Gel-Sinuplasty for Chronic Rhinosinusitis With and Without Nasal Polyposis

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ClinicalTrials.gov Identifier: NCT03472144

Recruitment Status : Unknown

Verified March 2018 by LifeBridge Health.
Recruitment status was: Recruiting

First Posted : March 21, 2018

Last Update Posted : March 21, 2018

Sponsor:

Information provided by (Responsible Party):

LifeBridge Health

Study Description

Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Chronic Sinusitis, Ethmoidal Chronic Sinusitis - Ethmoidal Anterior Chronic Sinusitis Chronic Sinusitis - Ethmoidal, Posterior Chronic Sinusitis, Sphenoidal Chronic Sinusitis - Frontoethmoidal Nasal Polyps Nasal Polyp - Posterior	Drug: gel loaded with steroids (momentasone) Drug: gel loaded with antibiotic (Levofloxacin) Drug: gel loaded with both steroids and antibiotic	Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Intervention Model Description:	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).
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:	Principle investigator will be non blinded and all others will be blinded
Primary Purpose:	Supportive Care
Official Title:	Gel-Sinuplasty for Chronic Rhinosinusitis With and Without Nasal Polyposis
Actual Study Start Date :	July 7, 2017
Estimated Primary Completion Date :	July 7, 2019
Estimated Study Completion Date :	December 7, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ofloxacin Levofloxacin Ofloxacin hydrochloride

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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	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. Other Name: Momentasone
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	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. Other Name: Levofloxacin
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	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. Other Name: Momentasone, Levofloxacin
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	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. Other Name: Momentasone
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	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. Other Name: Levofloxacin
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	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. Other Name: Momentasone, Levofloxacin
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	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. Other Name: Momentasone
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	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. Other Name: Levofloxacin
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	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. Other Name: Momentasone, Levofloxacin
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	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. Other Name: Momentasone
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	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. Other Name: Levofloxacin
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	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. Other Name: Momentasone, Levofloxacin

Outcome Measures

Primary Outcome 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 Outcome 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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Chronic sinusitis symptoms with or without polyps
Trial of at least 2 courses of oral antimicrobial treatment without significant improvement
CAT scan showing evidence of bilateral symmetric chronic sinusitis with or without polypss
Endoscopic confirmation of CRS

Exclusion Criteria:

Minor (Less than <18 years of age).
Pregnant and breastfeeding women.
Allergy to specific antibiotics
Patient currently taking oral corticosteroids.
Patient currently taking oral antibiotics.

Contacts and Locations

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): NCT03472144

Contacts

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Contact: Alan H. Shikani, MD	410-601-6673	ashikani@gmail.com

Locations

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United States, Maryland
Sinai Hospital of Baltimore	Recruiting
Baltimore, Maryland, United States, 21215
Contact: Alan H Shikani, MD 410-601-6673 Ashikani@gmail.com
Contact: Hosai T Hesham, MD 410-601-6673 hosaihesham@gmail.com

Sponsors and Collaborators

LifeBridge Health

Investigators

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Principal Investigator:	Alan H. Shikani, MD	Sinai Hospital of Baltimore

More Information

Publications of 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.

Other Publications:

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, Araújo 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.

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Responsible Party:	LifeBridge Health
ClinicalTrials.gov Identifier:	NCT03472144
Other Study ID Numbers:	2397
First Posted:	March 21, 2018 Key Record Dates
Last Update Posted:	March 21, 2018
Last Verified:	March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided
Plan Description:	undecided so far

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No
Product Manufactured in and Exported from the U.S.:	No

Additional relevant MeSH terms:

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Sinusitis Ethmoid Sinusitis Sphenoid Sinusitis Nasal Polyps Polyps Chronic Disease Pathological Conditions, Anatomical Respiratory Tract Infections Infections Paranasal Sinus Diseases Nose Diseases Respiratory Tract Diseases Otorhinolaryngologic Diseases Disease Attributes Pathologic Processes	Anti-Bacterial Agents Levofloxacin Ofloxacin Antibiotics, Antitubercular Anti-Infective Agents Antitubercular Agents Anti-Infective Agents, Urinary Renal Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Cytochrome P-450 CYP1A2 Inhibitors Cytochrome P-450 Enzyme Inhibitors

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