NCT04161014

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Holdsworth House Medical Practice · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective clinical pilot study for subjects diagnosed with Occupational Progressive Pneumoconiosis. Subjects will be treated with Nintedanib 150mg twice daily for 3 years.

Detailed description

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.

Conditions

• Pneumoconiosis Coal
• Asbestosis
• Silicosis

Interventions

Type	Name	Description
DRUG	Nintedanib 150 MG [Ofev]	Nintedanib 150mg twice daily for 3 years

Timeline

• Start date: 2020-10-09
• Primary completion: 2024-12-01
• Completion: 2025-02-01
• First posted: 2019-11-13
• Last updated: 2021-02-10

Locations

1 site across 1 country: Australia