A Phase II, Double-blind, Placebo-controlled, Randomised, 6-way Cross-over, Single-dose Study to Investigate the Local and Systemic Effects of 3 Doses of Inhaled AZD3199 (a β2-agonist) Compared to Formoterol in Asthmatic Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- S-potassium, Peak Effect Over 0 - 4 h Post-dose
研究概览
简要总结
The purpose of this study is to investigate the pharmacodynamics of single doses of AZD3199 in asthmatic patients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Asthmatic patients with pre-bronchodilatory FEV1 above 60% of predicted normal and above 1.5 liters.
- •Men and post-menopausal women above 18 years of age.
- •Reversible airway obstruction in response to classical beta2-agonist (salbutamol)
- •Non/ex-smokers
排除标准
- •Any clinically significant disease or disorder other than asthma
- •Any clinically relevant abnormal findings at screening examinations
- •Treatment with systemic glucocorticosteroids within the past 30 days
- •Inhaled corticosteroid use if dosing is not kept constant
研究组 & 干预措施
crossover dose 1
AZD3199 120 microgram
干预措施: AZD3199 (Drug)
crossover dose 2
AZD3199 480 microgram
干预措施: AZD3199 (Drug)
crossover dose 3
AZD3199 1920 microgram
干预措施: AZD3199 (Drug)
crossover dose 4
Placebo
干预措施: Placebo (Drug)
crossover dose 5
Formoterol 9 microgram
干预措施: Formoterol (Drug)
crossover dose 6
Formoterol 36 microgram
干预措施: Formoterol (Drug)
结局指标
主要结局
S-potassium, Peak Effect Over 0 - 4 h Post-dose
时间窗: 0, 15min, 30min,1h, 2h, 4h
Minimum S-potassium concentration (A well-known effect of beta2-agonists (AZD3199 is a beta2-agonist) is a reduction in serum potassium levels. The minimum value has therefore been evaluated.
FEV1 Peak Effect Within 0 - 24 h Post-dose
时间窗: 0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h
Maximum FEV1 value
E22-26: the Average of the FEV1 Value Between 22 and 26 h Post Dose for Every Treatment Visit.
时间窗: 22- 26 h post dose
Residual FEV1 24 h post-dose
S-potassium, Average Effect Over 0 - 4 h Post-dose
时间窗: 0, 15min, 30min,1h, 2h, 4h
Average S-potassium concentration
次要结局
- Systolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose(0, 30min, 2h, 4h)
- FEV1 Average Effect Over 0 - 24 h Post-dose(0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h)
- FEV1 Effect at 5 Min Post-dose(5min)
- Systolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose(0, 30min, 2h, 4h)
- Diastolic Blood Pressure, Average Effect Over 0 - 4 h Post-dose(0, 30min, 2h, 4h)
- Pulse, Peak Effect Over 0 - 4 h Post-dose(0, 30min, 2h, 4h)
- Heart Rate, Average Effect Over 0 - 4 h Post-dose(0, 30min, 2h, 4h)
- Tremor, Average Effect Over 0 - 4 h Post-dose(0, 15min, 30min, 1h, 2h, 4h)
- Palpitations, Peak Effect Over 0 - 4 h Post-dose(0, 15min, 30min, 1h, 2h, 4h)
- Pulse, Average Effect Over 0 - 4 h Post-dose(0, 30min, 2h, 4h)
- Palpitations, Average Effect Over 0 - 4 h Post-dose(0, 15min, 30min, 1h, 2h, 4h)
- FEV1 Average Effect Over 0 - 12 h Post-dose(0, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 8h, 10h, 12h)
- FEV1 Average Effect Over 12 - 24 h Post-dose(12h, 14h, 18h, 22h, 24h)
- Diastolic Blood Pressure, Peak Effect Over 0 - 4 h Post-dose(0, 30min, 2h, 4h)
- Heart Rate, Peak Effect Over 0 - 4 h Post-dose(0, 30min, 2h, 4h)
- QTcB, Peak Effect Over 0 - 4 h Post-dose(0, 30min, 2h, 4h)
- QTcB, Average Effect Over 0 - 4 h Post-dose(0, 30min, 2h, 4h)
- Tremor, Peak Effect Over 0 - 4 h Post-dose(0, 15min, 30min, 1h, 2h, 4h)
- Plasma AZD3199 Cmax(0, 5min, 15min, 30min, 1h, 2h, 4h, 8h, 12h, 24h)
- Plasma AZD3199 AUC0-24(0, 5min, 15min, 30min, 1h, 2h, 4h, 8h, 12h, 24h)