Prospective Randomized, Placebo-controlled Clinical Study to Study the Effect of Postoperative Additive Systemic Steroids in Chronic Rhinosinusitis With Nasal Polyps
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 106
- 主要终点
- Nasal Polyp Score (NPS)
研究概览
简要总结
This study investigate the additive effect of systemic postoperative steroids in patients with chronic rhinosinusitis (CRSwNP). All patients receive a functional endoscopic sinus surgery (FESS) followed by topical steroid spray for 3 months. Postoperatively, patients will be randomized to either an additional systemic steroid or a placebo for 1 month. Patients will be followed for 2 years. Effect on Nasal Polyp score (NPS), Lund-Kennedy-Score (LKS), recurrence rates, smell scores, Rhinosinusitis Disability Index (RSDI), Short-Form 36 (SF-36) and mucus/serum biomarkers will be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
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
- •refractory to medical therapy
- •no previous sinus surgery
- •Lund-Kennedy-Score ≥ 1
- •Lund-Mackay-Score ≥ 10
排除标准
- •ciliary impairment
- •autoimmune disease
- •cystic fibrosis
- •immunodeficiency
研究组 & 干预措施
Systemic steroid (Prednisolone)
Prednisolone 50mg (tapered down until postoperative day (POD) 14, then 5mg for 14 days), tablets
干预措施: Systemic Steroid (Prednisolone) (Drug)
Placebo
Lactose monohydrate, tablets
干预措施: Placebo (Other)
结局指标
主要结局
Nasal Polyp Score (NPS)
时间窗: first visit until 24 months, change is measured between baseline and each follow-up time point up to 24 months (follow-up time points are as follows: 3 weeks, 3 months, 6 months, 9 months, 12 months, 18 months)
Each nostril will be assessed separately. The highest score will be graded. Each nostril will be scored from 0-4 (0=no polyps, 1=polyps confined to the middle meatus, 3=polyps extending beyond middle meatus, 4=large polyps causing almost complete nasal obstruction)
次要结局
- Lund-Kennedy-Score (LKS)(first visit until 24 months, change is measured between baseline and each follow-up time point up to 24 months (follow-up time points are as follows: 3 weeks, 3 months, 6 months, 9 months, 12 months, 18 months))
- Smell Scores(first visit until 24 months, change is measured between baseline and each follow-up time point up to 24 months (follow-up time points are as follows: 3 weeks, 3 months, 6 months, 9 months, 12 months, 18 months))
- Sinonasal Symptom Score(first visit until 24 months, change is measured between baseline and each follow-up time point up to 24 months (follow-up time points are as follows: 3 weeks, 3 months, 6 months, 9 months, 12 months, 18 months))
- Mucus and serum biomarker levels(first visit until 24 months, change is measured between baseline and each follow-up time point up to 24 months (follow-up time points are as follows: 3 weeks, 3 months, 6 months, 9 months, 12 months, 18 months))
- RSDI (Rhinosinusitis Disability Index)(first visit until 24 months, change is measured between baseline and each follow-up time point up to 24 months (follow-up time points are as follows: 3 weeks, 3 months, 6 months, 9 months, 12 months, 18 months))
- SF-36 (Short Form-36)(first visit until 24 months, change is measured between baseline and each follow-up time point up to 24 months (follow-up time points are as follows: 3 weeks, 3 months, 6 months, 9 months, 12 months, 18 months))
- Recurrence rates(first visit until 24 months, change is measured between baseline and each follow-up time point up to 24 months (follow-up time points are as follows: 3 weeks, 3 months, 6 months, 9 months, 12 months, 18 months))
研究者
Sarina Mueller
PD Dr. med.
Friedrich-Alexander-Universität Erlangen-Nürnberg