The SHIELD Whole Lung Lavage Study
- Conditions
- Silicosis
- Registration Number
- NCT05402176
- Lead Sponsor
- The University of Queensland
- Brief Summary
An observational cohort study that will assess the efficacy of Whole Lung Lavage in workers with silicosis or silica-induced bronchitis.
- Detailed Description
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:
1. Complex pulmonary function tests (PFTs) - standard care
2. HRCT scan (if not within 6 months of WLL) - standard care
3. Blood tests
4. Cardiopulmonary exercise testing
5. Forced oscillatory technique
6. XV Lung Ventilation Analysis
7. Questionnaires (K-BILD and LCQ)
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 30
-
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)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome for evaluating WLL will be change in dual blind read CT ICOERD score from baseline to 3 months post WLL. 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
The Royal Prince Alfred Hospital
🇦🇺Sydney, New South Wales, Australia
The Prince Charles Hospital
🇦🇺Brisbane, Queensland, Australia
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
The Austin Hospital
🇦🇺Melbourne, Victoria, Australia