Comparison of Nasal Steroids After FESS in CRSwNP

Study Overview
=================
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.

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.

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

Conditions
-----------------
Sinusitis, Nasal Polyps

Intervention / Treatment
-----------------
* Drug: fluticasone nasal spray
* Drug: Budesonide head upright
* Drug: Budesonide head forward


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients who have had FESS for CRSwNP within the study period Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: fluticasone nasal spray<br>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<br>* use 2-50 mcg sprays to each nostril two times per day<br>* Other names: Flonase;|
| Active Comparator: budesonide respule in head upright<br>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<br>* (0.5 mg/2mL) to instill into each nostril in the upright position two times per day<br>* Other names: pulmicort respules;|
| Active Comparator: budesonide head forward<br>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<br>* (0.5 mg/2mL) to instill into each nostril in the head forward position two times per day<br>* Other names: 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic rhinosinusitis with polyps, Nasal steroids, Functional endoscopic sinus surgery, SNOT-22, Lund-Kennedy