Adjunctive Treatment for Chronic Rhinosinusitis With Nasal Polyposis

NCT ID: NCT03607175

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-24
• Study Completion Date: 2025-12-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Steroid-eluting implant (Propel)

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.

Group Type: ACTIVE_COMPARATOR

Propel Stent

Intervention Type: DEVICE

same information as included in the arm/group descriptions

Triamcinolone-impregnated CMC foam

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.

Group Type: EXPERIMENTAL

Triamcinolone-impregnated CMC foam

Intervention Type: DRUG

same information as included in the arm/group descriptions

Interventions

Triamcinolone-impregnated CMC foam

same information as included in the arm/group descriptions

Intervention Type: DRUG

Propel Stent

same information as included in the arm/group descriptions

Intervention Type: DEVICE

Other Intervention Names

Kenalog-40

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

State University of New York - Downstate Medical Center

OTHER

Sponsor Role: collaborator

Marina Boruk

OTHER

Sponsor Role: lead

Responsible Party

Marina Boruk

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Marina Boruk, MD

Role: PRINCIPAL_INVESTIGATOR

SUNY Downstate Med Ctr

Locations

SUNY Downstate Medical Center

Brooklyn, New York, United States

Countries

United States

Central Contacts

Marina Boruk, MD

Role: CONTACT

marina.boruk@downstate.edu

646-481-1311

Matthew D Adams, MD

Role: CONTACT

matthew.adams@downstate.edu

814-592-5634

Facility Contacts

Marina Boruk, MD

Role: primary

marina.boruk@downstate.edu

646-481-1311

Matthew D Adams, MD

Role: backup

matthew.adams@downstate.edu

814-592-5634

Other Identifiers

1161972-3

Identifier Type: -

Identifier Source: org_study_id