Effect of Roflumilast on Exacerbation Rate in Patients With COPD. The HERMES Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 1,568
- 试验地点
- 1
- 主要终点
- COPD Exacerbation Rate (Moderate or Severe)
研究概览
简要总结
The aim of the study is to compare the effect of roflumilast on exacerbation rate and pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily in the morning at one dose level. The study duration will be up to 56 weeks. The study will provide further data on safety and tolerability of roflumilast.
For additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673 (toll free).
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
- •COPD patients having at least one exacerbation within last year
- •FEV1/FVC ratio (post-bronchodilator) ≤ 70%
- •FEV1 (post-bronchodilator) ≤ 50% of predicted
排除标准
- •COPD exacerbation not resolved at first baseline visit
- •Diagnosis of asthma and/or other relevant lung disease
研究组 & 干预措施
Roflumilast
500 mcg, once daily, oral administration in the morning
干预措施: Roflumilast (Drug)
Placebo
once daily
干预措施: Placebo (Drug)
结局指标
主要结局
COPD Exacerbation Rate (Moderate or Severe)
时间窗: 52 weeks treatment period
Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year. A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management \[American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005\].
Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)
时间窗: Change from baseline over 52 weeks of treatment
Mean change from baseline during the treatment period in pre-bronchodilator FEV1 \[L\]
次要结局
- Time to Mortality Due to Any Reason(52 weeks treatment period)
- Mean Transition Dyspnea Index (TDI) Focal Score During the Treatment Period(Change from baseline over 52 weeks of treatment)
- Natural Log-transformed C-reactive Protein (CRP)(Change from baseline to last post randomization measurement (52 weeks))
- Post-bronchodilator FEV1 [L](Change from baseline over 52 weeks of treatment)