Silicosis - Harnessing New Ideas to Conquer the Re-emergence of an Ancient Lung Disease: The SHIELD Whole Lung Lavage Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- The primary outcome for evaluating WLL will be change in dual blind read CT ICOERD score from baseline to 3 months post WLL.
研究概览
简要总结
An observational cohort study that will assess the efficacy of Whole Lung Lavage in workers with silicosis or silica-induced bronchitis.
详细描述
BACKGROUND: Silicosis is a fatal lung disease caused by inhaling silica particles. Australia is currently facing an epidemic with hundreds of young workers having contracted silicosis from machining engineered stone.
AIMS: To determine the effectiveness and safety of Whole Lung Lavage (WLL) in workers with silicosis due to significant engineered stone exposure.
DESIGN: Participants (30) with silicosis or silica-induced bronchitis who are scheduled to undergo WLL as part of their normal care will be enrolled. They will undergo the following interventions pre and 3 months post WLL, some of which would have been carried out as part of routine standard care:
- Complex pulmonary function tests (PFTs) - standard care
- HRCT scan (if not within 6 months of WLL) - standard care
- Blood tests
- Cardiopulmonary exercise testing
- Forced oscillatory technique
- XV Lung Ventilation Analysis
- Questionnaires (K-BILD and LCQ)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Males and females aged >=18 years and scheduled for WLL at the study site as part of routine clinical care
- •History of exposure to respirable crystalline silica (RCS) while working in an at-risk industry (e.g. stonemasonry, construction, tunnelling, concreting, mining)
- •Elimination of workplace exposure to RCS for a minimum of 6 months
- •Ground glass nodularity > extent of solid nodularity on HRCT, as judged by investigator or evidence of silica-induced bronchitis
- •Evidence of disease progression within the past 2 years, defined as any of
- •a relative decline in the FVC or FEV1 of at least 5% of the predicted value,
- •worsening of respiratory symptoms
- •increased extent of silicosis on high-resolution CT scan
- •Able to understand and sign a written informed consent form (or legally authorised representative)
排除标准
- •Ongoing workplace exposure to RCS or removal of workplace exposure of less than 6 months
- •Progressive massive fibrosis, defined as areas of confluent fibrosis with diameter > 10mm on HRCT.
- •FEV1 or FVC < 50% predicted
- •DLCO <50% predicted
- •Contraindication to WLL, as judged by the investigator
- •Actively or imminently listed for lung transplantation
- •Females with a positive pregnancy test at screening or currently breastfeeding
- •Any history of malignancy likely to result in significant disability or likely to require significant medical or surgical intervention within the next 24 months
- •Any condition other than silicosis that, in the opinion of the investigator, is likely to result in the death of the participant within the next 24 months
- •Significantly impaired cardiac function
结局指标
主要结局
The primary outcome for evaluating WLL will be change in dual blind read CT ICOERD score from baseline to 3 months post WLL.
时间窗: 3 months
Change in absolute dual-read CT ICOERD score at 3 months post-WLL. Data collected will be evaluated by a central reader blinded to treatment assignment. Baseline characteristics will be summarised for each group. Differences between group mean changes in CT ICOERD scores from baseline to 3 months will be tested using an independent sample t-test.
次要结局
未报告次要终点