EUCTR2006-004610-41-IT进行中（未招募）不适用
A randomized, double-blind, placebo-controlled two-year trial to examine the changes in Exercise Endurance and COPD Patients Treated with Tiotropium (Spiriva HandiHaler) 18 µg once daily (EXACTT trial) - EXACTT
BOEHRINGER ING.0 个研究点目标入组 538 人开始时间: 2007年11月12日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 538
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Male or female -40 years old or more -with a diagnosis of COPD (pre-bronchodilator FEV1 60% or less then predicted, post bronchodilator FEV1 65% or less then predicted, FEV1/FVC less then 70%) -smoking history 10 or more pack-years
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Patients with significant diseases other than COPD. A significant disease is defined as a disease or condition which, in the opinion of the investigator, may put the patient at risk because of participation in the study or may influence either the results of the study or the patient?s ability to participate in the study. -Patients with a history of asthma. -A history of thoracotomy with pulmonary resection. -Patients requiring the use of supplemental oxygen therapy. -Patients with any respiratory tract infection or COPD exacerbation in the 6 weeks prior to Visit 1 or during the washout period prior to Visit 3. These patients may be randomized 6 weeks following recovery from the infection or exacerbation -Patients with a recent history (i.e., 12 months or less) of myocardial infarction. -Patients with any unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year; or who have been hospitalized for cardiac failure during the past year. -Malignancy for which patient is undergoing radiation therapy or chemotherapy, within the last 5 years. -Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception. -A known hypersensitivity to anticholinergic drugs, lactose or any other component of the inhalation capsule, or to components in Atrovent or in the provided rescue medication. -Patients who are currently in a pulmonary or cardiac rehabilitation program or who have completed a pulmonary or cardiac rehabilitation program within 13 weeks of Visit 1. -Patients with a history of significant alcohol or drug abuse in the previous year. -Participation in another trial with an investigational drug within 30 days or 6 half lives (whichever is greater) of the start of the study. -Patients with a history of orthopaedic, muscular, neurological or cardiac disease that would interfere with regular participation in aerobic exercise or with exercise testing -Patients with prostatic hyperplasia or bladder neck obstruction. Patients with symptomatically controlled prostatic hyperplasia on medications may be included and should continue their medications -Patients with known narrow-angle glaucoma. -Patients with known moderate to severe renal impairment. -Patients with a body mass index < 18 kg/m**2 or > 35 kg/m**2. Patients who experience oxygen desaturation (oxygen saturation <=85%) during the incremental exercise test or during the constant work rate tests at Visit 3 and 3r. -History of life-threatening pulmonary obstruction, interstitial lung disease, cystic fibrosis, pulmonary thromboembolic disease or clinically evident bronchiectasis.
研究者
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