Chronic Rhinosinusitis, Chronic Rhinosinusitis Without Polyps, Endoscopic Sinus Surgery, Oral Steroids
Conditions
Brief 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.
Interventions
DRUGPrednisone
DRUGFlonase
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sino-nasal Outcome Test (SNOT-22) Over Time | Baseline, 1, week, 1 month, 3 months, and 6 months | SNOT-22 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. |
| Lund Kennedy Endoscopy Score Over Time | Baseline, 1, week, 1 month, 3 months, and 6 months | The Lund-Kennedy score is a validated scale by which clinicians grade the endoscopic appearance of the sinonasal cavity for sinusitis patients. There are 5 parameters rated on a scale of 0-2 for each side of the nose, for a maximum total score of 20 points. Higher scores represent a worse endoscopic appearance. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prednisone Participants received oral prednisone taper for 12 days postoperatively. | 33 |
| Placebo Participants received oral placebo for 12 days postoperatively. | 39 |
| Total | 72 |
Baseline characteristics
| Characteristic | Prednisone | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 48.8 years STANDARD_DEVIATION 15.3 | 49.9 years STANDARD_DEVIATION 14.7 | 49.4 years STANDARD_DEVIATION 14.9 |
| Lund-Kennedy Endoscopy Score | 3.8 score on a scale STANDARD_DEVIATION 3.1 | 2.9 score on a scale STANDARD_DEVIATION 2.5 | 3.3 score on a scale STANDARD_DEVIATION 2.8 |
| Race/Ethnicity, Customized Asian | 1 Participants | 4 Participants | 5 Participants |
| Race/Ethnicity, Customized Black | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Latino | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 30 Participants | 30 Participants | 60 Participants |
| Region of Enrollment United States | 33 Participants | 39 Participants | 72 Participants |
| Sex: Female, Male Female | 15 Participants | 21 Participants | 36 Participants |
| Sex: Female, Male Male | 18 Participants | 18 Participants | 36 Participants |
| Sino-nasal Outcome Test 22 (SNOT-22) | 43.8 score on a scale STANDARD_DEVIATION 21.5 | 43.0 score on a scale STANDARD_DEVIATION 22.4 | 43.4 score on a scale STANDARD_DEVIATION 21.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 40 |
| other Total, other adverse events | 14 / 41 | 19 / 40 |
| serious Total, serious adverse events | 0 / 41 | 0 / 40 |
Outcome results
Primary
Lund Kennedy Endoscopy Score Over Time
The Lund-Kennedy score is a validated scale by which clinicians grade the endoscopic appearance of the sinonasal cavity for sinusitis patients. There are 5 parameters rated on a scale of 0-2 for each side of the nose, for a maximum total score of 20 points. Higher scores represent a worse endoscopic appearance.
Time frame: Baseline, 1, week, 1 month, 3 months, and 6 months
Population: Participants who completed the protocol are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prednisone | Lund Kennedy Endoscopy Score Over Time | 1 week | 5.9 score on a scale | Standard Deviation 3 |
| Prednisone | Lund Kennedy Endoscopy Score Over Time | 3 months | 1.9 score on a scale | Standard Deviation 2.1 |
| Prednisone | Lund Kennedy Endoscopy Score Over Time | 1 month | 3.5 score on a scale | Standard Deviation 2.7 |
| Prednisone | Lund Kennedy Endoscopy Score Over Time | 6 months | 1.3 score on a scale | Standard Deviation 1.7 |
| Prednisone | Lund Kennedy Endoscopy Score Over Time | Baseline | 2.9 score on a scale | Standard Deviation 2.5 |
| Placebo | Lund Kennedy Endoscopy Score Over Time | 6 months | 1.8 score on a scale | Standard Deviation 1.8 |
| Placebo | Lund Kennedy Endoscopy Score Over Time | Baseline | 3.8 score on a scale | Standard Deviation 3.1 |
| Placebo | Lund Kennedy Endoscopy Score Over Time | 1 week | 5.3 score on a scale | Standard Deviation 2.6 |
| Placebo | Lund Kennedy Endoscopy Score Over Time | 1 month | 3.8 score on a scale | Standard Deviation 2.6 |
| Placebo | Lund Kennedy Endoscopy Score Over Time | 3 months | 2.4 score on a scale | Standard Deviation 2.1 |
Comparison: Comparison of baseline and 1 weekp-value: 0.376t-test, 2 sided
Comparison: Comparison of baseline and 1 monthp-value: 0.685t-test, 2 sided
Comparison: Comparison of baseline and 3 monthsp-value: 0.388t-test, 2 sided
Comparison: Comparison of baseline and 6 monthsp-value: 0.233t-test, 2 sided
Primary
Sino-nasal Outcome Test (SNOT-22) Over Time
SNOT-22 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: Baseline, 1, week, 1 month, 3 months, and 6 months
Population: Participants who completed the protocol are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prednisone | Sino-nasal Outcome Test (SNOT-22) Over Time | 1 week | 39.7 score on a scale | Standard Deviation 22.5 |
| Prednisone | Sino-nasal Outcome Test (SNOT-22) Over Time | 3 months | 28.3 score on a scale | Standard Deviation 19.5 |
| Prednisone | Sino-nasal Outcome Test (SNOT-22) Over Time | 1 month | 26.6 score on a scale | Standard Deviation 20.8 |
| Prednisone | Sino-nasal Outcome Test (SNOT-22) Over Time | 6 months | 34.2 score on a scale | Standard Deviation 20.6 |
| Prednisone | Sino-nasal Outcome Test (SNOT-22) Over Time | Baseline | 43.8 score on a scale | Standard Deviation 21.5 |
| Placebo | Sino-nasal Outcome Test (SNOT-22) Over Time | 6 months | 25.2 score on a scale | Standard Deviation 19.7 |
| Placebo | Sino-nasal Outcome Test (SNOT-22) Over Time | Baseline | 42.9 score on a scale | Standard Deviation 22.4 |
| Placebo | Sino-nasal Outcome Test (SNOT-22) Over Time | 1 week | 38.5 score on a scale | Standard Deviation 21.2 |
| Placebo | Sino-nasal Outcome Test (SNOT-22) Over Time | 1 month | 28.6 score on a scale | Standard Deviation 18 |
| Placebo | Sino-nasal Outcome Test (SNOT-22) Over Time | 3 months | 20.3 score on a scale | Standard Deviation 15.2 |
Comparison: Comparison of baseline and 1 weekp-value: 0.819t-test, 2 sided
Comparison: Comparison of baseline and 1 monthp-value: 0.665t-test, 2 sided
Comparison: Comparison of baseline and 3 monthsp-value: 0.071t-test, 2 sided
Comparison: Comparison of baseline and 6 monthsp-value: 0.097t-test, 2 sided