Gel-Sinuplasty for Chronic Rhinosinusitis With and Without Nasal Polyposis

NCT03472144 | Unknown Phase 3 FDA Drug

• 1 other identifier: 2397
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Sinusitis, Ethmoidal; Chronic Sinusitis - Ethmoidal Anterior; Chronic Sinusitis; Chronic Sinusitis - Ethmoidal, Posterior; Chronic Sinusitis, Sphenoidal; Chronic Sinusitis - Frontoethmoidal; Nasal Polyps; Nasal Polyp - Posterior

Outcome Measures

Primary Outcomes (2)

• Clinical improvement reported on SNOT-22 questionnaire

  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.

  The total duration of the actual study is 30 months, and the follow up period per patient will 6 months postoperatively.

• Improvement in the Lund-Kennedy endoscopic appearance scores. Improvement in the Lund-Kennedy endoscopic appearance scores

  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)

  The total duration of the actual study is 30 months, and the follow up period per patient will 6 months postoperatively.

Secondary Outcomes (1)

• Radiological improvement of the Lund-Mackay score

  The total duration of the actual study is 30 months, and the follow up period per patient will 6 months postoperatively.

Study Arms (12)

CRSwNP - Subgrp 1(Momentasone - Right)

EXPERIMENTAL

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)

CRSwNP-Subgrp 2(Levofloxacin - Right)

EXPERIMENTAL

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)

CRSwNP-Subgrp 3(Steroid/Antibotic Right)

EXPERIMENTAL

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

CRSsNP - Subgrp 1 (Momentasone Right)

EXPERIMENTAL

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)

CRSsNP - Subgrp 2 (Levofloxacin Right)

EXPERIMENTAL

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)

CRSsNP-Subgrp 3(Steroid/Antibiotic Right

EXPERIMENTAL

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

CRSwNP - Subgrp 1 (Momentasone Left)

ACTIVE COMPARATOR

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)

CRSwNP - Subgrp 2 (Levofloxacin Left)

ACTIVE COMPARATOR

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)

CRSwNP-Subgrp 3(Steroid/Antibiotic Left)

ACTIVE COMPARATOR

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

CRSsNP - Subgrp 1 (Momentasone Left)

ACTIVE COMPARATOR

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)

CRSsNP - Subgrp 2 (Levofloxacin Left)

ACTIVE COMPARATOR

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)

CRSsNP-Subgrp 3(Steroid/Antibiotic Left)

ACTIVE COMPARATOR

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

Interventions

gel loaded with steroids (momentasone) DRUG

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.

Also known as: Momentasone

CRSsNP - Subgrp 1 (Momentasone Left); CRSsNP - Subgrp 1 (Momentasone Right); CRSwNP - Subgrp 1 (Momentasone Left); CRSwNP - Subgrp 1(Momentasone - Right)

gel loaded with antibiotic (Levofloxacin) DRUG

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.

Also known as: Levofloxacin

CRSsNP - Subgrp 2 (Levofloxacin Left); CRSsNP - Subgrp 2 (Levofloxacin Right); CRSwNP - Subgrp 2 (Levofloxacin Left); CRSwNP-Subgrp 2(Levofloxacin - Right)

gel loaded with both steroids and antibiotic DRUG

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.

Also known as: Momentasone, Levofloxacin

CRSsNP-Subgrp 3(Steroid/Antibiotic Left); CRSsNP-Subgrp 3(Steroid/Antibiotic Right; CRSwNP-Subgrp 3(Steroid/Antibiotic Left); CRSwNP-Subgrp 3(Steroid/Antibotic Right)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• LifeBridge Health: lead

Study Sites (1)

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

RECRUITING

Related Publications (9)

• 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. doi: 10.1016/j.otohns.2007.06.726.

  PMID: 17761281 BACKGROUND

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

  PMID: 18197013 BACKGROUND

• 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. doi: 10.1016/j.otohns.2007.02.004.

  PMID: 17903570 BACKGROUND

• Alves DA, Machado D, Melo A, Pereira RF, Severino P, de Hollanda LM, Araujo 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. doi: 10.1155/2016/9702129. Epub 2016 Sep 5.

  PMID: 27689094 BACKGROUND

• 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.

  PMID: 24597493 BACKGROUND

• 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. doi: 10.1007/s11095-006-9104-4. Epub 2006 Nov 11.

  PMID: 17096184 BACKGROUND

• 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. No abstract available.

  PMID: 20738346 RESULT

• 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.

  PMID: 24817242 RESULT

• 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. doi: 10.1177/000348941212101104.

  PMID: 23193904 RESULT

MeSH Terms

Conditions

Nasal Polyps

Interventions

Steroids; Anti-Bacterial Agents; Levofloxacin

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Alan H. Shikani, MD

  Sinai Hospital of Baltimore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alan H. Shikani, MD

CONTACT

410-601-6673; ashikani@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Principle investigator will be non blinded and all others will be blinded
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: December 15, 2017
• First Posted: March 21, 2018
• Study Start: July 7, 2017
• Primary Completion: July 7, 2019
• Study Completion: December 7, 2019
• Last Updated: March 21, 2018

Record last verified: 2018-03

Locations

US (1)