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Perioperative Oral Steroids for Chronic Rhinosinusitis Without Polyps (CRSsNP)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02748070
Recruitment Status : Completed
First Posted : April 22, 2016
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Peter Hwang, Stanford University

Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Rhinosinusitis Endoscopic Sinus Surgery Chronic Rhinosinusitis Without Polyps Oral Steroids Drug: Prednisone Drug: Flonase Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
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)
Study Start Date : August 2015
Actual Primary Completion Date : July 2019
Actual Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids
Drug Information available for: Prednisone

Arm Intervention/treatment
Experimental: Prednisone
Provided oral steroid and topical steroid
Drug: Prednisone
Drug: Flonase
Placebo Comparator: Placebo
Provided oral placebo and topical steroid
Drug: Flonase



Primary Outcome Measures :
  1. 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 ]
  2. 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 :
  1. Steroid Side Effect Questionnaire [ Time Frame: Baseline 1 week after surgery, change from baseline 4-6 weeks after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University

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Responsible Party: Peter Hwang, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT02748070    
Other Study ID Numbers: 33096
First Posted: April 22, 2016    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Sinusitis
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