Randomized, Placebo-controlled, Double-blind, Cross-over Trial With Bronchipret and Sinupret to Evaluate Acceleration of Mucociliary Clearance (MCC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bionorica SE
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Time to perception of sweetness
研究概览
简要总结
Proof of concept: Superiority of Bronchipret or Sinupret to placebo in respect to mucociliary clearance
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteers who have given their signed declaration of consent and have signed the data protection declaration
- •Male or female volunteers 25 - 40 years
- •Current smokers (5-20 cigarettes per day since 5 years at least)
- •Ability to taste sweetness of saccharin
- •Perception of sweetness within 30 minutes after placement of saccharin behind nasal valve
排除标准
- •Ciliary dyskinesia
- •Cystic fibrosis
- •COPD/emphysema
- •Chronic rhinosinusitis
- •Acute respiratory tract infection within the last 6 weeks prior to enrolment
- •Septal or sinus surgery
- •Symptomatic allergic rhinitis
- •Known allergic rhinitis
- •Treatment with not-permitted previous or concomitant therapy
- •History of snuff consumption for longer than 1 month or intranasal consumption of recreational drugs such as cocaine or heroin for longer than 1 month
- •Any disease or condition that might affect the safety of the subject during the trial, according to the investigator's judgement
研究组 & 干预措施
administration of Bronchipret
7 days of administration of Bronchipret, 2 FCT t.i.d
干预措施: administration of Bronchipret (Drug)
administration of Bronchipret
7 days of administration of Bronchipret, 2 FCT t.i.d
干预措施: administration of Bronchipret Placebo (Drug)
administration of Sinupret
7 days of administration of Sinupret, 2 CT t.i.d
干预措施: administration of Sinupret (Drug)
administration of Sinupret
7 days of administration of Sinupret, 2 CT t.i.d
干预措施: administration of Sinupret Placebo (Drug)
administration of Bronchipret Placebo
7 days of administration of Bronchipret Placebo, 2 FCT t.i.d
干预措施: administration of Bronchipret (Drug)
administration of Bronchipret Placebo
7 days of administration of Bronchipret Placebo, 2 FCT t.i.d
干预措施: administration of Bronchipret Placebo (Drug)
administration of Sinupret Placebo
7 days of administration of Sinupret Placebo, 2 CT t.i.d
干预措施: administration of Sinupret (Drug)
administration of Sinupret Placebo
7 days of administration of Sinupret Placebo, 2 CT t.i.d
干预措施: administration of Sinupret Placebo (Drug)
结局指标
主要结局
Time to perception of sweetness
时间窗: after 7 days of treatment
Time to perception of sweetness after 7 days of treatment with the investigational products - relative to the time to perception of sweetness at the begin-ning of treatment
次要结局
- Perception of Sweetness of Saccharin(4 - 7 weeks)