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

Silicosis Clinical Trial

— NiPPs  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04161014
• Other study ID #: NiPPs
• Status: Recruiting
• Phase: Phase 2
• Start date: October 9, 2020
• Est. completion date: February 2025

Study information

• Verified date: February 2021
• Source: Holdsworth House Medical Practice
• Contact: Trina Vincent, RN
• Phone: 0280381044
• Email: trina.vincent[@]holdsworthhouse.com.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Asbestosis
• Pneumoconiosis
• Pneumoconiosis Coal
• Silicosis

Intervention

Drug:
• Nintedanib 150 MG [Ofev]
Nintedanib 150mg twice daily for 3 years

Locations

Country	Name	City	State
Australia	Holdsworth House Medical Practice	Sydney	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
Holdsworth House Medical Practice	Boehringer Ingelheim

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	annual decline in FVC	measured in millilitres per year, calculated from serial measurements	36 months
Secondary	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
Secondary	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
Secondary	Time to referral for Lung transplantation	Respiratory deterioration which necessitates a referral for lung transplant	36 months
Secondary	Time to death	Respiratory deterioration leading to death	12, 24 and 36 months