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Systemic Corticosteroids in the Perioperative Management of Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)

Primary Purpose

Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Prednisone
Placebo
Sponsored by
Loma Linda University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP) focused on measuring CRSsNP, Steroids, Corticosteroids, Endoscopic, Surgery, Perioperative

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients (ages 18-80) with a diagnosis of chronic rhinosinusitis without nasal polyps (CRSsNP) that have failed a 6 week trial of maximal medical therapy and have elected to undergo endoscopic sinus surgery will be offered enrollment in this study.
  • Diagnosis of chronic rhinosinusitis (CRS) is based on the European Position on Rhinosinusitis (EPOS) 2012 guidelines.
  • These include a greater than 12 week history of inflammation of the nose or paranasal sinuses characterized by at least 2 symptoms.

  • These symptoms must include at least one of the following:

    • nasal obstruction
    • rhinorrhea
    • postnasal drip.
  • Additional symptoms can include facial pain/pressure or anosmia/hyposmia.
  • These symptoms must be supplemented by either endoscopic signs of disease or characteristic CT changes.
  • The presence or absence of nasal polyps defines the subtype (with polyps: CRSwNP; without polyps: CRSsNP).

Exclusion Criteria:

  • Patients will be excluded if they have nasal polyps or suspected allergic fungal rhinosinusitis (AFRS) based on classic endoscopy and CT findings.
  • Additionally, patients with known immunocompromise or mucociliary disorders will be excluded.
  • Patients that received oral corticosteroids within 6 weeks prior to the planned surgery will also be excluded.

Sites / Locations

  • Loma Linda Sinus and Allergy Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Steroid

Placebo

Arm Description

The steroid arm will take prednisone 10mg tabs starting 7 days prior to surgery with a taper (4 tabs/day for 3 days, 3 tabs/day for 3 days, 2 tabs/day for 3 days, 1 tab/day for 3 days).

The placebo arm will receive placebo pills identical in appearance to prednisone 10mg pills. They will start taking them 7 days prior to surgery with a taper (4 tabs/day for 3 days, 3 tabs/day for 3 days, 2 tabs/day for 3 days, 1 tab/day for 3 days).

Outcomes

Primary Outcome Measures

Lund-Kennedy Endoscopy Score (LKES)
Objective endoscopic measure of sino-nasal mucosal health

Secondary Outcome Measures

Sino-nasal Outcomes Test (SNOT-22)
Patient completed survey that objectifies sinonasal symptoms
Boezaart bleeding score
Surgeon completed survey of bleeding during surgery
Estimated blood loss
Estimation of blood lost during surgery, as reported by anesthesiologist
Difficulty of surgery score
Surgeon completed survey of surgical difficulty

Full Information

First Posted
March 20, 2014
Last Updated
August 26, 2019
Sponsor
Loma Linda University
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1. Study Identification

Unique Protocol Identification Number
NCT02119273
Brief Title
Systemic Corticosteroids in the Perioperative Management of Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
Official Title
Systemic Corticosteroids in the Perioperative Management of Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of enrollment
Study Start Date
September 2014 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Oral corticosteroids are commonly utilized for the management of chronic rhinosinusitis with and without nasal polyps (CRSwNP and CRSsNP, respectively). Although strong evidence supports the benefit of routine and perioperative oral corticosteroids for CRSwNP, there is limited evidence to support their utility for CRSsNP. The investigators intend to perform a randomized, double blind, placebo controlled clinical trial to investigate the impact of steroids used within 2 weeks prior to surgery for CRSsNP. Patients with CRSsNP that present to the investigators office will be included if they have failed maximal medical management and have elected to undergo endoscopic sinus surgery (ESS) after July 1, 2014. The investigators hypothesis is that oral corticosteroids given 2 weeks prior to surgery will improve subjective and objective outcome measures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
Keywords
CRSsNP, Steroids, Corticosteroids, Endoscopic, Surgery, Perioperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Steroid
Arm Type
Experimental
Arm Description
The steroid arm will take prednisone 10mg tabs starting 7 days prior to surgery with a taper (4 tabs/day for 3 days, 3 tabs/day for 3 days, 2 tabs/day for 3 days, 1 tab/day for 3 days).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The placebo arm will receive placebo pills identical in appearance to prednisone 10mg pills. They will start taking them 7 days prior to surgery with a taper (4 tabs/day for 3 days, 3 tabs/day for 3 days, 2 tabs/day for 3 days, 1 tab/day for 3 days).
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
See arm description
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
See arm description
Primary Outcome Measure Information:
Title
Lund-Kennedy Endoscopy Score (LKES)
Description
Objective endoscopic measure of sino-nasal mucosal health
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Sino-nasal Outcomes Test (SNOT-22)
Description
Patient completed survey that objectifies sinonasal symptoms
Time Frame
12 weeks
Title
Boezaart bleeding score
Description
Surgeon completed survey of bleeding during surgery
Time Frame
Day of surgery
Title
Estimated blood loss
Description
Estimation of blood lost during surgery, as reported by anesthesiologist
Time Frame
Day of surgery
Title
Difficulty of surgery score
Description
Surgeon completed survey of surgical difficulty
Time Frame
Day of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients (ages 18-80) with a diagnosis of chronic rhinosinusitis without nasal polyps (CRSsNP) that have failed a 6 week trial of maximal medical therapy and have elected to undergo endoscopic sinus surgery will be offered enrollment in this study. Diagnosis of chronic rhinosinusitis (CRS) is based on the European Position on Rhinosinusitis (EPOS) 2012 guidelines. These include a greater than 12 week history of inflammation of the nose or paranasal sinuses characterized by at least 2 symptoms. These symptoms must include at least one of the following: nasal obstruction rhinorrhea postnasal drip. Additional symptoms can include facial pain/pressure or anosmia/hyposmia. These symptoms must be supplemented by either endoscopic signs of disease or characteristic CT changes. The presence or absence of nasal polyps defines the subtype (with polyps: CRSwNP; without polyps: CRSsNP). Exclusion Criteria: Patients will be excluded if they have nasal polyps or suspected allergic fungal rhinosinusitis (AFRS) based on classic endoscopy and CT findings. Additionally, patients with known immunocompromise or mucociliary disorders will be excluded. Patients that received oral corticosteroids within 6 weeks prior to the planned surgery will also be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin Seiberling, MD
Organizational Affiliation
Loma Linda Department of Otolaryngology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda Sinus and Allergy Center
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States

12. IPD Sharing Statement

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Systemic Corticosteroids in the Perioperative Management of Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)

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