Gel-Sinuplasty for Chronic Rhinosinusitis With and Without Nasal Polyposis

March 13, 2018 updated by: LifeBridge Health
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Recruiting
        • Sinai Hospital of Baltimore
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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)
The total duration of the actual study is 30 months, and the follow up period per patient will 6 months postoperatively.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LifeBridge Health

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 7, 2017

Primary Completion (ANTICIPATED)

July 7, 2019

Study Completion (ANTICIPATED)

December 7, 2019

Study Registration Dates

First Submitted

December 15, 2017

First Submitted That Met QC Criteria

March 13, 2018

First Posted (ACTUAL)

March 21, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 21, 2018

Last Update Submitted That Met QC Criteria

March 13, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2397

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

undecided so far

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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