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Perioperative Oral Steroids for Chronic Rhinosinusitis Without Polyps (CRSsNP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Peter Haichin Hwang, Stanford University
ClinicalTrials.gov Identifier:
NCT02748070
First received: April 15, 2016
Last updated: April 19, 2016
Last verified: April 2016
  Purpose
While oral steroids have been shown to be effective in the management of patients with chronic rhinosinusitis with polyps, its role in treating chronic rhinosinusitis without polyps (CRSsNP) is ambiguous. Despite a lack of strong clinical evidence to suggest a benefit in this disease state, steroids are often prescribed as a component of post-operative care after sinus surgery for patients without polyps. Oral steroids carry with them significant adverse effects, and should be prescribed thoughtfully. The aims of this study are to determine if oral steroids in the peri-operative period improves patient outcomes in CRS without polyps.

Condition Intervention
Chronic Rhinosinusitis
Endoscopic Sinus Surgery
Chronic Rhinosinusitis Without Polyps
Oral Steroids
Drug: Prednisone
Drug: Flonase

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of Perioperative Systemic Steroids in Patients With Chronic Rhinosinusitis Without Polyps (CRSsNP)

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Sino-nasal Outcome Test (SNOT 22) [ Time Frame: Baseline, change from baseline 1 week after surgery, change from baseline 4-6 weeks after surgery, change from baseline 8-12 weeks after surgery , change from baseline 6 months after surgery ]
  • Lund-Kennedy score [ Time Frame: Baseline, change from baseline 1 week after surgery, change from baseline 4-6 weeks after surgery, change from baseline 8-12 weeks after surgery , change from baseline 6 months after surgery ]

Secondary Outcome Measures:
  • Steroid Side Effect Questionnaire [ Time Frame: Baseline 1 week after surgery, change from baseline 4-6 weeks after surgery ]

Estimated Enrollment: 76
Study Start Date: August 2015
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prednisone
Provided oral steroid and topical steroid
Drug: Prednisone Drug: Flonase
Placebo Comparator: Placebo
Provided oral placebo and topical steroid
Drug: Flonase

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • CRSsNP as defined by Clinical Practice Guideline (Update) on Adult Sinusitis
  • scheduled to undergo endoscopic sinus surgery

Exclusion Criteria:

  • chronic rhinosinusitis with polyps (CRSwNP)
  • Aspirin exacerbated respiratory disease
  • Cystic fibrosis
  • Immunosuppressive states (Human immunodeficiency virus, transplant)
  • Oral steroid use within 30 days of surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02748070

Contacts
Contact: Peter H Hwang, M.D. 650-725-6500 phwang@ohns.stanford.edu
Contact: Julia E Noel, M.D. 650-725-6500 jtomlin2@stanford.edu

Locations
United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Peter H Hwang, M.D.    650-725-6500    phwang@stanford.edu   
Contact: Julia E Noel, M.D.    650-725-6500    jtomlin2@stanford.edu   
Sponsors and Collaborators
Stanford University
  More Information

Responsible Party: Peter Haichin Hwang, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT02748070     History of Changes
Other Study ID Numbers: 33096
Study First Received: April 15, 2016
Last Updated: April 19, 2016

Additional relevant MeSH terms:
Polyps
Sinusitis
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

ClinicalTrials.gov processed this record on May 25, 2017