JPRN-jRCT2031230611尚未招募3 期
A Phase 3, 24-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Efficacy and Safety Study With Open-Label Extension of BLU-5937 in Adult Participants With Refractory Chronic Cough Including Unexplained Chronic Cough (CALM-2)
Kawamoto Mika0 个研究点目标入组 825 人开始时间: 2024年2月1日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 825
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
- >= 18age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •Capable of giving signed informed consent
- •-Refractory chronic cough (including unexplained chronic cough) for at least one year
- •-Women of child-bearing potential must use a highly effective contraception method during the study and for at least 14 days after the last dose
排除标准
- •-Current smoker/vaper (all forms of smoking and inhaled substances, including , cannabis/tobacco smoke and nicotine vapors) or individuals who have given up smoking within the past 6 months, or those with >20 pack-year smoking history
- •-Diagnosis of Chronic Obstructive Pulmonary Disease (COPD), bronchiectasis, idiopathic pulmonary fibrosis or uncontrolled asthma
- •-Respiratory tract infection within 4 weeks before screening
- •-Laboratory confirmed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection at screening
- •-History of malignancy in the last 5 years
- •-History of alcohol or drug abuse within the last 3 years
- •-Has a positive serologic test for human immunodeficiency virus (HIV), hepatitis B virus surface antigen, or hepatitis C virus.
- •-Previous participation in a BLU-5937 trial
研究者
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