Oral Steroid Treatment for Chronic Rhinosinusitis

This study has been withdrawn prior to enrollment.
(Lack of proposed funding.)
Sponsor:
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01255683
First received: December 6, 2010
Last updated: April 7, 2011
Last verified: December 2010

December 6, 2010
April 7, 2011
December 2010
November 2011   (final data collection date for primary outcome measure)
Health-related quality-of-life [ Time Frame: Change from baseline to 6 months ] [ Designated as safety issue: No ]
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.
Health-related quality-of-life [ Time Frame: Change from baseline to 6 months ] [ Designated as safety issue: No ]
The two main outcome measures to evaluate changes in QoL include the SNOT-22 and NOSE instruments. The SNOT-22 is a validated, 22-item outcome measure applicable to both sinonasal conditions and surgical treatments (score range: 0-110). Derived from the SNOT-20, two additional questions were added to measure nasal blockage and sense of taste/smell. 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.
Complete list of historical versions of study NCT01255683 on ClinicalTrials.gov Archive Site
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Oral Steroid Treatment for Chronic Rhinosinusitis
Single-arm Clinical Evaluation of Oral Steroid Treatment for Chronic Rhinosinusitis

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).

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Adult study population with a confirmed diagnosis of chronic sinusitis presenting to the tertiary rhinology clinic at Oregon Health & Science University (OHSU).

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.
Chronic rhinosinusitis
Intervention: Drug: oral corticosteroid taper
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
25
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01255683
unfunded2
No
Timothy L. Smith, MD, MPH, Oregon Health & Science University
Oregon Health and Science University
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Oregon Health and Science University
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP