A Double-blind, Randomised, Placebo-controlled, Crossover Study to Assess the Efficacy of XEN-D0501, a Transient Receptor Potential Vanilloid Receptor 1 (TRPV1) Antagonist, in Reducing the Frequency of Cough in Patients With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Xention Ltd
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Change from baseline at the end of each treatment period in objective daytime cough frequency
研究概览
简要总结
The purpose of this study is to determine the effectiveness of XEN-D0501 over placebo in reducing the daytime cough frequency in patients with chronic obstructive pulmonary disease (COPD).
The effectiveness of XEN-D0501 placebo in reducing capsaicin cough responses, objective 24-hour cough frequency, hourly change in cough frequency, cough severity (via visual analogue scale [VAS]), urge to cough (via VAS), global rating of change scale, Clinical COPD Questionnaire (CCQ), Leicester Cough Questionnaire (LCQ), and St George's Respiratory Questionnaire (SGRQ-C) will be evaluated.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male/female subjects aged 40 or over with COPD
排除标准
- •Clinically significant medical history
- •Abnormal laboratory results, ECGs or vital signs
研究组 & 干预措施
XEN-D0501
4mg BID Days 1-13, 4mg once daily (OD) Day 14
干预措施: XEN-D0501 (Drug)
Placebo to Match
BID Days 1-13, once daily (OD) Day 14
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline at the end of each treatment period in objective daytime cough frequency
时间窗: 12 weeks
次要结局
未报告次要终点