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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

Tracking Information
First Submitted Date  ICMJE July 23, 2018
First Posted Date  ICMJE July 31, 2018
Last Update Posted Date August 6, 2018
Actual Study Start Date  ICMJE July 18, 2018
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 2, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: July 23, 2018)
Postoperative POSE Score [ Time Frame: 30 days ]
Comparison of the mean POSE scores for the two treatments at day 30 to determine there is noninferiority
Change History Complete list of historical versions of study NCT03607175 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adjunctive Treatment for Chronic Rhinosinusitis With Nasal Polyposis
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE 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
Condition  ICMJE
  • Chronic Rhinosinusitis
  • Nasal Polyps
Intervention  ICMJE
  • Drug: Triamcinolone-impregnated CMC foam
    same information as included in the arm/group descriptions
    Other Name: Kenalog-40
  • Device: Propel Stent
    same information as included in the arm/group descriptions
Study Arms  ICMJE
  • 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.
    Intervention: Device: Propel Stent
  • 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.
    Intervention: Drug: Triamcinolone-impregnated CMC foam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 23, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2019
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Boruk, MD 646-481-1311 marina.boruk@downstate.edu
Contact: Ho, MD 8622851230 sandra.ho@downstate.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03607175
Other Study ID Numbers  ICMJE 1161972-3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Marina Boruk, State University of New York - Downstate Medical Center
Study Sponsor  ICMJE Marina Boruk
Collaborators  ICMJE State University of New York - Downstate Medical Center
Investigators  ICMJE
Principal Investigator: Marina Boruk, MD SUNY Downstate Med Ctr
PRS Account State University of New York - Downstate Medical Center
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP