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

Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02119273
• Other study ID #: 5140031
• Status: Withdrawn
• Phase: Phase 4
• Start date: September 2014
• Est. completion date: April 2018

Study information

• Verified date: August 2019
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
• Nasal Polyps
• Polyps
• Sinusitis

Intervention

Drug:
• Prednisone
See arm description
• Placebo
See arm description

Locations

Country	Name	City	State
United States	Loma Linda Sinus and Allergy Center	Redlands	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lund-Kennedy Endoscopy Score (LKES)	Objective endoscopic measure of sino-nasal mucosal health	12 weeks
Secondary	Sino-nasal Outcomes Test (SNOT-22)	Patient completed survey that objectifies sinonasal symptoms	12 weeks
Secondary	Boezaart bleeding score	Surgeon completed survey of bleeding during surgery	Day of surgery
Secondary	Estimated blood loss	Estimation of blood lost during surgery, as reported by anesthesiologist	Day of surgery
Secondary	Difficulty of surgery score	Surgeon completed survey of surgical difficulty	Day of surgery