JPRN-jRCT2031200185已完成2 期
Randomized, Double-blind, Parallel Group, Phase 2b Dose-finding, Efficacy and Safety Study of 12-week Twice Daily Oral Administration of BAY 1817080 Compared to Placebo in the Treatment of Refractory and/or Unexplained Chronic Cough (RUCC) - PAGANINI
Myoishi Masashi0 个研究点目标入组 310 人开始时间: 2020年11月6日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 310
研究概览
简要总结
The study met its objective to detect a dose-response signal of eliapixant for the treatment of RUCC. The identified optimal dose was 75 mg BID, showing a clinically relevant effect in cough count reduction after 12 weeks of intervention and a good safety and tolerability profile. The only study intervention-related serious TEAE was observed in the 150 mg BID group and was a case of moderate drug-induced liver injury.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Adults >= 18 years of age at the time of signing the informed consent.
- •-A cough that has lasted for at least 12 months (unresponsive to treatment options) with a diagnosis of refractory chronic cough and/or idiopathic (unexplained) chronic cough.
- •-Persistent cough for at least the last 8 weeks before screening. -Women of childbearing potential must agree to use acceptable effective or highly effective birth control methods during the study and for at least 30 days after the last dose.
- •-Capable of giving signed informed consent.
排除标准
- •-Smoking history within the last 12 months before screening (all forms of smoking, including e-cigarettes, cannabis and others), and any former smoker with more than 20 pack-years.
- •-Ongoing or previous exposure to inhalational toxic fumes (e.g. ammonia, chlorine, nitrogen dioxide, phosgene and sulfur dioxide) within the last 12 months before screening.
- •-Respiratory tract infection within 4 weeks before screening.
- •-History of chronic bronchitis.
- •-Systolic blood pressure >= 160 mmHg and/or diastolic blood pressure >= 100 mmHg at screening visit.
- •-Positive SARS-CoV-2 virus RNA and/or serology IgG tests at screening visit.
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