NCT00629239已完成2 期
A 4-week Double-blind, Placebo-controlled, Randomized, Parallel Group Phase IIa Study to Assess the Tolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Number of Patients Experiencing Adverse Events
研究概览
简要总结
The purpose of this study is to see if treatment with AZD4818 for four weeks is tolerable, safe and effective in treating COPD and, if so, how it compares with placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of COPD, with symptoms for more than 1 year
- •Current or ex-smokers with a smoking history of at least 10 pack-years (1 pack-year=20 cigarettes/day for 1 year)
- •Lung function (FEV1) 40 to 80% of the predicted normal value after using a short acting bronchodilator
排除标准
- •Clinical suspicion of active tuberculosis
- •Any current clinically significant respiratory tract disorder other than COPD
- •History of current clinically relevant arrhythmia, heart block, ECG abnormalities, or unstable angina
研究组 & 干预措施
2
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
1
Experimental
AZD4818
干预措施: AZD4818 (Drug)
结局指标
主要结局
Number of Patients Experiencing Adverse Events
时间窗: At all study visits
Number of patients who had an Adverse Event
次要结局
- Forced Expiratory Volume 1 (FEV1)(Before treatment and after 1, 2, 3 and 4 weeks of treatment)
- Forced Vital Capacity (FVC)(Before treatment and after 1, 2, 3 and 4 weeks of treatment)
- Vital Capacity (VC)(Before treatment and after 1, 2, 3 and 4 weeks of treatment)
- Inspiratory Capacity (IC)(Before treatment and after 1, 2, 3 and 4 weeks of treatment)
- Forced Expiratory Flow (FEF) 25%-75%(Before treatment and after 1, 2, 3 and 4 weeks of treatment)
- Peak Expiratory Flow (PEF) Morning(Daily during run-in and treatment)
- Peak Expiratory Flow (PEF) Evening(Daily during run-in and treatment)
- The Clinical COPD ( Chronic Obstructive Pulmonary Disease) Questionnaire (CCQ) Total(Before treatment and after 1, 2, 3 and 4 weeks of treatment)
- Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness(Daily during run-in and treatment)
- Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness(Daily during run-in and treatment)
- Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score(Daily during run-in and treatment)
- Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Sleep Score(Daily during run-in and treatment)
- 6-minute Walk Test(Before treatment and after 4 weeks of treatment)
研究者
研究点 (1)
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