跳至主要内容
临床试验/jRCT2080220680
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

AstraZeneca0 个研究点目标入组 24 人开始时间: 待定
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

发起方
AstraZeneca

相似试验

Symbicort SMART | 临床试验