A Pilot Study to Investigate the Potential of Buparid/PARI SINUS Versus Budes® Nasal Spray to Avoid or Postpone Sinus Surgery in Adult Patients With Chronic Rhinosinusitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 3
- 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 endpoint to assess the potential of Buparid/PARI SINUS to postpone sinus surgery in patients with chronic Rhinosinusitis.
详细描述
The objective of this study is to analyse whether Buparid/PARI SINUS has a higher potential to avoid or postpone sinus surgery in adult patients with CRS than Standard of Care therapy with Budes® Nasal Spray. The results of this study are expected to provide estimates for a proper sample size calculation to conduct a pivotal study.
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
- •Patient without alternative other than sinus surgery
- •Patient's written informed consent obtained prior to any screening or study-specific procedure
- •Male or female, ≥ 18 years of age
- •Patient is able to undergo nasal therapy without restrictions
- •Capable to correctly use the PARI SINUS device
- •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 is able to participate in the study according to Investigator's opinion
排除标准
- •Patients with cystic fibrosis
- •Patients with polyposis nasi grade I-IV
- •Patients with prior FESS (Functional Endoscopic Sinus Surgery)
- •Pregnant or breastfeeding women
- •Any active invasive bacterial, viral or fungal infection within one week prior to first investigational medicinal product (IMP) administration
- •No clinically relevant abnormal parameters of vital signs, blood biochemistry or renal/hepatic function
- •Unlikely to comply with visits, inhalation procedures or other measurements scheduled in the protocol
- •Receipt of an investigational drug as part of a clinical trial within 4 weeks prior to first administration of IMP
- •Any co-existing medical condition that in the Investigator's judgement will substantially increase the risk associated with the patient's participation in the clinical trial
- •Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary procedures
- •Drug or alcohol abuse
- •End-stage malignancies
- •Known hypersensitivity to Budesonide
- •Patients with oral steroid therapy within the last 3 months
- •Patients needing > 1 mg/day Budesonide (or steroidal equivalent) for therapy of asthma
- •Patients on therapy with leukotriene-receptor antagonists, decongestants, antihistamines or antibiotics
- •Patients with frequent epistaxis (> 1 episode per week)
研究组 & 干预措施
Buparid; Treatment A
Buparid 1mg budesonide/2 ml nebulizer solution
干预措施: Budesonide (Drug)
Budes; Treatment B
Budes Nasal Spray 50 µg budesonide/pump
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 thickness of the mucosa or opacification. The outcome investigated is the intraindividual mean score of 2 independent raters assessing the same images.
次要结局
- Nasal Obstruction(4 weeks / 8 weeks)
- Health-specific Quality of Life(change of SNOT-20 total score from baseline to week 48)
- Inflammation of the Nasal Mucosa and Paranasal Sinus(Changes from Baseline at Week 8)
- Safety Assessment(48 weeks)