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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04161014




Registration number
NCT04161014
Ethics application status
Date submitted
7/11/2019
Date registered
13/11/2019
Date last updated
13/11/2019

Titles & IDs
Public title
The Nintedanib in Progressive Pneumoconiosis Study (NiPPS): a Collaborative NSW Treatment Trial
Scientific title
The Nintedanib in Progressive Pneumoconiosis Study (NiPPS): a Collaborative NSW Treatment Trial
Secondary ID [1] 0 0
NiPPs
Universal Trial Number (UTN)
Trial acronym
NiPPs
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pneumoconiosis Coal 0 0
Asbestosis 0 0
Silicosis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Nintedanib 150 MG [Ofev]

Other: Treatment Arm - Nintedanib 150mg twice daily for 3 years


Treatment: Drugs: Nintedanib 150 MG [Ofev]
Nintedanib 150mg twice daily for 3 years

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
annual decline in FVC - measured in millilitres per year, calculated from serial measurements
Timepoint [1] 0 0
36 months
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
week 52
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
36 months
Secondary outcome [3] 0 0
Time to referral for Lung transplantation - Respiratory deterioration which necessitates a referral for lung transplant
Timepoint [3] 0 0
36 months
Secondary outcome [4] 0 0
Time to death - Respiratory deterioration leading to death
Timepoint [4] 0 0
12, 24 and 36 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Supportive Care
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Holdsworth House Medical Practice - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Holdsworth House Medical Practice
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Boehringer Ingelheim
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT04161014
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Deborah Yates, A/Prof
Address 0 0
Holdsworth House Medical Practice
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trina Vincent, RN
Address 0 0
Country 0 0
Phone 0 0
0280381044
Fax 0 0
Email 0 0
trina.vincent@holdsworthhouse.com.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04161014