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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04161014
Ethics application status
Date submitted
7/11/2019
Date registered
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
Timepoint [1] 0 0
36 months
Secondary outcome [1] 0 0
K-BILD score
Timepoint [1] 0 0
week 52
Secondary outcome [2] 0 0
Time to acute exacerbation
Timepoint [2] 0 0
36 months
Secondary outcome [3] 0 0
Time to referral for Lung transplantation
Timepoint [3] 0 0
36 months
Secondary outcome [4] 0 0
Time 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
Sex
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
Other
Allocation to intervention
Not applicable
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2025
Actual
Sample size
Target
100
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04161014