NCT01332422已完成不适用
Special Drug Use Investigation for ADOAIR Metered-dose Inhaler (Pediatric)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 主要终点
- Safety and efficacy for a long term under the practical use conditions. As the priority investigation items, (1)Systemic effects accompanying steroid administration (2) Events related to nervous system, musculoskeletal system and circulatory systems
研究概览
简要总结
To investigate possible problems or questions in safety and efficacy of ADOAIR 100 DISKUS and ADOAIR 50 AEROSOL 120 in Japanese pediatric patients with bronchial asthma for a long term under the practical use conditions. In this special drug use investigation, the following items shall be handled as the priority investigation items for information collection.
- Systemic effects accompanying steroid administration; influences on adrenocortical function, influences on bone metabolisms (fracture, osteoporosis, etc.), cataract, glaucoma
- Events related to nervous system, musculoskeletal system and circulatory system; tremor, headache, cramp, tachycardia, etc.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ADOAIR must be used for the first time
- •ADOAIR used for a long-term
排除标准
- •Patients with hypersensitivity to salmeterol and fluticasone
- •Patients with infection which salmeterol and fluticasone is not effective
- •Patients with deep mycosis
研究组 & 干预措施
Pediatric patients prescribed ADOAIR
Pediatric patients with asthma prescribed ADOAIR during study period
干预措施: Salmeterol and Fluticasone (Drug)
结局指标
主要结局
Safety and efficacy for a long term under the practical use conditions. As the priority investigation items, (1)Systemic effects accompanying steroid administration (2) Events related to nervous system, musculoskeletal system and circulatory systems
时间窗: One year
次要结局
未报告次要终点
研究者
相似试验
已完成
不适用
Special Drug Use Investigation for ADOAIR DISKUS COPD (Salmeterol and Fluticasone)Pulmonary Disease, Chronic ObstructiveNCT01332409GlaxoSmithKline2,000
已完成
不适用
Special Drug Use Investigation for ADOAIR (Fluticasone/Salmeterol)Respiratory DisordersNCT01395862GlaxoSmithKline1,001
已完成
不适用
Drug Use Investigation for ADOAIR (Fluticasone/Salmeterol)Respiratory DisordersNCT01395849GlaxoSmithKline2,116
已完成
不适用
Special Drug Use Surveillance for Brentuximab Vedotin Intravenous Infusion "Relapsed or Refractory CD30-positive Peripheral T Cell Lymphoma or Pediatric Hodgkin Lymphoma"Peripheral T Cell LymphomaPediatric Hodgkin LymphomaNCT04213209Takeda95
已完成
不适用
Special Drug Use-results Survey of Duodopa Enteral Solution in Patients With Parkinson's DiseaseParkinson's DiseaseNCT02906488AbbVie839