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Completed

NCT Number: NCT02927834

Oral Steroids in Chronic Rhinosinusitis Without Nasal Polyps

Chronic rhinosinusitis is a common disease that effects millions of people world wide. Despite its frequency it is unclear what treatment options are the best for these patients. Typically patients with chronic rhinosinusitis without nasal polyps (CRSsNP) are given a long term antibiotic (3 weeks), nasal steroid sprays, saline nasal irrigation and occasionally oral steroids. Oral steroids benefit patients with chronic rhinosinusitis with nasal polyps (CRSwNP) however their role in non polyp patients is less clear. It is the goal of this study to see if oral steroids benefit the treatment outcomes in those patients with chronic rhinosinusitis without nasal polyps. In addition this study will look to see if a short course (5 day burst) versus a longer course (21 day taper) of oral steroids make a difference in outcomes.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

About this study

The investigators will compare patients with CRSsNP who are treated with antibiotics/nasal steroid sprays, and compare them to chronic sinusitis patients who receive antibiotics/nasal steroid spray along with a course of oral steroids. The goal is to determine if oral steroids have a role in CRSsNP, and if so, the most effective dosage.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • They have three-months of persistent symptoms meeting criteria for chronic rhinosinusitis as defined by the taskforce on rhinosinusitis.
  • They have a CT-scan in the clinic or have a viewable recent (< 3 weeks prior to clinic visit) CT-scan with a Lund Mackay score of 6 or greater. A Lund Mackay score of 6 or greater is felt to be indicative of at least moderate CRS.
  • They do not have nasal polyps on initial clinic nasal endoscopy
  • They are willing to participate in a clinical study
  • They are between the ages of 18 to 80.

Exclusion criteria

  • They have a condition in which the use of systemic corticosteroids is contraindicated such as diabetes will be excluded.
  • They are unable to or unwilling to take the prescribed antibiotics or steroids will excluded.
  • They have been treated with a > 3 week course of antibiotics and/or systemic steroids will also be excluded.
  • They have variants of chronic sinusitis known to be refractory to medical therapy such as Wegener's granulomatosis, primary ciliary dyskinesia or sarcoidosis.
  • They have sinusitis secondary to prior surgery, a dental procedure or anatomical variants.
  • They have nasal polyps on physical exam.
  • They are pregnant. Subjects who are possibly pregnant will be excluded based on history. Pregnancy testing is not standard of care for diagnostic imaging.
  • They have a Lund-Mackay score on CT scan of < 6
  • They are < 18 or > 80 years old

Treatment and study plan

6 day Prednisone

Drug

6 day prednisone burst

Augmentin

Drug

Antibiotic augmentin for 3 weeks

21 day Prednisone

Drug

21 day prednisone burst

Primary outcomes

  1. Sinonasal Outcome Test (SNOT 20)

    Time frame: 4 weeks post treatment

    Sinonasal outcome test to access nasal/sinus symptoms. 20 questions, each question scored 0-5. 0 meaning no symptoms, 5 worse. 0- 100 total with lower number meaning better outcome

  2. Nasal Endoscopy

    Time frame: 4 weeks post treatment

    Physical exam findings of the nasal cavity. Scored 0-12. Lower score is better

  3. CT Scan Changes

    Time frame: 4 week post treatment

    CT scan of the sinuses, Lund Mackay score to access severity of sinus disease on CT scan. Scored on scale 0-20 with lower score better.

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study title

The Role of Oral Steroids in the Management of Chronic Rhinosinusitis Without Nasal Polyps

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Oct 7, 2016
Registry last updated
Dec 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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