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The SHIELD Whole Lung Lavage Study

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05402176
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	The University of Queensland
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Daniel Chambers
Principal Investigator Affiliation	The Prince Charles Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	Australia
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Silicosis

Additional Details

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)

Contact a Trial Team

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