Investigator Initiated, Placebo Controlled, Randomized Pilot Trial on the Influence of Fluticasone and Salmeterol on Airway Dendritic Cells (DCs) in Smokers With COPD Stage GOLD 0 or 1.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- The number and the CCR7 expression of DCs in bronchoalveolar lavage fluid before and after therapy with fluticasone or fluticasone/salmeterol, as compared to placebo.
研究概览
简要总结
Airway dendritic cells (DCs) play a key role in smoke-related lung diseases. In this study, the researchers investigate the effects of fluticasone and salmeterol on human airway DCs in smokers. The researchers hypothesize that fluticasone and salmeterol impact on the number and the characteristics of airway DCs in smokers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men aged 30 - 60 years
- •At least 15 years of smoking
- •Current smoker, at least 10 cigarettes per day
排除标准
- •Any acute or chronic disease (except COPD oder hypertension)
- •Any regular medication (except drugs against hypertension)
- •FEV1 < 80% predicted
- •Oxygen saturation < 90%
- •Acute infections of the lower respiratory tract in the last 7 days before the first day of the study
研究组 & 干预措施
A
Inhalation of Fluticasone (via discus) twice daily for 28 days
干预措施: fluticasone (Drug)
B
Inhalation of Fluticasone and Salmeterol (via discus) twice daily for 28 days
干预措施: fluticasone/salmeterol (Drug)
C
Inhalation of Placebo (via discus) twice daily for 28 days.
干预措施: placebo (Drug)
结局指标
主要结局
The number and the CCR7 expression of DCs in bronchoalveolar lavage fluid before and after therapy with fluticasone or fluticasone/salmeterol, as compared to placebo.
时间窗: 2 time points (A and B). Time point A: day 0 (directly before the inhalation therapy). Time point B: day 29 (directly after the inhalation therapy).
次要结局
- The expression of other surface molecules on DCs in bronchoalveolar lavage fluid before and after therapy with fluticasone or fluticasone/salmeterol, as compared to placebo.(2 time points (A and B). Time point A: day 0 (directly before the inhalation therapy). Time point B: day 29 (directly after the inhalation therapy).)