NCT00525512已完成4 期
A Randomized, Double-blind, Placebo-controlled Two-year Trial to Examine the Changes in Exercise Endurance and COPD Treated With Tiotropium Once Daily (EXACTT)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 519
- 试验地点
- 62
- 主要终点
- 90% Constant Work Rate (CWR) Treadmill Endurance Time at 96 Weeks - Double-Blind Phase
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
tiotropium 18mcg
Experimental
Oral inhalation once daily of 18mcg tiotropium via handihaler
干预措施: tiotropium 18 mcg (Drug)
Placebo
Placebo Comparator
Oral inhalation once daily of placebo matching tiotropium via handihaler
干预措施: Placebo (Drug)
结局指标
主要结局
90% Constant Work Rate (CWR) Treadmill Endurance Time at 96 Weeks - Double-Blind Phase
时间窗: baseline, 96 weeks
Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.
次要结局
- Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase(baseline, 48 weeks)
- Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase(baseline, 64 weeks)
- Post-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase(baseline, 48 weeks)
- Post-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase(baseline, 64 weeks)
- Change From Baseline in Physician Global Evaluation at 32 Weeks - Double-Blind Phase(baseline, 32 weeks)
- 90% Constant Work Rate (CWR) Treadmill Endurance Time at 8 Weeks - Double-Blind Phase(baseline, 8 weeks)
- 90% Constant Work Rate (CWR) Treadmill Endurance Time at 32 Weeks - Double-Blind Phase(baseline, 32 weeks)
- 90% Constant Work Rate (CWR) Treadmill Endurance Time at 80 Weeks - Double-Blind Phase(baseline, 80 weeks)
- Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase(baseline, 8 weeks)
- Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase(baseline, 80 weeks)
- Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase(baseline, 96 weeks)
- Pre-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase(baseline, 16 weeks)
- 90% Constant Work Rate (CWR) Treadmill Endurance Time at 64 Weeks - Double-Blind Phase(baseline, 64 weeks)
- Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase(baseline, 80 weeks)
- Pre-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase(baseline, 32 weeks)
- Pre-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase(baseline, 64 weeks)
- Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase(baseline, 32 weeks)
- Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase(baseline, 8 weeks)
- Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase(baseline, 16 weeks)
- Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase(baseline, 32 weeks)
- Post-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase(baseline, 8 weeks)
- Post-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase(baseline, 16 weeks)
- 90% Constant Work Rate (CWR) Treadmill Endurance Time at 16 Weeks - Double-Blind Phase(baseline, 16 weeks)
- 90% Constant Work Rate (CWR) Treadmill Endurance Time at 48 Weeks - Double-Blind Phase(baseline, 48 weeks)
- Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase(baseline, 16 weeks)
- Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase(baseline, 96 weeks)
- Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase(baseline, 48 weeks)
- Pre-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase(baseline, 96 weeks)
- Pre-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase(baseline, 48 weeks)
- Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase(baseline, 64 weeks)
- Pre-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase(baseline, 8 weeks)
- Pre-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase(baseline, 80 weeks)
- Borg Scale of Dyspnea at Isotime After 96 Weeks - Double-Blind Phase(baseline, 96 weeks)
- Borg Scale of Peak Dyspnea After 96 Weeks - Double-Blind Phase(baseline, 96 weeks)
- Post-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase(baseline, 32 weeks)
- Post-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase(baseline, 80 weeks)
- Post-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase(baseline, 96 weeks)
- Borg Scale of Peak Leg Discomfort After 96 Weeks - Double-Blind Phase(baseline, 96 weeks)
- Change From Baseline in Physician Global Evaluation at 8 Weeks - Double-Blind Phase(baseline, 8 weeks)
- Change From Baseline in Physician Global Evaluation at 16 Weeks - Double-Blind Phase(baseline, 16 weeks)
- Change From Baseline in Physician Global Evaluation at 48 Weeks - Double-Blind Phase(baseline, 48 weeks)
- Change From Baseline in Physician Global Evaluation at 96 Weeks - Double-Blind Phase(baseline, 96 weeks)
- Change From Baseline in Patient Global Evaluation at 16 Weeks - Double-Blind Phase(baseline, 16 weeks)
- Change From Baseline in Physician Global Evaluation at 64 Weeks - Double-Blind Phase(baseline, 64 weeks)
- Change From Baseline in Physician Global Evaluation at 80 Weeks - Double-Blind Phase(baseline, 80 weeks)
- Change From Baseline in Patient Global Evaluation at 48 Weeks - Double-Blind Phase(baseline, 48 weeks)
- Saint George's Respiratory Questionnaire Total Score at 96 Weeks - Double-Blind Phase(baseline, 96 weeks)
- Patients With COPD Exacerbation (Survival Analysis) - Double-Blind Phase(baseline, 96 weeks)
- Change From Baseline in Patient Global Evaluation at 8 Weeks - Double-Blind Phase(baseline, 8 weeks)
- Change From Baseline in Patient Global Evaluation at 96 Weeks - Double-Blind Phase(baseline, 96 weeks)
- Change From Baseline in Patient Global Evaluation at 32 Weeks - Double-Blind Phase(baseline, 32 weeks)
- Change From Baseline in Patient Global Evaluation at 64 Weeks - Double-Blind Phase(baseline, 64 weeks)
- Change From Baseline in Patient Global Evaluation at 80 Weeks - Double-Blind Phase(baseline, 80 weeks)
- Saint George's Respiratory Questionnaire Activity Component Score at 96 Weeks - Double-Blind Phase(baseline, 96 weeks)
- Saint George's Respiratory Questionnaire Symptoms Component Score at 96 Weeks - Double-Blind Phase(baseline, 96 weeks)
- Saint George's Respiratory Questionnaire Impact Component Score at 96 Weeks - Double-Blind Phase(baseline, 96 weeks)
- Saint George's Respiratory Questionnaire Activity Component Score at 100 Weeks - Open-Label Phase(baseline, 100 weeks)
- Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 100 Weeks - Open-Label Phase(baseline, 100 weeks)
- Saint George's Respiratory Questionnaire Impact Component Score at 100 Weeks - Open-Label Phase(baseline, 100 weeks)
- Saint George's Respiratory Questionnaire Symptoms Component Score at 100 Weeks - Open-Label Phase(baseline, 100 weeks)
- Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status(From first drug administration until 30 days after last drug administration)
- 90% Constant Work Rate (CWR) Treadmill Endurance Time at 100 Weeks - Open-Label Phase(baseline, 100 weeks)
- Post-treatment Forced Vital Capacity (FVC) at 100 Weeks - Open-Label Phase(baseline, 100 weeks)
- Saint George's Respiratory Questionnaire Total Score at 100 Weeks - Open-Label Phase(baseline, 100 weeks)
研究者
研究点 (62)
Loading locations...
相似试验
已完成
不适用
The Effects of a Six-week Exercise Programme Undertaken by Women With Rheumatoid ArthritisPhysical ActivityRheumatoid ArthritisNCT02819830Siobhan Graham25
进行中（未招募）
不适用
Exercise As Intervention in Chronic Lymphocytic LeukemiaChronic Lymphocytic LeukemiaNCT06396611Universidade do Porto11
撤回
不适用
SUPERvised Three-month Exercise Program in MEN With Prostate cAncer Receiving Androgen-deprivaTioN thERapyMetastasisProstatic NeoplasmsNCT06282185Canisius-Wilhelmina Hospital20
已完成
不适用
Chronic Study on Body Composition, Training, Performance, and RecoveryDamage MuscleBody Weight ChangesPerformance Enhancing Product UseNCT04230824Pharmanex69
已完成
3 期
Tiotropium+Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 2)Pulmonary Disease, Chronic ObstructiveNCT02006732Boehringer Ingelheim809