The Nintedanib in Progressive Pneumoconiosis Study (NiPPS): a Collaborative NSW Treatment Trial
NiPPs
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2020
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2019
CompletedFirst Posted
Study publicly available on registry
November 13, 2019
CompletedStudy Start
First participant enrolled
October 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2025
CompletedFebruary 10, 2021
February 1, 2021
4.1 years
November 7, 2019
February 8, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
annual decline in FVC
measured in millilitres per year, calculated from serial measurements
36 months
Secondary Outcomes (4)
K-BILD score
week 52
Time to acute exacerbation
36 months
Time to referral for Lung transplantation
36 months
Time to death
12, 24 and 36 months
Study Arms (1)
Treatment Arm
OTHERNintedanib 150mg twice daily for 3 years
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Holdsworth House Medical Practicelead
- Boehringer Ingelheimcollaborator
Study Sites (1)
Holdsworth House Medical Practice
Sydney, New South Wales, 2010, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Deborah Yates, A/Prof
Holdsworth House Medical Practice
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor Deborah Yates
Study Record Dates
First Submitted
November 7, 2019
First Posted
November 13, 2019
Study Start
October 9, 2020
Primary Completion
December 1, 2024
Study Completion
February 1, 2025
Last Updated
February 10, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share