The SHIELD Whole Lung Lavage Study

NCT05402176 | Unknown

• 1 other identifier: SHIELD WLL
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Silicosis

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Whole Lung Lavage OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Respirable crystalline silica (RCS) exposed workers with silicosis or silica induced bronchitis.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Queensland: lead

Study Sites (4)

The Royal Prince Alfred Hospital

Sydney, New South Wales, Australia

Location

The Prince Charles Hospital

Brisbane, Queensland, Australia

Location

The Alfred Hospital

Melbourne, Victoria, Australia

Location

The Austin Hospital

Melbourne, Victoria, Australia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biomarkers (blood ACE and ferritin) and WLL effluent.

MeSH Terms

Conditions

Silicosis

Condition Hierarchy (Ancestors)

Pneumoconiosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Lung Injury; Occupational Diseases

Study Officials

• Daniel Chambers

  The Prince Charles Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel Chambers

CONTACT

(07) 3646 7498; daniel.chambers@health.qld.gov.au

Vidya Vidya

CONTACT

(07) 3139 4000; Vidya.Navaratnam@health.qld.gov.au

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: June 2, 2022
• Study Start: June 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: June 2, 2022

Record last verified: 2022-05

Locations

AU (4)