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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prednisone | Experimental | Provided oral steroid and topical steroid |
|
| Placebo | Placebo Comparator | Provided oral placebo and topical steroid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisone | Drug |
| ||
| Flonase |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 1, week, 1 month, 3 months, and 6 months |
| 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. | Baseline, 1, week, 1 month, 3 months, and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julia E Noel, MD | Stanford University | Principal Investigator |
| Michael T Chang, MD | Stanford University | Principal Investigator |
| Peter H Hwang, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33662124 | Derived | Chang MT, Noel J, Ayoub NF, Qian ZJ, Dholakia S, Nayak JV, Patel ZM, Hwang PH. Oral Corticosteroids Following Endoscopic Sinus Surgery for Chronic Rhinosinusitis Without Nasal Polyposis: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2021 May 1;147(5):434-441. doi: 10.1001/jamaoto.2021.0011. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prednisone | Participants received oral prednisone taper for 12 days postoperatively. |
| FG001 | Placebo | Participants received oral placebo for 12 days postoperatively. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients who completed the protocol are included in the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Prednisone | Participants received oral prednisone taper for 12 days postoperatively. |
| BG001 | Placebo | Participants received oral placebo for 12 days postoperatively. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 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. | Participants who completed the protocol are included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1, week, 1 month, 3 months, and 6 months |
|
6 months
Adverse events were collection as usual; additionally, a patient-completed survey was used to measure adverse effects related to treatment. This survey was designed to capture potential side effects of systemic corticosteroids.
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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 | Prednisone | Participants received oral prednisone taper for 12 days postoperatively. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Easy bruising | Blood and lymphatic system disorders | Systematic Assessment | Collected by patient-completed survey |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Chang | Stanford University | (650) 725-6500 | michael.t.chang@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 17, 2015 | Jul 2, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 2, 2020 | Jul 2, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Sino-nasal Outcome Test 22 (SNOT-22) | 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. | Mean | Standard Deviation | score on a scale |
|
| Lund-Kennedy Endoscopy Score | 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. | Mean | Standard Deviation | score on a scale |
|
|
|
|
| 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. | Participants who completed the protocol are included in the analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1, week, 1 month, 3 months, and 6 months |
|
|
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| 14 |
| 41 |
| EG001 | Placebo | Participants received oral placebo for 12 days postoperatively. | 0 | 40 | 0 | 40 | 19 | 40 |
|
| Water retention | Blood and lymphatic system disorders | Systematic Assessment | Collected by patient-completed survey |
|
| Blurry vision | Eye disorders | Systematic Assessment | Collected by patient-completed survey |
|
| Increased appetite | Gastrointestinal disorders | Systematic Assessment | Collected by patient-completed survey |
|
| Weight gain | Gastrointestinal disorders | Systematic Assessment | Collected by patient-completed survey |
|
| Stomach discomfort | Gastrointestinal disorders | Systematic Assessment | Collected by patient-completed survey |
|
| Muscle weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment | Collected by patient-completed survey |
|
| Headache | Nervous system disorders | Systematic Assessment | Collected by patient-completed survey |
|
| Mood swings | Psychiatric disorders | Systematic Assessment | Collected by patient-completed survey |
|
| Increased aggression | Psychiatric disorders | Systematic Assessment | Collected by patient-completed survey |
|
| Nervouseness | Psychiatric disorders | Systematic Assessment | Collected by patient-completed survey |
|
| Difficulty sleeping | Psychiatric disorders | Systematic Assessment | Collected by patient-completed survey |
|
| High blood pressure | Vascular disorders | Systematic Assessment | Collected by patient-completed survey |
|
| Nosebleed | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| 1 month |
|
| 3 months |
|
| 6 months |
|
| 0.685 |
| Other |
| Comparison of baseline and 3 months | t-test, 2 sided | 0.388 | Other |
| Comparison of baseline and 6 months | t-test, 2 sided | 0.233 | Other |