Effect of Indacaterol on Inspiratory Capacity (IC)
2016年2月16日 更新者：Novartis Pharmaceuticals
A Randomized, Double-blind, Placebo Controlled, Multicenter, 3-period Crossover Study to Compare the Effect of Indacaterol (150μg o.d.) on Inspiratory Capacity to Placebo in Patients With Moderate COPD, Using Open Label Tiotropium (18μg o.d.) as Active Control
This study is being conducted to assess the effect of indacaterol (150 μg o.d.) on inspiratory capacity (IC), using placebo and open label tiotropium (18 μg o.d.) as comparators in patients with moderate chronic obstructive pulmonary disease (COPD).
In particular, spirometric timepoints are included to elucidate the peak-IC in a period of approximately 4 hour post inhalation
研究概览
研究类型
介入性
注册 (实际的)
173
阶段
- 第三阶段
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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-
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Aschaffenburg、德国
- Novartis Investigative Site
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Berlin、德国
- Novartis Investigative Site
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Dresden、德国
- Novartis Investigative Site
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Erfurt、德国
- Novartis Investigative Site
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Frankfurt am Main、德国
- Novartis Investigative Site
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Fulda、德国
- Novartis Investigative Site
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Geesthacht、德国
- Novartis Investigative Site
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Großhansdorf、德国
- Novartis Investigative Site
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Halle、德国
- Novartis Investigative Site
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Hamburg、德国
- Novartis Investigative Site
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Kiel、德国
- Novartis Investigative Site
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Koblenz、德国
- Novartis Investigative Site
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Leipzig、德国
- Novartis Investigative Site
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Mannheim、德国
- Novartis Investigative Site
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Marburg、德国
- Novartis Investigative Site
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Neumünster、德国
- Novartis Investigative Site
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Potsdam、德国
- Novartis Investigative Site
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Rathenow、德国
- Novartis Investigative Site
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Rüdersdorf、德国
- Novartis Investigative Site
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Witten、德国
- Novartis Investigator Site
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Zerbst、德国
- Novartis Investigative Site
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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:
Co-operative outpatients with a diagnosis of COPD (moderate as classified by the GOLD Guidelines, 2008) and including:
- Smoking history of at least 10 pack years
- Post-bronchodilator FEV1 <80% and ≥50% of the predicted normal value (Visit 2).
- Post-bronchodilator FEV1/forced vital capacity (FVC) <70% (Visit 2).
Exclusion Criteria:
- Patients who received any corticosteroid (including inhaled) for 3 months prior to screening
Other protocol-defined inclusion/exclusion criteria may apply
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：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Indacaterol - placebo - tiotropium
In treatment period 1, patients received indacaterol 150µg once daily; in treatment period 2, patients received placebo to indacaterol once daily; in treatment period 3, patients received tiotropium 18µg once daily.
Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device.
There was a washout period of 13 days between each period.
Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued.
Salbutamol rescue use was allowed during the treatment period as needed.
|
Indacaterol 150µg once daily (o.d.) delivered via single-dose dry powder inhaler (SDDPI)
Tiotropium 18µg o.d.
delivered via a proprietary inhalation device.
Placebo to indacaterol o.d.
delivered via SDDPI
|
|
实验性的：Placebo - Tiotropium - Indacaterol
In treatment period 1, patients received placebo to indacaterol once daily; in treatment period 2, patients received tiotropium 18µg once daily; in treatment period 3, patients received indacaterol 150µg once daily.
Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device.
There was a washout period of 13 days between each period.
Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued.
Salbutamol rescue use was allowed during the treatment period as needed.
|
Indacaterol 150µg once daily (o.d.) delivered via single-dose dry powder inhaler (SDDPI)
Tiotropium 18µg o.d.
delivered via a proprietary inhalation device.
Placebo to indacaterol o.d.
delivered via SDDPI
|
|
实验性的：Tiotropium - indacaterol - placebo
In treatment period 1, patients received tiotropium 18µg once daily; in treatment period 2, patients received indacaterol 150µg once daily; in treatment period 3, patients received placebo to indacaterol once daily.
Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device.
There was a washout period of 13 days between each period.
Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued.
Salbutamol rescue use was allowed during the treatment period as needed.
|
Indacaterol 150µg once daily (o.d.) delivered via single-dose dry powder inhaler (SDDPI)
Tiotropium 18µg o.d.
delivered via a proprietary inhalation device.
Placebo to indacaterol o.d.
delivered via SDDPI
|
|
实验性的：Placebo - indacaterol - tiotropium
In treatment period 1, patients received placebo to indacaterol once daily; in treatment period 2, patients received indacaterol 150µg once daily; in treatment period 3, patients received tiotropium 18µg once daily.
Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device.
There was a washout period of 13 days between each period.
Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued.
Salbutamol rescue use was allowed during the treatment period as needed.
|
Indacaterol 150µg once daily (o.d.) delivered via single-dose dry powder inhaler (SDDPI)
Tiotropium 18µg o.d.
delivered via a proprietary inhalation device.
Placebo to indacaterol o.d.
delivered via SDDPI
|
|
实验性的：Indacaterol - tiotropium - placebo
In treatment period 1, patients received indacaterol 150µg once daily; in treatment period 2, patients received tiotropium 18µg once daily; in treatment period 3, patients received placebo to indacaterol once daily.
Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device.
There was a washout period of 13 days between each period.
Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued.
Salbutamol rescue use was allowed during the treatment period as needed.
|
Indacaterol 150µg once daily (o.d.) delivered via single-dose dry powder inhaler (SDDPI)
Tiotropium 18µg o.d.
delivered via a proprietary inhalation device.
Placebo to indacaterol o.d.
delivered via SDDPI
|
|
实验性的：Tiotropium - placebo - indacaterol
In treatment period 1, patients received tiotropium 18µg once daily; in treatment period 2, patients received placebo to indacaterol once daily; in treatment period 3, patients received indacaterol 150µg once daily.
Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device.
There was a washout period of 13 days between each period.
Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued.
Salbutamol rescue use was allowed during the treatment period as needed.
|
Indacaterol 150µg once daily (o.d.) delivered via single-dose dry powder inhaler (SDDPI)
Tiotropium 18µg o.d.
delivered via a proprietary inhalation device.
Placebo to indacaterol o.d.
delivered via SDDPI
|
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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Peak Inspiratory Capacity (IC) After 21 Days of Treatment
大体时间：21 days
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IC was measured with spirometry conducted according to internationally accepted standards.
Peak IC was defined as the maximum IC of the mean over the 3 values which were measured each at 30min, 2 hour, 3 hour and 4 hour post dose by body plethysmography.
Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
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21 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Trough IC After 20 Days of Treatment
大体时间：20 days
|
Trough IC was measured with spirometry conducted according to internationally accepted standards.
Trough IC was calculated as the mean of the three measurements of pre-dose body plethysmography (days 21, 55 and 89).
Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
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20 days
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Peak Residual Volume (RV) After 21 Days of Treatment
大体时间：21 days
|
Peak RV was measured with spirometry conducted according to internationally accepted standards.
Peak RV was calculated as the Total Lung Capacity minus the maximum of the three Inspiratory Vital Capacity measurements which were measured each at 30 min, 2 hours, 3 hours and 4 hours post dose (at days 21, 55 and 89).
Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
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21 days
|
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Peak Total Lung Capacity (TLC) After 21 Days of Treatment
大体时间：21 days
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TLC was measured with spirometry conducted according to internationally accepted standards.
Peak TLC was calculated as the mean of the three Functional Residual Capacity peak measurements plus the mean of the three Inspiratory Capacity measurements which were measured each at 30 min, 2 hours, 3 hours and 4 hours post dose (at days 21, 55 and 89).
Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
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21 days
|
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Peak Residual Volume/Peak Total Lung Capacity (RV/TLC) Ratio After 21 Days of Treatment
大体时间：21 days
|
Peak RV/TLC ratio was measured with spirometry conducted according to internationally accepted standards.
Peak RV/TLC was defined as the peak RV/peak TLC.
Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
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21 days
|
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Peak Specific Airway Resistance (sRaw) After 21 Days of Treatment
大体时间：21 days
|
Peak sRaw was measured with spirometry conducted according to internationally accepted standards.
Peak sRaw was the mean of the three measurements which were measured each at 30 min, 2 hours, 3 hours and 4 hours post dose (at days 21, 55 and 89).
Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
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21 days
|
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FEV1 30 Minutes Post-dose After 21 Days of Treatment
大体时间：21 days
|
FEV1 was measured with spirometry conducted according to internationally accepted standards.
FEV1 was measured 30 minutes post-dose.
Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
|
21 days
|
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Trough Forced Expiratory Volume in 1 Second (FEV1) After 20 Days of Treatment
大体时间：20 days
|
FEV1 was measured with spirometry conducted according to internationally accepted standards.
FEV1 was measured pre-dose after 20 days of treatment.
Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
|
20 days
|
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。
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
2009年11月1日
初级完成 (实际的)
2011年1月1日
研究注册日期
首次提交
2009年11月11日
首先提交符合 QC 标准的
2009年11月12日
首次发布 (估计)
2009年11月13日
研究记录更新
最后更新发布 (估计)
2016年2月17日
上次提交的符合 QC 标准的更新
2016年2月16日
最后验证
2016年2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.