Single Dose Ranging Study of BI 1744 CL (Olodaterol) in Chronic Obstructive Pulmonary Disease
2014年5月27日 更新者：Boehringer Ingelheim
Single Dose Preliminary Dose-ranging and Safety in Patients With COPD
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.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
36
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Heerlen、荷兰
- 1222.3.1 Atrium medisch centrum
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
40年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion criteria:
- Diagnosis of chronic obstructive pulmonary disease
- Smoking history of more than 10-pack years
Exclusion criteria:
- History of asthma, allergic rhinitis, myocardial infarction or unstable of life-threatening cardiac arrhythmias
- Marked baseline prolongation of QT/QTc interval
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：olodaterol 2 mcg
solution for inhalation
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solution for inhalation
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实验性的：olodaterol 5 mcg
solution for inhalation
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solution for inhalation
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实验性的：olodaterol 10 mcg
solution for inhalation
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solution for inhalation
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实验性的：olodaterol 20 mcg
solution for inhalation
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solution for inhalation
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实验性的：olodaterol 40 mcg
solution for inhalation
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solution for inhalation
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安慰剂比较：placebo
solution for inhalation
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solution for inhalation
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Forced Expiratory Volume in One Second (FEV1) at 24 Hours After a Single-dose of Study Treatment
大体时间：24 hours post-dosing
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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.
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24 hours post-dosing
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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FEV1 AUC 0 - 3 Hours
大体时间：-10 minutes (min), 30min, 1 hour (h), 2h and 3h post-dosing
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The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from zero time to 3 hours, using the trapezoidal rule divided by 3 hours to give the results in litres.
The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.
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-10 minutes (min), 30min, 1 hour (h), 2h and 3h post-dosing
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FEV1 AUC 0 - 12 Hours
大体时间：-10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h and 12h post-dosing
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The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from zero time to 12 hours, using the trapezoidal rule divided by 12 hours to give the results in litres.
The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.
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-10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h and 12h post-dosing
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FEV1 AUC 0 - 24 Hours
大体时间：-10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 22h, 23h and 24h post-dosing
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The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from zero time to 24 hours, using the trapezoidal rule divided by 24 hours to give the results in litres.
The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.
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-10 minutes (min), 30min, 1 hour (h), 2h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 22h, 23h and 24h post-dosing
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FEV1 AUC 12 - 24 Hours
大体时间：12h, 14h, 22h, 23h and 24h post-dosing
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The FEV1 AUC was calculated as the area under the curve above zero as the horizontal axis from 12 hours to 24 hours, using the trapezoidal rule divided by 12 hours to give the results in litres.
The test-day baseline (defined as the pulmonary function test (PFT) at 10 minutes before inhalation of study medication) was assigned to time zero.
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12h, 14h, 22h, 23h and 24h post-dosing
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Peak FEV1 From 0 to 3 Hours
大体时间：0 to 3 hours post-dosing
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Peak FEV1 was defined as the maximum values of FEV1 from 0 to 3 hours.
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0 to 3 hours post-dosing
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Peak Forced Vital Capacity (FVC) From 0 to 3 Hours
大体时间：0 to 3 hours post-dosing
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Peak FVC was defined as the maximum values of FVC from 0 to 3 hours.
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0 to 3 hours post-dosing
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Time to Peak Bronchodilator Response
大体时间：0 to 3 hours post-dosing
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A bronchodilator response was considered to have been achieved if an FEV1 measurement of at least 12% greater than the test-day baseline value was recorded at any time during the first 3 hours of observation after dosing.
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0 to 3 hours post-dosing
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Time to Onset of Response
大体时间：0 to 3 hours post-dosing
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Onset of the bronchodilator response after a single dose of study treatment was defined as the linear interpolation of the time of the first bronchodilator response and the time of the observation just prior to the first bronchodilator response (even if that is the baseline observation).
If none of the FEV1 values in the first 3 hours after dosing exceeded 12% of the pre-dose value, then the onset was set to 3 hours plus 1 minute.
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0 to 3 hours post-dosing
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Number of Patients Requiring Rescue Medication on a Test-day
大体时间：Visits 1,2,4,5,6
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Number of Patients Requiring Rescue Medication on a Test-day.
Salbutamol inhalation aerosol MDI (Ventolin®, 100 μg/actuation) was provided for use as rescue medication.
Administration of rescue medication can occur at any point during the pulmonary function testing as deemed necessary by the patient or the investigator.
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Visits 1,2,4,5,6
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Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG
大体时间：2 weeks
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Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG.
New abnormal findings or worsenings of baseline conditions were reported as Adverse Events (cardiac disorders and investigations).
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2 weeks
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Laboratory Testing: Average Change From Baseline of Potassium and Calcium
大体时间：Baseline and Visit 6
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Laboratory testing: Average change from baseline of potassium and calcium measured on test-days
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Baseline and Visit 6
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2005年12月1日
初级完成 (实际的)
2006年11月1日
研究完成 (实际的)
2006年11月1日
研究注册日期
首次提交
2013年3月8日
首先提交符合 QC 标准的
2013年3月8日
首次发布 (估计)
2013年3月12日
研究记录更新
最后更新发布 (估计)
2014年6月30日
上次提交的符合 QC 标准的更新
2014年5月27日
最后验证
2014年5月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 1222.3
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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