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

NCT02119273 | Withdrawn Phase 4

• 1 other identifier: 5140031
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)

Keywords

CRSsNP; Steroids; Corticosteroids; Endoscopic; Surgery; Perioperative

Outcome Measures

Primary Outcomes (1)

• Lund-Kennedy Endoscopy Score (LKES)

  Objective endoscopic measure of sino-nasal mucosal health

  12 weeks

Secondary Outcomes (4)

• Sino-nasal Outcomes Test (SNOT-22)

  12 weeks

• Boezaart bleeding score

  Day of surgery

• Estimated blood loss

  Day of surgery

• Difficulty of surgery score

  Day of surgery

Study Arms (2)

Steroid

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Prednisone DRUG

See arm description

Steroid

Placebo DRUG

See arm description

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda Sinus and Allergy Center

Redlands, California, 92374, United States

Location

MeSH Terms

Interventions

Prednisone

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Kristin Seiberling, MD

  Loma Linda Department of Otolaryngology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: March 20, 2014
• First Posted: April 21, 2014
• Study Start: September 1, 2014
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

US (1)