Silicosis Clinical Trial
— NiPPsOfficial 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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | February 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Pneumoconiosis diagnosis confirmed at the Occupational MDT (Occ-MDT) - diffuse fibrosing lung disease of extent >10% on HRCT with protocol criteria for progression - Asbestosis, silicosis, coal worker's pneumoconiosis and diffuse dust fibrosis - FVC =45% predicted and TLCO above 30% predicted Exclusion Criteria: - idiopathic pulmonary fibrosis (IPF) and non-occupational progressive pulmonary fibrosis - ILD due to connective tissues disorders, hypersensitivity pneumonitis, non-occupational interstitial pneumonia, non-occupational sarcoidosis - contraindications to Nintedanib (forthcoming surgery, use of anticoagulants, high CVD risk, liver function abnormalities) |
Country | Name | City | State |
---|---|---|---|
Australia | Holdsworth House Medical Practice | Sydney | New South Wales |
Lead Sponsor | Collaborator |
---|---|
Holdsworth House Medical Practice | Boehringer Ingelheim |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | annual decline in FVC | measured in millilitres per year, calculated from serial measurements | 36 months | |
Secondary | K-BILD score | Absolute change from baseline in King's Brief Interstitial Lung Disease Questionnaire (K-BILD) total score. The KBILD domain and total score ranges are 0-100; 100 represents best health status | week 52 | |
Secondary | Time to acute exacerbation | an acute, clinically significant respiratory deterioration characterized by evidence of new, widespread alveolar abnormality, including unexplained worsening or development of dyspnea,new diffuse pulmonary infiltrates visualized on chest radiography, HRCT, or both, or the development of parenchymal abnormalities with no pneumothorax or pleural effusion (new ground-glass opacities) since the preceding visit; and exclusion of any known causes of acute worsening, including infection, left heart failure, pulmonary embolism, and any identifiable cause of acute lung injury, in accordance with routine clinical practice and microbiologic studies. | 36 months | |
Secondary | Time to referral for Lung transplantation | Respiratory deterioration which necessitates a referral for lung transplant | 36 months | |
Secondary | Time to death | Respiratory deterioration leading to death | 12, 24 and 36 months |
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