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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.
 
ClinicalTrials.gov Identifier: NCT04161014
Recruitment Status : Not yet recruiting
First Posted : November 13, 2019
Last Update Posted : November 13, 2019
Sponsor:
Collaborator:
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
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
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : February 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



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

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 ClinicalTrials.gov identifier (NCT number): NCT04161014


Contacts
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Contact: Trina Vincent, RN 0280381044 trina.vincent@holdsworthhouse.com.au
Contact: Deborah Yates, A/Prof 02 93317228 deborah.yates@holdsworthhouse.com.au

Locations
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Australia, New South Wales
Holdsworth House Medical Practice
Sydney, New South Wales, Australia, 2010
Contact: Trina Vincent, RN    0280381044    trina.vincent@holdsworthhouse.com.au   
Sponsors and Collaborators
Holdsworth House Medical Practice
Boehringer Ingelheim
Investigators
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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
ClinicalTrials.gov Identifier: NCT04161014    
Other Study ID Numbers: NiPPs
First Posted: November 13, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
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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Silicosis
Pneumoconiosis
Asbestosis
Anthracosis
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Lung Injury
Occupational Diseases
Nintedanib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action