Gel-Sinuplasty for Chronic Rhinosinusitis With and Without Nasal Polyposis

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Gel-Sinuplasty for Chronic Rhinosinusitis With and Without Nasal Polyposis

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

Intervention / Treatment
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* Drug: gel loaded with steroids (momentasone)
* Drug: gel loaded with antibiotic (Levofloxacin)
* Drug: gel loaded with both steroids and antibiotic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Minor (Less than &lt;18 years of age). Pregnant and breastfeeding women. Allergy to specific antibiotics Patient currently taking oral corticosteroids. Patient currently taking oral antibiotics.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CRSwNP - Subgrp 1(Momentasone - Right)<br>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)<br>* 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.<br>* Other names: Momentasone;|
| Experimental: CRSwNP-Subgrp 2(Levofloxacin - Right)<br>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)<br>* 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.<br>* Other names: Levofloxacin;|
| Experimental: CRSwNP-Subgrp 3(Steroid/Antibotic Right)<br>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<br>* 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.<br>* Other names: Momentasone, Levofloxacin;|
| Experimental: CRSsNP - Subgrp 1 (Momentasone Right)<br>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)<br>* 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.<br>* Other names: Momentasone;|
| Experimental: CRSsNP - Subgrp 2 (Levofloxacin Right)<br>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)<br>* 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.<br>* Other names: Levofloxacin;|
| Experimental: CRSsNP-Subgrp 3(Steroid/Antibiotic Right<br>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<br>* 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.<br>* Other names: Momentasone, Levofloxacin;|
| Active Comparator: CRSwNP - Subgrp 1 (Momentasone Left)<br>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)<br>* 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.<br>* Other names: Momentasone;|
| Active Comparator: CRSwNP - Subgrp 2 (Levofloxacin Left)<br>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)<br>* 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.<br>* Other names: Levofloxacin;|
| Active Comparator: CRSwNP-Subgrp 3(Steroid/Antibiotic Left)<br>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<br>* 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.<br>* Other names: Momentasone, Levofloxacin;|
| Active Comparator: CRSsNP - Subgrp 1 (Momentasone Left)<br>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)<br>* 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.<br>* Other names: Momentasone;|
| Active Comparator: CRSsNP - Subgrp 2 (Levofloxacin Left)<br>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)<br>* 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.<br>* Other names: Levofloxacin;|
| Active Comparator: CRSsNP-Subgrp 3(Steroid/Antibiotic Left)<br>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<br>* 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.<br>* Other names: Momentasone, Levofloxacin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological improvement of the Lund-Mackay score | 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. |