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

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.

Study Overview

• Status: Withdrawn
• Conditions: Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
• Intervention / Treatment: Drug: Placebo; Drug: Prednisone

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Redlands, California, United States, 92374
      • Loma Linda Sinus and Allergy Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Steroid; 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).	Drug: Prednisone; See arm description
PLACEBO_COMPARATOR: Placebo; 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).	Drug: Placebo; See arm description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lund-Kennedy Endoscopy Score (LKES)	Objective endoscopic measure of sino-nasal mucosal health	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sino-nasal Outcomes Test (SNOT-22)	Patient completed survey that objectifies sinonasal symptoms	12 weeks
Boezaart bleeding score	Surgeon completed survey of bleeding during surgery	Day of surgery
Estimated blood loss	Estimation of blood lost during surgery, as reported by anesthesiologist	Day of surgery
Difficulty of surgery score	Surgeon completed survey of surgical difficulty	Day of surgery

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Kristin Seiberling, MD, Loma Linda Department of Otolaryngology

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (ACTUAL): April 1, 2018
• Study Completion (ACTUAL): April 1, 2018

Study Registration Dates

• First Submitted: March 20, 2014
• First Submitted That Met QC Criteria: April 18, 2014
• First Posted (ESTIMATE): April 21, 2014

Study Record Updates

• Last Update Posted (ACTUAL): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 26, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Surgery; Perioperative; Steroids; Corticosteroids; Endoscopic; CRSsNP
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Pathological Conditions, Anatomical; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Nasal Polyps; Polyps; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisone
• Other Study ID Numbers: 5140031