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

Phase 4

Withdrawn

• Conditions: Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
• Interventions: Drug: Placebo; Drug: Prednisone

• Registration Number: NCT02119273
• Lead Sponsor: Loma Linda University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-20
• Study First Submitted QC: 2014-04-18
• Study First Posted: 2014-04-21
• Study Start: 2014-09
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-26
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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).
Steroid	Prednisone	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).

Primary Outcome Measures

Name	Time	Method
Lund-Kennedy Endoscopy Score (LKES)	12 weeks	Objective endoscopic measure of sino-nasal mucosal health

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Loma Linda Sinus and Allergy Center; 🇺🇸 Redlands, California, United States