The Nintedanib in Progressive Pneumoconiosis Study (NiPPS): a Collaborative NSW Treatment Trial (NCT04161014) | Clinical Trial Compass
UnknownPhase 2
The Nintedanib in Progressive Pneumoconiosis Study (NiPPS): a Collaborative NSW Treatment Trial
Australia100 participantsStarted 2020-10-09
Plain-language summary
Prospective clinical pilot study for subjects diagnosed with Occupational Progressive Pneumoconiosis.
Subjects will be treated with Nintedanib 150mg twice daily for 3 years.
Who can participate
Age range18 Years
SexALL
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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)