A Study to Assess the Efficacy of AF-219, a P2X3 Receptor Antagonist, in Subjects With Chronic Cough (EPiCC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 主要终点
- Change From Baseline in Daytime Objective Cough Frequency
研究概览
简要总结
This is a randomised, double-blind, placebo-controlled, crossover, single centre study of gefapixant (AF-219/MK-7264) in participants with idiopathic or treatment resistant chronic cough designed to evaluate the effectiveness of gefapixant in reducing daytime objective cough frequency.
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
- 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
- •History of cough for more than 8 weeks
- •Normal chest radiograph
- •Idiopathic or treatment resistant cough (idiopathic defined as a cough for which no objective evidence of an underlying trigger can be determined after investigation or a cough that is unresponsive to 8 weeks of targeted treatment for identified underlying triggers including reflux disease, asthma and post-nasal drip [treatment-resistant]).
排除标准
- •Current smoker
- •Individuals who have given up smoking within the past 6 months, or those with >20 pack-year smoking history
- •Treatment with an angiotensin-converting-enzyme inhibitor (ACE-inhibitor) as the potential cause of a participant's cough, or requiring treatment with an ACE-inhibitor during the study or within 4 weeks prior to Day 0
- •Forced Expiratory Volume (FEV1)/Forced Vital Capacity (FVC) <60%
研究组 & 干预措施
Gefapixant 600 mg>Placebo
Gefapixant, 600 mg, twice daily (BID), taken orally for 2 weeks followed by a 2-week washout period and then placebo to gefapixant, BID, taken orally for 2 weeks.
干预措施: Gefapixant (Drug)
Gefapixant 600 mg>Placebo
Gefapixant, 600 mg, twice daily (BID), taken orally for 2 weeks followed by a 2-week washout period and then placebo to gefapixant, BID, taken orally for 2 weeks.
干预措施: Placebo (Drug)
Placebo>Gefapixant 600 mg
Placebo to gefapixant BID, taken orally for 2 weeks followed by a 2-week washout period and then gefapixant, 600 mg, BID, taken orally for 2 weeks.
干预措施: Gefapixant (Drug)
Placebo>Gefapixant 600 mg
Placebo to gefapixant BID, taken orally for 2 weeks followed by a 2-week washout period and then gefapixant, 600 mg, BID, taken orally for 2 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Daytime Objective Cough Frequency
时间窗: Baseline (Day 0) and Day 14 of each study period
Daytime Objective Cough Frequency (per hour) is the total number of cough events during the monitoring period (in general, 24-hr interval) the participant is awake divided by the total duration (in hours) for the monitoring period the participants is awake. 24-hour sound recordings were collected using a digital recording device. Change from baseline in awake cough frequency = (post-treatment awake cough frequency - baseline awake cough frequency). A negative result indicates a decrease in cough frequency, while a positive result indicates an increase in cough frequency.
次要结局
- Change From Baseline of Daytime Cough Severity Score Using a Visual Analogue Scale (VAS)(Baseline (Day 0) and Day 15 of each study period)
- Change From Baseline in Nighttime Objective Cough Frequency(Baseline (Day 0) and Day 14 of each study period)
- Change From Baseline of Nighttime Cough Severity Score Using a Visual Analogue Scale (VAS)(Baseline (Day 0) and Day 15 of each study period)
- Change From Baseline of 24-hour Objective Cough Frequency(24 hours at Baseline (Day 0) and Day 14 of each study period)
- Global Rating of Change Score for Cough Frequency(Day 15 of each study period)
- Global Rating of Change Score for Cough Severity(Day 15 of each study period)
- Change From Baseline in Cough-specific Quality of Life Questionnaire (CQLQ)(Baseline (Day 0) and Day 15 of each study period)
- Change From Baseline in Urge to Cough Questionnaire (UtCQ) 100 mm Visual Analogue Scale(Baseline (Day 0) and Day 15 of each study period)