A Randomized, Double Blind , Placebo Controlled Trial to Compare the Effect of Tiotropium Inhalation Capsules on Exercise Tolerance in Patients With COPD Participating in 8 Weeks of Pulmonary Rehabilitation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 234
- 试验地点
- 23
- 主要终点
- Change in six minute walk distance after 8 weeks of pulmonary rehabilitation.
研究概览
简要总结
The objective of this trial is to determine whether tiotropium inhalation capsules (Spiriva, Bromuro de Tiotropio), compared to placebo, enhances the improvement in exercise tolerance seen in patients with chronic obstructive pulmonary disease (COPD) who participate in pulmonary rehabilitation.
详细描述
This is an 25-week multicenter, single country, randomised, double-blind, placebo-controlled, parallel group study to compare the efficacy of tiotropium inhalation capsules (Spiriva, Bromuro de Tiotropio) in patients with COPD participating in a pulmonary rehabilitation program.
Following an initial screening, patients will perform a six minute walk test (Visit 1) and enter a 4-week run-in period. Patients will subsequently be randomized to tiotropium or placebo inhalation capsules taken once daily in the morning for the next 25 weeks. After successfully completing 4 weeks of study drug self-administration, patients will enter a period of pulmonary rehabilitation.
Pulmonary rehabilitation will include aerobic lower limb exercise 3 times weekly for 8 weeks. After the last pulmonary rehabilitation session, patients will continue on study medication for a 12 week follow-up period.
Six minute walk tests will be repeated during the run-in period at Week 0 (Visit 2) and Week 4 (Visit 3), at the conclusion of the 8 weeks of pulmonary rehabilitation (Visit 6) and the 12 weeks of follow-up (Visit 9).
Pulmonary function testing will be conducted prior to the start of therapy at Visit 1 and at Visits 2 (week 0 ), 3 (week 4 ), 6 (week 13 ) and 9 (week 25 ).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPD patients with FEV1 less 60% of predicted FEV1 less 70% of FVC.
排除标准
- •Patients with any respiratory infection in the six weeks prior to the Screening Visit or during the run-in period (between Visits 1 and 2).
- •Patients with a recent history (i.e., 6 months - or less) of myocardial infarction.
- •Patients with any cardiac arrhythmia requiring drug therapy in the past year or who have been hospitalized for heart failure within the past three years.
- •Patients with symptomatic benign prostatic hypertrophy or bladder neck obstruction.
- •Patients with known narrow-angle glaucoma.
结局指标
主要结局
Change in six minute walk distance after 8 weeks of pulmonary rehabilitation.
时间窗: week 13
次要结局
- Individual FVC measurement(week 4, 13, 25)
- Patient activity measurement(week 4, 9, 13, 17, 21, 25)
- Six minute walk distance(week 13, 25)
- Changes from baseline in Pulse rate and blood pressure in conjunction with spirometry(25 weeks)
- Individual FEV1 measurement(week 4, 13, 25)
- COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest(week 4, 13, 25)
- St. George's Hospital Respiratory Questionnaire (SGRQ)(Time Frame: week 4, 13, 25)
- Transition dyspnea index(week 4, 13, 25)
- Amount of salbutamol therapy used during the treatment period(25 weeks)
- Physician's global evaluation(week 4, 13, 25)
- Number and length of exacerbations of COPD(25 weeks)
- Patient peak flow rates (PEFR) twice daily(25 weeks)
- 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)