Efficacy and Safety of Budesonide Inhalation Suspension Via Transnasal Nebulization Compared With Budesonide Aqueous Nasal Spray and Oral Steroids for the Treatment of Chronic Rhinosinusitis With Polyposis.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 主要终点
- Clinical responses including 4 major symptoms(nasal obstruction, rhinorrhea, loss of smell,and headache/facial pain)
研究概览
简要总结
Topical and systemic steroids constitute the first choice in medical treatment for nasal polyps. This study aimed to evaluate the efficacy and safety of a short course of budesonide inhalation suspension via transnasal nebulization in the preoperative management of chronic rhinosinusitis with nasal polyposis. The second aim was to compare budesonide inhalation suspension with budesonide aqueous nasal spray and oral prednisone in nasal polyp treatment.
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
- 23 Years 至 64 Years（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 (nasal obstruction, rhinorhea, loss of smell, and headache/facial pain) for at least 12 weeks, confirmed by abnormalities in all sinuses on computed tomography (CT) scan. The diagnosis of CRSwNP was based on the standard criteria issued in the European Position Paper on Rhinosinusitis and Nasal Polyps guidelines.
- •Bilateral nasal polyps were present and endoscopic biopsy demonstrated eosinophilic polyposis. Patients were not recruited who had large polyps (total Kennedy score＝6).
排除标准
- •a previous oral corticosteroid treatment.
- •recent sinus surgery
- •ASA intolerance
- •cystic fibrosis
- •pregnancy
- •serious or unstable concurrent disease or psychological disorder.
研究组 & 干预措施
budesonide inhalation suspension
干预措施: budesonide (Drug)
budesonide aqueous nasal spray
干预措施: budesonide (Drug)
oral steroids
干预措施: Prednisone (Drug)
结局指标
主要结局
Clinical responses including 4 major symptoms(nasal obstruction, rhinorrhea, loss of smell,and headache/facial pain)
时间窗: 2 weeks
The primary efficacy outcome measure was the patients' assessment of four major symptoms improvement on an ordinal scaled visual analogue score of 0 to 10, where 0 indicates that no symptom is present and 10 signifies the presence of the most severe nasal obstruction, rhinorrhea, alteration in the sense of smell and headache/ facial pain.
次要结局
- Physicians' assessment of nasal polyp size reduction(2 weeks)