About The Study
Disease target: Silicosis and silica-induced bronchitis
Recruitment target: 30 participants
Duration: 3 years
Study Locations
QLD
- The Prince Charles Hospital
VIC
- The Alfred Hospital
NSW
- Royal Prince Alfred Hospital
What is involved?
This study is for people who have silicosis and are scheduled to undergo a whole lung lavage (WLL) as part of their care. Silicosis is a scarring condition of the lungs caused by inhaling silica dust and is difficult to treat. The research project is aiming to understand the effectiveness of whole lung lavage (WLL) as a treatment option for silicosis.
Investigational medicinal product, comparator and randomisation
- Whole lung lavage
Can I participate?
Inclusion Criteria
- Adults >= 18 years who are scheduled for WLL as part of their routine clinical care
- History of exposure to respirable crystalline silica (RCS) while working in at at-risk industry
- 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 in the past two years, defined as any of:
– A relative delice in FVC or FEV1 of at least 5% of the predicted value
– Worsening of respiratory symptoms
– Increased extent of silicosis on high resolution CT scan
Exclusion Criteria
- Ongoing workplace exposure to RCS or removal of workplace exposure of less than 6 months
- Progressive massive fibrosis (PMF) 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 transplantations
- Females with positive pregnancy test at screening or currently breastfeeding
- Significantly impaired cardiac function
- 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 history of malignancy likely to result in significant disability or likely to require significant medical or surgical intervention within the next 24 months
- SHIELD Trial Summary SHIELD-PACT-Trial-Summary.pdf
Further information or how to participate
If you would like to take part or have any questions about this research study, please fill out our Patient Trial Enquiry Form or email enquiries@pactnetwork.com.au.
This study is sponsored by the University of Queensland.
Clinicaltrials.gov ID: NCT05402176