Perioperative Oral Steroids for Chronic Rhinosinusitis Without Polyps (CRSsNP)

Not Applicable

Completed

• Conditions: Endoscopic Sinus Surgery; Oral Steroids; Chronic Rhinosinusitis Without Polyps; Chronic Rhinosinusitis
• Interventions: Drug: Flonase; Drug: Prednisone

• Registration Number: NCT02748070
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2016-04-15
• Study First Submitted QC: 2016-04-19
• Study First Posted: 2016-04-22
• Primary Completion: 2019-07-15
• Study Completion: 2019-07-15
• Status Verified: 2020-07
• Results First Submitted: 2020-07-13
• Results First Submitted QC: 2020-07-13
• Last Update Submitted: 2020-07-23
• Results First Posted: 2020-07-24
• Last Update Posted: 2020-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

• CRSsNP as defined by Clinical Practice Guideline (Update) on Adult Sinusitis
• scheduled to undergo endoscopic sinus surgery

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Flonase	Provided oral placebo and topical steroid
Prednisone	Flonase	Provided oral steroid and topical steroid
Prednisone	Prednisone	Provided oral steroid and topical steroid

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States