Comparison of Nasal Steroids After FESS in CRSwNP

Sinusitis Clinical Trial

Official title:

A Comparison of Budesonide Nasal Irrigation in Different Head Positions and Fluticasone Nasal Spray in Post-operative Functional Endoscopic Sinus Surgery Patients With Chronic Rhinosinusitis With Nasal Polyposis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02194062
• Other study ID #: 1407014259
• Status: Completed
• Phase: N/A
• First received: July 15, 2014
• Last updated: January 12, 2018
• Start date: January 2015
• Est. completion date: August 2015

Study information

• Verified date: January 2018
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare intranasal fluticasone spray with budesonide nasal saline rinses in both the upright and head forward positions in patients who have had functional endoscopic sinus surgery (FESS) for chronic rhinosinusitis with nasal polyposis (CRSwNP) and measure differences in Sinonasal Outcome Test-22 (SNOT-22) scores and Lund- Kennedy scores on rigid nasal endoscopy at time points 1 week, 3 weeks, 6 weeks, 2 months, 4 months, and 6 months post-op.

Description:

Chronic rhinosinusitis (CRS) is an inflammatory condition of the lining of the nose and sinuses that lasts 12 weeks or longer with objective evidence of mucosal inflammation (1). CRSwNP is characterized by the presence of bilateral nasal polyps in the middle meatus. Patients with CRSwNP for whom medical therapy has failed, often have functional endoscopic sinus surgery.

Nasal steroids are important post-operatively to prevent polyps from recurring. Many studies have shown that nasal steroids are superior to placebo in maintaining improvement in symptom scores, such as SNOT-22, post-operatively by preventing polyps from returning (2). Nasal steroids can reduce inflammation locally and can prevent disease relapse without the systemic effects of oral steroids. However, there is no consensus as to which nasal steroid and which delivery method is most effective in treating these patients. Traditional nasal sprays, such as fluticasone spray, may not deliver the medication widely in the nasal cavity. Budesonide is available in a respule form that can be used to instill the medication in the nose. In an attempt to more effectively deliver the medication, changes in patient's head position has been prescribed to achieve better delivery (3). The safety of intranasal budesonide, a more potent steroid than fluticasone, has been established (4, 5). However, any improved efficacy over fluticasone nasal spray remains anecdotal as head to head comparisons have not previously been performed.

Practice patterns among rhinologists in the post-operative prescription of nasal steroids vary widely. Determining which medication/delivery method is more effective will help rhinologists better treat their patients and prevent symptoms, for which the surgery was performed, from returning.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients who have had FESS for CRSwNP within the study period

Exclusion Criteria:

1. Patients who are under the age of 18

2. Concurrent oral corticosteroid use of the equivalent of greater than 10 mg of prednisone use per day

3. The use of medications that accelerate the clearance of systemic cortisol (Dilantin, rifampin, amphetamines, and lithium)

4. The use of medications that inhibit the clearance of systemic cortisol (ketoconazole, amphotericin B, bupropion, fluoroquinolones)

5. Known hypersensitivity to corticosteroids

6. A personal history of Wegener's Granulomatosis or other autoimmune disease with nasal manifestations

Related Conditions & MeSH terms

• Nasal Polyps
• Sinusitis

Intervention

Drug:
• fluticasone nasal spray
use 2-50 mcg sprays to each nostril two times per day
• Budesonide head upright
(0.5 mg/2mL) to instill into each nostril in the upright position two times per day
• Budesonide head forward
(0.5 mg/2mL) to instill into each nostril in the head forward position two times per day

Locations

Country	Name	City	State
United States	Yale Physicians Bldg	New Haven	Connecticut
United States	Yale ENT Stratford	Stratford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

References & Publications (5)

Beule A, Athanasiadis T, Athanasiadis E, Field J, Wormald PJ. Efficacy of different techniques of sinonasal irrigation after modified Lothrop procedure. Am J Rhinol Allergy. 2009 Jan-Feb;23(1):85-90. doi: 10.2500/ajra.2009.23.3265. — View Citation

Bhalla RK, Payton K, Wright ED. Safety of budesonide in saline sinonasal irrigations in the management of chronic rhinosinusitis with polyposis: lack of significant adrenal suppression. J Otolaryngol Head Neck Surg. 2008 Dec;37(6):821-5. — View Citation

Fokkens WJ, Lund VJ, Mullol J, Bachert C, Alobid I, Baroody F, Cohen N, Cervin A, Douglas R, Gevaert P, Georgalas C, Goossens H, Harvey R, Hellings P, Hopkins C, Jones N, Joos G, Kalogjera L, Kern B, Kowalski M, Price D, Riechelmann H, Schlosser R, Senior B, Thomas M, Toskala E, Voegels R, Wang de Y, Wormald PJ. EPOS 2012: European position paper on rhinosinusitis and nasal polyps 2012. A summary for otorhinolaryngologists. Rhinology. 2012 Mar;50(1):1-12. doi: 10.4193/Rhino50E2. — View Citation

Sachanandani NS, Piccirillo JF, Kramper MA, Thawley SE, Vlahiotis A. The effect of nasally administered budesonide respules on adrenal cortex function in patients with chronic rhinosinusitis. Arch Otolaryngol Head Neck Surg. 2009 Mar;135(3):303-7. doi: 10.1001/archoto.2008.555. — View Citation

Snidvongs K, Kalish L, Sacks R, Sivasubramaniam R, Cope D, Harvey RJ. Sinus surgery and delivery method influence the effectiveness of topical corticosteroids for chronic rhinosinusitis: systematic review and meta-analysis. Am J Rhinol Allergy. 2013 May-Jun;27(3):221-33. doi: 10.2500/ajra.2013.27.3880. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SNOT-22 Scores	SNOT22 is a validated scale which measures sinonasal symptoms for sinusitis patients. The 22 questions are rated on a scale of 0-5 for a maximum total score of 110. Higher scores represent more symptomatic patients.	6 months post-op.
Secondary	Lund-Kennedy Scoring for Nasal Endoscopy	The Lund Kennedy scoring system for nasal endoscopy rates the severity of the sinusitis based on the endoscopic appearance of the nasal mucosa. Edema, secretions and the presence of polyps are rated from 0-2, for a total maximum score of 6 per each side of the nose. Higher scores represent more severe disease.	6 months post-op