Effects of Tiotropium on Breathing Capacity and Exercise Limitation in Early Stages of Chronic Obstructive Pulmonary Disease
A Randomized, Double-blind, Placebo-controlled, 6-week, Crossover Study to Examine the Effects of Tiotropium (Spiriva® HandiHaler®, 18 µg Once Daily) on Dynamic Hyperinflation and Physical Exercise Capacity in Patients With Early Stage Chronic Obstructive Pulmonary Disease (COPD)
研究概览
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Ontario
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Kingston、Ontario、加拿大
- 205.440.2003 Boehringer Ingelheim Investigational Site
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Quebec
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Montreal、Quebec、加拿大
- 205.440.2001 Boehringer Ingelheim Investigational Site
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Montreal、Quebec、加拿大
- 205.440.2004 Boehringer Ingelheim Investigational Site
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Ste-Foy、Quebec、加拿大
- 205.440.2002 Boehringer Ingelheim Investigational Site
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Alabama
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Birmingham、Alabama、美国
- 205.440.1006 Boehringer Ingelheim Investigational Site
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Jasper、Alabama、美国
- 205.440.1015 Boehringer Ingelheim Investigational Site
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California
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Torrance、California、美国
- 205.440.1002 Boehringer Ingelheim Investigational Site
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Connecticut
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Hartford、Connecticut、美国
- 205.440.1018 Boehringer Ingelheim Investigational Site
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Illinois
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Springfield、Illinois、美国
- 205.440.1008 Boehringer Ingelheim Investigational Site
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Indiana
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Muncie、Indiana、美国
- 205.440.1017 Boehringer Ingelheim Investigational Site
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Michigan
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Livonia、Michigan、美国
- 205.440.1020 Boehringer Ingelheim Investigational Site
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New Hampshire
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Lebanon、New Hampshire、美国
- 205.440.1011 Boehringer Ingelheim Investigational Site
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North Carolina
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Charlotte、North Carolina、美国
- 205.440.1019 Boehringer Ingelheim Investigational Site
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Pennsylvania
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Pittsburgh、Pennsylvania、美国
- 205.440.1013 Boehringer Ingelheim Investigational Site
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South Carolina
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Spartanburg、South Carolina、美国
- 205.440.1007 Boehringer Ingelheim Investigational Site
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion criteria:
For COPD subjects: Male or female, age of 40 years or older, smoking history >10 pack-years, symptomatic defined as baseline dyspnea index focal score of 9 or more and / or daily cough with production of sputum for three months per year during at least two consecutive years, diagnosis of early stage COPD according to: post-bronchodilator FEV1/FVC ratio <70%., FEV1 >/=50% post-bronchodilator predicted normal, and a decreased Inspiratory Capacity during exercise. For Age / Gender Matched Controls: Male or female, age of 40 years or older, nonsmoker, with no significant diseases.
Exclusion criteria:
Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patient's ability to participate in the study.
Patients with a history of asthma, Patients requiring the use of supplemental oxygen therapy, Patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnoea, such as arthritis in the leg, angina pectoris, claudication or other conditions, or Patients with contraindications to exercise.
Note: Additional exclusion criteria for Age / Gender Matched Controls: Patients with a significant disease including COPD.
学习计划
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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有源比较器:18 mcg tiotropium
Patient to receive 1 tiotropium bromide inhalation powder capsule daily (in the morning) via HandiHaler
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double blind randomized crossover
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安慰剂比较:Placebo
Patient to receive 1 placebo inhalation powder capsule daily (in the morning) identical to those containing tiotropium bromide inhalation powder via HandiHaler
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inhalation powder capsule identical to those containing tiotropium bromide inhalation powder
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无干预:Control
Age and gender matched control subjects to conduct incremental and constant work rate exercise tests for comparison to subjects with early stage COPD
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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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Change From Baseline in Inspiratory Capacity (IC) at Isotime
大体时间:baseline, six weeks of treatment
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Inspiratory capacity (IC) during CWR exercise testing measured at isotime (isotime was established during CWR exercise testing at baseline).
Isotime is the minimum exercise time among all tests.
Constant work rate exercise means the exercise is done under constant work rate.
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baseline, six weeks of treatment
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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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Constant Work Rate (CWR) Endurance Time
大体时间:six weeks of treatment
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CWR exercise duration calculated as the length of time of the exercise period
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six weeks of treatment
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Change From Baseline in Modified Borg Scale Ratings for Dyspnea Intensity at Isotime
大体时间:baseline, six weeks of treatment
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Modified Borg Scale is a participant rating of the intensity of dyspnea measured on a scale ranging from 0 (Nothing at all) to 10 (Maximal, most severe ever experienced).
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baseline, six weeks of treatment
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合作者和调查者
合作者
出版物和有用的链接
一般刊物
- Gagnon P, Casaburi R, Saey D, Porszasz J, Provencher S, Milot J, Bourbeau J, O'Donnell DE, Maltais F. Cluster Analysis in Patients with GOLD 1 Chronic Obstructive Pulmonary Disease. PLoS One. 2015 Apr 23;10(4):e0123626. doi: 10.1371/journal.pone.0123626. eCollection 2015.
- Porszasz J, Blonshine S, Cao R, Paden HA, Casaburi R, Rossiter HB. Biological quality control for cardiopulmonary exercise testing in multicenter clinical trials. BMC Pulm Med. 2016 Jan 16;16:13. doi: 10.1186/s12890-016-0174-8.
- Casaburi R, Maltais F, Porszasz J, Albers F, Deng Q, Iqbal A, Paden HA, O'Donnell DE; 205.440 Investigators. Effects of tiotropium on hyperinflation and treadmill exercise tolerance in mild to moderate chronic obstructive pulmonary disease. Ann Am Thorac Soc. 2014 Nov;11(9):1351-61. doi: 10.1513/AnnalsATS.201404-174OC.
- O'Donnell DE, Maltais F, Porszasz J, Webb KA, Albers FC, Deng Q, Iqbal A, Paden HA, Casaburi R; 205.440 investigators. The continuum of physiological impairment during treadmill walking in patients with mild-to-moderate COPD: patient characterization phase of a randomized clinical trial. PLoS One. 2014 May 1;9(5):e96574. doi: 10.1371/journal.pone.0096574. eCollection 2014.
有用的网址
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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