NL-OMON38122已完成4 期
Effect of roflumilast on exacerbation rate in patients with COPD treated with fixed combinations of LABA and ICS. A 52-week, randomised double-blind trial with roflumilast 500 µg versus placebo. - REACT_RO-2455-404-RD
Takeda0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
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
- •2. History of COPD (according to GOLD 2009) for at least 12 months prior to baseline Visit V0 associated with chronic productive cough for 3 months in each of the 2 years prior to baseline Visit V0 (with other causes of productive cough excluded).
- •3. Age >= 40 years
- •4. Forced expiratory volume after one second (FEV1) / forced vital capacity (FVC) ratio (post-bronchodilator) < 70%
- •5. FEV1 (post-bronchodilator) <= 50% of predicted
- •6. At least two documented moderate or severe COPD exacerbations, separated by at least 10 days, within one year prior to baseline visit V0.
- •7. Patients must be pre-treated with LABA and ICS for at least 12 months before baseline Visit V0. Up to 3 months before baseline Visit V0 free or fixed combinations of LABA and ICS are allowed, including changes in dose, active substances, and brands. In the last 3 months before baseline Visit V0 patients must be pre-treated with fixed combinations of LABA and ICS at a constant dose (maximum approved dosage strength of the combination)
- •8. Former smoker (defined as smoking cessation at least one year ago) or current smoker both with a smoking history of at least 20 pack years.
排除标准
- •1. Moderate or severe COPD exacerbations and/or COPD exacerbations treated with antibiotics ongoing at the baseline visit V0
- •2. Lower respiratory tract infection not resolved 4 weeks prior to the baseline visit V0
- •3. Diagnosis of asthma and/or other relevant lung disease
- •4. Current participation in a pulmonary rehabilitation program or completion of a pulmonary rehabilitation program within 3 months preceding the baseline visit V0. However, physical exercise maintenance following the completion of the initial pulmonary rehabilitation program and which is continuously performed within 3 months preceding baseline Visit V0 and during the complete trial is allowed.
- •5.Known alpha-1-antitrypsin deficiency.;Exclusion criteria within ethical considerations in terms of general health are listed in the protocol, section 6.2.2.
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