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

Vectura Limited0 个研究点目标入组 175 人开始时间: 2012年8月1日最近更新: 2014年2月3日

研究概览

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•-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 25

•- 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

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