The SHIELD Whole Lung Lavage Study (SHIELD)

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Silicosis
• Intervention / Treatment: Other: Whole Lung Lavage

Detailed 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)

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Vidya Vidya; Phone Number: (07) 3139 4000; Email: Vidya.Navaratnam@health.qld.gov.au

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia
      • The Royal Prince Alfred Hospital
  • Queensland
    • Brisbane, Queensland, Australia
      • The Prince Charles Hospital
  • Victoria
    • Melbourne, Victoria, Australia
      • The Alfred Hospital
    • Melbourne, Victoria, Australia
      • The Austin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The University of Queensland

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: May 23, 2022
• First Submitted That Met QC Criteria: June 1, 2022
• First Posted (Actual): June 2, 2022

Study Record Updates

• Last Update Posted (Actual): June 2, 2022
• Last Update Submitted That Met QC Criteria: June 1, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Occupational Diseases; Pneumoconiosis; Lung Diseases, Interstitial; Lung Injury; Silicosis
• Other Study ID Numbers: SHIELD WLL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No