A Randomized, Adaptive, Double-Blind, Placebo-Controlled, Parallel-Arm, Phase 2b Study to Evaluate the Efficacy and Safety of Multiple Doses of BLU-5937 in Adult Participants With Refractory Chronic Cough
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 310
- 试验地点
- 115
- 主要终点
- Change from baseline in the 24-hour cough frequency
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 2b adaptive dose-finding study of BLU-5937 in participants with Refractory Chronic Cough (RCC).
详细描述
The primary objective of this study is to determine the therapeutic dose of BLU-5937 in patients with refractory chronic cough by assessing the change from baseline to week 4 in the 24-hour cough frequency with BLU-5937 relative to placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •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
研究组 & 干预措施
BLU-5937 Dose A
BLU-5937 oral dose A twice a day.
干预措施: BLU-5937 (Drug)
BLU-5937 Dose B
BLU-5937 oral dose B twice a day.
干预措施: BLU-5937 (Drug)
BLU-5937 Dose C
BLU-5937 oral dose C twice a day.
干预措施: BLU-5937 (Drug)
Placebo
Matching Placebo for BLU-5937 oral dose twice a day.
干预措施: Placebo (Drug)
BLU-5937 Dose A (Population with baseline cough < 25 coughs/hour)
BLU-5937 oral dose A twice a day.
干预措施: BLU-5937 (Drug)
Placebo (Population with baseline cough < 25 coughs/hour)
Matching Placebo for BLU-5937 oral dose twice a day.
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in the 24-hour cough frequency
时间窗: Week 4
Assessed using an ambulatory cough monitor
次要结局
- Change from Baseline in Leicester Cough Questionnaire (LCQ)(Week 4)
- Incidence (% of subjects) of treatment-emergent adverse events (TEAEs)(2 Weeks after the last study medication intake)
- Percentage of Participants with a Reduction from Baseline in the 24-hour Cough Frequency by ≥ 30%, 50% and 70%(Week 4)
- Change from baseline in cough severity(Week 4)
- Severity (mild, moderate, or severe) of treatment-emergent adverse events (TEAEs)(2 Weeks after the last study medication intake)