EUCTR2006-001009-27-SK进行中（未招募）1 期
A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess Long Term (one year) Efficacy and Safety Study of Tiotropium Inhalation Solution 5µg (2 puffs of 2.5µg) Delivered by the Respimat Inhaler in Patients with Chronic Obstructive Pulmonary Disease (COPD)
Boehringer Ingelheim Pharma GesmbH0 个研究点目标入组 3,000 人开始时间: 2006年10月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3,000
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 and female patients aged 40 years or more with a diagnosis of relatively stable, moderate to severe COPD and with a smoking history of at least 10 pack years will be eligible for inclusion in the trial. Patients must have a pre-bronchodilator FEV1 = 60% of predicted normal and FEV1 = 70% of FVC both at screening and on entry to the randomised phase of the trial.
- •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
- •Principal exclusion criteria are summarised as follows:
- •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 patients’ ability to participate in the study.
- •Recent history (i.e six months or less) of myocardial infarction.
- •Unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year.
- •Hospitalisation for cardiac failure during the past year.
- •Malignancy requiring resection, radiation or chemotherapy within the last five years.
- •Known narrow angle glaucoma.
- •Patients with a history of asthma, allergic rhinitis or who have a blood eosinophil count = 600 / mm3.
- •Patients with a life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis.
- •Known active tuberculosis.
- •Patients with a history of and /or active significant alcohol or drug abuse.
- •Patients who have undergone thoracotomy with pulmonary resection
- •Patients who regularly use daytime oxygen therapy for more than 1 hour per day.
- •Use of systemic corticosteroid medication at unstable doses (i.e less than six weeks on stable dose) or at doses in excess of the equivalent of 10mg prednisolone per day or 20mg every other day.
- •Known hypersensitivity to anticholinergic drugs, BAC, EDTA or any other components of the Respimat inhalation solution delivery system.
- •Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception.
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