NCT00076089已完成3 期
Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. A 52-week, Multicenter, Double-blind Study With 500 mcg Roflumilast Once Daily Versus Placebo.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,100
- 试验地点
- 40
- 主要终点
- change in FEV1 from baseline during the treatment period; number of COPD exacerbations.
研究概览
简要总结
The purpose of this study is to determine whether roflumilast is effective in the treatment of exacerbations in patients with chronic obstructive pulmonary disease (COPD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •FEV1/FVC ratio (post-bronchodilator) ≤70%
- •FEV1 (post-bronchodilator) ≤50% of predicted
- •Current smoker or ex-smoker
- •Clinically stable COPD indicated by no exacerbation and no change in COPD treatment of within 4 weeks prior to baseline
- •Availability of chest x-ray dated a maximum of 6 months prior to study baseline or a willingness to have a chest x-ray performed at baseline
排除标准
- •COPD exacerbation indicated by a treatment with systemic glucocorticoids not stopped 4 weeks prior to baseline
- •Lower respiratory tract infection not resolved 4 weeks prior to baseline
- •Diagnosis of asthma and/or other relevant lung disease
- •Known alpha-1-antitrypsin deficiency
- •Need for long-term oxygen therapy defined as ≥16 hours/day
结局指标
主要结局
change in FEV1 from baseline during the treatment period; number of COPD exacerbations.
次要结局
- pulmonary function variables
- number of COPD exacerbations of different type and various subgroups
- quality of life variables
- patient diary variables
- time to study withdrawal
- safety.
研究者
研究点 (40)
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不适用
The trial investigates the effect of 500 µg roflumilast tablets once dailyversus placebo on exacerbation rate and pulmonary function in patientswith Chronic Obstructive Pulmonary Disease (COPD) who are treatedwith a fixed combination of long-acting ß2-agonists (LABA) and inhaledglucocorticosteroids (ICS). Additionally it provides data on safety andtolerability in COPD patients treated with a fixed combination of LABAand ICS.severe chronic obstructive pulmonary disease (COPD)MedDRA version: 13.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2010-019685-87-GRycomed GmbH3,002