EUCTR2012-004864-24-BE进行中（未招募）1 期
Randomized, placebo-controlled, double-blind, cross-over trial with Bronchipret and Sinupret to evaluate acceleration of mucociliary clearance (MCC)
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Bionorica SE
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female volunteers 25 - 40 years (females being non-pregnant/non-breast-feeding and applying a safe method of contraception)
- •3. Current smokers (5-20 cigarettes per day since at least 5 years for a maximum of 20 years)
- •4. Ability to taste sweetness of saccharin
- •5. Perception of sweetness within 30 minutes after placement of saccharin behind nasal valve
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 56
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Ciliary dyskinesia
- •2. Cystic fibrosis
- •3. COPD/emphysema
- •5. Chronic rhinosinusitis
- •6. Acute respiratory tract infection within the last 6 weeks prior to enrolment
- •7. Septal or sinus surgery
- •8. Symptomatic allergic rhinitis
- •9. Known allergic rhinitis
- •10. Treatment with not-permitted previous or concomitant therapy
- •11. 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
- •12. Any disease or condition that might affect the safety of the subject during the trial, according to the investigator’s judgement
研究者
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