The SHIELD Whole Lung Lavage Study

Silicosis Clinical Trial

— SHIELD  

Official title:

Silicosis - Harnessing New Ideas to Conquer the Re-emergence of an Ancient Lung Disease: The SHIELD Whole Lung Lavage Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05402176
• Other study ID #: SHIELD WLL
• Status: Not yet recruiting
• Start date: June 2022
• Est. completion date: December 2024

Study information

• Verified date: May 2022
• Source: The University of Queensland
• Contact: Daniel Chambers
• Phone: (07) 3646 7498
• Email: daniel.chambers[@]health.qld.gov.au
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Silicosis

Intervention

Other:
• Whole Lung Lavage
Whole Lung Lavage (WLL) is performed as standard of care. Outcome following WLL is observed.

Locations

Country	Name	City	State
Australia	The Prince Charles Hospital	Brisbane	Queensland
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	The Austin Hospital	Melbourne	Victoria
Australia	The Royal Prince Alfred Hospital	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
The University of Queensland

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome for evaluating WLL will be change in dual blind read CT ICOERD score from baseline to 3 months post WLL.	Change in absolute dual-read CT ICOERD score at 3 months post-WLL. Data collected will be evaluated by a central reader blinded to treatment assignment. Baseline characteristics will be summarised for each group. Differences between group mean changes in CT ICOERD scores from baseline to 3 months will be tested using an independent sample t-test.	3 months