EUCTR2009-016251-21-BE进行中（未招募）1 期
Pharmacokinetics and dose-ranging of tiotropium inhalation solution delivered from the Respimat inhaler in patients with Chronic Obstructive Pulmonary Disease (COPD)
SCS Boehringer Ingelheim Comm.V0 个研究点目标入组 160 人开始时间: 2010年8月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
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
- •1. All patients must sign an informed consent consistent with ICH-GCP guidelines
- •and local legislations prior to any study-related procedures, which includes
- •medication washout and restrictions.
- •2. Male or female patients 40 years of age or older.
- •3. Patients must be current or ex-smokers with a smoking history of = 10 pack-
- •years (patients who have never smoked cigarettes must be excluded).
- •4. All patients must have a diagnosis of COPD and must meet the following criteria:
- •Relatively stable airway obstruction with a post-bronchodilator FEV1 < 80% of
- •predicted normal and post-bronchodilator FEV1 < 70% of post-bronchodilator
- •5. Patients must be able to perform technically acceptable pulmonary function tests
- •during the study period as required in the protocol.
- •6. Patients must be able to inhale medication in a competent manner from the
- •HandiHaler and Respimat devices.
- •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
- •1. Significant diseases other than COPD.
- •2. Patients with a recent history (i.e., six months or less) of myocardial infarction.
- •3. Patients with any unstable or life-threatening cardiac arrhythmia requiring
- •intervention or change in drug therapy during the past year.
- •4. Hospitalisation for cardiac failure during the past year.
- •5. Malignancy for which the patient has undergone resection, radiation therapy or
- •chemotherapy within the last five years. Patients with treated basal cell
- •carcinoma are allowed.
- •6. Patients with a history of asthma or who have a total blood eosinophil count
- •greater than 600/mm3.
- •7. Patients with a history of life threatening pulmonary obstruction, or a history of
- •cystic fibrosis or clinically evident bronchiectasis.
- •8. Known active tuberculosis.
- •9. Patients with a history (within the past two years) of and / or active significant
- •alcohol or drug abuse.
- •10. Patients who have undergone thoracotomy with pulmonary resection.
- •11. Patients who have completed a pulmonary rehabilitation program in the six
- •weeks prior to screening or patients who are currently in a pulmonary
- •rehabilitation program that will not be maintained throughout the duration of
- •12. Patients who regularly use daytime oxygen therapy for more than 1 hour per
- •day and in the investigator’s opinion will be unable to abstain from the use of
- •oxygen therapy.
- •13. Patients who have taken an investigational drug during the four week period
- •prior to screening.
- •14. Use of antihistamines (H1 receptor antagonists), anti-leukotrienes or
- •leukotriene receptor antagonists for asthma or excluded allergic conditions.
- •15. Use of cromolyn sodium or nedocromil sodium.
- •16. Use of systemic corticosteroid medication at unstable doses.
- •17. Known hypersensitivity to anticholinergic drugs, ß2-adrenergic drugs, lactose
- •or any other component of the study medication delivery systems.
- •18. Pregnant or nursing women
- •19. Women of childbearing potential not using a highly effective method of birth
- •20. Treatment with oral beta-adrenergics within 4 weeks prior to screening or
- •during the run-in period.
- •21. Treatment with indacaterol.
- •22. Treatment with tiotropium within 2 weeks prior to screening and within 3
- •weeks prior to randomisation.
- •23. Treatment with theophylline within specified time windows prior to screening.
- •24. Patients who are currently participating in another study.
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