A Pilot Study to Investigate the Efficacy and Safety of Buparid/PARI SINUS Versus Budes® Nasal Spray in the Therapy of Chronic Rhinosinusitis (CRS) With Polyposis Nasi in Adult Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 4
- 主要终点
- Change of Inflammation of the Nasal Mucosa and Paranasal Sinus
研究概览
简要总结
The study should create data for the selection of a clinically relevant primary endpoint to assess the efficacy and safety of Buparid/PARI SINUS as compared to Budes Nasal Spray in the therapy of chronic rhinosinusitis (CRS) with polyposis nasi in adult patients. Ideally, the selected parameter should allow a correlation between an objective methodology and the clinical outcome of the study patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with confirmed diagnosis of chronic rhinosinusitis (CRS) with polyposis nasi grade I-III
- •Patient with a PNIF of > 7 l/min separated for left and right side of the nose
- •Patient's written informed consent
- •Male or female,>= 18 years of age
- •Patient is able to undergo nasal therapy without restrictions
- •Capable of understanding the purpose and risk of the clinical trial
- •Female patients with childbearing potential must have a negative urine pregnancy test prior to first IMP administration
- •Patient has completed correctly the diary during the Wash-in Phase
排除标准
- •Patients with cystic fibrosis
- •Patients with polyposis nasi grade IV
- •Patients with prior sinonasal surgery (exemption: polypectomy)
- •Patients with primary ciliaritis
- •Pregnant or breastfeeding women
- •Patients with suspected active upper airway infection
- •Receipt of an investigational drug as part of a clinical trial within 4 weeks prior to first administration of IMP
- •Drug or alcohol abuse
- •End-stage malignancies
- •Known hypersensitivity to Budesonide
- •Patients with oral steroid therapy within the last 4 weeks
- •Patients with frequent epistaxis (> 2 per month)
研究组 & 干预措施
Budes; Treatment B
Budes® Nasal Spray 50 µg budesonide/pump
干预措施: Budesonide (Drug)
Buparid; Treatment A
Buparid 1 mg budesonide/2 ml nebuliser solution
干预措施: Budesonide (Drug)
结局指标
主要结局
Change of Inflammation of the Nasal Mucosa and Paranasal Sinus
时间窗: Change from Baseline to Week 8
Inflammation of the nasal mucosa and paranasal sinus was assessed using the Lund-Mackay score based on magnetic resonance imaging. The score can take on values between 0 and 24 points, with higher values indicating more severe impairment. The outcome investigated is the intraindividual mean score of 2 independent raters assessing the same images.
次要结局
- Safety Assessment(up to 26 weeks)