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Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease (INTRUST1)

2011年7月22日 更新者：Novartis Pharmaceuticals

A Randomized, Double-blind, Controlled, Parallel-group, 12-week Study to Compare the Efficacy and Safety of the Combination of Indacaterol 150 µg Once Daily With Open Label Tiotropium 18 µg Once Daily Versus Open Label Tiotropium 18 µg Once Daily in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease

This study assessed the efficacy and safety of indacaterol (150 µg once daily [od]) when combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients with chronic obstructive pulmonary disease (COPD)

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

1134

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

  • 丹麦
      • Copenhagen、丹麦
        • Novartis Investigator Site
      • Fredericia、丹麦
        • Novartis Investigator Site
      • Silkeborg、丹麦
        • Novartis Investigator Site
      • Soeborg、丹麦
        • Novartis Investigator Site
      • Vejle、丹麦
        • Novartis Investigator Site
  • 南非
      • Amanzimtoti、南非
        • Novartis Investigator Site
      • Cape Town、南非
        • Novartis Investigator Site
      • Johannesburg、南非
        • Novartis Investigator Site
      • Midrand、南非
        • Novartis Investigator Site
      • Umkomaas、南非
        • Novartis Investigator Site
  • 危地马拉
      • Guatemala、危地马拉
        • Novartis Investigative Site
      • Guatemala City、危地马拉
        • Novartis Investigative Site
  • 哥伦比亚
      • Barranquilla、哥伦比亚
        • Novartis Investigative Site
      • Bogota、哥伦比亚
        • Novartis Investigative Site
      • Bogota、哥伦比亚
        • Novartis Investigator Site
      • Medellin、哥伦比亚
        • Novartis Investigative Site
  • 墨西哥
      • Guadalajara、墨西哥
        • Novartis Investigative Site
      • Mexico City、墨西哥
        • Novartis Investigator Site
      • Monterrey、墨西哥
        • Novartis Investigative Site
      • Zapopan、墨西哥
        • Novartis Investigative Site
  • 德国
      • Berlin、德国
        • Novartis Investigator Site
      • Cottbus、德国
        • Novartis Investigator Site
      • Donaustauf、德国
        • Novartis Investigator Site
      • Dortmund、德国
        • Novartis Investigator Site
      • Erfurt、德国
        • Novartis Investigator Site
      • Frankfurt、德国
        • Novartis Investigator Site
      • Gelnhausen、德国
        • Novartis Investigator Site
      • Grosshansdorf、德国
        • Novartis Investigator Site
      • Hannover、德国
        • Novartis Investigator Site
      • Heidelberg、德国
        • Novartis Investigator Site
      • Leipzig、德国
        • Novartis Investigator Site
      • Mainz、德国
        • Novartis Investigator Site
      • Neu-Ulm、德国
        • Novartis Investigator Site
      • Neuss、德国
        • Novartis Investigator Site
      • Potsdam、德国
        • Novartis Investigator Site
      • Rostock、德国
        • Novartis Investigator Site
      • Schwabach、德国
        • Novartis Investigator Site
      • Schwetzingen、德国
        • Novartis Investigator Site
      • Straussberg、德国
        • Novartis Investigator Site
      • Wiesbaden、德国
        • Novartis Investigative Site
      • Wuppertal、德国
        • Novartis Investigator Site
  • 澳大利亚
      • Box Hill、澳大利亚
        • Novartis Investigator Site
      • Clayton、澳大利亚
        • Novartis Investigator Site
      • Garran、澳大利亚
        • Novartis Investigator Site
      • Glebe、澳大利亚
        • Novartis Investigator Site
      • Kogarah、澳大利亚
        • Novartis Investigator Site
      • Nedlands、澳大利亚
        • Novartis Investigator Site
  • 火鸡
      • Antalya、火鸡
        • Novartis Investigator Site
      • Canakkale、火鸡
        • Novartis Investigator Site
      • Isparta、火鸡
        • Novartis Investigator Site
      • Istanbul、火鸡
        • Novartis Investigator Site
      • Kartal、火鸡
        • Novartis Investigator Site
      • Kayseri、火鸡
        • Novartis Investigator Site
      • Kozlu / Zonguldak、火鸡
        • Novartis Investigator Site
      • Malatya、火鸡
        • Novartis Investigator Site
      • Manisa、火鸡
        • Novartis Investigator Site
      • Mecidiyekoy/Istanbul、火鸡
        • Novartis Investigator Site
      • Yenisehir/Izmir、火鸡
        • Novartis Investigator Site
  • 美国
    • Alabama
      • Birmingham、Alabama、美国、32509
        • Novartis Investigator Site
      • Mobile、Alabama、美国、36608
        • Novartis Investigator Site
    • Arizona
      • Scottsdale、Arizona、美国、85258
        • Novartis Investigative Site
      • Tucson、Arizona、美国、85723
        • Novartis Investigative Site
      • Tucson、Arizona、美国、85712
        • Novartis Investigative Site
    • Arkansas
      • Pine Bluff、Arkansas、美国、71603
        • Novartis Investigator Site
    • California
      • Fountain Valley、California、美国、92708
        • Novartis Investigator Site
      • Long Beach、California、美国、90822
        • Novartis Investigator Site
      • Los Angeles、California、美国、90095
        • Novartis Investigative Site
      • National City、California、美国、91950
        • Novartis Investigator Site
      • Palmdale、California、美国、93551
        • Novartis Investigator Site
      • Stockton、California、美国、95207
        • Novartis Investigative Site
      • Temecula、California、美国、92591
        • Novartis Investigator Site
    • Connecticut
      • Hartford、Connecticut、美国、06105-1208
        • Novartis Investigative Site
    • Florida
      • Clearwater、Florida、美国、33756
        • Novartis Investigative Site
      • Ft. Walton Beach、Florida、美国、32547
        • Novartis Investigator Site
      • Miami、Florida、美国、33136
        • Novartis Investigative Site
      • Miami、Florida、美国、331577
        • Novartis Investigative Site
      • Naranja、Florida、美国、33032
        • Novartis Investigative Site
      • Pensacola、Florida、美国、32514
        • Novartis Investigator Site
      • Sarasota、Florida、美国、34233
        • Novartis Investigator Site
    • Georgia
      • Atlanta、Georgia、美国、30342
        • Novartis Investigative Site
      • Conyers、Georgia、美国、30094
        • Novartis Investigator Site
    • Illinois
      • Normal、Illinois、美国、61761
        • Novartis Investigative Site
    • Iowa
      • Iowa City、Iowa、美国、52240
        • Novartis Investigative Site
    • Kansas
      • Kansas City、Kansas、美国、66160
        • Novartis Investigative Site
      • Lenexa、Kansas、美国、66215
        • Novartis Investigative Site
      • Topeka、Kansas、美国、66606
        • Novartis Investigative Site
    • Louisiana
      • Lafayette、Louisiana、美国、70503
        • Novartis Investigator Site
      • Metaire、Louisiana、美国、70002
        • Novartis Investigator Site
      • New Orleans、Louisiana、美国、70119
        • Novartis Investigator Site
      • Slidell、Louisiana、美国、70458
        • Novartis Investigator Site
    • Maryland
      • Columbia、Maryland、美国、21044
        • Novartis Investigator Site
    • Massachusetts
      • Brockton、Massachusetts、美国、02301
        • Novartis Investigator Site
    • Michigan
      • Clarkston、Michigan、美国、48346
        • Novartis Investigator Site
      • Detroit、Michigan、美国、48202
        • Novartis Investigator Site
    • Missouri
      • St Charles、Missouri、美国、63301
        • Novartis Investigative Site
    • Montana
      • Missoula、Montana、美国、59808
        • Novartis Investigator Site
    • Nebraska
      • Boys Town、Nebraska、美国、68010
        • Novartis Investigator Site
      • Omaha、Nebraska、美国、68114
        • Novartis Investigative Site
      • Omaha、Nebraska、美国、68134
        • Novartis Investigative Site
    • Nevada
      • Las Vegas、Nevada、美国、89119
        • Novartis Investigative Site
    • New Hampshire
      • Lebanon、New Hampshire、美国、03756
        • Novartis Investigator Site
    • New Jersey
      • Asbury Park、New Jersey、美国、07712
        • Novartis Investigator Site
    • New York
      • Rochester、New York、美国、14618
        • Novartis Investigative Site
    • North Carolina
      • Mooresville、North Carolina、美国、28117
        • Novartis Investigator Site
      • Winston-Salem、North Carolina、美国、27103
        • Novartis Investigative Site
    • Oklahoma
      • Tulsa、Oklahoma、美国、74135-2920
        • Novartis Investigator Site
    • Oregon
      • Medford、Oregon、美国、97504
        • Novartis Investigative Site
    • Pennsylvania
      • Bethlehem、Pennsylvania、美国、18020
        • Novartis Investigator Site
    • Rhode Island
      • Cumberland、Rhode Island、美国、02864
        • Novartis Investigative Site
    • South Carolina
      • Greenville、South Carolina、美国、29615
        • Novartis Investigator Site
      • Spartanburg、South Carolina、美国、29303
        • Novartis Investigative Site
    • Tennessee
      • Knoxville、Tennessee、美国、37919
        • Novartis Investigator Site
    • Texas
      • El Paso、Texas、美国、79903
        • Novartis Investigator Site
      • Houston、Texas、美国、77024
        • Novartis Investigative Site
      • Houston、Texas、美国、77079
        • Novartis Investigative Site
      • New Braunfels、Texas、美国、78130-6113
        • Novartis Investigative Center
    • Virginia
      • Newport News、Virginia、美国、23606
        • Novartis Investigator Site
      • Richmond、Virginia、美国、23225
        • Novartis Investigative Site
      • Richmond、Virginia、美国、23249
        • Novartis Investigator Site
  • 菲律宾
      • Manila、菲律宾
        • Novartis Investigator Site
  • 西班牙
      • Alicante、西班牙
        • Novartis Investigative Site
      • Barcelona、西班牙
        • Novartis Investigator Site
      • Begonte、西班牙
        • Novartis Investigator Site
      • Cadiz、西班牙
        • Novartis Investigator Site
      • Granollers、西班牙
        • Novartis Investigator Site
      • Jaén、西班牙
        • Novartis Investigative Site
      • La Coruna、西班牙
        • Novartis Investigator Site
      • Leon、西班牙
        • Novartis Investigator Site
      • Madrid、西班牙
        • Novartis Investigator Site
      • Pamplona、西班牙
        • Novartis Investigator Site
      • Torrelavega、西班牙
        • Novartis Investigator Site
      • Valencia、西班牙
        • Novartis Investigator Site
      • Vigo、西班牙
        • Novartis Investigator Site
  • 阿根廷
      • Buenos Aires、阿根廷
        • Novartis Investigative Site
      • Cordoba、阿根廷
        • Novartis Investigative Site
      • Corrientes、阿根廷
        • Novartis Investigative Site
      • Mendoza、阿根廷
        • Novartis Investigative Site
      • Rosario、阿根廷
        • Novartis Investigative Site

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 (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2007) and:

    1. Smoking history of at least 10 pack-years
    2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) ≤ 65% and ≥ 30% of the predicted normal value
    3. Post-bronchodilator FEV1/FVC (force vital capacity) < 70%

Exclusion Criteria:

  • Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid treatment or antibiotics and/or hospitalization in the 6 weeks prior to screening or during the run-in period
  • Patients who have had a respiratory tract infection within 6 weeks prior to screening or during the run-in period
  • Patients with a body mass index less than 15 or more than 40 kg/m^2
  • Patients with concomitant pulmonary disease
  • Patients with a history of asthma
  • Patients with diabetes Type I or uncontrolled diabetes Type II
  • Any patient with lung cancer or a history of lung cancer
  • Patients with a history of certain cardiovascular comorbid conditions

Other protocol-defined inclusion/exclusion criteria applied to the study.

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：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Indacaterol 150 μg and tiotropium 18 μg
Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
药品：Indacaterol 150 μg
Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
药品：Tiotropium 18 μg
Tiotropium was supplied in powder filled capsules together the manufacture's proprietary inhalation device (HandiHaler®).
有源比较器：Tiotropium 18 μg
Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
药品：Tiotropium 18 μg
Tiotropium was supplied in powder filled capsules together the manufacture's proprietary inhalation device (HandiHaler®).
药品：Placebo to indacaterol
Placebo to indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.

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
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose at the End of Treatment (Week 12)
大体时间：From 5 minutes to 8 hours post-dose at the end of treatment (Week 12, Day 84)
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, 4, 6, and 8 hours post-dose at the end of the study (Week 12, Day 84). Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
From 5 minutes to 8 hours post-dose at the end of treatment (Week 12, Day 84)

次要结果测量

结果测量
措施说明
大体时间
Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85)
大体时间：24 hours post-dose at the end of treatment (Week 12 + 1 day, Day 85)
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of the study (Week 12 + 1 day, Day 85). The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
24 hours post-dose at the end of treatment (Week 12 + 1 day, Day 85)
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose on Day 1
大体时间：From 5 minutes to 8 hours post-dose on Day 1
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
From 5 minutes to 8 hours post-dose on Day 1
Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2
大体时间：24 hours post-dose on Day 2
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 2. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
24 hours post-dose on Day 2
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose on Day 1
大体时间：From 5 minutes to 4 hours post-dose on Day 1
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, and 4 hours post-dose on Day 1. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
From 5 minutes to 4 hours post-dose on Day 1
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at the End of Treatment (Week 12)
大体时间：From 5 minutes to 4 hours post-dose at the end of treatment (Week 12)
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, and 4 hours post-dose at the end of treatment (Week 12). Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
From 5 minutes to 4 hours post-dose at the end of treatment (Week 12)

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

Novartis Pharmaceuticals

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。

一般刊物

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3月1日

初级完成 (实际的)

2010年3月1日

研究完成 (实际的)

2010年3月1日

研究注册日期

首次提交

2009年2月15日

首先提交符合 QC 标准的

2009年2月15日

首次发布 (估计)

2009年2月18日

研究记录更新

最后更新发布 (估计)

2011年8月18日

上次提交的符合 QC 标准的更新

2011年7月22日

最后验证

2011年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CQAB149B2341

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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医疗条件

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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