Steroid Treatments for Chronic Sinusitis with Nasal Polyps

Overseen By Matthew D Adams, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Marina Boruk

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Marina Boruk, MD

Principal Investigator

SUNY Downstate Med Ctr

Eligibility Criteria

This trial is for individuals planning to undergo surgery for nasal polyps and chronic sinusitis, who can consent and commit to the study duration. It excludes those with steroid intolerance, incomplete pre-op regimens, oral steroid dependence, immune deficiencies, or pregnancy/breastfeeding; also excluded are those with narrow angle glaucoma or cataracts.

Inclusion Criteria

I am willing and able to follow all study rules and attend all appointments.

Provision of signed and dated informed consent form

I have nasal polyps and want surgery.

Exclusion Criteria

You have had bad reactions to corticosteroids in the past.

Subjects that did not complete the pre-op medical regimen described below

I rely on oral steroids for a health condition.

Treatment Details

Interventions

• Triamcinolone-impregnated CMC foam (Corticosteroid)

Trial Overview The study tests if CMC foam with triamcinolone (a steroid) is as effective and more comfortable than an FDA-approved Propel Stent after sinus surgery. Each patient will have one treatment in each nostril and be monitored through surveys and nasal cavity pictures over a 90-day period.

Participant Groups

Group I: Triamcinolone-impregnated CMC foam Experimental Treatment 1 Intervention

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 II: Steroid-eluting implant (Propel) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Marina Boruk

Lead Sponsor

Trials

1

Recruited

30+

State University of New York - Downstate Medical Center

Collaborator

Trials

67

Recruited

12,100+