NCT01395862已完成不适用
Special Drug Use Investigation for ADOAIR (Fluticasone/Salmeterol)
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
- 1,001
- 主要终点
- The number of incidence of adverse events in Japanese asthma patients treated with fluticasone and salmeterol for long-term
研究概览
简要总结
The purpose of this study is to detect adverse drug reactions for long-term use (particularly clinically significant adverse drug reactions) occurring in clinical settings, to examine factors likely to affect the safety and efficacy in the Japanese asthma patients who are treated with fluticasone propionate/salmeterol xinafoate.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must use fluticasone and salmeterol for the first time
- •Must use fluticasone and salmeterol for 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
Patients prescribed fluticasone and salmeterol
Patients with asthma prescribed fluticasone and salmeterol for long-term use during study period
干预措施: Salmeterol and Fluticasone (Drug)
结局指标
主要结局
The number of incidence of adverse events in Japanese asthma patients treated with fluticasone and salmeterol for long-term
时间窗: 1 year
次要结局
未报告次要终点
研究者
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