NCT00758459已完成2 期
A 6 Week Double-Blind, Placebo-controlled, Randomised, Parallel Group Phase IIa Study to Assess the Tolerability/Safety and Efficacy of AZD1236as an Oral Tablet 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
- 74
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events
研究概览
简要总结
The primary aim of this study is to investigate the tolerability and safety of AZD 1236 compared with placebo ("inactive substance") in COPD patients by assessment of Adverse Events, vital signs and laboratory safety assessments.
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
- Double (Participant, Investigator)
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
- •Diagnosis of COPD for 1 month
- •Men or postmenopausal women
- •Spirometry values indicating reduced lung function
- •Smoking history equivalent to using 20 cigarettes a day for 10 years
排除标准
- •Any current respiratory tract disorders other than COPD
- •Requirement for regular oxygen therapy
- •Use of oral or parenteral glucocorticosteroids within 30 days prior to the study
研究组 & 干预措施
1
Experimental
干预措施: AZD1236 (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Adverse Events
时间窗: all study visits
Number of patients who had an Adverse Event
次要结局
- Forced Expiratory Volume in 1 Second (FEV1)(Before treatment and after 1, 2, 4 and 6 weeks of treatment)
- Forced Vital Capacity (FVC)(Before treatment and after 1, 2, 4 and 6 weeks of treatment)
- Vital Capacity (VC)(Before treatment and after 1, 2, 4 and 6 weeks of treatment)
- Inspiratory Capacity (IC)(Before treatment and after 1, 2, 4 and 6 weeks of treatment)
- Forced Expiratory Flow (FEF)25-75%(Before treatment and after 1, 2, 4 and 6 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)
- Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire(CCQ) Total(Before treatment and after 1, 2, 4 and 6 weeks of treatment)
- Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness(Daily during run-in and treatment)
- Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness(Daily during run-in and treatment)
- Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score(Daily during run-in and treatment)
- Clinical Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Night Time Awakenings(Daily during run-in and treatment)
- 6-minute Walk Test(Before treatment and after 6 weeks of treatment)
研究者
研究点 (1)
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