Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04161014
Other study ID # NiPPs
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT01338064 - Oxidative Stress Biomarkers to Monitor and Early Detect Health Impairment in Workers Exposed to Silica (Caesar Stone) N/A
Not yet recruiting NCT01329003 - DNA-damage Pathways in Workers Exposed to Silica (Caesar Stone) N/A
Recruiting NCT05118256 - Pirfenidone for the Reduction of Metabolic, Inflammatory and Fibrogenic Activity in Complicated Silicosis Phase 2
Completed NCT02430259 - Efficacy of Weekly Rifapentine and Isoniazid for Tuberculosis Prevention Phase 3
Recruiting NCT06403800 - Silicosis and Silicotuberculosis Among Small Scale Gemstone Miners in Northern Tanzania
Not yet recruiting NCT06011785 - Using Silica 12CH to Mitigate the Effects and Symptoms of Silicosis in Brazil Early Phase 1
Not yet recruiting NCT05402176 - The SHIELD Whole Lung Lavage Study
Completed NCT02794701 - Comprehensive Risk Assessment of People With Silicosis: A Population-based Study
Completed NCT01977131 - Safety Study of Autologous Bone Marrow Stromal Cells With Modification by Hepatocyte Growth Factor to Treat Silicosis Phase 1/Phase 2
Completed NCT00005280 - Specialized Center of Research in Occupational and Immunologic Lung Disease N/A
Recruiting NCT05538299 - Silicosis Treatment, Action, Screening and Surveillance in Rwanda Trials
Completed NCT01725971 - Oscillation Mechanics of the Respiratory System in Never-smoking Patients With Silicosis N/A
Recruiting NCT06090370 - Reducing Silica Exposure Among Brick Kiln Workers in Nepal N/A
Completed NCT04205708 - Screening Strategy for Early Diagnosis of Silicosis in At-Risk Populations in Oklahoma
Recruiting NCT05546944 - The SHIELD Study-silicosis