NCT00430729已完成3 期
Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. A 52 Weeks Double Blind Study With 500mcg Roflumilast Once Daily Versus Placebo. Ratio-Study.
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
- 14
- 主要终点
- The frequency of patients experiencing at least one moderate or severe exacerbation during the treatment period.
研究概览
简要总结
The purpose of this study is to investigate the effect of 500mcg roflumilast vs placebo on exacerbation rate and pulmonary function as well as quality of life 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 a chest x-ray dated a maximum of 6 months prior to study baseline visit B0 or a willingness to have a chest x-ray performed before 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
The frequency of patients experiencing at least one moderate or severe exacerbation during the treatment period.
Change in FEV1 from baseline during the treatment period.
次要结局
- Pulmonary function variables; quality of life variables;patient diary variables;safety
研究者
研究点 (14)
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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