Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05402176
Other study ID # SHIELD WLL
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT01329003 - DNA-damage Pathways in Workers Exposed to Silica (Caesar Stone) N/A
Not yet recruiting NCT01338064 - Oxidative Stress Biomarkers to Monitor and Early Detect Health Impairment in Workers Exposed to Silica (Caesar Stone) N/A
Recruiting NCT04161014 - The Nintedanib in Progressive Pneumoconiosis Study (NiPPS): a Collaborative NSW Treatment Trial Phase 2
Recruiting NCT05118256 - Pirfenidone for the Reduction of Metabolic, Inflammatory and Fibrogenic Activity in Complicated Silicosis Phase 2
Completed NCT02430259 - Efficacy of Weekly Rifapentine and Isoniazid for Tuberculosis Prevention Phase 3
Recruiting NCT06403800 - Silicosis and Silicotuberculosis Among Small Scale Gemstone Miners in Northern Tanzania
Not yet recruiting NCT06011785 - Using Silica 12CH to Mitigate the Effects and Symptoms of Silicosis in Brazil Early Phase 1
Completed NCT02794701 - Comprehensive Risk Assessment of People With Silicosis: A Population-based Study
Completed NCT01977131 - Safety Study of Autologous Bone Marrow Stromal Cells With Modification by Hepatocyte Growth Factor to Treat Silicosis Phase 1/Phase 2
Completed NCT00005280 - Specialized Center of Research in Occupational and Immunologic Lung Disease N/A
Recruiting NCT05538299 - Silicosis Treatment, Action, Screening and Surveillance in Rwanda Trials
Completed NCT01725971 - Oscillation Mechanics of the Respiratory System in Never-smoking Patients With Silicosis N/A
Recruiting NCT06090370 - Reducing Silica Exposure Among Brick Kiln Workers in Nepal N/A
Completed NCT04205708 - Screening Strategy for Early Diagnosis of Silicosis in At-Risk Populations in Oklahoma
Recruiting NCT05546944 - The SHIELD Study-silicosis