EUCTR2004-000679-32-FI进行中（未招募）不适用
A comparison of the efficacy of Symbicort Single inhaler Therapy (Symbicort Turbuhaler 160/4.5 microg, one inhalation twice a day plus as-needed) and conventional best standard treatment for the treatment of persistent asthma in adolescents and adults. A randomised, open, parallel-group, multicentre, 26 weeks study - MONO
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,900
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
- •1. Provision of oral and written informed consent. For underage patients, informed consent from both patient and the patient’s parent/legal guardian must be obtained. If the patient cannot read and write, verbal consent from the patient is required.
- •2. Female or male outpatients aged over 12 years of age
- •3. Minimum of 3 months history of asthma, diagnosed according to the American Thoracic Society (ATS) definition
- •4. Prescribed inhaled GCS at a dose of over 320 µg/day and within the approved label for the relevant drug during the last 3 months prior to Visit 1.
- •5. a) daily maintenance treatment with both inhaled GCS and long-acting b2-agonist (LABA)(free or fixed combination) or
- •b) daily treatment with inhaled GCS alone (i.e. without LABA)
- •and a history of suboptimal asthma control the month prior to inclusion as judged by the investigator and use of over 3 inhalations of as-needed medication for symptom relief during the last 7 days before enrolment.
- •Are the trial subjects under 18? yes
- •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
- •1. Previous treatment with Symbicort Single inhaler Therapy (use of Symbicort Turbuhaler for both maintenance treatment and as-needed in response to symptoms as described in Section 3.4.1.3).
- •2. Use of any b-blocking agent, including eye-drops.
- •3. Use of oral GCS as maintenance treatment.
- •4. Known or suspected hypersensitivity to study therapy or excipients.
- •5. A history of smoking over 10 pack years (1 pack year = 1 pack (20 cigarettes) per day for one year or equivalent).
- •6. Pregnancy, breast-feeding or planned pregnancy during the study.
- •7. Fertile women not using acceptable contraceptives, as judged by the investigator.
- •8. Any significant disease or disorder, which, in the opinion of the investigator, may put the patient at risk because of participating in the study.
- •9. Any non-asthma related, clinically significant abnormal finding in physical examination and/or vital signs at Visit 1, which in the opinion of the investigator, may put the patient at risk because of his/her participation in the study.
- •10. Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to or at Visit 1.
- •11. Planned in-patient hospitalisation during the course of 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 this study.
- •14. Participating in another clinical trial during the course of this study or within 30 days prior to Visit 1.
- •15. Involvement in the planning or conduct of this study.
研究者
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