The Nintedanib in Progressive Pneumoconiosis Study (NiPPS): a Collaborative NSW Treatment Trial (NiPPs)
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|ClinicalTrials.gov Identifier: NCT04161014|
Recruitment Status : Not yet recruiting
First Posted : November 13, 2019
Last Update Posted : November 13, 2019
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|
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 (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|
Nintedanib 150mg twice daily for 3 years
Drug: Nintedanib 150 MG [Ofev]
Nintedanib 150mg twice daily for 3 years
- annual decline in FVC [ Time Frame: 36 months ]measured in millilitres per year, calculated from serial measurements
- 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
- 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.
- Time to referral for Lung transplantation [ Time Frame: 36 months ]Respiratory deterioration which necessitates a referral for lung transplant
- Time to death [ Time Frame: 12, 24 and 36 months ]Respiratory deterioration leading to death
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
|Contact: Trina Vincent, RNfirstname.lastname@example.org|
|Contact: Deborah Yates, A/Prof||02 email@example.com|
|Australia, New South Wales|
|Holdsworth House Medical Practice|
|Sydney, New South Wales, Australia, 2010|
|Contact: Trina Vincent, RN 0280381044 firstname.lastname@example.org|
|Principal Investigator:||Deborah Yates, A/Prof||Holdsworth House Medical Practice|