EUCTR2006-006519-60-DE进行中（未招募）不适用
A multi-centre, randomised, double-blind, cross-over design study to evaluate efficacy on exercise tolerance of budesonide/formoterol (Symbicort®Turbuhaler®) 320/9 µg one inhalation twice daily compared with placebo and formoterol (Oxis®) Turbuhaler 9 µg one inhalation twice daily in patients with severe chronic obstructive pulmonary disease (COPD). - CODEX
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
- 100
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 informed consent prior to conducting any study-related procedure
- •2. Out-patient, man or woman =40 years of age
- •3. A clinical diagnosis of COPD, and symptoms for more than 2 years prior to visit 2
- •4. A current or previous smoker with a smoking history equivalent to 10 or more
- •pack years (1 pack year = 20 cigarettes smoked per day for one year)
- •5. A history of at least one COPD exacerbation requiring a course of oral steroids
- •and/or antibiotics within 1-12 months before visit 2
- •6. FEV1=50% of predicted normal value (pre-bronchodilator)
- •7. FEV1/VC<70% (pre-bronchodilator)
- •8. FRC=120% of predicted normal value (pre-bronchdilator)
- •9. Wmax at least 20 watts from the incremental exercise test at visit 2
- •10. Ability to safely perform the maximal exercise test on cycle without medical
- •contraindications
- •11. Documented use of short-acting inhaled bronchodilator (ß2-agonists or
- •anticholinergics) as reliever medication
- •12. Able to read and write and use the electronic devices (eDiary and ePEF)
- •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
- •1. A history of asthma.
- •2. A history of seasonal allergic rhinitis before 40 years of age
- •3. Exacerbation of COPD during run-in or within 4 weeks (end of exacerbation)
- •prior to visit 2, requiring hospitalisation, a course of oral and/or inhaled steroids
- •and/or antibiotics
- •4. Significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart
- •failure, uncontrolled hypertension as defined by the investigator, or any other
- •relevant cardiovascular disorder as judged by the investigator
- •5. Regular oxygen therapy
- •6. Any current respiratory tract disorder other than COPD, which is considered by
- •the investigator to be clinically significant
- •7. 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 influence the
- •results of the study, or the patient’s ability to participate in the study
- •8. Signs and symptoms of peripheral arterial occlusion
- •9. SaO2=90% at rest
- •10. Any abnormality in ECG that could put patient at risk while performing exercise
- •testing, as judged by the investigator
- •11. Patient taking non-cardioselective ß-blocking agents
- •12. Use of inhaled corticosteroids within 2 weeks prior to visit 2 and during run-in.
- •13. Use of oral/parenteral corticosteriods within 4 weeks prior to visit 2 and during run-in.
- •14. Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women
- •not using acceptable contraceptive measures. Acceptable contraceptive methods
- •are methods of birth control which result in a low failure rate (ie, less than 1 %
- •per year) when used constantly and correctly such as implants, combined oral
- •contraceptives, some intrauterine devices, sexual abstinence or vasectomised
- •15. Known or suspected hypersensitivity to study therapy or excipients of the
- •investigational products
- •16. Scheduled in-patient hospitalisation during the course of the study
- •17. Patients who have participated in a clinical study evaluating an investigational
- •product in the last 4 weeks prior to enrolment, or during this study, or who have been previously
- •allocated a randomisation code in this study
- •18. Patients with a history of chronic alcohol or drug abuse or any condition associated with poor compliance
- •19. Patients participating in or scheduled for an intensive COPD rehabilitation program
- •20. Any clinically relevant abnormal findings in physical examination and vital signs,
- •which in the opinion of the investigator, may put the patient at risk because of
- •his/her participation in the study
- •21. Planned donation of blood during the study
- •22. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
研究者
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