EUCTR2010-020891-43-BG进行中（未招募）不适用
A 4-week, Double-Blind, Placebo-Controlled, Randomised, Parallel group, Multi-Centre, Phase IIa Study to Investigate the Tolerability and Safety of 100 mg Oral AZD2423 in Patients with Moderate to Severe COPD. - AZD2423 Safety and Tolerability Study in patients with moderate and severe COPD
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
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 of non-child bearing potential. Only women of non-child bearing potential are included in the study i.e. women who are permanently or surgically sterilised or post menopausal.
- •Between 40 and 80 years of age at Visit 1
- •Clinical diagnosis of COPD (GOLD stage 2 or 3)
- •FEV1/FVC <70% and FEV1 between 30 and 80% of the predicted normal post-bronchodilator (GOLD stage 2 or 3)
- •Current or ex-smokers
- •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
- •Any clinically significant disease or disorder (including history of abnormal immune function) which, in the opinion of the Investigator, may either put the subject at risk or influence the way the drug works
- •Any lung disease other than COPD, recent respiratory infections which have not resolved fully, active tuberculosis or at risk of reactivation of tuberculosis.
- •Any abnormal findings in physical examination, blood or urine test results, vital signs or ECG at Visit 1 that may put the subject at risk during the study, affect their ability to take part or influence the results of the study
- •Immunisation with a live vaccine within 3 months or other vaccination within 30 days before planned start of treatment
- •Cancer within the last 5 years (other than treated skin cancer or treated cervical cancer)
研究者
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