A Randomized, Double-Blind, Placebo-Controlled, Crossover, Dose Escalation Study of BLU-5937 in Subjects With Unexplained or Refractory Chronic Cough (RELIEF)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 68
- 试验地点
- 16
- 主要终点
- Change in Awake Objective Cough Frequency on Log-transformed Scale
研究概览
简要总结
This is a multi-center, randomized, double-blind, placebo-controlled, crossover, dose escalation study of BLU-5937 in subjects with unexplained or refractory chronic cough
详细描述
This study will have two 16-day treatment periods (four escalating doses or matching placebo at four days interval) separated by a 10 to 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
- Crossover
- 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
- •Unexplained or refractory chronic cough for at least one year
- •Chest radiograph or CT thorax within the last 60 months not demonstrating any abnormality considered to be significantly contributing to the chronic cough
- •Cough count of ≥ 10 per hour (Awake Cough Count) at Screening
- •Score of ≥ 40mm on the Cough Severity VAS at Screening
- •Women of child-bearing potential must have a negative serum pregnancy test at Screening
- •Women of child-bearing potential must use a highly effective contraception method from Screening through the Follow-Up Visit
- •Male subjects and their partners of child-bearing potential must use 2 methods of acceptable birth control
排除标准
- •Current smoker or individuals who have given up smoking within the past 6 months, or those with >20 pack-year smoking history
- •Diagnosis of COPD, bronchiectasis, idiopathic pulmonary fibrosis
- •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 Screening Visit
- •FEV1/FVC < 60%
- •History of upper respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Baseline Visit
- •History of concurrent malignancy or recurrence of malignancy within 2 years prior to Screening
- •History of a diagnosis of drug or alcohol dependency or abuse within the last 3 years
- •Clinically significant abnormal electrocardiogram (ECG) or laboratory tests at Screening
- •Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results
研究组 & 干预措施
BLU-5937 oral tablet BID
Randomized crossover design of 4 different doses (25, 50, 100, 200 mg BID) of BLU-5937 tablets to be administered orally BID
干预措施: BLU-5937 (Drug)
Placebo oral tablet BID
Randomized crossover design of matching placebo tablets to be administered orally BID
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Awake Objective Cough Frequency on Log-transformed Scale
时间窗: Period 1: baseline (Day 0) and 24 hours after Day 4, 8, 12, 16 doses ; Period 2: baseline (Day 30) and 24 hours after Day 34, 38, 42, 46 doses
Change in awake cough frequency (average hourly cough frequency while the subject is awake ) evaluated using the VitaloJAK cough monitor with 24-hour sound recordings collected
次要结局
未报告次要终点