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Perioperative Oral Steroids for Chronic Rhinosinusitis Without Polyps (CRSsNP)

Primary Purpose

Chronic Rhinosinusitis, Endoscopic Sinus Surgery, Chronic Rhinosinusitis Without Polyps

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prednisone
Flonase
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Rhinosinusitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Prednisone

Placebo

Arm Description

Provided oral steroid and topical steroid

Provided oral placebo and topical steroid

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
April 15, 2016
Last Updated
July 23, 2020
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT02748070
Brief Title
Perioperative Oral Steroids for Chronic Rhinosinusitis Without Polyps (CRSsNP)
Official Title
The Role of Perioperative Systemic Steroids in Patients With Chronic Rhinosinusitis Without Polyps (CRSsNP)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
July 15, 2019 (Actual)
Study Completion Date
July 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinosinusitis, Endoscopic Sinus Surgery, Chronic Rhinosinusitis Without Polyps, Oral Steroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prednisone
Arm Type
Experimental
Arm Description
Provided oral steroid and topical steroid
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Provided oral placebo and topical steroid
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Type
Drug
Intervention Name(s)
Flonase
Primary Outcome Measure Information:
Title
Sino-nasal Outcome Test (SNOT-22) Over Time
Description
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.
Time Frame
Baseline, 1, week, 1 month, 3 months, and 6 months
Title
Lund Kennedy Endoscopy Score Over Time
Description
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.
Time Frame
Baseline, 1, week, 1 month, 3 months, and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia E Noel, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael T Chang, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter H Hwang, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33662124
Citation
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.
Results Reference
derived

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Perioperative Oral Steroids for Chronic Rhinosinusitis Without Polyps (CRSsNP)

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