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Tiotropium In Exercise

2013年11月27日 更新者：Boehringer Ingelheim

A Randomized, Double-blind, Placebo-controlled Two-year Trial to Examine the Changes in Exercise Endurance and COPD Treated With Tiotropium Once Daily (EXACTT)

The objective of this study is to evaluate the effects on exercise duration of 96 weeks treatment with 18 mcg tiotropium (Spiriva HandiHaler) daily as compared to placebo, in patients with 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)

519

阶段

  • 第四阶段

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

  • 乌克兰
      • Dnyepropyetrovsk、乌克兰
        • 205.368.38003 Boehringer Ingelheim Investigational Site
      • Kiev、乌克兰
        • 205.368.38001 Boehringer Ingelheim Investigational Site
      • Kiev、乌克兰
        • 205.368.38002 Boehringer Ingelheim Investigational Site
  • 俄罗斯联邦
      • Moscow、俄罗斯联邦
        • 205.368.70001 Boehringer Ingelheim Investigational Site
      • Moscow、俄罗斯联邦
        • 205.368.70004 Boehringer Ingelheim Investigational Site
      • Moscow、俄罗斯联邦
        • 205.368.70005 Boehringer Ingelheim Investigational Site
      • Moscow、俄罗斯联邦
        • 205.368.70006 Boehringer Ingelheim Investigational Site
      • St. Petersburg、俄罗斯联邦
        • 205.368.70007 Boehringer Ingelheim Investigational Site
  • 加拿大
    • British Columbia
      • Vancouver、British Columbia、加拿大
        • 205.368.07006 Boehringer Ingelheim Investigational Site
    • Manitoba
      • Winnipeg、Manitoba、加拿大
        • 205.368.07001 Boehringer Ingelheim Investigational Site
      • Winnipeg、Manitoba、加拿大
        • 205.368.07003 Boehringer Ingelheim Investigational Site
    • Ontario
      • Hamilton、Ontario、加拿大
        • 205.368.07004 Boehringer Ingelheim Investigational Site
      • Hamilton、Ontario、加拿大
        • 205.368.07005 Boehringer Ingelheim Investigational Site
    • Quebec
      • Montreal、Quebec、加拿大
        • 205.368.07008 Boehringer Ingelheim Investigational Site
  • 台湾
      • Keelung、台湾
        • 205.368.88604 Boehringer Ingelheim Investigational Site
      • Taichung、台湾
        • 205.368.88602 Boehringer Ingelheim Investigational Site
      • Taipei City、台湾
        • 205.368.88603 Boehringer Ingelheim Investigational Site
      • Taoyuan、台湾
        • 205.368.88601 Chang Gung Memorial Hosp-Linkou
  • 巴西
      • Goiânia、巴西
        • 205.368.55003 Boehringer Ingelheim Investigational Site
      • Porto Alegre - RS、巴西
        • 205.368.55004 Boehringer Ingelheim Investigational Site
      • Sao Paulo、巴西
        • 205.368.55002 Boehringer Ingelheim Investigational Site
  • 德国
      • Berlin、德国
        • 205.368.49005 Boehringer Ingelheim Investigational Site
      • Freiburg/Breisgau、德国
        • 205.368.49004 Boehringer Ingelheim Investigational Site
      • Köln、德国
        • 205.368.49003 Boehringer Ingelheim Investigational Site
      • Münster、德国
        • 205.368.49006 Boehringer Ingelheim Investigational Site
      • Schmallenberg、德国
        • 205.368.49002 Boehringer Ingelheim Investigational Site
      • Tübingen、德国
        • 205.368.49001 Boehringer Ingelheim Investigational Site
  • 意大利
      • Ferrara、意大利
        • 205.368.39006 Boehringer Ingelheim Investigational Site
      • Milano、意大利
        • 205.368.39004 Boehringer Ingelheim Investigational Site
      • Parma、意大利
        • 205.368.39002 Boehringer Ingelheim Investigational Site
      • Pisa、意大利
        • 205.368.39001 Boehringer Ingelheim Investigational Site
  • 美国
    • Alabama
      • Jasper、Alabama、美国
        • 205.368.01023 Boehringer Ingelheim Investigational Site
    • Arizona
      • Phoenix、Arizona、美国
        • 205.368.01022 Boehringer Ingelheim Investigational Site
    • California
      • Los Angeles、California、美国
        • 205.368.01003 Boehringer Ingelheim Investigational Site
    • Colorado
      • Fort Collins、Colorado、美国
        • 205.368.01008 Boehringer Ingelheim Investigational Site
    • Connecticut
      • Hartford、Connecticut、美国
        • 205.368.01017 Boehringer Ingelheim Investigational Site
      • Waterbury、Connecticut、美国
        • 205.368.01028 Boehringer Ingelheim Investigational Site
    • Florida
      • Bay Pines、Florida、美国
        • 205.368.01004 Boehringer Ingelheim Investigational Site
      • North Miami Beach、Florida、美国
        • 205.368.01013 Boehringer Ingelheim Investigational Site
    • Kentucky
      • Hazard、Kentucky、美国
        • 205.368.01025 Boehringer Ingelheim Investigational Site
    • Maine
      • Biddeford、Maine、美国
        • 205.368.01029 Boehringer Ingelheim Investigational Site
    • Maryland
      • Baltimore、Maryland、美国
        • 205.368.01016 Boehringer Ingelheim Investigational Site
    • Massachusetts
      • Boston、Massachusetts、美国
        • 205.368.01002 Boehringer Ingelheim Investigational Site
    • Missouri
      • Kansas City、Missouri、美国
        • 205.368.01021 Boehringer Ingelheim Investigational Site
    • New York
      • Albany、New York、美国
        • 205.368.01014 Boehringer Ingelheim Investigational Site
    • Oklahoma
      • Tulsa、Oklahoma、美国
        • 205.368.01030 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Charleston、South Carolina、美国
        • 205.368.01018 Boehringer Ingelheim Investigational Site
      • Gaffney、South Carolina、美国
        • 205.368.01027 Boehringer Ingelheim Investigational Site
      • Greenville、South Carolina、美国
        • 205.368.01019 Boehringer Ingelheim Investigational Site
      • Spartanburg、South Carolina、美国
        • 205.368.01020 Boehringer Ingelheim Investigational Site
      • Union、South Carolina、美国
        • 205.368.01024 Boehringer Ingelheim Investigational Site
    • Texas
      • Dallas、Texas、美国
        • 205.368.01015 Boehringer Ingelheim Investigational Site
  • 葡萄牙
      • Coimbra、葡萄牙
        • 205.368.35103 Boehringer Ingelheim Investigational Site
      • Matosinhos、葡萄牙
        • 205.368.35102 Boehringer Ingelheim Investigational Site
  • 西班牙
      • Badalona (Barcelona)、西班牙
        • 205.368.34005 Hospital Germans Trias i Pujol
      • Barakaldo (Bilbao)、西班牙
        • 205.368.34002 Hospital de Cruces
      • Barcelona、西班牙
        • 205.368.34001 Hospital Clinic i Provincial de Barcelona
      • Madrid、西班牙
        • 205.368.34003 Hospital Gregorio Maranon
      • Sevilla、西班牙
        • 205.368.34004 Hospital Universitario Vírgen del Rocío
      • Sevilla、西班牙
        • 205.368.34006 Boehringer Ingelheim Investigational Site
  • 阿根廷
      • Rosario、阿根廷
        • 205.368.54001 Boehringer Ingelheim Investigational Site
      • Vicente López、阿根廷
        • 205.368.54002 Boehringer Ingelheim Investigational 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

  1. All patients must sign an informed consent
  2. Diagnosis of COPD with specific spirometric criteria (determined at study visits)
  3. Age >= 40 years
  4. Medical Research Council Dyspnoea score >= 2
  5. Current or ex-smoker with a >= 10 pack-year smoking history
  6. Ability to exercise on treadmill

Exclusion criteria

  1. Significant diseases other than COPD such as history of life-threatening pulmonary obstruction, thoracotomy with pulmonary resection, interstitial lung disease, CF, pulmonary thromboembolic disease, clinically evident bronchiectasis, active tuberculosis, or known moderate to severe renal impairment
  2. Clinical history of asthma
  3. Use of supplemental oxygen therapy
  4. Respiratory tract infection or COPD exacerbation in the 6 weeks prior to Visit 1 or during the washout period prior to Visit 3 (may randomize 6 weeks after recovery)
  5. Recent history (<= 12 months) of myocardial infarction
  6. Unstable or life-threatening cardiac arrhythmia
  7. Malignancy treated with radiation therapy or chemotherapy in the last 5 years
  8. Pregnant or nursing women
  9. Known hypersensitivity to anticholinergic drugs or any component of the study medications
  10. Participation in pulmonary or cardiac rehab program within 13 weeks of Visit 1
  11. Estimated life expectancy < 2 years
  12. Symptomatic prostatic hyperplasia or bladder neck obstruction
  13. Known narrow-angle glaucoma
  14. Any condition that is contraindicated for exercise
  15. Orthopaedic, muscular, neurological or cardiac disease that would interfere with regular participation in aerobic exercise or with exercise testing
  16. Body mass index < 18 kg/m2 or >35 kg/m2 list truncated for space

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：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：tiotropium 18mcg
Oral inhalation once daily of 18mcg tiotropium via handihaler
药品：tiotropium 18 mcg
Oral inhalation once daily of 18mcg tiotropium via handihaler
安慰剂比较：Placebo
Oral inhalation once daily of placebo matching tiotropium via handihaler
药品：Placebo
Oral inhalation of once-daily placebo matching tiotropium via handihaler

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
90% Constant Work Rate (CWR) Treadmill Endurance Time at 96 Weeks - Double-Blind Phase
大体时间：baseline, 96 weeks
Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
baseline, 96 weeks

次要结果测量

结果测量
措施说明
大体时间
90% Constant Work Rate (CWR) Treadmill Endurance Time at 8 Weeks - Double-Blind Phase
大体时间：baseline, 8 weeks
Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
baseline, 8 weeks
90% Constant Work Rate (CWR) Treadmill Endurance Time at 16 Weeks - Double-Blind Phase
大体时间：baseline, 16 weeks
Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
baseline, 16 weeks
90% Constant Work Rate (CWR) Treadmill Endurance Time at 32 Weeks - Double-Blind Phase
大体时间：baseline, 32 weeks
Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
baseline, 32 weeks
90% Constant Work Rate (CWR) Treadmill Endurance Time at 48 Weeks - Double-Blind Phase
大体时间：baseline, 48 weeks
Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
baseline, 48 weeks
90% Constant Work Rate (CWR) Treadmill Endurance Time at 64 Weeks - Double-Blind Phase
大体时间：baseline, 64 weeks
Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
baseline, 64 weeks
90% Constant Work Rate (CWR) Treadmill Endurance Time at 80 Weeks - Double-Blind Phase
大体时间：baseline, 80 weeks
Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
baseline, 80 weeks
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase
大体时间：baseline, 8 weeks
FEV1 is the maximal amount of air you can forcefully exhale in one second.
baseline, 8 weeks
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase
大体时间：baseline, 16 weeks
FEV1 is the maximal amount of air you can forcefully exhale in one second.
baseline, 16 weeks
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase
大体时间：baseline, 32 weeks
FEV1 is the maximal amount of air you can forcefully exhale in one second.
baseline, 32 weeks
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase
大体时间：baseline, 48 weeks
FEV1 is the maximal amount of air you can forcefully exhale in one second.
baseline, 48 weeks
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase
大体时间：baseline, 64 weeks
FEV1 is the maximal amount of air you can forcefully exhale in one second.
baseline, 64 weeks
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase
大体时间：baseline, 80 weeks
FEV1 is the maximal amount of air you can forcefully exhale in one second.
baseline, 80 weeks
Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase
大体时间：baseline, 96 weeks
FEV1 is the maximal amount of air you can forcefully exhale in one second.
baseline, 96 weeks
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase
大体时间：baseline, 8 weeks
FEV1 is the maximal amount of air you can forcefully exhale in one second.
baseline, 8 weeks
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase
大体时间：baseline, 16 weeks
FEV1 is the maximal amount of air you can forcefully exhale in one second.
baseline, 16 weeks
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase
大体时间：baseline, 32 weeks
FEV1 is the maximal amount of air you can forcefully exhale in one second.
baseline, 32 weeks
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase
大体时间：baseline, 48 weeks
FEV1 is the maximal amount of air you can forcefully exhale in one second.
baseline, 48 weeks
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase
大体时间：baseline, 64 weeks
FEV1 is the maximal amount of air you can forcefully exhale in one second.
baseline, 64 weeks
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase
大体时间：baseline, 80 weeks
FEV1 is the maximal amount of air you can forcefully exhale in one second.
baseline, 80 weeks
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase
大体时间：baseline, 96 weeks
FEV1 is the maximal amount of air you can forcefully exhale in one second.
baseline, 96 weeks
Pre-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase
大体时间：baseline, 8 weeks
FVC is the volume of air that can be forcibly blown out after full inspiration.
baseline, 8 weeks
Pre-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase
大体时间：baseline, 16 weeks
FVC is the volume of air that can be forcibly blown out after full inspiration.
baseline, 16 weeks
Pre-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase
大体时间：baseline, 32 weeks
FVC is the volume of air that can be forcibly blown out after full inspiration.
baseline, 32 weeks
Pre-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase
大体时间：baseline, 48 weeks
FVC is the volume of air that can be forcibly blown out after full inspiration.
baseline, 48 weeks
Pre-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase
大体时间：baseline, 64 weeks
FVC is the volume of air that can be forcibly blown out after full inspiration.
baseline, 64 weeks
Pre-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase
大体时间：baseline, 80 weeks
FVC is the volume of air that can be forcibly blown out after full inspiration.
baseline, 80 weeks
Pre-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase
大体时间：baseline, 96 weeks
FVC is the volume of air that can be forcibly blown out after full inspiration.
baseline, 96 weeks
Post-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase
大体时间：baseline, 8 weeks
FVC is the volume of air that can be forcibly blown out after full inspiration.
baseline, 8 weeks
Post-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase
大体时间：baseline, 16 weeks
FVC is the volume of air that can be forcibly blown out after full inspiration.
baseline, 16 weeks
Post-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase
大体时间：baseline, 32 weeks
FVC is the volume of air that can be forcibly blown out after full inspiration.
baseline, 32 weeks
Post-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase
大体时间：baseline, 48 weeks
FVC is the volume of air that can be forcibly blown out after full inspiration.
baseline, 48 weeks
Post-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase
大体时间：baseline, 64 weeks
FVC is the volume of air that can be forcibly blown out after full inspiration.
baseline, 64 weeks
Post-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase
大体时间：baseline, 80 weeks
FVC is the volume of air that can be forcibly blown out after full inspiration.
baseline, 80 weeks
Post-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase
大体时间：baseline, 96 weeks
FVC is the volume of air that can be forcibly blown out after full inspiration.
baseline, 96 weeks
Borg Scale of Dyspnea at Isotime After 96 Weeks - Double-Blind Phase
大体时间：baseline, 96 weeks
Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)
baseline, 96 weeks
Borg Scale of Peak Dyspnea After 96 Weeks - Double-Blind Phase
大体时间：baseline, 96 weeks
Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)
baseline, 96 weeks
Borg Scale of Peak Leg Discomfort After 96 Weeks - Double-Blind Phase
大体时间：baseline, 96 weeks
Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)
baseline, 96 weeks
Change From Baseline in Physician Global Evaluation at 8 Weeks - Double-Blind Phase
大体时间：baseline, 8 weeks
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
baseline, 8 weeks
Change From Baseline in Physician Global Evaluation at 16 Weeks - Double-Blind Phase
大体时间：baseline, 16 weeks
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
baseline, 16 weeks
Change From Baseline in Physician Global Evaluation at 32 Weeks - Double-Blind Phase
大体时间：baseline, 32 weeks
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
baseline, 32 weeks
Change From Baseline in Physician Global Evaluation at 48 Weeks - Double-Blind Phase
大体时间：baseline, 48 weeks
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
baseline, 48 weeks
Change From Baseline in Physician Global Evaluation at 64 Weeks - Double-Blind Phase
大体时间：baseline, 64 weeks
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
baseline, 64 weeks
Change From Baseline in Physician Global Evaluation at 80 Weeks - Double-Blind Phase
大体时间：baseline, 80 weeks
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
baseline, 80 weeks
Change From Baseline in Physician Global Evaluation at 96 Weeks - Double-Blind Phase
大体时间：baseline, 96 weeks
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
baseline, 96 weeks
Change From Baseline in Patient Global Evaluation at 8 Weeks - Double-Blind Phase
大体时间：baseline, 8 weeks
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
baseline, 8 weeks
Change From Baseline in Patient Global Evaluation at 16 Weeks - Double-Blind Phase
大体时间：baseline, 16 weeks
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
baseline, 16 weeks
Change From Baseline in Patient Global Evaluation at 32 Weeks - Double-Blind Phase
大体时间：baseline, 32 weeks
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
baseline, 32 weeks
Change From Baseline in Patient Global Evaluation at 48 Weeks - Double-Blind Phase
大体时间：baseline, 48 weeks
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
baseline, 48 weeks
Change From Baseline in Patient Global Evaluation at 64 Weeks - Double-Blind Phase
大体时间：baseline, 64 weeks
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
baseline, 64 weeks
Change From Baseline in Patient Global Evaluation at 80 Weeks - Double-Blind Phase
大体时间：baseline, 80 weeks
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
baseline, 80 weeks
Change From Baseline in Patient Global Evaluation at 96 Weeks - Double-Blind Phase
大体时间：baseline, 96 weeks
The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)
baseline, 96 weeks
Saint George's Respiratory Questionnaire Total Score at 96 Weeks - Double-Blind Phase
大体时间：baseline, 96 weeks
Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.
baseline, 96 weeks
Saint George's Respiratory Questionnaire Activity Component Score at 96 Weeks - Double-Blind Phase
大体时间：baseline, 96 weeks
Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.
baseline, 96 weeks
Saint George's Respiratory Questionnaire Impact Component Score at 96 Weeks - Double-Blind Phase
大体时间：baseline, 96 weeks
Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.
baseline, 96 weeks
Saint George's Respiratory Questionnaire Symptoms Component Score at 96 Weeks - Double-Blind Phase
大体时间：baseline, 96 weeks
Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.
baseline, 96 weeks
Patients With COPD Exacerbation (Survival Analysis) - Double-Blind Phase
大体时间：baseline, 96 weeks
COPD exacerbation is a complex of symptoms related to COPD with a duration of three days or more requiring a change of treatment.
baseline, 96 weeks
90% Constant Work Rate (CWR) Treadmill Endurance Time at 100 Weeks - Open-Label Phase
大体时间：baseline, 100 weeks
Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
baseline, 100 weeks
Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 100 Weeks - Open-Label Phase
大体时间：baseline, 100 weeks
FEV1 is the maximal amount of air you can forcefully exhale in one second.
baseline, 100 weeks
Post-treatment Forced Vital Capacity (FVC) at 100 Weeks - Open-Label Phase
大体时间：baseline, 100 weeks
FVC is the volume of air that can be forcibly blown out after full inspiration.
baseline, 100 weeks
Saint George's Respiratory Questionnaire Total Score at 100 Weeks - Open-Label Phase
大体时间：baseline, 100 weeks
Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.
baseline, 100 weeks
Saint George's Respiratory Questionnaire Activity Component Score at 100 Weeks - Open-Label Phase
大体时间：baseline, 100 weeks
Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.
baseline, 100 weeks
Saint George's Respiratory Questionnaire Impact Component Score at 100 Weeks - Open-Label Phase
大体时间：baseline, 100 weeks
Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.
baseline, 100 weeks
Saint George's Respiratory Questionnaire Symptoms Component Score at 100 Weeks - Open-Label Phase
大体时间：baseline, 100 weeks
Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.
baseline, 100 weeks
Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status
大体时间：From first drug administration until 30 days after last drug administration
Clinical Relevant Abnormalities for Vital Signs and Physical examination, including vital status. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Events.
From first drug administration until 30 days after last drug administration

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

Boehringer Ingelheim

合作者

Pfizer

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

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

2007年8月1日

初级完成 (实际的)

2010年6月1日

研究注册日期

首次提交

2007年9月3日

首先提交符合 QC 标准的

2007年9月3日

首次发布 (估计)

2007年9月5日

研究记录更新

最后更新发布 (估计)

2013年12月24日

上次提交的符合 QC 标准的更新

2013年11月27日

最后验证

2013年9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

  • 205.368
  • 2006-004610-41 (EudraCT编号：EudraCT)

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