Recruiting

Phase 3

Gel-SinuplastyGel-Sinuplasty for Chronic Rhinosinusitis With and Without Nasal Polyposis

Sponsor:

LifeBridge Health

Code:

NCT03472144

Conditions

Chronic Sinusitis, Ethmoidal

Chronic Sinusitis - Ethmoidal Anterior

Chronic Sinusitis

Chronic Sinusitis - Ethmoidal, Posterior

Chronic Sinusitis, Sphenoidal

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

gel loaded with steroids (momentasone)

gel loaded with antibiotic (Levofloxacin)

gel loaded with both steroids and antibiotic

Study Details

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).

Conditions

Chronic Sinusitis, Ethmoidal

Chronic Sinusitis - Ethmoidal Anterior

Chronic Sinusitis

Chronic Sinusitis - Ethmoidal, Posterior

Chronic Sinusitis, Sphenoidal

Study ID

NCT03472144

Start date

Jul 7, 2017

Status verified date

Mar, 2018

Completion date

Dec 7, 2019

Anticipated

Primary completion date

Jul 7, 2019

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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

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

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

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

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

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

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

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

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

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

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

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

Interventions

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.

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.

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.

Primary outcome measure

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. ]
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. ]

Central Contacts and Locations

Central contacts

Alan H. Shikani, MD

410-601-6673 ashikani@gmail.com

Locations

Sinai Hospital of Baltimore

Recruiting

Baltimore, Maryland, United States, 21215

Contacts

Alan H Shikani, MD

410-601-6673 Ashikani@gmail.com

Hosai T Hesham, MD

410-601-6673 hosaihesham@gmail.com

More Information

Sponsor

LifeBridge Health

Last update posted

Mar 21, 2018

Last verified

Mar, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by LifeBridge Health on 2018-03-21.