Single-arm Clinical Evaluation of Oral Steroid Treatment for Chronic Rhinosinusitis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Health-related quality-of-life
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Chronic rhinosinusitis
干预措施: oral corticosteroid taper (Drug)
结局指标
主要结局
Health-related quality-of-life
时间窗: 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.
次要结局
未报告次要终点