NCT03282591已完成2 期
A Randomized, Double-blind, Placebo-controlled Study of the Efficacy, Safety, and Tolerability of Serlopitant for the Treatment of Refractory Chronic Cough
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 185
- 试验地点
- 39
- 主要终点
- Change in 24-hour Objective Cough Frequency (Log Normalized Percent Change Relative to Placebo)
研究概览
简要总结
Study of the efficacy, safety, and tolerability of serlopitant for the treatment of refractory chronic cough
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
- •Female and males between 18 and 80 years of age
- •Have a diagnosis of treatment refractory chronic cough or unexplained cough for at least one year
- •Chest radiograph or computed tomography (CT) Thorax within the last 5 years not demonstrating any abnormality considered to be significantly contributing to the chronic cough
- •At Screening have a score of ≥ 40mm on the Cough Severity VAS
- •At Baseline (Day 0) have a score of ≥ 40mm on the Cough Severity VAS
- •All female subjects who are of childbearing potential must practice highly effective contraception (i.e., pregnancy prevention method with a failure rate of < 1% per year) from the time of the initial screening visit until 4 weeks after last dose of study drug. Please refer to the protocol for acceptable methods of contraception
排除标准
- •Prior treatment with serlopitant or other NK1-R antagonist
- •Presence of any medical condition or disability that could interfere with study
- •History of hypersensitivity to serlopitant or any of its components
- •Currently pregnant or male partner of pregnant female
- •Females of childbearing potential who are unable or unwilling to use adequate contraception or who are breast feeding
- •Current smoker or individuals who have given up smoking within the past 12 months
- •FEV1/FVC < 60%
- •Body mass index (BMI) <18 kg/m2 or ≥ 40 kg/m2 at Screening
- •History of upper or lower respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Baseline Visit (Day 0)
- •History of cystic fibrosis
- •History of opioid use within 1 week of the Baseline Visit (Day 0)
- •Requiring concomitant therapy with prohibited medications
- •Treatment with biologic therapies within 8 weeks or 5 half-lives prior to the Baseline Visit (Day 0), whichever is longer
- •Treatment with strong CYP3A4 inhibitors within 4 weeks prior to the Baseline Visit (Day 0)
- •Treatment with any investigational therapy within 4 weeks (investigational biologic therapies within 8 weeks) prior to the Baseline Visit (Day 0)
- •Serum creatinine, total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2x the upper limit of normal (ULN) during screening
- •Positive test for any drug of abuse
- •History of malignancy within 5 years prior to the Baseline Visit (Day 0), with the exception of completely treated and non-metastatic basal cell carcinoma or squamous cell carcinoma of the skin
- •Any known psychiatric diagnosis meeting DSM-5 criteria which may confound the assessment of serlopitant safety or efficacy, or interfere with the subject's ability to comply with protocol-mandated activities, within 3 years prior to randomization. Examples of such DSM-5 diagnoses include but are not limited to major depressive disorder, bipolar disorder, schizophrenia, psychotic disorder, intellectual disability, severe alcohol use disorder.
- •Known active hepatitis infection
- •Known history of human immunodeficiency virus (HIV) infection
研究组 & 干预措施
5 mg Serlopitant Tablets
Experimental
Serlopitant Tablets
干预措施: 5 mg Serlopitant Tablets (Drug)
Matching Placebo Tablets
Placebo Comparator
Placebo Tablets
干预措施: Matching Placebo Tablets (Drug)
结局指标
主要结局
Change in 24-hour Objective Cough Frequency (Log Normalized Percent Change Relative to Placebo)
时间窗: from Baseline to Day 84
Change in 24-hour objective cough frequency is total number of cough events during the monitoring period (24-hour interval)/24 (Total duration (in hours) for the monitoring period) which is captured through sound recordings by a custom-built digital recording device (VitaloJAK, Vitalograph, Ltd).
次要结局
- Change From Baseline in Cough Severity Visual Analog Scale (VAS)(from Baseline to Day 84)
- Change in Awake Objective Cough Frequency(from Baseline to Day 84)
- Percentage of Participants With ≥ 30% Reduction in 24-hour Objective Cough Frequency(from Baseline to Day 84)
- Percentage of Participants With ≥30% Reduction in Awake Objective Cough Frequency(from Baseline to Day 84)
研究者
研究点 (39)
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