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Perioperative Oral Steroids for Chronic Rhinosinusitis Without Polyps (CRSsNP)

This study is currently recruiting participants.
Verified April 2016 by Peter Haichin Hwang, Stanford University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02748070
First Posted: April 22, 2016
Last Update Posted: April 22, 2016
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):
Peter Haichin Hwang, Stanford University
  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: Quadruple (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 Peter Haichin Hwang, 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
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): 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
First Submitted: April 15, 2016
First Posted: April 22, 2016
Last Update Posted: April 22, 2016
Last Verified: April 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