NL-OMON44215已完成3 期
Study 117113: Mepolizumab vs. Placebo as add-on treatment for frequently exacerbating COPD patients characterized by eosinophil level - MEA117113
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 38
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Clinically documented history of COPD for at least 1 year in accordance with the definition by the American Thoracic Society/European Respiratory Society.
- •* Pre and post-salbutamol FEV1/FVC ratio of <0.70 at visit 1 and post-salbutamol FEV1> 20% and *80% of predicted.
- •* At least two moderate COPD exacerbations or at least one severe COPD exacerbation in the 12 months prior to visit 1. See protocol page 27-28 for details.
- •* A well documented requirement for optimized standard of care background therapy that includes ICS plus 2 additional COPD medications (i.e., triple therapy) for the 12 months prior to visit 1. See protocol page 28 for details.
- •* Males and females 40 years and above.
- •* Current smoger, ex-smoker or never smoker. See protocol page 28-29 for details.
排除标准
- •* Asthma and other respiratory disorders. See protocol page 29 for details.
- •* Pneumonia, exacerbation, lower respiratory infection within the 4 weeks prior to visit 1.
- •* Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to visit 1.
- •* Other conditions that could lead to elevated eosinophils.
- •* Known, pre-existing parasitic infestation within 6 months prior to Visit 1
- •* Previous participation in any study of mepolizumab and received Investigational Product.
- •* Pregnancy or breastfeeding
研究者
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未知
不适用
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