NCT00313209已完成3 期
Effect of Roflumilast in COPD Patients Treated With Salmeterol. A 24-week, Double-blind Study With 500 μg Roflumilast Once Daily Versus Placebo. The EOS Study
适应症
干预措施
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
- 933
- 试验地点
- 2
- 主要终点
- Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)
研究概览
简要总结
The aim of the study is to compare the efficacy of roflumilast on pulmonary function and symptomatic parameters in patients with chronic obstructive pulmonary disease (COPD) during concomitant administration of salmeterol. The study duration will last up to 28 weeks. The study will provide further data on safety and tolerability of roflumilast.
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 (Participant, Investigator)
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
- •History of COPD for at least 12 months prior to baseline visit
- •FEV1/FVC ratio (post-bronchodilator) ≤ 70%
- •FEV1 (post-bronchodilator) between ≥ 40% and ≤ 70% of predicted
排除标准
- •COPD exacerbation indicated by a treatment with systemic glucocorticosteroids and/or antibiotics not stopped at least 4 weeks prior to baseline visit
研究组 & 干预措施
Roflumilast
Active Comparator
Roflumilast 500 µg
underlying medication: salmeterol 50 μg, twice daily, inhaled
干预措施: Roflumilast (Drug)
Placebo
Placebo Comparator
Placebo
underlying medication: salmeterol 50 μg, twice daily, inhaled
干预措施: Placebo (Drug)
结局指标
主要结局
Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)
时间窗: Change from baseline over 24 weeks of treatment
Mean change from baseline during the treatment period in pre-bronchodilator FEV1 \[L\]
次要结局
- Post-bronchodilator FEV1(Change from baseline over 24 weeks of treatment)
- COPD Exacerbation Rate (Mild, Moderate or Severe)(24 weeks treatment period)
- Transition Dyspnea Index (TDI) Focal Score(Change from baseline over 24 weeks of treatment)
- Shortness of Breath Questionnaire (SOBQ) Total Score(Change from baseline over 24 weeks of treatment)
研究者
研究点 (2)
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