A Randomised, Double-blind Placebo- and Active-controlled, Multi-centre, 6-way Cross-over, Single-dose Phase IIa Study to Investigate the Bronchodilatory and Systemic Effects of 4 Different Doses of Inhaled AZD8683 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 3
- 主要终点
- Change From Baseline in Peak FEV1 (0-24h)
研究概览
简要总结
This study in Chronic Obstructive Pulmonary Disease (COPD) patients will investigate the bronchodilatory effect of AZD8683. AZD8683 will be tested versus placebo and an active comparator.
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 bronchodilatory and systemic effects of 4 different doses 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
- 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, age ≥ 40 years at Visit
- •Women must be of non-childbearing potential or must have been stable on a highly effective contraceptive method for at least 3 months prior to Visit 1 and be willing to continue until follow-up
- •Clinical diagnosis of COPD for more than 1 year at Visit 1
- •FEV1 ≥ 30 to < 80% of the predicted normal value (post-bronchodilator) at Visit 2 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 (defined as use of oral/parenteral glucocorticosteroids (GCS) and/or antibiotics and/or hospitalisation related to COPD) within 6 weeks of Visit 1or during the enrolment period
- •Treatment with systemic GCS within 6 weeks of Visit 2 or during the enrolment period
- •Respiratory tract infection of clinical relevance within 30 days of Visit 4, as judged by the Investigator
- •Long-term oxygen therapy, as judged by the Investigator
研究组 & 干预措施
1
Single dose of AZD8683 50 µg
干预措施: AZD8683 (Drug)
2
Single dose of AZD8683 150 µg
干预措施: AZD8683 (Drug)
3
Single dose of AZD8683 300 µg
干预措施: AZD8683 (Drug)
4
Single dose of AZD8683 900 µg
干预措施: AZD8683 (Drug)
5
Single dose of placebo
干预措施: Placebo (Drug)
6
Single dose of tiotropium 18 µg
干预措施: Tiotropium (Drug)
结局指标
主要结局
Change From Baseline in Peak FEV1 (0-24h)
时间窗: The first 24 hours following dose administration
The maximum value over 24 hours post-dose, as change from baseline
Change From Baseline in Trough FEV1 (22-26h)
时间窗: 22 to 26 hours following dose administration
The average over 22 to 26 hours, as change from baseline
次要结局
- Maximum Increase in Systolic Blood Pressure [SBP](baseline, 24hr post dose)
- PK Parameters (AZD8683)(Pre-dose, 24hr post-dose)
- Average FEV1 as a Change From Baseline(The first 24 hours following dose administration)
- Maximum Increase in Diastolic Blood Pressure [DBP](The first 24 hours following dose administration)
- Maximum Increase Heart Rate [HR](baseline, 24hr post dose)
- Maximum Increase in QTcF(baseline, 24hr post dose)