A Randomised, Double-blind, Placebo and Active Controlled, Multi-centre, 6 Way Cross-over, Single-dose Phase IIa Study to Investigate the Local and Systemic Effects of 3 Different Doses of Inhaled AZD2115 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
- 39
- 试验地点
- 1
- 主要终点
- Peak Forced Expiratory Volume in 1 second (FEV1) defined as the maximum FEV1 from the spirometry assessments
研究概览
简要总结
This study in COPD patients will investigate the bronchodilatory effect of AZD2115. AZD2115 will be tested versus placebo and active comparators. The safety and tolerability of AZD2115 including investigations of clinically relevant systemically mediated effects will also be investigated.
详细描述
A randomised, double-blind, placebo and active controlled, multi-centre, 6 way cross-over, single-dose Phase IIa study to investigate the local and systemic effects of 3 different doses of inhaled AZD2115 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
- 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
- •Provision of informed consent prior to any study specific procedures
- •Male or female of non-childbearing potential (post-menopausal or surgically sterilised), age ≥40 years at Visit 1
- •Clinical diagnosis of COPD for more than 1 year at Visit 1, according to GOLD guidelines
- •Post-bronchodilator FEV1 ≥ 40 to < 80% of the predicted normal value and post-bronchodilator FEV1/FVC < 70%
- •Reversible airway obstruction
排除标准
- •Significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the result of the study, or the patient's ability to participate in the study.
- •An exacerbation of COPD within 6 weeks prior to Visit 1
- •Treatment with systemic glucocorticosteroids with 6 weeks of Visit
- •Recent or ongoing respiratory tract infection during enrolment period.
- •Need for long-term oxygen therapy and/or saturation O2 < 92%.
研究组 & 干预措施
Single dose of AZD2115 25 µg
干预措施: AZD2115 (Drug)
Single dose of AZD2115 80 µg
干预措施: AZD2115 (Drug)
Single dose of AZD2115 240 µg
干预措施: AZD2115 (Drug)
Single doses of placebo
干预措施: Placebo (Drug)
Single dose of indacaterol 150 µg
干预措施: Indacaterol (Drug)
Single dose of indacaterol 150 µg + tiotropium 18 µg
干预措施: Indacaterol + Tiotropium (Drug)
结局指标
主要结局
Peak Forced Expiratory Volume in 1 second (FEV1) defined as the maximum FEV1 from the spirometry assessments
时间窗: During the first 24 hours following administration
Trough FEV1defined as the average FEV1 from the spirometry assessments
时间窗: During 22 to 26 hours following administration
次要结局
- Average FEV1(FEV1 0-24h post-dose)
- Peak, average and trough Forced Vital Capacity (FVC)(FVC peak and average 0-24h post-dose and trough 22-26h post-dose)
- Systemic effect by assessment of blood pressure (BP)(Peak and average 0-4 h post dose)
- Systemic effect by assessment of heart rate (HR) and QT interval corrected for heart rate using Fridericia's formula (QTcF)(Peak and average 0-4 h post dose)
- Systemic effect by assessment of Potassium and Glucose(Peak and average 0-4 h post dose)
- Safety and tolerability of 3 different single doses of AZD2115(At screening, during 0-26 h post-dose and at follow-up)
- Plasma concentrations of AZD2115 after 3 different single doses measured as area under the curve over the time (AUC) and maximum concentration (Cmax), and time to maximum concentration (tmax)(0-24h post dose)