JPRN-jRCT2080220398未知3 期
Investigation of Safety and Efficacy of Budesonide Inhalation Suspension in the Long-Term Use in Japanese Children With Bronchial Asthma (Open Long-Term Extension Study Following Study SD-004-0765
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
- >= 1age old 至 <= 5age old（—）
- 性别
- All
入选标准
- •Ages Eligible for Study: 13 Months - 65 Months
- •Genders Eligible for Study: Both
- •Inclusion Criteria:
- •1. Clinical benefit from continued treatment with budesonide inhalation suspension was expected in patients with bronchial asthma participating in study SD-004-0765, as judged by the investigator(s) at the completion of that study (Visit 11, Week 24), and the patient's caregiver wished the continued treatment with budesonide inhalation suspension
- •2. A written consent to participate in this study had been obtained from the patient's legal representative (a person who exercises parental authority for the patient, or if no one was applicable, a guardian: in principle, the patient's parent).
- •3. The patient was younger than 5 years old. Patients aged 5 years could be included in this study if no other effective treatment for the patient's bronchial asthma was available as judged by the investigator(s).
排除标准
- •1. Concurrent severe diseases of liver, kidney, heart or other complications.
- •2. 2. Contra-indications (eg, known or suspected allergy) to budesonide or excipients contained in the investigational product.
- •3. Other conditions, in which the investigator(s) judges patient's participation in this study inappropriate.
研究者
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