Gel-Sinuplasty for Chronic Rhinosinusitis With and Without Nasal Polyposis

LifeBridge Health

Status and phase: Unknown; Phase 3

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

Treatments: Drug: gel loaded with antibiotic (Levofloxacin); Drug: gel loaded with steroids (momentasone); Drug: gel loaded with both steroids and antibiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT03472144

2397

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 12 patient groups

CRSwNP - Subgrp 1(Momentasone - Right)

Experimental group

Description:

Patients undergoing balloon sinuplasty will receive a gel loaded with steroids (Momentasone) only on right side and placebo on left side

Treatment:

Drug: gel loaded with steroids (momentasone)

CRSwNP-Subgrp 2(Levofloxacin - Right)

Experimental group

Description:

Patients undergoing balloon sinuplasty with receive a gel loaded with antibiotic (Levofloxacin) only on right side and placebo on left side

Treatment:

Drug: gel loaded with antibiotic (Levofloxacin)

CRSwNP-Subgrp 3(Steroid/Antibotic Right)

Experimental group

Description:

Patients undergoing balloon sinuplasty will receive a gel loaded with both steroids and antibiotic on right side and placebo on left side

Treatment:

Drug: gel loaded with both steroids and antibiotic

CRSsNP - Subgrp 1 (Momentasone Right)

Experimental group

Description:

Patients undergoing ballon sinuplasty will receive a gel loaded with steroids (Momentasone) only on right side and placebo on left side

Treatment:

Drug: gel loaded with steroids (momentasone)

CRSsNP - Subgrp 2 (Levofloxacin Right)

Experimental group

Description:

Patients undergoing balloon sinuplasty will receive a gel loaded with antibiotic (Levofloxacin) only on right side and placebo on left side

Treatment:

Drug: gel loaded with antibiotic (Levofloxacin)

CRSsNP-Subgrp 3(Steroid/Antibiotic Right

Experimental group

Description:

Patients undergoing balloon sinuplasty will receive a gel loaded with both steroids and antibiotic on right side and placebo on left side

Treatment:

Drug: gel loaded with both steroids and antibiotic

CRSwNP - Subgrp 1 (Momentasone Left)

Active Comparator group

Description:

Patients undergoing balloon sinuplasty will receive a gel loaded with steroids (Momentasone) only on left side and placebo on right side

Treatment:

Drug: gel loaded with steroids (momentasone)

CRSwNP - Subgrp 2 (Levofloxacin Left)

Active Comparator group

Description:

Patients undergoing balloon sinuplasty will receive a gel loaded with antibiotic (Levofloxacin) only left side and placebo on right side

Treatment:

Drug: gel loaded with antibiotic (Levofloxacin)

CRSwNP-Subgrp 3(Steroid/Antibiotic Left)

Active Comparator group

Description:

Patients undergoing balloon sinuplasty will receive a gel loaded with both steroids and antibiotic on left side and placebo on right side

Treatment:

Drug: gel loaded with both steroids and antibiotic

CRSsNP - Subgrp 1 (Momentasone Left)

Active Comparator group

Description:

Patients undergoing balloon sinuplasty will receive a gel loaded with steroids (Momentasone) only left side and placebo on right side

Treatment:

Drug: gel loaded with steroids (momentasone)

CRSsNP - Subgrp 2 (Levofloxacin Left)

Active Comparator group

Description:

Patients undergoing balloon sinuplasty will receive a gel loaded with antibiotic (Levofloxacin) only left side and placebo on right side

Treatment:

Drug: gel loaded with antibiotic (Levofloxacin)

CRSsNP-Subgrp 3(Steroid/Antibiotic Left)

Active Comparator group

Description:

Patients undergoing balloon sinuplasty will receive a gel loaded with both steroids and antibiotic on left side and placebo on right side

Treatment:

Drug: gel loaded with both steroids and antibiotic