N/A
N=81
Perioperative Oral Steroids for Chronic Rhinosinusitis Without Polyps (CRSsNP)
Chronic Rhinosinusitis · Endoscopic Sinus Surgery · Chronic Rhinosinusitis Without Polyps · Oral Steroids
Bottom Line
View on ClinicalTrials.gov: NCT02748070 ↗Enrolled (actual)
81
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Sino-nasal Outcome Test (SNOT-22) Over Time — 43.8; 42.9; 39.7; 38.5 score on a scale — p=0.819
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Prednisone (Drug); Flonase (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sino-nasal Outcome Test (SNOT-22) Over Time |
43.8; 42.9; 39.7; 38.5; 26.6; 28.6 | 0.819 |
| PRIMARY Lund Kennedy Endoscopy Score Over Time |
2.9; 3.8; 5.9; 5.3; 3.5; 3.8 | 0.376 |
Summary
While oral steroids have been shown to be effective in the management of patients with chronic rhinosinusitis with polyps, its role in treating chronic rhinosinusitis without polyps (CRSsNP) is ambiguous. Despite a lack of strong clinical evidence to suggest a benefit in this disease state, steroids are often prescribed as a component of post-operative care after sinus surgery for patients without polyps. Oral steroids carry with them significant adverse effects, and should be prescribed thoughtfully. The aims of this study are to determine if oral steroids in the peri-operative period improves patient outcomes in CRS without polyps.
Eligibility Criteria
Inclusion Criteria
- CRSsNP as defined by Clinical Practice Guideline (Update) on Adult Sinusitis
- scheduled to undergo endoscopic sinus surgery
Exclusion Criteria
- chronic rhinosinusitis with polyps (CRSwNP)
- Aspirin exacerbated respiratory disease
- Cystic fibrosis
- Immunosuppressive states (Human immunodeficiency virus, transplant)
- Oral steroid use within 30 days of surgery
Data sourced from ClinicalTrials.gov (NCT02748070). 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.