ACTRN12611000482965已完成2 期
Effects of TD-4208 on FEV1 in Subjects with COPD
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 40 Years 至 75 Years（—）
- 性别
- All
入选标准
- •Diagnosis of moderate stable Chronic Obstructive Pulmonary.
- •Disease with FEV1/FVC <0.7 at screening.
- •Woman of non childbearing potential.
- •Female participants of childbearing potential must test negative for pregnancy and must be using a highly effective method of birth control during the study and for at least 1 month after completion of study dosing.
- •Female participants must not be breastfeeding.
- •Men must agree to use a highly effective method of birth control with partners of childbearing potential during the study and for 1 month after completion of study dosing.
- •Current or past smoking history >10 pack-years.
- •Must be capable of performing reproducible spirometry maneuvers.
排除标准
- •History of significant respiratory disease other than COPD, and/ or requires daily long-term oxygen therapy.
- •Exacerbation of COPD, lung infection within 6 weeks prior to study.
- •Start of or change in dose of COPD treatment 4 weeks before study.
- •Daily using of maintenance systemic/inhaled corticosteroids (>1000 microgram of fluticasone propionate equivalent or >5 mg prednisone).
- •Use of bronchodilators or medication for the treatment of COPD, aspirin , anti-inflammatories for a specific time, prior to the first dose or is not willing to abstain from their use for the specified time periods prior to study dose administration.
- •Symptomatic prostrate hypertorphy, bladder neck obstruction, active cancer, narrow angle glaucoma.
- •Clinical significant hypersensitivity to medications.
- •Participants have an uncontrolled hematologic, immunologic, renal, neurologic, hepatic, endocrine or other disease that may place participant at risk.
- •Cerebrovascular, cardiovacular disease or abnormal ECG.
- •History of drug or alcohol abuse.
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