Single Dose Preliminary Dose-ranging and Safety in Patients With COPD
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Forced Expiratory Volume in One Second (FEV1) at 24 Hours After a Single-dose of Study Treatment
研究概览
简要总结
Primary objective: To investigate bronchodilator effect and safety of single doses of BI 1744 CL inhaled via Respimat inhaler, Secondary objective: to characterize pharmacokinetics of BI 1744 CL. Olodaterol dose 40 mcg was investigated only in the open-label extension part for additional PK assessments which are not defined as primary or secondary endpoints.
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
- Double
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
olodaterol 2 mcg
solution for inhalation
干预措施: single dose of 2 mcg (Drug)
olodaterol 5 mcg
solution for inhalation
干预措施: single dose of 5 mcg (Drug)
olodaterol 10 mcg
solution for inhalation
干预措施: single dose of 10 mcg (Drug)
olodaterol 20 mcg
solution for inhalation
干预措施: single dose of 20 mcg (Drug)
olodaterol 40 mcg
solution for inhalation
干预措施: single dose of 40 mcg (Drug)
placebo
solution for inhalation
干预措施: single dose of placebo (Drug)
结局指标
主要结局
Forced Expiratory Volume in One Second (FEV1) at 24 Hours After a Single-dose of Study Treatment
时间窗: 24 hours post-dosing
Forced expiratory volume in one second (FEV1) at 24 hours after a single-dose of study treatment. Means are adjusted with test-day baseline, patient, treatment, and period as fixed effects. Test-day baseline value was defined as the value at 10 minutes before inhalation of study medication.
次要结局
- FEV1 AUC 0 - 24 Hours(-10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 22h, 23h and 24h post-dosing)
- FEV1 AUC 0 - 3 Hours(-10 minutes (min), 30min, 1 hour (h), 2h and 3h post-dosing)
- FEV1 AUC 0 - 12 Hours(-10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h and 12h post-dosing)
- FEV1 AUC 12 - 24 Hours(12h, 14h, 22h, 23h and 24h post-dosing)
- Peak FEV1 From 0 to 3 Hours(0 to 3 hours post-dosing)
- Peak Forced Vital Capacity (FVC) From 0 to 3 Hours(0 to 3 hours post-dosing)
- Time to Peak Bronchodilator Response(0 to 3 hours post-dosing)
- Time to Onset of Response(0 to 3 hours post-dosing)
- Number of Patients Requiring Rescue Medication on a Test-day(Visits 1,2,4,5,6)
- Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG(2 weeks)
- Laboratory Testing: Average Change From Baseline of Potassium and Calcium(Baseline and Visit 6)