A Double-blind, Placebo-controlled, Randomised, Multi-centre, 3-way Cross-over, Single-dose Phase II Study to Investigate the Local and Systemic Effects of Inhaled AZD8683 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose
研究概览
简要总结
The purpose of this study is to investigate effects of inhaled AZD8683 compared to placebo in COPD patients.
详细描述
A double-blind, placebo-controlled, randomised, multi-centre, 3-way cross-over, single-dose phase II study to investigate the local and systemic effects of inhaled AZD8683 in patients with chronic obstructive pulmonary disease (COPD)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, 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
- •Clinical diagnosis of COPD
- •Current or ex-smokers
- •FEV1 40 - 80% of the predicted normal value (post-bronchodilator) and post-bronchodilator FEV1/FVC < 70%
排除标准
- •Any clinically significant disease or disorder
- •Any clinically relevant abnormal findings at screening examinations
- •Family history or presence of glaucoma
- •Need of long term oxygen therapy
研究组 & 干预措施
First 50 mcg, then 200 mcg, then placebo
period 1: AZD8683 50 mcg, period 2: washout, period 3: AZD8683 200 mcg, period 4:washout, period5: placebo
干预措施: AZD8683, 50 mcg (Drug)
First 50 mcg, then 200 mcg, then placebo
period 1: AZD8683 50 mcg, period 2: washout, period 3: AZD8683 200 mcg, period 4:washout, period5: placebo
干预措施: Placebo (Drug)
First 50 mcg, then 200 mcg, then placebo
period 1: AZD8683 50 mcg, period 2: washout, period 3: AZD8683 200 mcg, period 4:washout, period5: placebo
干预措施: AZD8683, 200 mcg (Drug)
First 50 mcg, then placebo, then 200 mcg
period 1: AZD8683 50 mcg, period 2: washout, period 3: placebo, period 4: washout, period5:AZD8683 200 mcg
干预措施: AZD8683, 50 mcg (Drug)
First 50 mcg, then placebo, then 200 mcg
period 1: AZD8683 50 mcg, period 2: washout, period 3: placebo, period 4: washout, period5:AZD8683 200 mcg
干预措施: Placebo (Drug)
First 50 mcg, then placebo, then 200 mcg
period 1: AZD8683 50 mcg, period 2: washout, period 3: placebo, period 4: washout, period5:AZD8683 200 mcg
干预措施: AZD8683, 200 mcg (Drug)
First 200 mcg, then placebo, then 50 mcg
period 1: AZD8683 200 mcg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD8683 50 mcg
干预措施: AZD8683, 50 mcg (Drug)
First 200 mcg, then placebo, then 50 mcg
period 1: AZD8683 200 mcg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD8683 50 mcg
干预措施: Placebo (Drug)
First 200 mcg, then placebo, then 50 mcg
period 1: AZD8683 200 mcg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD8683 50 mcg
干预措施: AZD8683, 200 mcg (Drug)
First 200 mcg, then 50 mcg, then placebo
period 1: AZD8683 200 mcg, period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period 5: placebo
干预措施: AZD8683, 50 mcg (Drug)
First 200 mcg, then 50 mcg, then placebo
period 1: AZD8683 200 mcg, period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period 5: placebo
干预措施: Placebo (Drug)
First 200 mcg, then 50 mcg, then placebo
period 1: AZD8683 200 mcg, period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period 5: placebo
干预措施: AZD8683, 200 mcg (Drug)
First placebo, then 200 mcg, then 50 mcg
period 1: placebo , period 2: washout, period 3: AZD8683 200 mcg, period 4: washout, period5: AZD8683 50 mcg
干预措施: AZD8683, 50 mcg (Drug)
First placebo, then 200 mcg, then 50 mcg
period 1: placebo , period 2: washout, period 3: AZD8683 200 mcg, period 4: washout, period5: AZD8683 50 mcg
干预措施: Placebo (Drug)
First placebo, then 200 mcg, then 50 mcg
period 1: placebo , period 2: washout, period 3: AZD8683 200 mcg, period 4: washout, period5: AZD8683 50 mcg
干预措施: AZD8683, 200 mcg (Drug)
First placebo, then 50 mcg, then 200 mcg
period 1: placebo , period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period5: AZD8683 200 mcg
干预措施: AZD8683, 50 mcg (Drug)
First placebo, then 50 mcg, then 200 mcg
period 1: placebo , period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period5: AZD8683 200 mcg
干预措施: Placebo (Drug)
First placebo, then 50 mcg, then 200 mcg
period 1: placebo , period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period5: AZD8683 200 mcg
干预措施: AZD8683, 200 mcg (Drug)
结局指标
主要结局
Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose
时间窗: 0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h
Maximum FEV1 value
Forced Expiratory Volume in One Second (FEV1), Average Effect Over 22 - 26 Hours Post-dose
时间窗: 22 h, 24 h, 26 h
Trough FEV1 value
次要结局
- Forced Expiratory Volume in One Second (FEV1), Average Effect Over 0 - 24 Hours Post-dose(0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h)
- Forced Vital Capacity (FVC), Peak Effect Over 0 - 24 Hours Post-dose(0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h)
- Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose(0, 30 min, 2 h, 4 h)
- Diastolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose(0, 30 min, 2 h, 4 h)
- Pulse, Average Effect Over 0 - 4 Hours Post-dose(0, 30 min, 2 h, 4 h)
- Heart Rate, Average Effect Over 0 - 4 Hours Post-dose(0, 30 min, 2 h, 4 h)
- QTcF, Average Effect Over 0 - 4 Hours Post-dose(0, 30 min, 2 h, 4 h)
- Plasma AZD8683 Cmax(0, 5 min, 15 min, 30 min, 45 min, 1 h, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h)
- Plasma AZD8683 AUC0-24(0, 5 min, 15 min, 30 min, 45 min, 1 h, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h)