NL-OMON50167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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 8
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
- •1. Adults * 18 years of age at the time of signing the informed consent.
- •2. A cough that has lasted for at least 12 months with persistently bothersome
- •refractory (unresponsive to treatment options) or idiopathic (unexplained)
- •chronic cough.
- •3. persistent cough for at least 8 weeks before screening.
- •4. 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.
- •5. Capable of giving signed informed consent.
排除标准
- •1. 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.
- •2. 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.
- •3. Respiratory tract infection within 4 weeks before screening.
- •4. History of chronic bronchitis.
- •5.Systolic blood pressure * 160 mmHg and/or diastolic blood pressure * 100 mmHg
- •at screening visit.
- •6. Positive SARS-CoV-2 virus RNA and/or serology IgG tests at screening visit.
研究者
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