Clinical trial NCT03472144: Gel-Sinuplasty for Chronic Rhinosinusitis With and Without Nasal Polyposis
Official title: Gel-Sinuplasty for Chronic Rhinosinusitis With and Without Nasal Polyposis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chronic Sinusitis, Ethmoidal
Chronic Sinusitis - Ethmoidal Anterior
Chronic Sinusitis
Chronic Sinusitis - Ethmoidal, Posterior
Chronic Sinusitis, Sphenoidal
Chronic Sinusitis - Frontoethmoidal
Nasal Polyps
Nasal Polyp - Posterior
Lead sponsor: LifeBridge Health
Sponsor class: OTHER
First posted: 2018-03-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: SUPPORTIVE_CARE

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).

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.

Eligibility criteria: 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 \&lt;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.

Primary outcomes:
measure: Clinical improvement reported on SNOT-22 questionnaire
timeFrame: The total duration of the actual study is 30 months, and the follow up period per patient will 6 months postoperatively.
measure: Improvement in the Lund-Kennedy endoscopic appearance scores. Improvement in the Lund-Kennedy endoscopic appearance scores
timeFrame: The total duration of the actual study is 30 months, and the follow up period per patient will 6 months postoperatively.
Secondary outcomes:
measure: Radiological improvement of the Lund-Mackay score
timeFrame: The total duration of the actual study is 30 months, and the follow up period per patient will 6 months postoperatively.
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
Study officials:
affiliation: Sinai Hospital of Baltimore
name: Alan H. Shikani, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rosenfeld RM, Andes D, Bhattacharyya N, Cheung D, Eisenberg S, Ganiats TG, Gelzer A, Hamilos D, Haydon RC 3rd, Hudgins PA, Jones S, Krouse HJ, Lee LH, Mahoney MC, Marple BF, Mitchell CJ, Nathan R, Shiffman RN, Smith TL, Witsell DL. Clinical practice guideline: adult sinusitis. Otolaryngol Head Neck Surg. 2007 Sep;137(3 Suppl):S1-31. doi: 10.1016/j.otohns.2007.06.726.
citation: Vaughan WC. Review of balloon sinuplasty. Curr Opin Otolaryngol Head Neck Surg. 2008 Feb;16(1):2-9. doi: 10.1097/MOO.0b013e3282f5e955.
citation: Hopkins C, Browne JP, Slack R, Lund V, Brown P. The Lund-Mackay staging system for chronic rhinosinusitis: how is it used and what does it predict? Otolaryngol Head Neck Surg. 2007 Oct;137(4):555-61. doi: 10.1016/j.otohns.2007.02.004.
citation: Alves DA, Machado D, Melo A, Pereira RF, Severino P, de Hollanda LM, Araujo DR, Lancellotti M. Preparation of Thermosensitive Gel for Controlled Release of Levofloxacin and Their Application in the Treatment of Multidrug-Resistant Bacteria. Biomed Res Int. 2016;2016:9702129. doi: 10.1155/2016/9702129. Epub 2016 Sep 5.
citation: Li C, Gu J, Mao X, Ao H, Yang X. Preparation of levofloxacin thermo-sensitive gel and clinical application in the treatment of suppurative otitis media. Acta Otolaryngol. 2014 May;134(5):468-74. doi: 10.3109/00016489.2013.878473. Epub 2014 Mar 6.
citation: Dumortier G, Grossiord JL, Agnely F, Chaumeil JC. A review of poloxamer 407 pharmaceutical and pharmacological characteristics. Pharm Res. 2006 Dec;23(12):2709-28. doi: 10.1007/s11095-006-9104-4. Epub 2006 Nov 11.
citation: Shikani AH, Chahine KA, Alqudah MA. The rhinotopic protocol for chronic refractory rhinosinusitis: how we do it. Clin Otolaryngol. 2010 Aug;35(4):329-32. doi: 10.1111/j.1749-4486.2010.02157.x. No abstract available.
citation: Shikani AH, Chahine KA, Alqudah MA. Rhinotopic therapy for refractory chronic rhinosinusitis: a study of 20 cases. Ear Nose Throat J. 2014 Apr-May;93(4-5):E48-54.
citation: Shikani AH, Kourelis K, Rohayem Z, Basaraba RJ, Leid JG. Topical gel therapy for sinonasal polyposis in Samter's triad: preliminary report. Ann Otol Rhinol Laryngol. 2012 Nov;121(11):719-24. doi: 10.1177/000348941212101104.