EUCTR2005-001090-10-DK进行中（未招募）1 期
A randomised, double blind, double dummy, multicentre phase III study comparing the efficacy of budesonide/formoterol (Symbicort® forte Turbuhaler®) and oral prednisolone + formoterol (Oxis® Turbuhaler) during two weeks, in COPD patients with an acute exacerbation, followed by twelve weeks open follow up period with budesonide/formoterol (Symbicort forte Turbuhaler) - SPACE - SPACE
AstraZeneca AB, AstraZeneca Sverige0 个研究点目标入组 120 人开始时间: 2006年6月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
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
- •2.Male and female aged 40 years and over
- •3.Established clinical diagnosis of COPD (COPD diagnosis according to GOLD guidelines12) for more than 6 months prior to inclusion in the study
- •4.Current or previous smoker with a history equivalent to 10 or more pack years (1 pack year = 20 cigarettes smoked per day for one year)
- •5.COPD patients with an acute exacerbation with a history within the last week of progressing dyspnoea and/or increase in sputum production and/or volume within the last week, as judged both by patient and investigator
- •6.FEV1 of > 30 and < 60% of predicted normal after the initial acute treatment at the primary care/hospital centre (= post bronchodilator)
- •7.Patients, who, based on the clinical examination after the initial acute treatment, are candidates for a course of oral steroids for the treatment of an acute COPD exacerbation
- •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.Patients requiring hospitalisation or immediate treatment in an intensive care unit for whatever reason
- •2.Patients with clinical signs of heart right sided heart failure (e.g peripheral oedema need of treatment with diuretics)
- •3.Any significant disease or disorder (e.g. pulmonary other than COPD, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) 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 patients ability to participate in the study
- •4.Diagnosis/history of asthma
- •5.Oxygen saturation (SpO2) <92% after the initial acute treatment
- •6.Requirement for regular use of oxygen therapy
- •7.Regular treatment with any inhaled GCS >1 000 µg/day at study entry
- •8.Use/in need of non-cardioselective beta-blocking agents
- •9.Participation in a clinical study evaluating an investigational drug in the last 30 days prior to visit 1 or previous randomisation in this study
- •10.Previous exacerbation of COPD within 30 days prior to Visit 1 requiring hospitalisation and/or a course of oral steroids and/or antibiotics and/or increased dose of ordinary COPD medication
- •11.Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures as judged by the investigator
- •12.History of chronic alcohol or drug abuse, difficulties in reading and/or understanding Swedish or any other condition associated with poor compliance
- •13.Known or suspected hypersensitivity to study therapy or excipients
- •14.Participation in or scheduled for an intensive COPD rehabilitation program
- •15.Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the investigational site)
- •16.Previous randomisation of treatment in the present study
研究者
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