A Pan-European, open label, randomised study comparing the efficacy and cost-effectiveness of Symbicort Maintenance and Reliever Therapy (Symbicort SMART) using a maintenance dose of Symbicort 160/4.5 micrograms of 1 or 2 inhalations twice daily in the treatment of persistent asthma. EUROSMART - EUROSMART

AstraZeneca AB0 个研究点目标入组 8,250 人开始时间: 2008年2月21日最近更新: 2019年11月25日

试验速览

暂无简介。

•Provision of informed consent.
•Adult outpatients with a minimum of 6 months history of persistent asthma.
•Use of IGCS for at leat one month with the same daily dose of at least 600ug beclamethasone, 400ug budesonide, 200ug fluticasone, 400ug mometasone, 250ug beclomethasone, 250ug beclomethasone ultrafine particles or 320ug ciclesonide.
•Subjects with a history of use of SABAs for symptom relief during the previous 30 days.
•Use of at least one as needed inhalation for symptom relief on at least 4 of the last 7 days of the run-in period for subjects treated with IGCS without LABA and on at least 2 of the last 7 days of the run-in period for subjects treated with IGCS and LABA.
•No severe asthma exacerbation during run-in period. No change in asthma maintenance treatment during run-in period
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Subjects currently treated with Symbicort SMART
•Known or suspected hypersensitivity to study therapy or excipients of the IMP including lactose
•Asthma exacerbation within the last 14 days prior to visit 1
•Subjects using oral, rectal or parenteral GCS during the last 14 days prior to visit 1.
•Use of any beta-blocking agents. Use of systemic treatment with potent CYP3A4 inhibitors. Subjects treated with omazilumab, nebublised bronchodilators and/or nebulised glucocorticosteroids.
•Subjects aged over >40 years with a smoking history of more than 10 pack-years. Preganancy, breast-feeding or planned pregnancy during the study.
•Suspected poor capability to follow instructions of the study. Participation in a clinical study during last 30 days. Planned hosptialisation during study.

发起方