Characterisation of 24-hour FEV1-time Profiles of Inhaled BI 1744 CL and Inhaled Foradil Iin Patients With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 11
- 主要终点
- FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After Six Weeks of Treatment
研究概览
简要总结
The study is intended to characterize the lung function profile of BI1744 in COPD patients where patients will perform pulmonary function tests at regular intervals for 24 hours at the end of a 6 week treatment period. Each patient will receive all four treatments.
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
- •Patients willing to participate with confirmed diagnosis of COPD
- •40 years of age or older
- •having a 10 pack year smoking history
- •able to perform serial pulmonary function tests
- •able to use both a DPI and Respimat device
排除标准
- •Significant other disease
- •clinically relevant abnormal hematology, chemistry, or urinalysis
- •history of asthma
- •diagnosis of thyrotoxicosis
- •paroxysmal tachycardia related to beta agonists
- •history of MI within 1 year, cardiac arrhythmia, hospitalization for heart failure within 1 year
- •active tuberculosis, cystic fibrosis, clinically evident bronchiectasis
- •significant alcohol or drug use
- •pulmonary resection
- •taking oral beta adrenergics
- •taking unstable oral steroids
- •daytime oxygen
- •enrolled in rehabilitation program
- •enrolled in another study or taking investigational products
- •pregnant or nursing women, women of child bearing potential not willing to use two methods of birth control
- •those who are not willing to comply with pulmonary medication washouts
研究组 & 干预措施
BI 1744 (Olodaterol) Low Dose
BI1744 Low Dose once daily
干预措施: bi1744 (Drug)
BI 1744 (Olodaterol) Med Dose
BI 1744 Med Dose once daily
干预措施: BI 1744 (Drug)
Placebo
Placebo once daily
干预措施: Placebo (Drug)
Foradil
Foradil 12 mcg twice daily
干预措施: Foradil (Drug)
结局指标
主要结局
FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After Six Weeks of Treatment
时间窗: 1 hour (h) and 10 minutes (min) prior to am dose on the first day of treatment (baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min relative to am dose after six weeks of treatment
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.
FEV1 Area Under Curve 12-24h (AUC 12-24h) Response After Six Weeks of Treatment
时间窗: 1 h and 10 min prior to am dose on the first day of treatment (baseline) and 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.
次要结局
- Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 h (AUC 0-24h) Response After Six Weeks of Treatment(1 h and 10 min prior to am dose on the first day of treatment (baseline) and -30 min, 30 min, 60 min, 2h, 3h, 4h, 6h, 8h, 10h, 11 hr 50 min,12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment.)
- Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After Six Weeks of Treatment(1 hour (h) prior and 10 minutes (min) prior to first dose (baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to the last am dose after six weeks of treatment)
- Peak FEV1 (0-3h) Response(Baseline and 6 weeks)
- Trough FEV1 Response(Baseline and 6 weeks)
- Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response(1 hour (h) and 10 minutes (min) prior to am dose on the first day of treatment (baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min relative to am dose after six weeks of treatment)
- FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response(1 h and 10 min prior to am dose on the first day of treatment (baseline) and 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment)
- FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response(1 h and 10 min prior to am dose on the first day of treatment (baseline) and -30 min, 30 min, 60 min, 2h, 3h, 4h, 6h, 8h, 10h, 11 hr 50 min,12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment.)
- Peak FVC (0-3h) Response(Baseline and 6 weeks)
- Trough FVC Response(Baseline and 6 weeks)
- Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG(6 weeks)