EUCTR2008-008192-34-BE进行中（未招募）不适用
The efficacy and safety of erdosteine in the long term therapy of Chronic Obstructive Pulmonary Disease (COPD). A 12-month, randomised, double blind, placebo-controlled, parallel group, multicenter, study - Study RESTORE
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
- 542
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
- •Outpatients of both sexes, aged between 40 and 80 years. Diagnosis of COPD (Stage II and III according to GOLD 2007) as follows: post-bronchodilator FEV1/FVC < 70% and FEV1 between 30%-70% predicted (and at least 0.7L absolute value). Current or past cigarette smokers with a smoking history of at least 10 pack-years. On a stable therapeutic regimen for COPD for at least 8 weeks prior to inclusion. Having experienced at least 2 acute exacerbations of COPD within 2-12 months prior to inclusion. Presence of chronic COPD symptoms (cough, sputum production, dyspnoea), and a mean cough and sputum score (derived from BCSS) of at least 1.5 for each symptom during run-in. Written informed consent to participate.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 220
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 342
排除标准
- •Female subjects: pregnant, lactating mother or lack of efficient contraception in a subject with child-bearing potential. Acute exacerbation of COPD within 8 weeks prior to inclusion. Treatment with antibiotics and /or systemic steroids and/or hospitalisation within 8 weeks prior to inclusion. COPD Stage IV. Current or past diagnosis of asthma. Clinically significant or unstable concurrent disease, including significant pulmonary disease (e.g. tuberculosis, cystic fibrosis, bronchiectasis, lung cancer). Significant renal impairment as indicated by creatinine clearance < 25 ml/min. Active peptic ulcer. Subjects with liver cirrhosis as well as patients with cystathionine-synthetase deficiency. Long term oxygen therapy. Known or suspected hypersensitivity to erdosteine. Participation in another clinical trial with an investigational drug in the 60 days prior to inclusion
研究者
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