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Adjunctive Treatment for Chronic Rhinosinusitis With Nasal Polyposis

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ClinicalTrials.gov Identifier: NCT03607175
Recruitment Status : Recruiting
First Posted : July 31, 2018
Last Update Posted : August 6, 2018
Sponsor:
Collaborator:
State University of New York - Downstate Medical Center
Information provided by (Responsible Party):
Marina Boruk, State University of New York - Downstate Medical Center

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. Paried 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.


Condition or disease Intervention/treatment Phase
Chronic Rhinosinusitis Nasal Polyps Drug: Triamcinolone-impregnated CMC foam Device: Propel Stent Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Study is an intrapatient control design, each subject will receive both interventions, one in each nostril
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participants and outcomes assessor will be blinded to the side that the steroid eluting implant and the triamcinolone-impregnated foam in on.
Primary Purpose: Treatment
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
Actual Study Start Date : July 18, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Active Comparator: 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.
Device: Propel Stent
same information as included in the arm/group descriptions

Experimental: 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.
Drug: Triamcinolone-impregnated CMC foam
same information as included in the arm/group descriptions
Other Name: Kenalog-40




Primary Outcome Measures :
  1. Postoperative Perioperative Sinus Endoscopy Score [ Time Frame: 30 days ]

    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




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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03607175


Contacts
Contact: Boruk, MD 646-481-1311 marina.boruk@downstate.edu
Contact: Ho, MD 8622851230 sandra.ho@downstate.edu

Locations
United States, New York
SUNY Downstate Medical Center Recruiting
Brooklyn, New York, United States, 11203
Contact: Boruk, MD    646-481-1311    marina.boruk@downstate.edu   
Contact: Ho, MD    8622851230    sandra.ho@downtate.edu   
Sponsors and Collaborators
Marina Boruk
State University of New York - Downstate Medical Center
Investigators
Principal Investigator: Marina Boruk, MD SUNY Downstate Med Ctr

Responsible Party: Marina Boruk, Principal Investigator, State University of New York - Downstate Medical Center
ClinicalTrials.gov Identifier: NCT03607175     History of Changes
Other Study ID Numbers: 1161972-3
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sinusitis
Nasal Polyps
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Carboxymethylcellulose Sodium
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Laxatives
Gastrointestinal Agents