NL-OMON34054已完成3 期
A Randomised, Double-Blind, Double-Dummy, Parallel-Group, Multicentre Study to assess efficacy and safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder and Fluticasone Propionate FP)/Salmeterol Inhalation Powder in the Treatment of Persistent Asthma in Adults and Adolescents. - HZA113091
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 62
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
- 12 至 99（—）
入选标准
- •* Age 12 years and above.
- •* Bronchial asthma (acc. to NIH), at least 12 weeks.
- •* Evening FEV1 of 40-85%.
- •* At least 12% and at least 200ml reversibility of FEV1.
- •* Inhaled corticosteroid for at least 12 weeks and be maintained on a medium dose (e.g. FP 250 mcg twice daily) for at least the last 4 weeks.
- •* Females of childbearing potential: reliable method of contraception.
排除标准
- •* Life-threatening asthma within the last 5 years.
- •* Respiratory infection within the last 4 weeks.
- •* Asthma exacerbation within the last 12 weeks.
- •* Visual evidence of candidiasis.
- •* History of severe milk protein allergy.
- •* Potent CYP3A4 inhibitor within the last 4 weeks.
- •* Current smoker or a smoking history of 10 pack years. Use of inhaled tobacco products within the past 3 months.
- •* Pregnancy or breastfeeding.
研究者
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