Status:
UNKNOWN
The SHIELD Whole Lung Lavage Study
Lead Sponsor:
The University of Queensland
Conditions:
Silicosis
Eligibility:
All Genders
18+ years
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 e...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05402176
Start Date
June 1 2022
End Date
December 1 2024
Last Update
June 2 2022
Active Locations (4)
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1
The Royal Prince Alfred Hospital
Sydney, New South Wales, Australia
2
The Prince Charles Hospital
Brisbane, Queensland, Australia
3
The Alfred Hospital
Melbourne, Victoria, Australia
4
The Austin Hospital
Melbourne, Victoria, Australia