Nasal Polyps, Sinusitis
Conditions
Keywords
Chronic rhinosinusitis with polyps, Nasal steroids, Functional endoscopic sinus surgery, SNOT-22, Lund-Kennedy
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.
Interventions
DRUGBudesonide head upright
(0.5 mg/2mL) to instill into each nostril in the upright position two times per day
use 2-50 mcg sprays to each nostril two times per day
DRUGBudesonide head forward
(0.5 mg/2mL) to instill into each nostril in the head forward position two times per day
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SNOT-22 Scores | 6 months post-op. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lund-Kennedy Scoring for Nasal Endoscopy | 6 months post-op | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 10 |
| 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 | 10 |
| 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 | 12 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 2 | 5 |
Baseline characteristics
| Characteristic | Fluticasone Nasal Spray | Budesonide Respule in Head Upright | Budesonide Head Forward | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 10 Participants | 12 Participants | 32 Participants |
| Age, Continuous | 48.4 years STANDARD_DEVIATION 1 | 44.8 years STANDARD_DEVIATION 1 | 39.6 years STANDARD_DEVIATION 1 | 43.9 years STANDARD_DEVIATION 1 |
| asthma no | 5 participants | 5 participants | 7 participants | 17 participants |
| asthma yes | 5 participants | 5 participants | 5 participants | 15 participants |
| Region of Enrollment United States | 10 participants | 10 participants | 12 participants | 32 participants |
| Sex: Female, Male Female | 5 Participants | 6 Participants | 5 Participants | 16 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 7 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 | 0 / 12 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 12 |
Outcome results
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.
Time frame: 6 months post-op.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Fluticasone Nasal Spray | SNOT-22 Scores | 31.5 units on a scale |
| Budesonide Respule in Head Upright | SNOT-22 Scores | 10.29 units on a scale |
| Budesonide Head Forward | SNOT-22 Scores | 15.88 units on a scale |
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.
Time frame: 6 months post-op
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Fluticasone Nasal Spray | Lund-Kennedy Scoring for Nasal Endoscopy | 2.69 units on a scale |
| Budesonide Respule in Head Upright | Lund-Kennedy Scoring for Nasal Endoscopy | 0.5 units on a scale |
| Budesonide Head Forward | Lund-Kennedy Scoring for Nasal Endoscopy | 1.13 units on a scale |