Gel-Sinuplasty for Chronic Rhinosinusitis With and Without Nasal Polyposis

Overview

To assess the efficacy of intra-sinus installation of a poloxamer gel that releases antibiotics and corticosteroids topically after balloon sinuplasty in chronic sinusitis patients with or without polyps. This is a single-blinded Randomized Control Trial study, in which every patient receives active gel on one side and placebo on the other (L or R to be randomly selected).

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 7, 2019

Detailed Description

STUDY DESIGN This is a single-blinded Randomized Control Trial study, in which every patient receives active gel on one side and placebo on the other (L or R to be randomly selected). Sixty patients will be included in this study. These are patients undergoing balloon sinuplasty for Chronic sinusitis with and without polyps.

As the patients will enter the study- they will be divided into Chronic sinusitis with Polyps (CRSwNP) and Chronic rhinosinusitis without polyps (CRSsNP). Each patient will be assigned in chronological order as they will join the study.

For each group, all even numbered patients will receive the active gel application on right side and all odd number patients will receive the active gel on left side.

Then patient selection for CRSwNP and CRSsNP will be as such Each group will have 3 subgroups. Subgroup 1- gel will be loaded with steroids only Subgroup 2- gel will be loaded with antibiotic (Levaquin) only Subgroup 3- gel will be loaded with both steroids and antibiotic CRSwNP group with right side gel application Subgroup 1- patient number- 1,7,13,19,25 Subgroup 2- patient number- 3,9,15,21,27 Subgroup 3- patient number- 5,11,17,23,29 CRSwNP group with left side gel application Subgroup 1- patient number- 2,8,14,20,26 Subgroup 2- patient number- 4,10,16,22,28 Subgroup 3- patient number- 6,12,18,24,30

A similar patient randomization will be done with the CRSsNP group

Surgery will consist of plain balloon sinuplasty or hybrid balloon sinuplasty with removal of ethmoids polypss using a Blakesley forceps. During surgery, and immediately after removal of diseased mucosa, 5 ccs of an active poloxamer gel containing the antibiotic or corticosteroids or both will be instilled inside the ethmoid/ maxillary sinus/frontal cavities on one side using either the balloon catheter or as a curved suction tip. The same procedure is performed in the other side, this time with instillation of plain gel without antibiotic or corticosteroids (placebo).

The purpose of the study is to assess the efficacy of intra-sinus installation of a poloxamer gel that releases antibiotics and corticosteroids topically after balloon sinuplasty in chronic sinusitis patients with or without polyps. The assessment of the healing process will be done at the end of one month then at two, three and six months. Total number of visits would be 8 including the operation day.

Interventions

  • Drug: gel loaded with steroids (momentasone)
    • One of the purpose of this study is to evaluate the efficacy of a gel that actively releases local corticosteroids (momentasone) after balloon sinuplasty for chronic sinusitis patients.
  • Drug: gel loaded with antibiotic (Levofloxacin)
    • One of the purpose of this study is to evaluate the efficacy of a gel that actively releases local antibiotic(levofloxacin) after balloon sinuplasty for chronic sinusitis patients.
  • Drug: gel loaded with both steroids and antibiotic
    • One of the purpose of this study is to evaluate the efficacy of a gel that actively releases local both steroids (momentasone)and antibiotic(levofloxacin) after balloon sinuplasty for chronic sinusitis patients.

Arms, Groups and Cohorts

  • Experimental: CRSwNP – Subgrp 1(Momentasone – Right)
    • Patients undergoing balloon sinuplasty will receive a gel loaded with steroids (Momentasone) only on right side and placebo on left side
  • Experimental: CRSwNP-Subgrp 2(Levofloxacin – Right)
    • Patients undergoing balloon sinuplasty with receive a gel loaded with antibiotic (Levofloxacin) only on right side and placebo on left side
  • Experimental: CRSwNP-Subgrp 3(Steroid/Antibotic Right)
    • Patients undergoing balloon sinuplasty will receive a gel loaded with both steroids and antibiotic on right side and placebo on left side
  • Experimental: CRSsNP – Subgrp 1 (Momentasone Right)
    • Patients undergoing ballon sinuplasty will receive a gel loaded with steroids (Momentasone) only on right side and placebo on left side
  • Experimental: CRSsNP – Subgrp 2 (Levofloxacin Right)
    • Patients undergoing balloon sinuplasty will receive a gel loaded with antibiotic (Levofloxacin) only on right side and placebo on left side
  • Experimental: CRSsNP-Subgrp 3(Steroid/Antibiotic Right
    • Patients undergoing balloon sinuplasty will receive a gel loaded with both steroids and antibiotic on right side and placebo on left side
  • Active Comparator: CRSwNP – Subgrp 1 (Momentasone Left)
    • Patients undergoing balloon sinuplasty will receive a gel loaded with steroids (Momentasone) only on left side and placebo on right side
  • Active Comparator: CRSwNP – Subgrp 2 (Levofloxacin Left)
    • Patients undergoing balloon sinuplasty will receive a gel loaded with antibiotic (Levofloxacin) only left side and placebo on right side
  • Active Comparator: CRSwNP-Subgrp 3(Steroid/Antibiotic Left)
    • Patients undergoing balloon sinuplasty will receive a gel loaded with both steroids and antibiotic on left side and placebo on right side
  • Active Comparator: CRSsNP – Subgrp 1 (Momentasone Left)
    • Patients undergoing balloon sinuplasty will receive a gel loaded with steroids (Momentasone) only left side and placebo on right side
  • Active Comparator: CRSsNP – Subgrp 2 (Levofloxacin Left)
    • Patients undergoing balloon sinuplasty will receive a gel loaded with antibiotic (Levofloxacin) only left side and placebo on right side
  • Active Comparator: CRSsNP-Subgrp 3(Steroid/Antibiotic Left)
    • Patients undergoing balloon sinuplasty will receive a gel loaded with both steroids and antibiotic on left side and placebo on right side

Clinical Trial Outcome Measures

Primary Measures

  • Clinical improvement reported on SNOT-22 questionnaire
    • Time Frame: The total duration of the actual study is 30 months, and the follow up period per patient will 6 months postoperatively.
    • Assessment of the healing process will be done at the end of one month then at two, three and six months. Total number of visits would be 8 including the operation day.
  • Improvement in the Lund-Kennedy endoscopic appearance scores. Improvement in the Lund-Kennedy endoscopic appearance scores
    • Time Frame: The total duration of the actual study is 30 months, and the follow up period per patient will 6 months postoperatively.
    • Assessment of the healing process will be done at the end of one month then at two, three and six months. Total number of visits would be 8 including the operation day. Polyps (left, right) Edema (left, right) Discharge (left, right) Scarring (left, right) Crusting (left, right) Scoring: Polyps on left side – (0 absent, 1 polyps in middle meatus, 2 polyps beyond middle meatus) Polyps on right side – (0 absent, 1 polyps in middle meatus, 2 polyps beyond middle meatus) Edema, scarring and crusting on left side (0 absent, 1 mild, 2 severe) Edema, scarring and crusting on right side (0 absent, 1 mild, 2 severe) Discharge on left side (0, no discharge, 1 clear, thin discharge, 2 thick purulent discharge) Discharge on right side (0, no discharge, 1 clear, thin discharge, 2 thick purulent discharge)

Secondary Measures

  • Radiological improvement of the Lund-Mackay score
    • Time Frame: The total duration of the actual study is 30 months, and the follow up period per patient will 6 months postoperatively.
    • Assessment of the healing process will be done at the end of one month then at two, three and six months. Total number of visits would be 8 including the operation day. Paranasal sinuses Right Left Maxillary (0, 1, 2) Anterior Ethmoid (0, 1, 2) Posterior Ethmoid (0, 1, 2) Sphenoid (0, 1, 2) Frontal (0, 1, 2) Ostiomeatal complex (0, 2) Total Note: 0- without abnormalities; 1- partial opacification; 2-total opacification 0-no obstruction; 2-obstructed

Participating in This Clinical Trial

Inclusion Criteria

1. Chronic sinusitis symptoms with or without polyps

2. Trial of at least 2 courses of oral antimicrobial treatment without significant improvement

3. CAT scan showing evidence of bilateral symmetric chronic sinusitis with or without polypss

4. Endoscopic confirmation of CRS

Exclusion Criteria

1. Minor (Less than <18 years of age).

2. Pregnant and breastfeeding women.

3. Allergy to specific antibiotics

4. Patient currently taking oral corticosteroids.

5. Patient currently taking oral antibiotics.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • LifeBridge Health
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Alan H. Shikani, MD, Principal Investigator, Sinai Hospital of Baltimore
  • Overall Contact(s)
    • Alan H. Shikani, MD, 410-601-6673, ashikani@gmail.com

References

Rosenfeld RM, Andes D, Bhattacharyya N, Cheung D, Eisenberg S, Ganiats TG, Gelzer A, Hamilos D, Haydon RC 3rd, Hudgins PA, Jones S, Krouse HJ, Lee LH, Mahoney MC, Marple BF, Mitchell CJ, Nathan R, Shiffman RN, Smith TL, Witsell DL. Clinical practice guideline: adult sinusitis. Otolaryngol Head Neck Surg. 2007 Sep;137(3 Suppl):S1-31.

Vaughan WC. Review of balloon sinuplasty. Curr Opin Otolaryngol Head Neck Surg. 2008 Feb;16(1):2-9. doi: 10.1097/MOO.0b013e3282f5e955. Review.

Hopkins C, Browne JP, Slack R, Lund V, Brown P. The Lund-Mackay staging system for chronic rhinosinusitis: how is it used and what does it predict? Otolaryngol Head Neck Surg. 2007 Oct;137(4):555-61.

Alves DA, Machado D, Melo A, Pereira RF, Severino P, de Hollanda LM, Ara├║jo DR, Lancellotti M. Preparation of Thermosensitive Gel for Controlled Release of Levofloxacin and Their Application in the Treatment of Multidrug-Resistant Bacteria. Biomed Res Int. 2016;2016:9702129. Epub 2016 Sep 5.

Li C, Gu J, Mao X, Ao H, Yang X. Preparation of levofloxacin thermo-sensitive gel and clinical application in the treatment of suppurative otitis media. Acta Otolaryngol. 2014 May;134(5):468-74. doi: 10.3109/00016489.2013.878473. Epub 2014 Mar 6.

Dumortier G, Grossiord JL, Agnely F, Chaumeil JC. A review of poloxamer 407 pharmaceutical and pharmacological characteristics. Pharm Res. 2006 Dec;23(12):2709-28. Epub 2006 Nov 11. Review.

Citations Reporting on Results

Shikani AH, Chahine KA, Alqudah MA. The rhinotopic protocol for chronic refractory rhinosinusitis: how we do it. Clin Otolaryngol. 2010 Aug;35(4):329-32. doi: 10.1111/j.1749-4486.2010.02157.x.

Shikani AH, Chahine KA, Alqudah MA. Rhinotopic therapy for refractory chronic rhinosinusitis: a study of 20 cases. Ear Nose Throat J. 2014 Apr-May;93(4-5):E48-54.

Shikani AH, Kourelis K, Rohayem Z, Basaraba RJ, Leid JG. Topical gel therapy for sinonasal polyposis in Samter's triad: preliminary report. Ann Otol Rhinol Laryngol. 2012 Nov;121(11):719-24.

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