surgery with validated SNOT-22 and NOSE questionnaires and to assess the cost-effectiveness of triamcinolone-impregnated carboxymethylcellulose foam versus steroid-eluting implant in management of CRSwNP in the early postoperative period. The endpoints are the POSE scores, the SNOT-22 and NOSE scores at days 7, 14, 30 and 90.

Conditions

Chronic Rhinosinusitis; Nasal Polyps

Outcome Measures

Primary Outcomes (1)

• Postoperative Perioperative Sinus Endoscopy Score

  The Perioperative Sinus Endoscopy score sums the combined scores determined from middle turbinate position, middle meatal status, ethmoid cavity appearance, as well as secondary sinus blockage (frontal and sphenoid). Each category is scored from 0-2, with 0 being not present, 1 as partially present, and 2 being fully present. The highest total score is 16, with scores ranging from 18-20 when the frontal and sphenoid sinuses are also included. The higher the score, the worse the status of the nasal cavity. Comparison of the mean POSE scores for the two treatments at day 30 to determine there is noninferiority

  30 days

Study Arms (2)

Steroid-eluting implant (Propel)

ACTIVE COMPARATOR

Mometasone furoate implant. 370ug of mometasone furoate with each application. One application to be used at the conclusion of surgery and left in place for 1 month or less depending on if it requires removal during office debridement.

Device: Propel Stent

Triamcinolone-impregnated CMC foam

EXPERIMENTAL

Applied to one nostril at end of case through randomization. Experimental drug is triamcinolone-acetonide 40mg/mL. 2mL will be combined with 5mL sterile water and mixed with carboxymethylcellulose foam and placed in the nares at the conclusion of the surgery. This will only be applied once and will remain in the nares until it dissolves or 7 days.

Drug: Triamcinolone-impregnated CMC foam

Interventions

Triamcinolone-impregnated CMC foam DRUG

same information as included in the arm/group descriptions

Also known as: Kenalog-40

Triamcinolone-impregnated CMC foam

Propel Stent DEVICE

same information as included in the arm/group descriptions

Steroid-eluting implant (Propel)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Diagnosis of nasal polyposis and desiring surgery

You may not qualify if:

• A known history of intolerance to corticosteroids
• An oral steroid-dependent condition
• A history of immune deficiency
• Pre-existing narrow angle glaucoma or cataracts
• Subjects that did not complete the pre-op medical regimen described below
• Pregnant and/or breastfeeding

Sponsors & Collaborators

• Marina Boruk: lead
• State University of New York - Downstate Medical Center: collaborator

Study Sites (1)

SUNY Downstate Medical Center

Brooklyn, New York, 11203, United States

Location

MeSH Terms

Conditions

Nasal Polyps

Interventions

Triamcinolone

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Marina Boruk, MD

  SUNY Downstate Med Ctr

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marina Boruk, MD

CONTACT

646-481-1311; marina.boruk@downstate.edu

Matthew D Adams, MD

CONTACT

814-592-5634; matthew.adams@downstate.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcomes assessor will be blinded to the side that the steroid eluting implant and the triamcinolone-impregnated foam in on.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Study is an intrapatient control design, each subject will receive both interventions, one in each nostril

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: July 31, 2018
• Study Start: July 24, 2023
• Primary Completion: September 30, 2025
• Study Completion: December 30, 2025
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)