The Nintedanib in Progressive Pneumoconiosis Study (NiPPS): a Collaborative NSW Treatment Trial

• Status: Recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Prospective clinical pilot study for subjects diagnosed with Occupational Progressive Pneumoconiosis.

Subjects will be treated with Nintedanib 150mg twice daily for 3 years.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Holdsworth House Medical Practice
• Collaborator: Boehringer Ingelheim
• Treatments: Nintedanib

Criteria

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)