Adjunctive Treatment for Chronic Rhinosinusitis With Nasal Polyposis

Marina Boruk

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Chronic Rhinosinusitis; Nasal Polyps

Treatments: Device: Propel Stent; Drug: Triamcinolone-impregnated CMC foam

Study type: Interventional

Funder types: Other

Identifiers

NCT03607175

1161972-3

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Steroid-eluting implant (Propel)

Active Comparator group

Description:

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.

Treatment:

Device: Propel Stent

Triamcinolone-impregnated CMC foam

Experimental group

Description:

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.

Treatment:

Drug: Triamcinolone-impregnated CMC foam