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).
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Single-arm Clinical Evaluation of Oral Steroid Treatment for Chronic Rhinosinusitis|
- 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.
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||November 2011|
|Estimated Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01255683
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|