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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-09

Study Completion Date

2025-02-28

Brief Summary

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

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

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Detailed Description

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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

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Pneumoconiosis Coal Asbestosis Silicosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective clinical pilot study

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Treatment Arm

Nintedanib 150mg twice daily for 3 years

Group Type OTHER

Nintedanib 150 MG [Ofev]

Intervention Type DRUG

Nintedanib 150mg twice daily for 3 years

Interventions

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Nintedanib 150 MG [Ofev]

Nintedanib 150mg twice daily for 3 years

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No