Effects and Safety of Budesonide Inhalation Suspension Via Transnasal Nebulization in Eosinophilic Chronic Rhinosinusitis With Nasal Polyps
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- reduction of nasal polyp size
研究概览
简要总结
This randomized, double-blind, placebo-controlled clinical trial enrolled subjects with eosinophilic CRSwNP. Subjects were randomized to receive either budesonide inhalation suspension or placebo for 14 days. Visual analogue scales (VAS）of nasal symptoms, endoscopic polyp scores and morning serum cortical levels were assessed pre- and post-treatment. Polyp samples were evaluated for inflammatory cytokines, matrix metalloproteinases (MMPs) and tissue inhibitors of metalloproteinases (TIMPs) by immunoassay; collagen by histochemistry; and frequencies of different inflammatory T cell infiltration by flow cytometry. this study is undertaken to evaluate the efficacy of short-term prescription of budesonide inhalation suspension via transnasal nebulization by clinical and immunologic assessments. As outcome parameters for remodeling, differences in the expression of collagen and albumin were investigated before and after budesonide treatment. Meanwhile, TGF-β, MMPs and TIMPs expression differences in nasal polyps were investigated to explore underlying mechanisms of tissue reconstitution.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Diagnosis of chronic rhinosinusitis was made on the basis of symptoms of rhinosinusitis for at least 12 weeks, confirmed by abnormalities in all sinuses on computed tomography scan.
- •Bilateral nasal polyps were present.
- •CRSwNP was defined as eosinophilic when percent of tissue eosinophils exceeded 10% of total infiltrating cells.
- •All patients had taken no steroids or antibiotics for at least 4 weeks before sample collection.
排除标准
- •cystic fibrosis
- •pregnancy
- •serious or unstable concurrent disease
- •psychological disorder.
研究组 & 干预措施
placebo
干预措施: placebo (Other)
budesonide
干预措施: budesonide (Drug)
结局指标
主要结局
reduction of nasal polyp size
时间窗: from baseline to two weeks
endoscopic polyp scores are assessed pre- and post-treatment.
patients' assessment of symptoms improvement
时间窗: from baseline to two weeks
Four major symptoms, including nasal obstruction, discharge, loss of smell, headache/ facial pain, and TNSS were assessed by the patient pre- and post-treatment
次要结局
- remodeling effect of budesonide transnasal nebulization in CRSwNP(from baseline to 2 weeks)
- immunologic effect of budesonide transnasal nebulization in CRSwNP(from baseline to 2 weeks)
研究者
Luo Zhang
Director, Beijing Institute of Otolaryngology.
Beijing Tongren Hospital