A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-selection Study of S-600918 in Patients With Refractory Chronic Cough
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 406
- 试验地点
- 135
- 主要终点
- Percent Change in Number of Coughs Per Hour in 24 Hours Following 4 Weeks of Study Treatment
研究概览
简要总结
The primary objective of this study is to determine the optimal dose of S-600918 in patients with refractory chronic cough by evaluating the change from baseline in 24-hour cough frequency (coughs per hour) with S-600918 compared with 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
- 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
- •Having refractory chronic cough (including unexplained chronic cough) for at least 1 year.
- •If female and of childbearing potential, agreement to use one of the allowed contraceptive methods.
- •Capable of giving signed informed consent.
排除标准
- •Currently smokes or uses potentially irritating inhalational agents (eg, e-cigarettes, smokeless cigarettes, vaping); stopped smoking or using potentially irritating inhalational agents within the last year; or has a smoking history of 20 pack-years or more.
- •Has chronic obstructive pulmonary disease or uncontrolled asthma.
- •Has a clinically unstable medical condition.
- •History of or ongoing significant psychiatric disorder.
- •History of respiratory tract infection or significant change in lung function or a pulmonary condition in the last 4 weeks.
- •History of malignancy in the last 5 years.
- •History of severe drug allergy.
- •History of alcohol or drug abuse in the last year or currently uses any form of marijuana or illicit drugs.
- •Has a clinically significant finding on a chest x-ray or chest computed tomography (CT) scan in the last year.
- •Has systolic blood pressure > 160 mm Hg or diastolic blood pressure > 90 mm Hg.
- •Received S-600918 previously.
- •Received an investigational drug in the last 3 months.
- •Received an angiotensin converting enzyme (ACE) inhibitor in the last 3 months or requires such treatment.
- •Has a positive serologic test for human immunodeficiency virus (HIV) antigen or antibody, hepatitis B virus surface antigen, or hepatitis C virus ribonucleic acid (RNA).
- •If female, pregnant or trying to become pregnant or breastfeeding.
研究组 & 干预措施
S-600918 50 mg
Participants will receive 50 mg S-600918 orally once a day for 28 days.
干预措施: S-600918 (Drug)
S-600918 150 mg
Participants will receive 150 mg S-600918 orally once a day for 28 days.
干预措施: S-600918 (Drug)
S-600918 300 mg
Participants will receive 300 mg S-600918 orally once a day for 28 days.
干预措施: S-600918 (Drug)
Placebo
Participants will receive placebo to S-600918 orally once a day for 28 days.
干预措施: Placebo to S-600918 (Drug)
结局指标
主要结局
Percent Change in Number of Coughs Per Hour in 24 Hours Following 4 Weeks of Study Treatment
时间窗: Baseline to Week 4
Change in cough was calculated based upon the number of coughs per hour in 24 hours at Week 4 and baseline. Results are presented as percent change from baseline. Reported percent change is based on a mixed model for the log-transformed ratio of the number of coughs per hour in 24 hours at each visit with treatment, week, and treatment-by-week as fixed effect, participant as random effect, and region (Japan, Europe, or the United States) and the log-transformed coughs per hour in 24 hours at baseline as covariates. The number of coughs per hour while awake was measured using a cough monitor.
次要结局
- Number of Participants With 30%, 50%, and 70% Reduction in Number of Coughs Per Hour Over 24 Hours After 4 Weeks of Study Treatment(Baseline to Week 4)
- Percent Change in Number of Coughs Per Hour While Awake Following 4 Weeks of Study Treatment(Baseline to Week 4)
- Number of Participants With 30%, 50% and 70% Reduction in Number of Coughs Per Hour While Awake After 4 Weeks of Study Treatment(Baseline to Week 4)
- Percent Change in Number of Coughs Per Hour While Asleep Following 4 Weeks of Study Treatment(Baseline to Week 4)
- Change From Baseline in Weekly Cough Severity Following 4 Weeks of Study Treatment(Baseline to Week 4)
- Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score(Baseline to Week 4)
- Number of Responders Defined as Participants With an Increase in LCQ of ≥ 1.3 Points(Baseline to Week 4)
- Change From Baseline in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)(Baseline to Week 4)
- Change From Baseline in Short Form (36) Health Survey (SF-36)(Baseline to Week 4)
- Number of Responders as Assessed by Patient Global Impression of Change (PGIC)(Week 4)