JPRN-jRCT2080220437未知3 期
An Open-Label, Multi-Center, Long Term Study to Investigate the Safety and Efficacy of Budesonide Turbuhaler Treatment for 48 Weeks (Following 6 Weeks Phase III Study) in Japanese Children With Bronchial Asthma Aged 5 Years to 15 Years Old
适应症
试验速览
- 阶段
- 3 期
- 发起方
- AstraZeneca
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 5age old 至 <= 15age old(—)
- 性别
- All
入选标准
- •Ages Eligible for Study: 5 Years - 15 Years
- •Genders Eligible for Study: Both
- •Inclusion Criteria:
- •- When the investigator will obtain the signed written informed consent of Phase III study (D5254C00769) from patient's legal representative, the investigator will also provide the information of this study
排除标准
- •- Respiratory infections that, in the opinion of the investigator(s), may affect the efficacy evaluation e.g., lower airways infection such as pneumonia, infection with no available effective antimicrobial drugs or with deep seated mycosis
研究者
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