Perioperative Oral Steroids for Chronic Rhinosinusitis Without Polyps (CRSsNP)

Chronic Rhinosinusitis Clinical Trial

Official title:

The Role of Perioperative Systemic Steroids in Patients With Chronic Rhinosinusitis Without Polyps (CRSsNP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02748070
• Other study ID #: 33096
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: July 15, 2019

Study information

• Verified date: July 2020
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: July 15, 2019
• Est. primary completion date: July 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Rhinosinusitis
• Chronic Rhinosinusitis Without Polyps
• Endoscopic Sinus Surgery
• Oral Steroids
• Polyps
• Sinusitis

Intervention

Drug:
• Prednisone

• Flonase

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline, 1, week, 1 month, 3 months, and 6 months
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.	Baseline, 1, week, 1 month, 3 months, and 6 months