Single Dose Study to Assess Efficacy, Safety and Tolerability of LAS100977 in Asthmatic Patients.
2018年5月7日 更新者：AstraZeneca
A Phase IIa, Randomised, Single Dose, Double-blind, Double-dummy, 6 Way Complete Cross-over, Placebo Controlled Clinical Trial to Assess the Efficacy, Safety and Tolerability of 4 Doses of LAS100977 QD Compared to Placebo and an Active Comparator in Patients With Persistent Asthma.
The purpose of this study is to evaluate the pharmacodynamics of single doses of inhaled LAS100977 QD in patients with persistent asthma.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
62
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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Berlin、德国、10117
- Almirall Investigational Sites#6
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Berlin、德国、14050
- Almirall Investigational Sites#4
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Berlin、德国、14057
- Almirall Investigational Sites#1
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Frankfurt、德国、60596
- Almirall Investigational Sites#3
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Grosshansdorf、德国、22927
- Almirall Investigational Sites#2
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Hamburg、德国、20249
- Almirall Investigational Sites#8
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Wiesbaden、德国、65187
- Almirall Investigational Sites#5
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London、英国、W1G 8HT
- Almirall Investigational Sites#2
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Manchester、英国、M3 9QZ
- Almirall Investigational Sites#1
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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
18年 至 70年 (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:
- Adult male and female patients aged 18-70 years (both included).
- Clinical diagnosis of persistent asthma (according to GINA guidelines 2009 update) for at least 6 months prior to screening.
- Screening FEV1 value of 60% < FEV1 ≤ 85% of the predicted normal value.
- FEV1 reversibility ≥ 12% and an absolute increase of at least 200 ml over baseline value after inhalation of 400µg (four inhalations) of salbutamol.
- Pre-dose FEV1 value of first treatment period within the range of ± 20% of the FEV1 measured at screening prior to salbutamol inhalation.
- Patients on a stable dose and regimen
Exclusion Criteria:
- Current smokers, former smokers within the last 6 months, or ex-smokers with a history of more than 10 pack-years.
- Patients diagnosed with COPD.
- Recent Respiratory tract infections within 6 weeks before Screening Visit.
- Intubation (ever) or hospitalization for longer than 24 hours for the management of an asthma exacerbation within the preceding 6 weeks of the screening visit.
- Clinically significant respiratory conditions.
- Clinically significant cardiovascular conditions.
- Patients unable to properly use a dry powder or pMDI inhaler device or unable to perform acceptable spirometry.
- Clinically relevant abnormalities laboratory, ECG parameters or physical examination results at the screening evaluation that in the investigator's opinion, preclude study participation.
- Patients who intend to use any concomitant medication not permitted by this protocol or who have not undergone the required washout period for a particular prohibited medication.
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 |
|---|---|
|
实验性的：LAS100977 0.625 μg
Single-dose LAS100977 0.625 μg, during double-blind treatment period
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Dry powder inhalation, once-daily, single-dose
Pressurized inhalation, once-daily
|
|
实验性的：LAS100977 1.25 μg
Single-dose LAS100977 1.25 μg, during double-blind treatment period
|
Pressurized inhalation, once-daily
Dry powder inhalation, once-daily, single-dose
|
|
实验性的：LAS100977 2.5 μg
Single-dose LAS100977 2.5 μg, during double-blind treatment period
|
Pressurized inhalation, once-daily
Dry powder inhalation, once-daily, single-dose
|
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有源比较器：Salbutamol
Single-dose salbutamol 400 μg, during double-blind treatment period
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Pressurized inhalation suspension, once-daily, single-dose
Dry powder inhalation, once-daily
|
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安慰剂比较：Placebo
Placebo to LAS100977, and placebo to salbutamol
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Pressurized inhalation, once-daily
Dry powder inhalation, once-daily
|
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实验性的：LAS100977 0.313 μg
Single-dose LAS100977 0.313 μg, during double-blind treatment period
|
Pressurized inhalation, once-daily
Dry powder inhalation, once-daily, single-dose
|
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 |
|---|---|---|
|
Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)
大体时间：Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
|
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min).
The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning.
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 were selected.
|
Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)
大体时间：Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
|
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min).
The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning.
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 were selected.
|
Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
|
|
Peak Forced Expiratory Volume in One Second (FEV1)
大体时间：+15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
|
The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning on Day 1.
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 were selected.
|
+15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
|
|
Time to Peak Forced Expiratory Volume in One Second (FEV1)
大体时间：+15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
|
The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning.
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 were selected.
|
+15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
|
|
Change From Baseline to Trough Forced Expiratory Volume in One Second (FEV1)
大体时间：Baseline and +23 h and +24 h post-dose
|
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min).
Trough at Day 2 was computed as the average of the two values measured at 23 and 24 hours after administration of the morning dose of investigational medicinal product on Day 1.
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
|
Baseline and +23 h and +24 h post-dose
|
|
Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-24h at Day 1
大体时间：Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h and +24 h
|
FEV1 was normalized to baseline.
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min).
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
|
Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h and +24 h
|
|
Absolute Values of Forced Expiratory Volume (FEV1) at Each Timepoint
大体时间：Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
|
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min).
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
|
Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
|
|
Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
大体时间：Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
|
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min).
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
The number of participants analyzed differed between timepoints - the number of participants analyzed at 0.25 h is shown.
|
Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
|
|
Percentage Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
大体时间：Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
|
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min).
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
The number of participants analyzed differed between timepoints - the number of participants analyzed at 0.25 h is shown.
|
Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
|
|
Change From Baseline in Peak Forced Vital Capacity (FVC)
大体时间：Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
|
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min).
The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning.
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
|
Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
|
|
Peak Forced Vital Capacity (FVC)
大体时间：+15 min, +30 min, +1 h, +2 h, +3 h, +4 h
|
The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning.
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
|
+15 min, +30 min, +1 h, +2 h, +3 h, +4 h
|
|
Time to Peak Forced Vital Capacity (FVC)
大体时间：+15 min, +30 min, +1 h, +2 h, +3 h, +4 h
|
The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning.
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
|
+15 min, +30 min, +1 h, +2 h, +3 h, +4 h
|
|
Change From Baseline to Trough Forced Vital Capacity (FVC)
大体时间：Baseline and +23 h +24 h post-dose
|
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min).
Trough at Day 2 was computed as the average of the two values measured at 23 and 24 hours after administration of the morning dose of investigational medicinal product on Day 1.
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
|
Baseline and +23 h +24 h post-dose
|
|
Change From Baseline in Normalized Forced Vital Capacity (FVC) Area Under the Curve (AUC)
大体时间：Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h and +24 h
|
FVC was normalized to baseline.
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min).
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
|
Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h and +24 h
|
|
Absolute Values of Forced Vital Capacity (FVC) at Each Timepoint
大体时间：Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
|
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min).
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
The number of participants analyzed differed between timepoints - the number of participants analyzed at 0.25 h is shown.
|
Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
|
|
Change From Baseline in Forced Vital Capacity (FVC) at Each Timepoint
大体时间：Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
|
Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min).
At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected.
The number of participants analyzed differed between timepoints - the number of participants analyzed at 0.25 h is shown.
|
Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
|
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。
赞助
调查人员
- 研究主任：Carol Astbury, PhD、AstraZeneca
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 (实际的)
2011年8月1日
初级完成 (实际的)
2012年2月1日
研究完成 (实际的)
2012年2月1日
研究注册日期
首次提交
2011年8月29日
首先提交符合 QC 标准的
2011年8月29日
首次发布 (估计)
2011年8月30日
研究记录更新
最后更新发布 (实际的)
2018年5月8日
上次提交的符合 QC 标准的更新
2018年5月7日
最后验证
2018年4月1日
更多信息
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.