A Comparison of Tolerability of 10 Inhalations of Symbicort® Turbuhaler® 160/4.5 μg and 10 Inhalations of Terbutaline Turbuhaler® 0.4 mg on Top of Symbicort® Turbuhaler® 160/4.5 μg 1 Inhalation Bid, Randomized, Double-blind, Cross Over, Phase III Study in Japanese Adults Asthma Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
The primary objective of the study is to compare the tolerability of Symbicort® Turbuhaler® 160/4.5 μg 10 inhalations with terbutaline Turbuhaler® 0.4 mg 10 inhalations for 3 days on top of Symbicort® Turbuhaler® 160/4.5 μg 1 inhalation twice a day (bid) in adult asthma 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
- 16 Years 至 65 Years（Child, 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
- •A minimum of 6 months documented history of asthma according to the JGL2006/GINA2006 definition
- •FEV1> 70% of predicted normal value pre-bronchodilator
排除标准
- •Having a known or suspected allergy to study therapy (active drugs or additive)
- •Having a known clinical history of hypertension, relevant arrhythmias or other heart disease, eg, ischemic heart disease, cardiomyopathy, valvular heart disease, or heart failure
- •Having been treated with oral, parenteral or rectal glucocorticoids within 4 weeks, or with depot parenteral glucocorticoids within 3 months
- •Respiratory infection significantly affecting the asthma, as judged by the investigator within 4 weeks
研究组 & 干预措施
First Symbicort, then Terbutaline
Symbicort Turbuhaler 160/4.5μg for 3 days First , then Terbutaline Turbuhaler 0.4 mg for 3 days
干预措施: Symbicort Turbuhaler (Drug)
First Symbicort, then Terbutaline
Symbicort Turbuhaler 160/4.5μg for 3 days First , then Terbutaline Turbuhaler 0.4 mg for 3 days
干预措施: Terbutaline Turbuhaler (Drug)
First Turbuhaler, then Symbicort
Terbutaline Turbuhaler 0.4 mg for 3 days First, then Symbicort Turbuhaler 160/4.5μg for 3 days,
干预措施: Symbicort Turbuhaler (Drug)
First Turbuhaler, then Symbicort
Terbutaline Turbuhaler 0.4 mg for 3 days First, then Symbicort Turbuhaler 160/4.5μg for 3 days,
干预措施: Terbutaline Turbuhaler (Drug)
结局指标
主要结局
Adverse Events
时间窗: 3 days
Total number of adverse events
Serum Potassium - Average Concentration From Trapezoidal Area Under the Curve (AUC)
时间窗: up to 740 min after start dosing for each treatment day
The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
Blood Glucose - Average Concentration From Trapezoidal Area Under the Curve (AUC)
时间窗: up to 140 min after start dosing for each treatment day
The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
Electrocardiogram (ECG)- Average Trapezoidal Area Under the Curve (AUC)
时间窗: up to 740 min after start dosing for each treatment day
The mean AUC of QTcF (ECG interval measured from the beginning of the Q wave to the end of the T wave, corrected for heart rate using Fridericia's formula)was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
Vital Sign (Blood Pressure)- Average Trapezoidal Area Under the Curve (AUC)
时间窗: up to 740 min after start dosing for each treatment day
The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
Vital Sign (Pulse Rate)- Average Trapezoidal Area Under the Curve (AUC)
时间窗: up to 740 min after start dosing for each treatment day
The mean AUC value was calculated as AUC (calculated using the trapezoidal method) divided by the length of the sampling period.
次要结局
未报告次要终点