EUCTR2011-005030-19-BG进行中（未招募）不适用
A randomised double-blind, parallel group, dose-ranging study to evaluate the efficacy and safety of three different total daily doses of fluticasone propionate inhaled from a new dry powder inhaler in subjects with severe persistent asthma requiring oral corticosteroid therapy - Clinical study to evaluate the use of a new VR506 inhaler to treate severe asthma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 174
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Adolescents aged 12 to 17 years (inclusive) and adults aged 18 to 65 years (inclusive)
- •-Documented clinical history of severe asthma requiring oral prednisone/prednisolone therapy
- •-Adult asthmatic subjects having FEV1 =40% of predicted value based on National Health and Nutrition Examination Survey (NHANES) III reference equations for United States (US) centres, and European Community for Coal and Steel (ECCS) reference equations for all other centres
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
排除标准
- •- Subjects who have or who have had an upper or lower respiratory tract infection within 28 days of the Screening Visit
- •- Subjects with asthma that required admission to an intensive care unit and/or ventilation within the previous 12 months
- •- History of lung cancer
研究者
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