NCT03267108终止3 期
A Randomized, Double-Blind, Placebo-Controlled Dose Escalation and Verification Clinical Study to Assess the Safety and Efficacy of Pulsed Inhaled Nitric Oxide (iNO) in Subjects at Risk of Pulmonary Hypertension Associated With Pulmonary Fibrosis on Long Term Oxygen Therapy (Part 1 and Part 2) - REBUILD
Bellerophon Pulse Technologies125 个研究点 分布在 1 个国家目标入组 145 人开始时间: 2020年12月14日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 145
- 试验地点
- 125
- 主要终点
- Change in Moderate to Vigorous Physical Activity (MVPA) as Measured by Actigraphy
研究概览
简要总结
A randomized, double-blind, placebo-controlled dose escalation and verification study to assess the safety and efficacy of pulsed inhaled nitric oxide (iNO) in subjects at risk for pulmonary hypertension associated with pulmonary fibrosis on long term oxygen therapy (Part 1 and Part 2) - REBUILD
详细描述
This is a Phase 3, randomized, double-blind, placebo-controlled dose escalation and verification clinical study to assess the safety and efficacy of pulsed inhaled nitric oxide (iNO) in subjects at risk for pulmonary hypertension associated with pulmonary fibrosis on long term oxygen therapy (Part 1 and Part 2) - REBUILD
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A high resolution CT scan performed in the 6 months prior to screening associated with one of the following conditions and confirmed using guidelines, as per American Thoracic Society (ATS) / European Respiratory Society (ERS) / Japanese Respiratory Society (JRS) / Latin American Thoracic Association (ALAT):
- •Major IIPs (idiopathic interstitial pneumonias) diagnosis or suspected as one of the following:
- •Idiopathic pulmonary fibrosis
- •Idiopathic nonspecific interstitial pneumonia
- •Respiratory bronchiolitis-interstitial lung disease
- •Desquamative interstitial pneumonia
- •Cryptogenic organizing pneumonia
- •Acute interstitial pneumonia
- •Rare IIPs diagnosis by one of the following:
- •Idiopathic lymphoid interstitial pneumonia
- •Idiopathic pleuroparenchymal fibroelastosis
- •Unclassifiable idiopathic interstitial pneumonias
- •Chronic hypersensitivity pneumonitis
- •Occupational lung disease
- •Connective Tissue Disease associated with IPF (CTD-ILD)
- •Interstitial Pneumonia with Autoimmune Features (IPAF)
- •Have been using oxygen therapy by nasal cannula for at least 4 weeks (including use limited to exertion)
- •6MWD ≥ 100 meters and ≤ 400 meters at screening and Baseline/Randomization visits.
- •World Health Organization (WHO) Functional Class II-IV
- •Forced Vital Capacity ≥ 40% predicted within the 60 day Screening period
- •Age between 18 and 80 years (inclusive) at screening
排除标准
- •For women of child-bearing potential: Pregnant or breastfeeding females at Screening, or planning to get pregnant, or unwilling to use appropriate contraception if sexually active to avoid pregnancy during the study and for at least 30 days after discontinuation of the study drug.
- •Heart failure with reduced ejection fraction (HFrEF; systolic heart failure) with an ejection fraction of < 40%; or severe HF with preserved EF (HFpEF; diastolic HF)
- •History of sarcoidosis
- •History of chronic thrombo-embolic pulmonary hypertension (CTEPH; WHO group 4 PH)
- •Smoking within 3 months of Screening and/or unwilling to avoid smoking throughout the study
- •Body mass index (BMI) >40 kg/m2 at screening
- •Intermittent uncontrolled atrial fibrillation, in the opinion of the Principal Investigator
- •Known severe hepatic impairment, in the opinion of the Principal Investigator
- •Known severe renal impairment (Chronic Kidney Disease Epidemiology Collaboration (CKDEPI) 2009 equation [Levy 2009] calculated creatinine clearance <30 ml/min) at screening
结局指标
主要结局
Change in Moderate to Vigorous Physical Activity (MVPA) as Measured by Actigraphy
时间窗: Baseline to Month 4
Part 1 - Blinded Treatment Period
Adverse Events and Serious Adverse Events with Long Term INOpulse Therapy
时间窗: Baseline to Month 4
Part 2 - Open Label Extension (OLE)
次要结局
- Time to Clinical Worsening(Baseline to Month 4)
- Change in St. George Respiratory Questionnaire (SGRQ) - Activity, Impacts & Total(Baseline to Month 4)
- Time to Clinical Deterioration(Baseline to Month 4)
- Change in Overall Activity as Measured by Actigraphy(Baseline to M4)
- Time to Clinical Improvement(Baseline to Month 4)
- Change in University of California San Diego (UCSD) Shortness of Breath Questionnaire (SOBQ)(Baseline to Month 4)
- Change in 6 Minute Walk Distance(Baseline to Month 4)
研究者
研究点 (125)
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