The SHIELD Whole Lung Lavage Study

Study Overview
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Brief Summary
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An observational cohort study that will assess the efficacy of Whole Lung Lavage in workers with silicosis or silica-induced bronchitis.

Detailed Description
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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)

Official Title
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Silicosis - Harnessing New Ideas to Conquer the Re-emergence of an Ancient Lung Disease: The SHIELD Whole Lung Lavage Study

Conditions
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Silicosis

Intervention / Treatment
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* Other: Whole Lung Lavage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Whole Lung Lavage|Whole Lung Lavage (WLL) is performed as standard of care. Outcome following WLL is observed.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome for evaluating WLL will be change in dual blind read CT ICOERD score from baseline to 3 months post WLL. | 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. | 3 months |