Perioperative Oral Steroids for Chronic Rhinosinusitis Without Polyps (CRSsNP)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2019-07-15

Brief Summary

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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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Detailed Description

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Conditions

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Chronic Rhinosinusitis Endoscopic Sinus Surgery Chronic Rhinosinusitis Without Polyps Oral Steroids

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Prednisone

Provided oral steroid and topical steroid

Group Type EXPERIMENTAL

Prednisone

Intervention Type DRUG

Flonase

Intervention Type DRUG

Placebo

Provided oral placebo and topical steroid

Group Type PLACEBO_COMPARATOR

Flonase

Intervention Type DRUG

Interventions

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Prednisone

Intervention Type DRUG

Flonase

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes