A Double-Blind, Randomized, Placebo Controlled Study of the Efficacy and Safety of Three Doses of Orvepitant in Subjects With Chronic Refractory Cough
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 315
- 试验地点
- 66
- 主要终点
- Change From Baseline to Week 12 in Awake Objective Cough Frequency
研究概览
简要总结
The purpose of this study is to determine the effectiveness of three doses of orvepitant, taken once a day, in the treatment of chronic refractory cough.
详细描述
A multi-center, double-blind, randomized, parallel group, placebo-controlled dose range study in subjects with chronic refractory cough (CRC).
Doses of orvepitant (10 mg/day, 20 mg/day and 30 mg/day) and placebo will be investigated in four parallel groups.
Each group will compromise of approximately 73 subjects, randomized 1:1:1:1 (approximately 292 subjects in total).
All subjects will enter a three-week screening period to determine eligibility. Eligible subjects will be randomized at the Baseline/Day 1 visit and enter a 12-week double-blind dosing period. During this period there will be four visits at Weeks 2, 4, 8 and 12. There will be a final safety follow-up visit at Week 14.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects ≥18 years of age.
- •Diagnosis of CRC or unexplained cough for at least 1 year (see ACCP/BTS guidelines attached).
- •An awake average cough frequency of ≥10 coughs/ hour, as assessed using an ACM during the screening period.
排除标准
- •Subjects with respiratory tract infection (<4 weeks prior to study start)
- •Current smokers or ex-smokers with <6 months' abstinence or cumulative history of >10 pack years
- •Treatment with Angiotensin Converting Enzyme (ACE) inhibitors within 3 months of screening
- •FEV1 <80% predicted, measured at screening using spirometry
- •History of cystic fibrosis, idiopathic pulmonary fibrosis, clinically significant bronchiectasis, moderate to severe asthma, chronic obstructive pulmonary disease (COPD)
- •Any clinically significant abnormal laboratory test result(s)
- •Inability to comply with the use of prohibited and allowed medications as described in the protocol.
研究组 & 干预措施
Orvepitant 10mg
Orvepitant 10mg tablet, once daily for 12 weeks
干预措施: Orvepitant Maleate (Drug)
Orvepitant 20mg
Orvepitant 20mg tablet, once daily for 12 weeks
干预措施: Orvepitant Maleate (Drug)
Orvepitant 30mg
Orvepitant 30mg tablet, once daily for 12 weeks
干预措施: Orvepitant Maleate (Drug)
Placebo
Placebo to match tablet, once daily for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to Week 12 in Awake Objective Cough Frequency
时间窗: Baseline to Week 12
Objective cough frequency measured by ambulatory cough monitoring device
次要结局
- Change in Awake Objective Cough Frequency at Week 2 Compared to Baseline(Baseline to Week 2)
- Change in Awake Objective Cough Frequency at Week 4 Compared to Baseline(Week 4)
- Change in the Leicester Cough Questionnaire (LCQ) at Week 2 Compared to Baseline(Baseline to Week 2)
- Change in the Leicester Cough Questionnaire (LCQ) at Week 4 Compared to Baseline(Baseline to Week 4)
- Change in the Leicester Cough Questionnaire (LCQ) at Week 8 Compared to Baseline(Baseline to Week 8)
- Change in the Leicester Cough Questionnaire (LCQ) at Week 12 Compared to Baseline(Baseline to Week 12)
- Change in the Cough Severity Visual Analogue Scale (VAS) at Week 2 Compared to Baseline - Day-time(Baseline to Week 2)
- Change in the Cough Severity Visual Analogue Scale (VAS) at Week 4 Compared to Baseline - Day-time(Baseline to Week 4)
- Change in the Cough Severity Visual Analogue Scale (VAS) at Week 8 Compared to Baseline - Day-time(Baseline to Week 8)
- Change in the Cough Severity Visual Analogue Scale (VAS) at Week 12 Compared to Baseline - Day-time(Baseline to Week 12)
- Change in the Cough Severity Visual Analogue Scale (VAS) at Week 2 Compared to Baseline - Night-time(Baseline to Week 2)
- Change in the Cough Severity Visual Analogue Scale (VAS) at Week 4 Compared to Baseline - Night-time(Baseline to Week 4)
- Change in the Cough Severity Visual Analogue Scale (VAS) at Week 8 Compared to Baseline - Night-time(Baseline to Week 8)
- Change in the Cough Severity Visual Analogue Scale (VAS) at Week 12 Compared to Baseline - Night-time(Baseline to Week 12)
- Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 2 Compared to Baseline(Baseline to Week 2)
- Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 4 Compared to Baseline(Baseline to Week 4)
- Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 8 Compared to Baseline(Baseline to Week 8)
- Change in the Urge-to-cough Visual Analogue Scale (VAS) at Week 12 Compared to Baseline(Baseline to Week 12)
- Global Rating of Change in Cough Frequency at Week 2(Baseline to Week 2)
- Global Rating of Change in Cough Frequency at Week 4(Baseline to Week 4)
- Global Rating of Change in Cough Frequency at Week 8(Baseline to Week 8)
- Global Rating of Change in Cough Frequency at Week 12(Baseline to Week 12)
- Global Rating of Change in Cough Severity at Week 2(Baseline to Week 2)
- Global Rating of Change in Cough Severity at Week 4(Baseline to Week 4)
- Global Rating of Change in Cough Severity at Week 8(Baseline to Week 8)
- Global Rating of Change in Cough Severity at Week 12(Baseline to Week 12)