The Nintedanib in Progressive Pneumoconiosis Study (NiPPS): a Collaborative NSW Treatment Trial
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- STATUS
- Recruiting
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- End date
- Feb 19, 2025
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- participants needed
- 100
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- sponsor
- Holdsworth House Medical Practice
Summary
Prospective clinical pilot study for subjects diagnosed with Occupational Progressive Pneumoconiosis.
Subjects will be treated with Nintedanib 150mg twice daily for 3 years.
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.
Details
| Condition | Anthracosis, Asbestosis, Silicosis |
|---|---|
| Treatment | Nintedanib 150 MG [Ofev] |
| Clinical Study Identifier | NCT04161014 |
| Sponsor | Holdsworth House Medical Practice |
| Last Modified on | 19 February 2021 |
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