EUCTR2006-006512-30-IT进行中（未招募）不适用
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 ug of 1 or 2 inhalations twice daily in the treatment of persistent asthma - EUROSMART
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- ASTRAZENECA
- 入组人数
- 11,500
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
- •For inclusion in the study run-in period subjects must fulfil all of the following criteria at visit 1: 1. Provision of informed consent. The signed and dated informed consent must have been obtained before conducting any study-related procedures, including withdrawal of concomitant medication. 2. Outpatients, of either sex, >= 18 years with a minimum of 6 months documented history of persistent asthma according to the American Thoracic Society definition (ATS 1987). 3. Use of IGCS for at least one month with the same daily dose of at least 500µg beclomethasone, 400µg budesonide (metered dose), 200µg fluticasone, 400µg mometasone, 250µg beclomethasone ultrafine particles or 320µg ciclesonide. 4. Subjects with history of use of rapid - acting ß2 agonists for symptom relief during the last 30 days (SABA or formoterol). To be randomised to the treatment period, the following criteria must be fulfilled at visit 2: 5. 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 both IGCS and LABA. 6. No change in asthma maintenance treatment during the run-in period. 7. No severe asthma exacerbation during the 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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Any of the following is regarded as a criterion for exclusion from the study: 1. Subjects currently treated with Symbicort SMART. 2. Known or suspected hypersensitivity to study therapy or excipients of the investigational product including lactose. 3. Asthma exacerbation within the last 14 days prior to or at visit 1. 4. Subjects using oral, rectal or parenteral GCS during the last 14 days prior to visit 1. 5. Use of any â-blocking agent, including eye-drops. 6. Use of systemic treatment with potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, ritonavir). 7. Subjects treated with omazilumab, nebulised bronchodilators and/or nebulised glucocorticosteroids. 8. Subject aged > 40 years with a smoking history of + 10 pack-years. 9. Subjects with COPD or other significant respiratory disease as judged by the investigator. 10. Pregnancy, breast-feeding or planned pregnancy during the study. Women of child bearing potential not using acceptable contraceptive measures, as judged by the investigator. 11. Any significant disease or disorder or clinically significant abnormal finding, which, in the opinion of the investigator, may put the subject at risk because of participating in the study, or influence the results of the study or the subject's ability to participate in the study. 12. Suspected poor capability to follow instructions of the study, e.g. because of a history of drug abuse, difficulty in reading and/or understand instructions or any other reason, as judged by the investigator. 13. Previous allocation of randomisation code in the present study. 14. Participation in a clinical study during the last 30 days. 15. Planned hospitalisation during the study. 16. Involvement in the planning or conduct of the study.
研究者
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