jRCT2080220680未知3 期
A Comparison of Tolerability of 10 Inhalations of Symbicort Turbuhaler 160/4.5 mcg and 10 Inhalations of Terbutaline Turbuhaler 0.4 mg on Top of Symbicort Turbuhaler 160/4.5 mcg 1 Inhalation Bid, Randomized, Double-Blind, Cross Over, Phase III Study in Japanese Adults Asthma Patients
适应症
试验速览
- 阶段
- 3 期
- 发起方
- AstraZeneca
- 入组人数
- 24
- 主要终点
- Vital signs
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Treatment, Randomized, Double Blind Crossover Assignment, Pharmacodynamics Study
入排标准
- 年龄范围
- 16age old over 至 65age old under(—)
- 性别
- All
入选标准
- •Provision of informed consent prior to any study specific procedure
- •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 with 3 months
- •Respiratory infection significantly affecting the asthma, as judged by the investigator within 4 weeks
结局指标
主要结局
Vital signs
blood pressure, pulse rate, body temperature
次要结局
未报告次要终点
研究者
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