Perioperative Oral Steroids for Chronic Rhinosinusitis Without Polyps (CRSsNP)

Stanford University

Status: Completed

Conditions: Chronic Rhinosinusitis; Chronic Rhinosinusitis Without Polyps; Endoscopic Sinus Surgery; Oral Steroids

Treatments: Drug: Prednisone; Drug: Flonase

Study type: Interventional

Funder types: Other

Identifiers

NCT02748070

33096

Details and patient eligibility

About

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.

Enrollment: 81 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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81 participants in 2 patient groups, including a placebo group

Prednisone

Experimental group

Description:

Provided oral steroid and topical steroid

Treatment:

Drug: Prednisone

Drug: Flonase

Placebo

Placebo Comparator group

Description:

Provided oral placebo and topical steroid

Treatment:

Drug: Flonase