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

  • STATUS
    Recruiting
  • End date
    Feb 19, 2025
  • participants needed
    100
  • sponsor
    Holdsworth House Medical Practice
Updated on 19 February 2021

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 IdentifierNCT04161014
SponsorHoldsworth House Medical Practice
Last Modified on19 February 2021

Eligibility

Yes No Not Sure

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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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