Comparison of Nasal Steroids After FESS in CRSwNP

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

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.

Study Overview

• Status: Completed
• Conditions: Sinusitis; Nasal Polyps
• Intervention / Treatment: Drug: fluticasone nasal spray; Drug: Budesonide head upright; Drug: Budesonide head forward

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale Physicians Bldg
    • Stratford, Connecticut, United States, 06614
      • Yale ENT Stratford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: fluticasone nasal spray; Group one will be prescribed fluticasone nasal spray ( to use 2-50 mcg sprays to each nostril two times per day)	Drug: fluticasone nasal spray; use 2-50 mcg sprays to each nostril two times per day; Other Names: Flonase; fluticasone propionate nasal
Active Comparator: budesonide respule in head upright; Group two will be prescribed budesonide respules (0.5 mg/2mL) to instill into each nostril in the upright position two times per day	Drug: Budesonide head upright; (0.5 mg/2mL) to instill into each nostril in the upright position two times per day; Other Names: budesonide; pulmicort respules
Active Comparator: budesonide head forward; Group three will be prescribed budesonide respules (0.5 mg/2mL) to use instill into each nostril in the head forward position two times per day with their head angled downwards by having their head lean forward off the side of a bed.	Drug: Budesonide head forward; (0.5 mg/2mL) to instill into each nostril in the head forward position two times per day; Other Names: budesonide; pulmicort respules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: R. Peter Manes, MD, Yale University School of Medicine, Asst Professor

Publications and helpful links

General Publications

• 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.
• 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.
• 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/Rhino12.000.
• 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.
• 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.
• Neubauer PD, Schwam ZG, Manes RP. Comparison of intranasal fluticasone spray, budesonide atomizer, and budesonide respules in patients with chronic rhinosinusitis with polyposis after endoscopic sinus surgery. Int Forum Allergy Rhinol. 2016 Mar;6(3):233-7. doi: 10.1002/alr.21688. Epub 2015 Dec 17.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: July 15, 2014
• First Submitted That Met QC Criteria: July 17, 2014
• First Posted (Estimate): July 18, 2014

Study Record Updates

• Last Update Posted (Actual): February 8, 2018
• Last Update Submitted That Met QC Criteria: January 12, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Functional endoscopic sinus surgery; Chronic rhinosinusitis with polyps; Nasal steroids; SNOT-22; Lund-Kennedy
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Pathological Conditions, Anatomical; Paranasal Sinus Diseases; Nose Diseases; Polyps; Sinusitis; Nasal Polyps; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Budesonide; Fluticasone; Xhance
• Other Study ID Numbers: 1407014259