Comparison of Nasal Steroids After FESS in CRSwNP
| Status: | Completed |
|---|---|
| Conditions: | Sinusitis |
| Therapuetic Areas: | Otolaryngology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/10/2018 |
| Start Date: | January 2015 |
| End Date: | August 2015 |
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.
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.
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.
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.
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
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