A Phase 2 Study to Assess the Efficacy and Safety of AX-8 in Patients With Chronic Cough
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Axalbion SA
- 入组人数
- 108
- 试验地点
- 16
- 主要终点
- Part 1 of the study: Change from Baseline in objective cough frequency in the 8 hours after the first dose of the day (i.e., Dose 1) on the 1st day of treatment of each study period
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, crossover, multicenter study of AX-8 in participants with unexplained or refractory chronic cough designed to evaluate the effectiveness of AX-8 in reducing cough frequency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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) of the thorax approximately 12 months before screening not demonstrating any abnormality considered to be significantly contributing to the chronic cough
- •Have a diagnosis of refractory chronic cough (RCC) or unexplained chronic cough (UCC) for at least one year
- •Women of childbearing potential and their male partners must use 2 acceptable methods of contraception
- •Male subjects and their female partners of childbearing potential must use 2 acceptable methods of contraception
- •Have provided written informed consent
排除标准
- •Positive diagnostic nucleic acid test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
- •Current smoker (including e-cigarettes), individuals who have given up smoking within the past 12 months, or individuals with a smoking history of 20 pack-years
- •Treatment with an ACE-inhibitor as the potential cause of a subject's cough or requiring treatment with an ACE-inhibitor during the study or within 12 weeks prior to the Baseline Visit
- •History of upper or lower respiratory tract infection or recent significant change in pulmonary status within 4 weeks
- •History of cystic fibrosis
- •Positive test for any drug of abuse
- •History of malignancy within 5 years prior to the Baseline Visit
- •History of infection or known active infection with human immunodeficiency (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
- •History of hypersensitivity or intolerance to AX-8 or other TRPM8 agonists or any of the excipients
研究组 & 干预措施
AX-8 to Placebo, Part 1 of the study
AX-8 BID, taken for 2 weeks, followed by a 1-week washout period and then Placebo BID, taken for 2 weeks.
干预措施: AX-8, Part 1 of the study (Drug)
AX-8 to Placebo, Part 1 of the study
AX-8 BID, taken for 2 weeks, followed by a 1-week washout period and then Placebo BID, taken for 2 weeks.
干预措施: Placebo, Part 1 of the study (Drug)
Placebo to AX-8, Part 1 of the study
Placebo BID, taken for 2 weeks, followed by a 1-week washout period and then AX-8 BID, taken for 2 weeks.
干预措施: AX-8, Part 1 of the study (Drug)
Placebo to AX-8, Part 1 of the study
Placebo BID, taken for 2 weeks, followed by a 1-week washout period and then AX-8 BID, taken for 2 weeks.
干预措施: Placebo, Part 1 of the study (Drug)
AX-8 to Placebo, Part 2 of the study
AX-8 TID, taken for 2 weeks, followed by a 1-week washout period and then Placebo BID, taken for 2 weeks.
干预措施: AX-8, Part 2 of the study (Drug)
AX-8 to Placebo, Part 2 of the study
AX-8 TID, taken for 2 weeks, followed by a 1-week washout period and then Placebo BID, taken for 2 weeks.
干预措施: Placebo, Part 2 of the study (Drug)
Placebo to AX-8, Part 2 of the study
Placebo TID, taken for 2 weeks, followed by a 1-week washout period and then AX-8 BID, taken for 2 weeks.
干预措施: AX-8, Part 2 of the study (Drug)
Placebo to AX-8, Part 2 of the study
Placebo TID, taken for 2 weeks, followed by a 1-week washout period and then AX-8 BID, taken for 2 weeks.
干预措施: Placebo, Part 2 of the study (Drug)
结局指标
主要结局
Part 1 of the study: Change from Baseline in objective cough frequency in the 8 hours after the first dose of the day (i.e., Dose 1) on the 1st day of treatment of each study period
时间窗: Baseline (i.e., Days -1 and 22) and the 1st day of treatment (i.e., Days 1 and 23) of each study period
Assessment of number of coughs per hour to be evaluated using a digital recording device
Part 2 of the study: Change from Baseline in objective cough frequency in the 4 hours after the first dose of the day (i.e., Dose 1) on the 1st day of treatment of each study period
时间窗: Baseline (i.e., Days -1 and 22) and the 1st day of treatment (i.e., Days 1 and 23) of each study period
Assessment of number of coughs per hour to be evaluated using a digital recording device
次要结局
- Change from Baseline in Cough Severity Visual Analog Scale (VAS) score(Baseline (i.e., Days -1 and 22), the 1st day of treatment (i.e., Days 1 and 23) and the 14th day of treatment (i.e., Days 14 and 36) of each study period)
- Change from Baseline in awake cough frequency(Baseline (i.e., Days -1 and 22), the 1st day of treatment (i.e., Days 1 and 23) and the 14th day of treatment (i.e., Days 14 and 36) of each study period)
- Incidence (percent of participants) of treatment-emergent adverse events (TEAEs)(From first dose of study drug (i.e., Dose 1 on Day 1) to follow-up visit (i.e., Day 50, included))
- Incidence (percent of participants) of serious adverse events (SAEs)(From screening visit (i.e., Days -21 to -2) to follow-up visit (i.e., Day 50, included))