A Dose Escalation Study to Assess the Efficacy and Safety of Bradanicline in Subjects With Refractory Chronic Cough
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 17
- 主要终点
- Awake coughs per hour at Days 7, 14, 21, 43, 50, 57
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, crossover, dose escalation study of bradanicline in subjects with chronic cough
详细描述
This study will have two 21-day treatment periods separated by a 14-day washout period. There will be a 14-day follow-up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chest radiograph or computed tomography (CT) scan of the thorax within the last 1 year not demonstrating any abnormality considered to be significantly contributing to the refractory chronic cough
- •Diagnosis of refractory chronic cough or unexplained cough for at least one year
- •Women of child-bearing potential who use 2 forms of acceptable birth control method
- •Male subjects and their partners of child-bearing potential who use 2 methods of acceptable birth control
- •Has provided written informed consent
排除标准
- •Current smoker (cigarettes or e-cigarettes) or has given up smoking within the past 12 months
- •Currently taking an ACE-inhibitor or requiring treatment with an ACE-inhibitor during the study or within 12 weeks prior to the Baseline Visit
- •Has an upper or lower respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Baseline Visit
- •Has a history of cystic fibrosis
- •Has a history of malignancy within 5 years prior to the Baseline Visit
- •Has active hepatitis infection
- •Has a history of human immunodeficiency virus (HIV) infection
- •Has a positive test for any drug of abuse
- •Has a history of hypersensitivity to bradanicline or any of its components
研究组 & 干预措施
Bradanicline QD
Randomized crossover design of 3 different doses of bradanicline (film-coated tablets) to be administered orally QD
干预措施: Bradanicline (Drug)
Bradanicline QD
Randomized crossover design of 3 different doses of bradanicline (film-coated tablets) to be administered orally QD
干预措施: Placebo (Drug)
Placebo
Randomized crossover design of matching placebo tablets to be administered orally QD
干预措施: Bradanicline (Drug)
Placebo
Randomized crossover design of matching placebo tablets to be administered orally QD
干预措施: Placebo (Drug)
结局指标
主要结局
Awake coughs per hour at Days 7, 14, 21, 43, 50, 57
时间窗: Change from Baseline at Days 7, 14, 21, 43, 50, 57
Assessment of awake coughs per hour (average hourly cough frequency while the participant is awake based on sound recordings), to be evaluated using a digital recording device
次要结局
- 24-hour coughs per hour at Days 7, 14, 21, 43, 50, 57(Change from Baseline at Days 7, 14, 21, 43, 50, 57)
- Percentage of participants who have at least one adverse event (AE) during the treatment periods, washout, and follow-up(up to 57 days)