NCT05747508Unknown2 期
A Randomized, Double-Blind, Placebo-Controlled Dose Escalation Clinical Study to Assess the Safety and Efficacy of Pulsed Inhaled Nitric Oxide (iNO) in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis on Long Term Oxygen Therapy (Part 1 and Part 2)
适应症
试验速览
- 阶段
- 2 期
- 发起方
- Bellerophon
- 入组人数
- 85
- 试验地点
- 46
- 主要终点
- Efficacy of escalating doses of iNO in patient's life participation as assessed in minutes per day of moderate to vigorous activity.
研究概览
简要总结
A randomized, double-blind, placebo-controlled dose escalation study to assess the safety and efficacy of pulsed, inhaled nitric oxide (iNO) in subjects with pulmonary fibrosis on long term oxygen therapy.
详细描述
A Phase 2b, randomized, double-blind, placebo-controlled dose escalation clinical study to assess the safety and efficacy of pulsed, inhaled nitric oxide in subjects with and without pulmonary hypertension associated with pulmonary fibrosis on long term oxygen therapy (Part 1 and Part 2)
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with pulmonary fibrosis by high resolution CT scan performed in the 6 months prior to screening associated with one of the following conditions and confirmed using one of the following guidelines, as per American Thoracic Society (AGS) / European Respiratory Society (ERS) / Japanese Respiratory Society (JRS) / Latin American Thoracic Association (ALAT):
- •Major idiopathic interstitial pneumonias (IIPs) 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
- •Have been using oxygen therapy by nasal cannula for at least 4 weeks
- •6-Minute Walk Distance (6MWD) ≥ 100 meters and ≤ 450 meters at screening and Baseline/Randomization visits
- •World Health Organization (WHO) Functional Class II-IV
- •Forced Vital Capacity ≥ 40% predicated within the last 6 months prior to the screening run-in period
- •Age between 18 and 85 years (inclusive)
排除标准
- •Pregnant or breastfeeding females at Screening
- •In the last 6 months prior to screening, evidence of any connective tissue disease with FVC > 60% unless there is evidence of moderate to severe fibrosis on CT scan in the opinion of the local radiologist/Investigator
结局指标
主要结局
Efficacy of escalating doses of iNO in patient's life participation as assessed in minutes per day of moderate to vigorous activity.
时间窗: Change from baseline to week 8 or 16
Part 1 - Blinded Treatment Period
次要结局
未报告次要终点
研究者
研究点 (46)
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