Adjunctive Treatment for Chronic Rhinosinusitis With Nasal Polyposis

Nasal Polyps Clinical Trial

Official title:

Randomized Clinical Control Trial Comparing the Effects of a Steroid Eluting Implant Versus Triamcinolone-impregnated Carboxymethylcellulose Foam on the Postoperative Clinic Experience in Patients That Underwent Functional Endoscopic Surgery for Nasal Polyposis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03607175
• Other study ID #: 1161972-3
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: July 24, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: July 2023
• Source: State University of New York - Downstate Medical Center
• Contact: Marina Boruk, MD
• Phone: 646-481-1311
• Email: marina.boruk[@]downstate.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Chronic Rhinosinusitis
• Nasal Polyps

Intervention

Drug:
• Triamcinolone-impregnated CMC foam
same information as included in the arm/group descriptions

Device:
• Propel Stent
same information as included in the arm/group descriptions

Locations

Country	Name	City	State
United States	SUNY Downstate Medical Center	Brooklyn	New York

Sponsors (2)

Lead Sponsor	Collaborator
Marina Boruk	State University of New York - Downstate Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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