NCT03864328终止2 期
Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study With Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients With Idiopathic Pulmonary Fibrosis (IPF): SCENIC Trial
Respivant Sciences GmbH81 个研究点 分布在 6 个国家目标入组 108 人开始时间: 2019年3月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 108
- 试验地点
- 81
- 主要终点
- Change in 24-hour average cough count
研究概览
简要总结
Idiopathic pulmonary fibrosis (IPF) is a rare, progressive life-threatening disease that is characterized by exertional dyspnea and persistent dry cough.
Cough in IPF is both a presenting and a complicating clinical feature, which affects approximately three quarters of IPF cases. It is often a debilitating symptom that adversely affects quality of life (QoL) and is usually refractory to medical therapy.
Inhaled RVT-1601 (formerly, PA101B), a new inhalation formulation of cromolyn sodium delivered via the eFlow® Closed System (CS) nebulizer, is being evaluated in this Phase 2b study for the treatment of persistent cough in patients with IPF.
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
- 40 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects age 40 through 89 years
- •Confirmed diagnosis of IPF with clinical features consistent with the current clinical practice guidelines
- •Persistent cough for at least 8 weeks that is primarily due to IPF and not responsive to anti-tussive therapy
- •Daytime cough severity score of ≥ 40 mm on a 100-mm VAS
- •24-hour average cough count of at least 10 coughs per hour
- •Forced Vital Capacity (FVC) > 45% predicted value within 4 weeks
- •Diffusion capacity for carbon monoxide corrected for hemoglobin (DLCOc) > 30% predicted value within 4 weeks
- •Life expectancy of at least 12 months
排除标准
- •Current or recent history of clinically significant medical condition, laboratory abnormality, or illness that could place the subject at risk or compromise the quality of the study data
- •Significant coronary artery disease (i.e., myocardial infarction within 6 months or unstable angina within 1 month)
- •Upper or lower respiratory tract infection within 4 weeks
- •Acute exacerbation of IPF within 6 months
- •Lung transplantation expected within 12 months
- •Requiring supplemental O2 > 4 litres/min to maintain peripheral arterial O2 saturation (SpO2) > 88% at rest
- •History of malignancy likely to result in significant disability or likely to require significant medical or surgical intervention within the next 2 years
- •Current smoker (i.e., use of tobacco products within the last 3 months)
- •Current or recent history of drug or alcohol abuse within 12 months
- •Participation in any other investigational drug study within 4 weeks
- •Use of certain drugs for cough management within 4 weeks: prednisone, opiates, baclofen, gabapentin, pregabalin, thalidomide, amitriptyline, inhaled corticosteroids, or inhaled bronchodilators
- •Use of ACE inhibitors or cromolyn sodium within 4 weeks
- •Females who are pregnant or breastfeeding, or if of child-bearing potential unwilling to practice acceptable means of birth control during the study
- •History of hypersensitivity or intolerance to cromolyn sodium
研究组 & 干预措施
RVT-1601 Low Dose
Experimental
干预措施: RVT-1601 (Drug)
RVT-1601 Mid Dose
Experimental
干预措施: RVT-1601 (Drug)
RVT-1601 High Dose
Experimental
干预措施: RVT-1601 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change in 24-hour average cough count
时间窗: 12 weeks
Objective cough count monitoring performed using a digital recording device.
次要结局
- Change in cough severity(12 weeks)
- Change in cough-specific QoL(12 weeks)
研究者
研究点 (81)
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