Comparison of Topical Therapies in Post op Endoscopic Sinus Surgery Patients

NCT03303677 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: IRB201701952
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the study is to compare postoperative symptom scores and endoscopy findings between in patients who receive either nasal saline rinses, saline + budesonide, and saline + topical antibiotics and budesonide following endoscopic sinus surgery.

Conditions

Chronic Rhinosinusitis (Diagnosis)

Keywords

endoscopic sinus surgery; topical nasal therapy

Outcome Measures

Primary Outcomes (3)

• Change in symptom scores on Sino-nasal Outcome Test (SNOT)-22 surveys

  The Snot-22 contains 22 questions with a each question scored on a visual analog scale of 1-5 where 1 represents no problems with the symptom and 5 represents the symptom is as bad as it possibly can be. The Snot-22 has a cumulative score of 0-110.

  Up to 12 weeks post op

• Change in symptom scores on Rhinosinusitis Disability Index (RSDI)

  The RSDI contains 30 questions designed to measure the patient's disease-specific status in the physical, emotional, and functional domains. The questions present the patient with symptoms and ask if there experience the symptoms never, almost never, sometimes, almost always, and always. These are scored as 0-4, with never getting a score of 0 and always getting a score of 4 for a total score range of 0-120.

  Up to 12 weeks post op

• Nasal endoscopy findings

  Lund-Kennedy endoscopy scoring system. This system grades the endoscopic findings within the paranasal sinuses for the presence of: polyps, discharge, edema, scarring and crusting. Each side of the nasal cavity is scored separately and then combined for the total score. Polyps are scored as absent (0), present in middle meatus (1), or extending beyond middle meatus (2). Discharge is scored as absent (0), thin (1), and thick or purulent (2). Scarring, crusting, and edema are each scored separately as absent (0), mild (1), or severe (2). Combing the scores from both sides of the nasal cavity a total score from 0-20 is found

  Up to 12 weeks post op

Study Arms (3)

Saline

ACTIVE COMPARATOR

Post operative endoscopic sinus surgery patients using Saline nasal sinus irrigations to be performed twice daily. All patients will begin with normal saline irrigations immediately following surgery as per our department's standard of care. At their first one week post op appointment they will then begin treatment per the treatment arm.

Drug: Saline Nasal

Saline and budesonide

EXPERIMENTAL

Post operative endoscopic sinus surgery patients using saline + budesonide nasal sinus irrigations to be performed twice daily. All patients will begin with normal saline irrigations immediately following surgery as per our department's standard of care. At their first one week post op appointment they will then begin treatment per the treatment arm.

Drug: Saline Nasal; Drug: Budesonide Nasal

saline, budesonide, and topical antibiotic

EXPERIMENTAL

Post operative endoscopic sinus surgery patients using saline + budesonide + topical antibiotic nasal sinus irrigations. The antibiotic would be chosen based on intra operative culture sensitives as is our standard practice. The antibiotic would be selected from Levaquin, Vancomycin, Gentamicin, Ciprofloxacin, Mupirocin, and Trimethoprim/Sulfamethoxazole. All patients will begin with normal saline irrigations immediately following surgery as per our department's standard of care. At their first one week post op appointment they will then begin treatment per the treatment arm.

Drug: Saline Nasal; Drug: Budesonide Nasal; Drug: Topical Antibacterial (Product)

Interventions

Saline Nasal DRUG

topical nasal saline rinses

Saline; Saline and budesonide; saline, budesonide, and topical antibiotic

Budesonide Nasal DRUG

saline + budesonide nasal saline irrigation

Saline and budesonide; saline, budesonide, and topical antibiotic

Topical Antibacterial (Product) DRUG

The antibiotic would be chosen based on intra operative culture sensitives as is our standard practice. The antibiotic would be selected from Levaquin, Vancomycin, Gentamicin, Ciprofloxacin, Mupirocin, and Trimethoprim/Sulfamethoxazole

Also known as: Levaquin, Vancomycin, Gentamicin, Ciprofloxacin, Mupirocin, and Trimethoprim/Sulfamethoxazole

saline, budesonide, and topical antibiotic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with Chronic rhinosinusitis (CRS) defined by symptom, endoscopic, and radiographic criteria who are undergoing endoscopic sinus surgery

You may not qualify if:

• Age \<18
• endoscopic sinus surgery for reason other than CRS

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

Univeristy of Florida

Gainesville, Florida, 32611, United States

Location

Related Publications (12)

• Rosenfeld RM, Piccirillo JF, Chandrasekhar SS, Brook I, Ashok Kumar K, Kramper M, Orlandi RR, Palmer JN, Patel ZM, Peters A, Walsh SA, Corrigan MD. Clinical practice guideline (update): adult sinusitis. Otolaryngol Head Neck Surg. 2015 Apr;152(2 Suppl):S1-S39. doi: 10.1177/0194599815572097.

  PMID: 25832968 RESULT

• Rawal RB, Deal AM, Ebert CS Jr, Dhandha VH, Mitchell CA, Hang AX, Gore MR, Senior BA, Zanation AM. Post-operative budesonide irrigations for patients with polyposis: a blinded, randomized controlled trial. Rhinology. 2015 Sep;53(3):227-34. doi: 10.4193/Rhino14.196.

  PMID: 26363164 RESULT

• Lee VS, Davis GE. Culture-directed topical antibiotic treatment for chronic rhinosinusitis. Am J Rhinol Allergy. 2016 Nov 1;30(6):414-417. doi: 10.2500/ajra.2016.30.4380.

  PMID: 28124652 RESULT

• Lim M, Citardi MJ, Leong JL. Topical antimicrobials in the management of chronic rhinosinusitis: a systematic review. Am J Rhinol. 2008 Jul-Aug;22(4):381-9. doi: 10.2500/ajr.2008.22.3189.

  PMID: 18702902 RESULT

• Rudmik L, Smith TL. Evidence-based practice: postoperative care in endoscopic sinus surgery. Otolaryngol Clin North Am. 2012 Oct;45(5):1019-32. doi: 10.1016/j.otc.2012.06.006.

  PMID: 22980682 RESULT

• Portela RA, Hootnick J, McGinn J. Perioperative care in functional endoscopic sinus surgery: a survey study. Int Forum Allergy Rhinol. 2012 Jan-Feb;2(1):27-33. doi: 10.1002/alr.20098. Epub 2011 Oct 24.

  PMID: 22311838 RESULT

• Kim ST, Sung UH, Jung JH, Paik JY, Woo JH, Cha HE, Kang IG. The effect of maxillary sinus irrigation on early prognostic factors after endoscopic sinus surgery: a preliminary study. Am J Rhinol Allergy. 2013 Sep-Oct;27(5):e158-61. doi: 10.2500/ajra.2013.27.3967.

  PMID: 24119597 RESULT

• Giotakis AI, Karow EM, Scheithauer MO, Weber R, Riechelmann H. Saline irrigations following sinus surgery - a controlled, single blinded, randomized trial. Rhinology. 2016 Dec 1;54(4):302-310. doi: 10.4193/Rhino16.026.

  PMID: 27556896 RESULT

• Kang TW, Chung JH, Cho SH, Lee SH, Kim KR, Jeong JH. The Effectiveness of Budesonide Nasal Irrigation After Endoscopic Sinus Surgery in Chronic Rhinosinusitis With Asthma. Clin Exp Otorhinolaryngol. 2017 Mar;10(1):91-96. doi: 10.21053/ceo.2016.00220. Epub 2016 Jul 21.

  PMID: 27440128 RESULT

• Jang DW, Lachanas VA, Segel J, Kountakis SE. Budesonide nasal irrigations in the postoperative management of chronic rhinosinusitis. Int Forum Allergy Rhinol. 2013 Sep;3(9):708-11. doi: 10.1002/alr.21189. Epub 2013 Jun 17.

  PMID: 23776108 RESULT

• Oakley GM, Harvey RJ. Topical Steroids. Adv Otorhinolaryngol. 2016;79:121-30. doi: 10.1159/000445148. Epub 2016 Jul 28.

  PMID: 27466854 RESULT

• Wong KK, Marglani O, Westerberg BD, Javer AR. Systemic absorption of topical gentamicin sinus irrigation. J Otolaryngol Head Neck Surg. 2008 Jun;37(3):395-8.

  PMID: 19128645 RESULT

MeSH Terms

Conditions

Disease

Interventions

Sodium Chloride; Anti-Infective Agents; Pharmaceutical Preparations; Levofloxacin; Vancomycin; Gentamicins; Ciprofloxacin; Mupirocin; Trimethoprim; Sulfamethoxazole

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Aminoglycosides; Glycosides; Epoxy Compounds; Ethers, Cyclic; Ethers; Organic Chemicals; Pyrans; Heterocyclic Compounds, 1-Ring; Fatty Acids; Lipids; Pyrimidines; Benzenesulfonamides; Sulfonamides; Amides; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Jeb Justice, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization into one of three treatment arms

Study Record Dates

• First Submitted: September 26, 2017
• First Posted: October 6, 2017
• Study Start: April 1, 2018
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2019
• Last Updated: March 30, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)