A Double-blind, Double-dummy, Placebo-controlled, Randomised, Multi-centre, 5-way Cross-over, Single-dose Study to Investigate the Local and Systemic Effects of Inhaled AZD9164 Compared to Tiotropium in Subjects 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
- 25
- 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
Chronic Obstructive Pulmonary Disease (COPD) is a chronic respiratory condition with deteriorating lung function over the years. Patients with COPD experience symptoms of shortness of breath, cough and sputum production. This study is to assess the treatment effects after inhalation of three different single doses of AZD9164 (100, 400 and 1200 mcg) and one single dose of tiotropium (18 mcg). One dose of placebo will be given as comparator. 25 patients are to participate in the study and all will be recruited in Sweden. Each patient will visit the study doctor 9 times during the study, whereof 5 visits will be overnight visits. All examinations, treatment and the follow-up is free of charge.
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
- 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
- •A clinical diagnosis of COPD
- •FEV1 40 - 80% of the predicted normal value (post-bronchodilator) and post- bronchodilator FEV1/FVC < 70%
排除标准
- •Any clinically relevant abnormal findings at screening examinations
- •Any clinically significant disease or disorder
研究组 & 干预措施
AZD9164 100 mcg First, then Placebo for Spririva
1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
干预措施: AZD9164 (Drug)
AZD9164 100 mcg First, then Placebo for Spririva
1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
干预措施: Placebo (Drug)
AZD9164 400 mcg First, then Placebo for Spiriva
1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
干预措施: AZD9164 (Drug)
AZD9164 400 mcg First, then Placebo for Spiriva
1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
干预措施: Placebo (Drug)
AZD9164 1200 mcg First, then Placebo for Spiriva
1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
干预措施: AZD9164 (Drug)
AZD9164 1200 mcg First, then Placebo for Spiriva
1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
干预措施: Placebo (Drug)
Spiriva 18 mcg First, then Placebo for AZD9164
1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
干预措施: Tiotropium (Drug)
Spiriva 18 mcg First, then Placebo for AZD9164
1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
干预措施: Placebo (Drug)
Placebo for Spiriva First, then Placebo for AZD9164
1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
干预措施: Placebo (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, 15 min, 30 min, 60 min, 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, 15 min, 30 min, 60 min, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h)
- Forced Expiratory Volume in One Second (FEV1), Effect at 15 Minutes Post-dose(15 min)
- 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 AZD9164 Cmax(0, 5 min, 15 min, 30 min, 60 min, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h)
- Plasma AZD9164 AUC0-24(0, 5 min, 15 min, 30 min, 60 min, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h)