The SHIELD Whole Lung Lavage Study

The University of Queensland

Status: Not yet enrolling

Conditions: Silicosis

Treatments: Other: Whole Lung Lavage

Study type: Observational

Funder types: Other

Identifiers

NCT05402176

SHIELD WLL

Details and patient eligibility

About

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

Full 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)

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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