Comparison of Nasal Steroids After FESS in CRSwNP

NCT02194062 | Completed Results

• 1 other identifier: 1407014259
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Sinusitis; Nasal Polyps

Keywords

Chronic rhinosinusitis with polyps; Nasal steroids; Functional endoscopic sinus surgery; SNOT-22; Lund-Kennedy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Lund-Kennedy Scoring for Nasal Endoscopy

  6 months post-op

Study Arms (3)

fluticasone nasal spray

ACTIVE COMPARATOR

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

budesonide respule in head upright

ACTIVE COMPARATOR

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

budesonide head forward

ACTIVE COMPARATOR

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

Interventions

fluticasone nasal spray DRUG

use 2-50 mcg sprays to each nostril two times per day

Also known as: fluticasone propionate nasal, Flonase

fluticasone nasal spray

Budesonide head upright DRUG

(0.5 mg/2mL) to instill into each nostril in the upright position two times per day

Also known as: budesonide, pulmicort respules

budesonide respule in head upright

Budesonide head forward DRUG

(0.5 mg/2mL) to instill into each nostril in the head forward position two times per day

Also known as: budesonide, pulmicort respules

budesonide head forward

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients who are under the age of 18
• Concurrent oral corticosteroid use of the equivalent of greater than 10 mg of prednisone use per day
• The use of medications that accelerate the clearance of systemic cortisol (Dilantin, rifampin, amphetamines, and lithium)
• The use of medications that inhibit the clearance of systemic cortisol (ketoconazole, amphotericin B, bupropion, fluoroquinolones)
• Known hypersensitivity to corticosteroids
• A personal history of Wegener's Granulomatosis or other autoimmune disease with nasal manifestations

Sponsors & Collaborators

• Yale University: lead

Study Sites (2)

Yale Physicians Bldg

New Haven, Connecticut, 06510, United States

Location

Yale ENT Stratford

Stratford, Connecticut, 06614, United States

Location

Related Publications (6)

• 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.

  PMID: 22469599 BACKGROUND

• 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.

  PMID: 23710959 BACKGROUND

• 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.

  PMID: 19379619 BACKGROUND

• 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.

  PMID: 19128710 BACKGROUND

• 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.

  PMID: 19289711 BACKGROUND

• 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.

  PMID: 26679480 DERIVED

MeSH Terms

Conditions

Sinusitis; Nasal Polyps

Interventions

Fluticasone; Budesonide

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnenediones; Pregnenes; Pregnanes

Limitations and Caveats

Small numbers recruited due to time constraints. Not all patients included in final data analysis because of loss to follow up and time constraints of collecting the data.

Results Point of Contact

• Title: Paul Neubauer
• Organization: Yale School of Medicine

paul.neubauer@yale.edu

2037855430

Study Officials

• R. Peter Manes, MD

  Yale University School of Medicine, Asst Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2014
• First Posted: July 18, 2014
• Study Start: January 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: February 8, 2018
• Results First Posted: March 16, 2017

Record last verified: 2018-01

Locations

US (2)