EUCTR2007-005087-26-DE进行中（未招募）不适用
Randomised, Double-Blind, Parallel Group Study to Assess the Efficacy and Safety of 4 Weeks of Once Daily Treatment of 3 Doses of Orally Inhaled BI 1744 CL, each in fixed dose combination with 5µg Tiotropium Bromide (Delivered by the Respimat® Inhaler) compared with 5µg Tiotropium Bromide Monoproduct (Delivered by the Respimat® Inhaler) in Patients with COPD - Efficacy and Safety of 4 Weeks Once Daily Orally Inhaled fixed dose combination BI 1744/Tiotropium
Boehringer Ingelheim GmbH & Co. KG0 个研究点目标入组 130 人开始时间: 2008年4月17日最近更新:
适应症
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
- 130
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
- •Dagnosis of COPD.
- •Relatively stable airway obstruction with post-bronchodilator FEV1 =30% of predicted normal and <80% of predicted normal and FEV1 / FVC <70%.
- •Male or female patients, 40 years of age or older.
- •Current or ex-smokers with smoking history >10 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
- •Significant disease other than COPD.
- •Abnormal baseline laboratory results.
- •History of asthma or total blood eosinophil count =600/mm3.
- •Thyrotoxicosis.
- •Paroxysmal tachycardia (>100 beats per minute).
- •Marked baseline prolongation of QT/QTc interval.
- •History of additional risk factors for Torsade de Pointes (TdP).
- •History of myocardial infarction within 1 year of screening visit (Visit 1).
- •Clinically relevant cardiac arrhythmia.
- •Known active tuberculosis.
- •Malignancy for which patient has undergone resection, radiation therapy or
- •chemotherapy within last 5 years (patients with treated basal cell carcinoma are
- •History of life-threatening pulmonary obstruction.
- •History of cystic fibrosis.
- •Clinically evident bronchiectasis.
- •History of significant alcohol or drug abuse.
- •Regular daytime oxygen.
- •Rehabilitation programme within 6 weeks prior to start of study or during study.
- •Administration of investigational drug within one month or six half lives
- •(whichever is greater) prior to Screening Visit.
- •Known hypersensitivity to ß-adrenergics and/or anticholinergic drugs, BAC, EDTA or any other component of the Respimat® inhalation solution delivery system.
- •Pregnant or nursing women.
- •Women of childbearing potential not using two highly effective methods of birth control (one barrier and one non-barrier). Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. Female patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years.
- •Patients who have previously been randomized in this study or are currently participating in another study.
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