NCT01225965已完成不适用
An Efficacy and Feasibility Study to Investigate the Effect of Ectoin® Inhalation Solution (EIL) in Subjects With Inflammation and Airway Obstruction Followed by a Long Term Study Extension on the Prevention of Lung Function Decline
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bitop AG
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Reduction of inflammatory markers considered to be indicative for the protective efficacy of EIL in pulmonary inflammation in COPD
研究概览
简要总结
To investigate the physical inflammation inhibition effects of EIL (Ectoin-Hydro-Complex) in subjects of the established SALIA-cohort and the preventive effects on lung function decline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 75 Years 至 80 Years（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal females (75 - 80 years)
- •FEV1/FVC < 0,77 (in the investigation 2007/2008)
- •Inflammatory markers TFN-alpha > median or neutrophilic granulocytes > median (investigation 2007/2008)
- •Non smokers or ex smokers who have stopped smoking for longer than 6 months
排除标准
- •Participation in another clinical study in the previous month
- •Severe concomitant disease which may have an impact on the study participation
- •Hypersensitivity against Ectoin
- •Myocardial infarction or apoplexy within the last year
- •Uncontrolled hypertension: systolic blood pressure >200 mmHg or diastolic pressure >120 mmHg
- •Known aortic aneurysm
- •Other respiratory diseases (e.g. cystic fibrosis, alpha-1-Antitrypsin deficiency, sarcoidosis, allergic alveolitis, tuberculosis, etc.)
- •Patients who have had treatment with live attenuated vaccinations within 14 days prior to screening visit (Inactivated influenza vaccination is acceptable, provided it is not administered within 7 days prior to screening visit)
- •on investigators decision
研究组 & 干预措施
EIL05, Inhalation
Experimental
干预措施: Ectoin Inhalation Solution (Device)
Placebo, 0,9% NaCl
Placebo Comparator
干预措施: Placebo (Device)
结局指标
主要结局
Reduction of inflammatory markers considered to be indicative for the protective efficacy of EIL in pulmonary inflammation in COPD
时间窗: Baseline and 28 days after treatment start
Change of biomarkers in spautum, exhaled breath condensate and serum after treatment compared to baseline.
次要结局
- Vital signs(Baseline and 28 days after treatment start)
- Reduction of lung function decline(Baseline and 28 days after treatment start)
- Need for rescue medication(28 days (during treatment phase))
- Occurence of adverse events(28 days (during treatment phase))
- Lung function parameters(28 days (during treatment phase))
- Change in Quality of life(Baseline and 28 days after treatment start)
研究者
研究点 (1)
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