EUCTR2008-006869-86-HU进行中（未招募）不适用
A comparison of Symbicort® Maintenance and Reliever Therapy (Symbicort Turbuhaler® 160/4.5 mg, one inhalation bid plus as-needed) and Symbicort Turbuhaler 160/4.5 mg, one inhalation bid plus terbutaline Turbuhaler 0.4 mg/inhalation as needed, for treatment of asthma – a 12-month, randomized, double-blind, parallel group, active-controlled, multinational phase III study in asthmatic patients aged 16 years and above. - SAKURA
适应症
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
- 2,400
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 signed and dated informed consent at Visit 1 and prior to any study specific procedures. For patients under-age, signed informed consent from both the patient and the patient’s parent/legal guardian is required.
- •2. Outpatients of either gender aged =16 years at Visit 1
- •3. Diagnosis of asthma according to GINA 2007 with a documented history of at least 6 months duration prior to Visit 2
- •4. FEV1 ³ 50% of predicted normal value pre-bronchodilator
- •5. Reversible airway obstruction (according to a reversibility test performed at Visit 2), defined as an increase in FEV1 =12% relative to baseline for all patients 15-30 minutes after inhalation of in total 2 x 0.4 mg terbutaline (delivered dose) Turbuhaler
- •6. Prescribed use of inhaled GCS (any brand) for at least 12 weeks prior to Visit 2
- •7. The daily prescribed dose of inhaled GCS during the last 4 weeks prior to Visit 2 should have been constant and
- •at least 400 µg/day of fluticasone or Qvar,
- •at least 600 µg/day of budesonide,
- •at least 1000 µg/day of any other beclometasone dipropionate (BDP),
- •or equivalent dose of any other inhaled GCS (GINA 2007)
- •8. A history of at least 1 asthma exacerbation, as defined in Section 3.1, the last 12 months prior to Visit 2
- •For inclusion in the study treatment period patients must fulfill the following criteria at Visit 3:
- •9. Use of as-needed medication due to asthma symptoms on at least 5 of the last 7 days of the run-in period, not including the day of Visit 3
- •10. Capable of using a PEF meter and Turbuhaler and correctly filling in the diary
- •11. Morning PEF values recorded for at least 8 of the last 10 days of the run-in period (including the value obtained in the morning of Visit 3)
- •12. Not more than 10 inhalations of as-needed medication on any day of the run-in period
- •13. The patient must not have had an asthma exacerbation, as defined in Section 3.1, during the run-in period
- •14. The patient must be eligible for the study in accordance with the exclusion criteria
- •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. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
- •2. Previous randomization of treatment in the present study
- •3. Participation in another clinical study during the course of the study or within 4 weeks before Visit 2
- •4. Known or suspected hypersensitivity to study therapy or excipient
- •5. Respiratory infection affecting the asthma, as judged by the investigator, within 4 weeks prior to Visit 2
- •6. Intake of oral, rectal or parenteral GCS within 4 weeks and/or depot parenteral GCS within 12 weeks prior to Visit 2
- •7. Use of any ß-blocking agent, including eye-drops
- •8. Current or previous smoker with a smoking history of =10 pack years
- •9. Any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient’s ability to participate in the study
- •10. Any clinically relevant abnormal findings in physical examination, laboratory variables, vital signs or ECG at Visit 2, which, in the opinion of the investigator, may put the patient at risk because of his/her participation in the study
- •11. Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator
- •12. Planned hospitalisation during the study
- •13. Suspected poor capability, as judged by the investigator, of following instructions of the study
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