EUCTR2019-004169-42-FR进行中（未招募）1 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/orunexplained chronic cough (RUCC) - PAGANINI
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Bayer AG
- 入组人数
- 236
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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 that has lasted for at least 8 weeks before
- •3. 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.
- •4. Capable of giving signed informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 136
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. Uncontrolled hypertension despite optimal treatment with
- •antihypertensive(s), indicated by a sitting systolic blood pressure = 180
- •mmHg and/or diastolic blood pressure = 110 mmHg.
研究者
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