A Double-Blind, Randomised, Placebo Controlled, Two Period Cross-Over Study to Evaluate the Efficacy and Safety of Orvepitant in Chronic Cough in Patients With Idiopathic Pulmonary Fibrosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 34
- 主要终点
- Mean Change From Baseline in Weekly Average of the Daily Idiopathic Pulmonary Fibrosis Coughing Severity Scale (IPF CSS)
研究概览
简要总结
ORV-PF-01 is a two way, placebo controlled, cross-over study, to evaluate the effect of two doses of orvepitant on cough in patients with IPF.
详细描述
The study will be a multi-center, double-blind, randomised, placebo-controlled 2-period cross-over study in subjects with chronic cough due to idiopathic pulmonary fibrosis (IPF).
Subjects will participate in one of two cohorts (Cohort 1 and Cohort 2). Cohort 1 will evaluate a 30 mg orvepitant dose and Cohort 2 the 10 mg dose. Within each cohort, subjects will be randomised to receive either orvepitant or placebo in the first treatment period (Treatment Period A) followed by the alternate treatment in Treatment Period B. There will be a wash-out period of 3 weeks between the two treatment periods. Subjects will be randomised 1:1 to each of the two treatment orders and 1:1 to each cohort.
Subjects will enter a screening period of between 14 and 28 days to determine eligibility. Eligible subjects will be randomised at the Baseline visit and will participate in two identical 28 day treatment periods with the wash-out period between them. There will be a total of 8 visits including the Screening, Baseline and final Follow-up visits.
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)
盲法说明
Double-blind
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
- •Diagnosis of IPF established according to the 2018 or 2022 joint ATS/ERS/JRS/ALAT Clinical Practice Guideline
- •FEV1/FVC ratio ≥0.65 at the screening visit
- •Haemoglobin-corrected diffusion capacity of carbon monoxide (Hb-corrected DLCO) ≥25% within 12 months of the screening visit
- •Arterial oxygen saturation on room air or oxygen ≥90% at Screening
- •Life expectancy of at least 12 months
- •Cough that is attributed to IPF, which has not responded to anti-tussive treatment, and which has been present for at least 8 weeks prior to Screening
- •Mean daily IPF Coughing Severity Scale score ≥5 (after rounding) during the second week of the baseline assessment period
排除标准
- •Recent respiratory tract infection (<8 weeks prior to Screening)
- •Recent acute exacerbation of IPF (<8 weeks prior to Screening)
- •Current smokers or ex-smokers with <6 months' abstinence prior to Screening
- •Emphysema ≥50% on high-resolution computed tomography, or the extent of emphysema is greater than the extent of fibrosis according to the reported results of the most recent scan
- •Mean early morning cough scale score ≥5 and rest of the day cough scale score <5 (after rounding) during the second week of the baseline assessment period (assessed at Visit 2)
- •Cough that is predominantly productive in nature and attributable to lung pathology such as chronic bronchitis or bronchiectasis
研究组 & 干预措施
Orvepitant 30mg
Orvepitant 30mg tablet once daily for 4 weeks
干预措施: Orvepitant Maleate (Drug)
Orvepitant 10mg
Orvepitant 10mg tablet once daily for 4 weeks
干预措施: Orvepitant Maleate (Drug)
Placebo
Placebo tablet once daily for 4 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change From Baseline in Weekly Average of the Daily Idiopathic Pulmonary Fibrosis Coughing Severity Scale (IPF CSS)
时间窗: Week 4
A numerical rating scale from 0 (no coughing) to 10 (coughing as bad as you can imagine) for coughing severity in the last 24 hours
次要结局
- Mean Change From Baseline in Weekly Average of the Early Morning IPF Coughing Severity Scale(Week 4)
- Mean Change From Baseline in Weekly Average of the Rest of the Day IPF Coughing Severity Scale(Week 4)
- Mean Change From Baseline in Weekly Average of the Daily Urge to Cough Scale(Week 4)
- Mean Change From Baseline in Weekly Average of the Daily Cough Frequency Scale(Week 4)
- Mean Change From Baseline in Weekly Average of the Daily Dyspnoea Scale(Week 4)
- Mean Change From Baseline in Leicester Cough Questionnaire (LCQ) Total Score(Week 4)
- Mean Change From Baseline in Leicester Cough Questionnaire (LCQ) Physical Domain Score(Week 4)
- Mean Change From Baseline in Leicester Cough Questionnaire (LCQ) Psychological Domain Score(Week 4)
- Mean Change From Baseline in Leicester Cough Questionnaire (LCQ) Social Domain Score(Week 4)
- Mean Change From Baseline in 24-hour Cough Frequency(Week 4)
- Mean Change From Baseline in Awake Cough Frequency(Week 4)
- Mean Change From Baseline in Night-time Cough Frequency(Week 4)
- Mean Change From Baseline in the Number of Coughing Bouts(Week 4)
- Mean Change From Baseline in the Number of Coughs Per Bout(Week 4)