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

This study is currently recruiting participants.
Verified March 2017 by Kristin Seiberling, MD, Loma Linda University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02119273
First Posted: April 21, 2014
Last Update Posted: March 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Kristin Seiberling, MD, Loma Linda University
  Purpose
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.

Condition Intervention Phase
Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP) Drug: Prednisone Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Systemic Corticosteroids in the Perioperative Management of Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)

Resource links provided by NLM:


Further study details as provided by Kristin Seiberling, MD, Loma Linda University:

Primary Outcome Measures:
  • Lund-Kennedy Endoscopy Score (LKES) [ Time Frame: 12 weeks ]
    Objective endoscopic measure of sino-nasal mucosal health


Secondary Outcome Measures:
  • Sino-nasal Outcomes Test (SNOT-22) [ Time Frame: 12 weeks ]
    Patient completed survey that objectifies sinonasal symptoms

  • Boezaart bleeding score [ Time Frame: Day of surgery ]
    Surgeon completed survey of bleeding during surgery

  • Estimated blood loss [ Time Frame: Day of surgery ]
    Estimation of blood lost during surgery, as reported by anesthesiologist

  • Difficulty of surgery score [ Time Frame: Day of surgery ]
    Surgeon completed survey of surgical difficulty


Estimated Enrollment: 24
Study Start Date: September 2014
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02119273


Contacts
Contact: Kristin Seiberling, MD 909-558-4000 ext 22600 kseiberling@llu.edu

Locations
United States, California
Loma Linda Sinus and Allergy Center Recruiting
Redlands, California, United States, 92374
Contact: Kristin Seiberling, MD    909-558-4000 ext 22600    kseiberling@llu.edu   
Principal Investigator: Kristin Seiberling, MD         
Sub-Investigator: Christopher Church, MD         
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: Kristin Seiberling, MD Loma Linda Department of Otolaryngology
  More Information

Responsible Party: Kristin Seiberling, MD, Physician, Loma Linda University
ClinicalTrials.gov Identifier: NCT02119273     History of Changes
Other Study ID Numbers: 5140031
First Submitted: March 20, 2014
First Posted: April 21, 2014
Last Update Posted: March 27, 2017
Last Verified: March 2017

Keywords provided by Kristin Seiberling, MD, Loma Linda University:
CRSsNP
Steroids
Corticosteroids
Endoscopic
Surgery
Perioperative

Additional relevant MeSH terms:
Polyps
Sinusitis
Nasal Polyps
Pathological Conditions, Anatomical
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Prednisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents