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

NCT02119273 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2019-08-28

No results posted yet for this study

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)

Interventions

DRUG

Prednisone

See arm description

DRUG

Placebo

See arm description

Sponsors & Collaborators

  • Loma Linda University

    lead OTHER

Principal Investigators

  • Kristin Seiberling, MD · Loma Linda Department of Otolaryngology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2018-04-30
Completion
2018-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02119273 on ClinicalTrials.gov