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Gel-Sinuplasty for Chronic Rhinosinusitis With and Without Nasal Polyposis

Sponsor
LifeBridge Health (Other)
Overall Status
Unknown status
CT.gov ID
NCT03472144
Collaborator
(none)
60
Enrollment
1
Location
12
Arms
29
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

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
  • 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

Study Type:
Interventional
Anticipated 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).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 :
Jul 7, 2017
Anticipated Primary Completion Date :
Jul 7, 2019
Anticipated Study Completion Date :
Dec 7, 2019

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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Momentasone, Levofloxacin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Clinical improvement reported on SNOT-22 questionnaire [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 [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 [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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sinai Hospital of Baltimore Baltimore Maryland United States 21215

    Sponsors and Collaborators

    • LifeBridge Health

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    LifeBridge Health
    ClinicalTrials.gov Identifier:
    NCT03472144
    Other Study ID Numbers:
    • 2397
    First Posted:
    Mar 21, 2018
    Last Update Posted:
    Mar 21, 2018
    Last Verified:
    Mar 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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:
    Sinusitis
    Ethmoid Sinusitis
    Sphenoid Sinusitis
    Nasal Polyps
    Polyps
    Chronic Disease
    Anti-Bacterial Agents
    Levofloxacin
    Ofloxacin
    Antibiotics, Antitubercular

    Study Results

    No Results Posted as of Mar 21, 2018