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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04161014
Recruitment Status : Recruiting
First Posted : November 13, 2019
Last Update Posted : February 10, 2021
Boehringer Ingelheim
Information provided by (Responsible Party):
Deborah Yates, Holdsworth House Medical Practice

Brief Summary:

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

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

Condition or disease Intervention/treatment Phase
Pneumoconiosis Coal Asbestosis Silicosis Drug: Nintedanib 150 MG [Ofev] Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective clinical pilot study
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Nintedanib in Progressive Pneumoconiosis Study (NiPPS): a Collaborative NSW Treatment Trial
Actual Study Start Date : October 9, 2020
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : February 2025

Arm Intervention/treatment
Treatment Arm
Nintedanib 150mg twice daily for 3 years
Drug: Nintedanib 150 MG [Ofev]
Nintedanib 150mg twice daily for 3 years

Primary Outcome Measures :
  1. annual decline in FVC [ Time Frame: 36 months ]
    measured in millilitres per year, calculated from serial measurements

Secondary Outcome Measures :
  1. K-BILD score [ Time Frame: week 52 ]
    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

  2. Time to acute exacerbation [ Time Frame: 36 months ]
    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.

  3. Time to referral for Lung transplantation [ Time Frame: 36 months ]
    Respiratory deterioration which necessitates a referral for lung transplant

  4. Time to death [ Time Frame: 12, 24 and 36 months ]
    Respiratory deterioration leading to death

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04161014

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Contact: Trina Vincent, RN 0280381044
Contact: Deborah Yates, A/Prof 02 93317228

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Australia, New South Wales
Holdsworth House Medical Practice Recruiting
Sydney, New South Wales, Australia, 2010
Contact: Trina Vincent, RN    0280381044   
Sponsors and Collaborators
Holdsworth House Medical Practice
Boehringer Ingelheim
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Principal Investigator: Deborah Yates, A/Prof Holdsworth House Medical Practice
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Responsible Party: Deborah Yates, Associate Professor Deborah Yates, Holdsworth House Medical Practice Identifier: NCT04161014    
Other Study ID Numbers: NiPPs
First Posted: November 13, 2019    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Lung Injury
Occupational Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action