The Nintedanib in Progressive Pneumoconiosis Study (NiPPS): a Collaborative NSW Treatment Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- annual decline in FVC
研究概览
简要总结
Prospective clinical pilot study for subjects diagnosed with Occupational Progressive Pneumoconiosis.
Subjects will be treated with Nintedanib 150mg twice daily for 3 years.
详细描述
100 Patients with asbestosis, silicosis, coal workers pneumoconiosis and diffuse dust fibrosis will be included. Patients will have an FVC ≥45% predicted (no upper threshold), and a diffusion capacity of the lung for carbon monoxide (TLCO) above 30% predicted. Patients will be randomised to receive Nintedanib 150 mg twice daily, with the dose of the study drug reduced to 100 mg twice daily or interrupted temporarily in the case of adverse events (AEs).The primary end point will be the annual decline in FVC, measured in millilitres per year, calculated from serial measurements over 36 months.
Lung function testing will be performed at baseline; 2, 4, 6, 12, 18, 24, 30, 36, 44 and 52 weeks, and every 4 months thereafter until study cessation or withdrawal at a maximum of 36 months.
In patients who show clinical benefit as per the end points specified access to Nintedanib treatment will be continued.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Pneumoconiosis diagnosis confirmed at the Occupational MDT (Occ-MDT)
- •diffuse fibrosing lung disease of extent >10% on HRCT with protocol criteria for progression
- •Asbestosis, silicosis, coal worker's pneumoconiosis and diffuse dust fibrosis
- •FVC ≥45% predicted and TLCO above 30% predicted
排除标准
- •idiopathic pulmonary fibrosis (IPF) and non-occupational progressive pulmonary fibrosis
- •ILD due to connective tissues disorders, hypersensitivity pneumonitis, non-occupational interstitial pneumonia, non-occupational sarcoidosis
- •contraindications to Nintedanib (forthcoming surgery, use of anticoagulants, high CVD risk, liver function abnormalities)
研究组 & 干预措施
Treatment Arm
Nintedanib 150mg twice daily for 3 years
干预措施: Nintedanib 150 MG [Ofev] (Drug)
结局指标
主要结局
annual decline in FVC
时间窗: 36 months
measured in millilitres per year, calculated from serial measurements
次要结局
- K-BILD score(week 52)
- Time to acute exacerbation(36 months)
- Time to referral for Lung transplantation(36 months)
- Time to death(12, 24 and 36 months)
研究者
Deborah Yates
Associate Professor Deborah Yates
Holdsworth House Medical Practice