Aggravated Airway Inflammation: Research on Genomics and Optimal Operative Treatment (AirGOs Operative)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 5
- 主要终点
- Sino-nasal outcome test (SNOT-22)
研究概览
简要总结
This randomized study compares operative techniques in chronic rhinosinusitis with polyposis (CRSwNP) surgery. It aims to evaluate outcomes in asthma and CRSwNP, safety and costs. The investigators want to see if patients with certain clinical and/or genetic predispositions will benefit from extended surgery. They also aim to find biomarkers for detection and management models for of severe airway inflammation and to further develop markers for progressive disease forms.
详细描述
Please see study protocol
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient not responding to conservative treatment of 3 months of nasal steroid drops
- •Nasal polyp score ≥ 4/8
- •SNOT-22 ≥ 30
- •Lund-Mackay CT score ≥ 14
- •One previous endoscopic sinus surgery or at least one peroral corticosteroid course or at least 3 courses of antibiotics within 2 years
排除标准
- •Age <18 years, age > 65 years
- •Complication of CRS (f.e. mucocele, invasive fungal rhinosinusitis)
- •Other diagnosis than CRSwNP (inverted papilloma, antrochoanal polyp etc.)
- •Previous external sinus surgery or Draf 3 procedure (or indication for external approaches or Draf 3
- •Bleeding diathesis
- •Pregnancy/ breastfeeding
- •Cystic fibrosis
- •Primary ciliary dyskinesia (PCD)
- •Sarcoidosis
- •Granulomatosis with polyangitis (GPA)
- •Eosinophilic granulomatosis with polyangitis (EGPA)
- •Immunosupression (diagnosed Spesific Antibody Deficiency (SAD), common variable immunodeficiency (CVI), HIV or use of biologicals/immunosuppressive medication)
- •Immunotherapy
- •Daily use of systemic corticosteroids
- •Communication problems (f.e. neurological/psychiatric disease, language skills)
- •Unlikely to comply
- •Other severe disease
- •Inability to be operated.
结局指标
主要结局
Sino-nasal outcome test (SNOT-22)
时间窗: Baseline, Post-intervention every 3 months during 2 years
Change from baseline in patient symptoms as measured by the Sino-Nasal Outcomes Test (SNOT-22) survey. Scores are measured from 0-5 in a 22 item validated survey. Total scores range from 0-110 with higher scores indicating greater burden of sinonasal symptoms.
次要结局
未报告次要终点
研究者
Paula Virkkula
Chief Physician in Rhinology
Helsinki University Central Hospital