N/A
N=32
Comparison of Nasal Steroids After FESS in CRSwNP
Sinusitis · Nasal Polyps
Bottom Line
View on ClinicalTrials.gov: NCT02194062 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: SNOT-22 Scores — 31.5; 10.29; 15.88 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- fluticasone nasal spray (Drug); Budesonide head upright (Drug); Budesonide head forward (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY SNOT-22 Scores |
31.5; 10.29; 15.88 | — |
| SECONDARY Lund-Kennedy Scoring for Nasal Endoscopy |
2.69; 0.5; 1.13 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02194062). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.