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Oral Steroid Treatment for Chronic Rhinosinusitis

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. Identifier: NCT01255683
Recruitment Status : Withdrawn (Lack of proposed funding.)
First Posted : December 7, 2010
Last Update Posted : April 22, 2015
Information provided by:
Oregon Health and Science University

Brief Summary:
Despite the common use of oral steroids in the management of chronic rhinosinusitis (CRS), the natural history and efficacy of this treatment modality has not been fully elucidated. Specifically, patients who have undergone prior ESS and have recalcitrant CRS, the natural history of endoscopic improvement and quality of life (QoL) outcomes, following an oral steroid taper, is poorly defined. The purpose of this non-randomized single-arm clinical trial is to evaluate the effectiveness of an oral steroid taper in improving endoscopic grading, QoL, and olfactory function as well as defining the duration of improvement, in patients with recalcitrant CRS with prior endoscopic sinus surgery (ESS).

Condition or disease Intervention/treatment
Chronic Rhinosinusitis Drug: oral corticosteroid taper

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Single-arm Clinical Evaluation of Oral Steroid Treatment for Chronic Rhinosinusitis
Study Start Date : December 2010
Estimated Primary Completion Date : November 2011
Estimated Study Completion Date : November 2011

Group/Cohort Intervention/treatment
Chronic rhinosinusitis Drug: oral corticosteroid taper
This is an observational study in which patients self-select oral steroid treatment for symptoms of CRS. Drug treatments are NOT assigned in this investigation.

Primary Outcome Measures :
  1. Health-related quality-of-life [ Time Frame: Change from baseline to 6 months ]
    The two main outcome measures to evaluate changes in QoL include the Sinonasal Outcome Test-22 (SNOT-22) and Nasal Obstruction Scoring Evaluation (NOSE) instruments. The SNOT-22 is a validated, 22-item outcome measure applicable to both sinonasal conditions and surgical treatments (score range: 0-110). Lower total scores on the SNOT-22 imply better QoL. The SNOT-22 will be administered by the Study Coordinator to study participants at baseline, as well as 2 week, 1 month, 3 month, and 6 month follow-up appointments.

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:   No
Sampling Method:   Probability Sample
Study Population
Adult study population with a confirmed diagnosis of chronic sinusitis presenting to the tertiary rhinology clinic at Oregon Health & Science University (OHSU).

Inclusion Criteria:

  • Adult ( > 18 years of age)
  • CRS defined by 2007 Adult Sinusitis Guidelines.12
  • Subject must be able to complete QoL questionnaires written in English
  • Previous sinus surgery including unilateral or bilateral total ethmoidectomy
  • Minimum nasal blockage score on SinoNasal Outcomes Test-22 (SNOT-22) > 3
  • Severe sinonasal inflammation where the next treatment option is a 12- day oral prednisone taper
  • Obstruction of the ethmoid sinus region or middle meatus eligible for revision endoscopic sinus surgery
  • Lund-Kennedy endoscopy score > 4
  • Elects 12-day tapering dose of oral steroids (Prednisone) as a next treatment option

Exclusion Criteria:

  • Unable to complete questionnaires or clinical testing or cooperate with study evaluations in English
  • Contra-indication to oral steroids
  • Endoscopic sinus surgery < 3 months of presentation
  • Completed course of oral corticosteroids within the previous 3 month period
  • Subjects presenting with unilateral chronic rhinosinusitis
  • Pregnancy or possibility to become pregnant during the study

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 identifier (NCT number): NCT01255683

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United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
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Responsible Party: Timothy L. Smith, MD, MPH, Oregon Health & Science University Identifier: NCT01255683    
Other Study ID Numbers: unfunded2
First Posted: December 7, 2010    Key Record Dates
Last Update Posted: April 22, 2015
Last Verified: December 2010
Keywords provided by Oregon Health and Science University:
Additional relevant MeSH terms:
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Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases