The SHIELD Whole Lung Lavage Study (NCT05402176) | Clinical Trial Compass
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The SHIELD Whole Lung Lavage Study
Australia30 participantsStarted 2022-06
Plain-language summary
An observational cohort study that will assess the efficacy of Whole Lung Lavage in workers with silicosis or silica-induced bronchitis.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ot…
What they're measuring
1
The primary outcome for evaluating WLL will be change in dual blind read CT ICOERD score from baseline to 3 months post WLL.