NCT00274521已完成3 期
A Randomized, Double-blind, Placebo Controlled 25-week Trial to Compare the Effect of Tiotropium Inhalation Capsuled (18 Mcg) Once Daily on Exercise Tolerance in Patients With Chronic Obstructive Pulmonary Disease (COPD) Participating in 8 Weeks of Pulmonary Rehabilitation.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 19
- 主要终点
- The primary endpoint is the change in submaximal exercise tolerance (prior to treatment to after pulmonary rehabilitation) as measured by endurance time during a constant work rate treadmill exercise test at 80% of maximum work capacity
研究概览
简要总结
The study was designed to determine whether tiotropium inhalation capsules, compared to placebo, enhances the improvement in exercise tolerance seen in patients with chronic obstructive pulmonary disease (COPD) who participate in pulmonary rehabilitation. In addition, assessments of the effect of tiotropium on dyspnea and quality of life following pulmonary rehabilitation were taken.
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
- •History of COPD, FEV1 of less than or equal than 60% of predicted normal and less than or equal to 70% at Visit 1, Male or Female 40 years or greater, smoking history of more than 10 pack years (current or ex-smokers), patient can perform all study related tests, patients can inhale medication from HandiHaler and from meter dose inhaler, patients who would benefit from participation in a pulmonary rehab program and patients who had a medical clearance to participate in a pulmonary rehab program.
排除标准
- •Patients with significant diseases other than COPD, patients with clinically relevant abnormal baseline hematology, blood chemistry or urinalysis, all patients with SGOT greater than 80IU/L, bilirubin greater than 2.0 mg/dl or creatinine greater than 2.0 mg/dL, recent history of MI (6 months or less). any cardiac arrhythmia requiring drug therapy or has abeen hospitalized for heart failure with the past 3 years, active TB, history of CA or had treatment within the last 24 months, history of CF, bronchiectasis, interstitial lung disease or pulmonary thromboembolic disease.
结局指标
主要结局
The primary endpoint is the change in submaximal exercise tolerance (prior to treatment to after pulmonary rehabilitation) as measured by endurance time during a constant work rate treadmill exercise test at 80% of maximum work capacity
时间窗: week 13
次要结局
- Individual FEV1 measurement(week 4, 13, 25)
- Amount of albuterol therapy used during the treatment period(25 weeks)
- Number and length of exacerbations of COPD(25 weeks)
- Individual FVC measurement(week 4, 13, 25)
- St. George.s Hospital Respiratory Questionnaire (SGRQ)(week 4, 13, 25)
- Modified Borg scale(week 4, 13, 25)
- Patient peak flow rates twice daily(25 weeks)
- Patient activity measurement(week 9, 13, 17, 21, 25)
- Change in submaximal exercise tolerance during constant work rate exercise(week 25)
- Transition dyspnea index(week 4, 13, 25)
- Pulse rate and blood pressure in conjunction with spirometry(25 weeks)
- Physician's global evaluation(week 4, 13, 25)
- COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest)(week 4, 13, 25)
- Change in submaximal exercise tolerance prior to and after pulmonary rehabilitation.(week 13)
- Occurrence of adverse events(25 weeks)
- Changes in the physical examination from baseline and at the conclusion of patient participation in the trial(25 weeks)
研究者
研究点 (19)
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