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

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

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

Study Overview

• Status: Recruiting
• Conditions: Silicosis; Pneumoconiosis Coal; Asbestosis
• Intervention / Treatment: Drug: Nintedanib 150 MG [Ofev]

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Trina Vincent, RN; Phone Number: 0280381044; Email: trina.vincent@holdsworthhouse.com.au
• Study Contact Backup: Name: Deborah Yates, A/Prof; Phone Number: 02 93317228; Email: deborah.yates@holdsworthhouse.com.au

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2010
      • Recruiting
      • Holdsworth House Medical Practice
      • Contact: Trina Vincent, RN; Phone Number: 0280381044; Email: trina.vincent@holdsworthhouse.com.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Treatment Arm; Nintedanib 150mg twice daily for 3 years	Drug: Nintedanib 150 MG [Ofev]; Nintedanib 150mg twice daily for 3 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
annual decline in FVC	measured in millilitres per year, calculated from serial measurements	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
K-BILD score	Absolute change from baseline in King's Brief Interstitial Lung Disease Questionnaire (K-BILD) total score. The KBILD domain and total score ranges are 0-100; 100 represents best health status	week 52
Time to acute exacerbation	an acute, clinically significant respiratory deterioration characterized by evidence of new, widespread alveolar abnormality, including unexplained worsening or development of dyspnea,new diffuse pulmonary infiltrates visualized on chest radiography, HRCT, or both, or the development of parenchymal abnormalities with no pneumothorax or pleural effusion (new ground-glass opacities) since the preceding visit; and exclusion of any known causes of acute worsening, including infection, left heart failure, pulmonary embolism, and any identifiable cause of acute lung injury, in accordance with routine clinical practice and microbiologic studies.	36 months
Time to referral for Lung transplantation	Respiratory deterioration which necessitates a referral for lung transplant	36 months
Time to death	Respiratory deterioration leading to death	12, 24 and 36 months

Collaborators and Investigators

• Sponsor: Holdsworth House Medical Practice
• Collaborators: Boehringer Ingelheim
• Investigators: Principal Investigator: Deborah Yates, A/Prof, Holdsworth House Medical Practice

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2020
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): February 1, 2025

Study Registration Dates

• First Submitted: November 7, 2019
• First Submitted That Met QC Criteria: November 10, 2019
• First Posted (Actual): November 13, 2019

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Occupational Diseases; Lung Diseases, Interstitial; Lung Injury; Silicosis; Pneumoconiosis; Asbestosis; Anthracosis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Nintedanib
• Other Study ID Numbers: NiPPs

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No