Open-label, Randomized, 3-way Cross-over, Placebo Controlled, Single Dose Clinical Pharmacology Study in COPD Patients After Inhalation of CHF 5993 pMDI Using the Standard Actuator With or Without AeroChamber Plus Flow-Vu VHC Spacer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Area under the curve of B17MP, formoterol and glycopyrrolate
研究概览
简要总结
The study is performed to investigate the effect of the spacing device on the pharmacokinetics of CHF 5993 pMDI active ingredients administered with and without Aerochamber Plus Flow-vu antistatic VHC spacer as a single administration in COPD patients. Moreover, the general safety and tolerability of the treatments will be evaluated.
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
- None
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD patients
- •smokers or ex-smokers
- •post-bronchodilator FEV1 between 30 and 60% of predicted value
排除标准
- •Positive serology to HIV and hepatitis
- •Known respiratory disorder other than COPD
- •Recent COPD exacerbations or hospitalization for COPD
- •Treatment with non-permitted concomitant medication
- •clinically relevant concomitant disease
- •clinically relevant abnormal laboratory or ECG parameters
研究组 & 干预措施
CHF5993 pMDI + Spacer
CHF 5993 pMDI (Beclometasone/formoterol/glycopyrrolate 100/6/25 mcg per actuation) x 4 inhalations administered using Aerochamber Plus Flow-vu VHC spacer
干预措施: Beclometasone/formoterol/glycopyrrolate (Drug)
CHF5993 pMDI
CHF 5993 pMDI (Beclometasone/formoterol/glycopyrrolate 100/6/25 mcg per actuation) x 4 inhalations administered using standard actuator only
干预措施: Beclometasone/formoterol/glycopyrrolate (Drug)
Placebo pMDI
Placebo pMDI x 4 inhalations
干预措施: Placebo (Drug)
结局指标
主要结局
Area under the curve of B17MP, formoterol and glycopyrrolate
时间窗: Over 24 and 48h after single administration
AUCt (up to the last quantifiable concentration) and Cmax (maximum concentration) from plasma concentrations vs time profiles. over 24h for formoterol and B17MP, over 48h for glycopyrrolate
次要结局
- Other pharmacokinetic parameters for formoterol, glycopyrrolate and B17MP in plasma(over 24 or 48h after single administration)
- Lung function(30 min after single administration)
- cortisol urinary excretion(over 24 h after single administration)
- potassium plasma profile(over 24 h after single administration)
- Adverse events(over a period of 6 to 11 weeks)
- plasma cortisol(over 24 h after single administration)
- Vital signs(over 24 h after single administration)
- ECG parameters(over 24 h after single administration)