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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 241
- 试验地点
- 1
- 主要终点
- Number of Patients With Adverse Events (AEs).
研究概览
简要总结
This study will include the patients who are Japanese children with bronchial asthma aged 5 years to 15 years old and have completed the Phase III study (Study code: D5254C00769) at about 29 centres. To investigate the safety of budesonide Turbuhaler® with a daily dose of 100 µg to 800 µg for 54 weeks treatment including the prior 6 weeks Phase III study (Study D5254C00769, NCT00504062) as compared with conventional therapy in Japanese children with bronchial asthma in need of inhaled glucocorticosteroid treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who complete preceding the Phase III study and provide a signed written informed consent by patient's legal representative at Visit 1 or 4 weeks prior to Visit 1 of the study. A signed written informed assent should also be obtained from the patients themselves as much as possible
- •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
- •Concurrent serious diseases of liver, kidney, heart or other complications which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient's ability to participate in the study. Any clinically relevant abnormal findings in vital sign or physical examination at Visit 1 in this study, which in the opinion of the investigator may put the patient at risk because of his/her participation in the study.
- •Pregnant or possible pregnancy or planning to become pregnant during the study period
- •Other subjects who are considered inappropriate to participate in this study judged by the investigator
研究组 & 干预措施
BUD - Budesonide
Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily
干预措施: Budesonide (Drug)
CONV - Conventional Asthma Therapy
Conventional Asthma Therapy - according to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
干预措施: Conventional Asthma Therapy (Drug)
结局指标
主要结局
Number of Patients With Adverse Events (AEs).
时间窗: 54 weeks
AEs were defined as undesirable medical conditions or deteriorations of a pre-existing medical condition following/during exposure. All Serious AEs, AEs leading to withdrawal, Other relevant AE were recorded.
次要结局
- Number of Patients With Abnormal Clinical Laboratory Test Values.(54 weeks)
- Number of Patients With Abnormal Vital Sign Values for the Following Variables: Blood Pressure (Sitting) and Pulse Rate (Sitting), as Judged by the Investigator(54 weeks)
- Number of Patients With Abnormal Plasma Cortisol Values.(54 weeks)
- Height(Baseline and 54 weeks)
- Weight(Baseline and 54 weeks)
- Morning Peak Expiratory Flow (PEF) Percentage of Predicted Normal(54 weeks)
- Change From Baseline of Respiratory Condition at Asthma Attacks (Daytime)(Baseline and 54 weeks)
- Change From Baseline of Respiratory Condition at Asthma Attacks (Nighttime)(Baseline and 54 weeks)
- Change From Baseline of Use of Inhaled Short-acting B-2 Agonist (Daytime)(Baseline and 54 weeks)
- Change From Baseline of Use of Inhaled Short-acting B-2 Agonist (Night-time)(Baseline and 54 weeks)
- Change From Baseline in Disturbance of Daily Activities(Baseline and 54 weeks)
- Change From Baseline in Disturbance of Night-time Sleep(Baseline and 54 weeks)
- Forced Expiratory Volume in One Second (FEV1) Percentage of Predicted Normal Change From Baseline(54 weeks)