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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluticasone nasal spray | Drug | use 2-50 mcg sprays to each nostril two times per day |
|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| R. Peter Manes, MD | Yale University School of Medicine, Asst Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Physicians Bldg | New Haven | Connecticut | 06510 | United States | ||
| Yale ENT Stratford |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22469599 | Background | 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. | |
| 23710959 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluticasone Nasal Spray | Group one will be prescribed fluticasone nasal spray ( to use 2-50 mcg sprays to each nostril two times per day) fluticasone nasal spray: use 2-50 mcg sprays to each nostril two times per day |
| FG001 | 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 Budesonide: (0.5 mg/2mL) to instill into each nostril in the upright position two times per day |
| FG002 | 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. Budesonide: (0.5 mg/2mL) to instill into each nostril in the head forward position two times per day |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluticasone Nasal Spray | Group one will be prescribed fluticasone nasal spray ( to use 2-50 mcg sprays to each nostril two times per day) fluticasone nasal spray: use 2-50 mcg sprays to each nostril two times per day |
| BG001 | Budesonide Respule in Head Upright |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 6 months post-op. |
|
Adverse events were collected over 6 months
No difference in definitions for adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fluticasone Group | Fluticasone nasal spray ( to use 2-50 mcg sprays to each nostril two times per day) |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Neubauer | Yale School of Medicine | 2037855430 | paul.neubauer@yale.edu |
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| ID | Term |
|---|---|
| D012852 | Sinusitis |
| D009298 | Nasal Polyps |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Budesonide head upright | Drug | (0.5 mg/2mL) to instill into each nostril in the upright position two times per day |
|
|
| Budesonide head forward | Drug | (0.5 mg/2mL) to instill into each nostril in the head forward position two times per day |
|
|
| Stratford |
| Connecticut |
| 06614 |
| United States |
| 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. |
| 19379619 | 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. |
| 19128710 | 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. |
| 19289711 | 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. |
| 26679480 | Derived | 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. |
Group two will be prescribed budesonide respules (0.5 mg/2mL) to instill into each nostril in the upright position two times per day Budesonide: (0.5 mg/2mL) to instill into each nostril in the upright position two times per day |
| BG002 | 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. Budesonide: (0.5 mg/2mL) to instill into each nostril in the head forward position two times per day |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| asthma | Number | participants |
|
| OG002 | 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. Budesonide: (0.5 mg/2mL) to instill into each nostril in the head forward position two times per day |
|
|
| 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 6 months post-op |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Budesonide Respule in Head Upright | Budesonide respules (0.5 mg/2mL) to instill into each nostril in the upright position two times per day | 0 | 10 | 0 | 10 |
| EG002 | Budesonide Head Forward | 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. | 0 | 12 | 0 | 12 |
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| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |