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Gel-Sinuplasty for Chronic Rhinosinusitis With and Without Nasal Polyposis

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ClinicalTrials.gov Identifier: NCT03472144
Recruitment Status : Recruiting
First Posted : March 21, 2018
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
LifeBridge Health

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 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


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




Primary Outcome Measures :
  1. 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.

  2. 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 :
  1. 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



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:

  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.

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

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

Publications of Results:
Other Publications:
Responsible Party: LifeBridge Health
ClinicalTrials.gov Identifier: NCT03472144     History of Changes
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

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:
Polyps
Sinusitis
Nasal Polyps
Chronic Disease
Ethmoid Sinusitis
Sphenoid Sinusitis
Pathological Conditions, Anatomical
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
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