Silicosis Clinical Trial
Official title:
The Nintedanib in Progressive Pneumoconiosis Study (NiPPS): a Collaborative NSW Treatment Trial
Prospective clinical pilot study for subjects diagnosed with Occupational Progressive Pneumoconiosis. Subjects will be treated with Nintedanib 150mg twice daily for 3 years.
100 Patients with asbestosis, silicosis, coal workers pneumoconiosis and diffuse dust fibrosis will be included. Patients will have an FVC ≥45% predicted (no upper threshold), and a diffusion capacity of the lung for carbon monoxide (TLCO) above 30% predicted. Patients will be randomised to receive Nintedanib 150 mg twice daily, with the dose of the study drug reduced to 100 mg twice daily or interrupted temporarily in the case of adverse events (AEs).The primary end point will be the annual decline in FVC, measured in millilitres per year, calculated from serial measurements over 36 months. Lung function testing will be performed at baseline; 2, 4, 6, 12, 18, 24, 30, 36, 44 and 52 weeks, and every 4 months thereafter until study cessation or withdrawal at a maximum of 36 months. In patients who show clinical benefit as per the end points specified access to Nintedanib treatment will be continued. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT01338064 -
Oxidative Stress Biomarkers to Monitor and Early Detect Health Impairment in Workers Exposed to Silica (Caesar Stone)
|
N/A | |
| Not yet recruiting |
NCT01329003 -
DNA-damage Pathways in Workers Exposed to Silica (Caesar Stone)
|
N/A | |
| 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 | |
| Not yet recruiting |
NCT05402176 -
The SHIELD Whole Lung Lavage Study
|
||
| 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
|