Pneumoconiosis CoalPhase 2NiPPsNCT04161014
The Nintedanib in Progressive Pneumoconiosis Study (NiPPS): a Collaborative NSW Treatment Trial
A Phase 2 study testing Nintedanib 150 MG [Ofev] in people with Pneumoconiosis Coal and Asbestosis, run by Holdsworth House Medical Practice at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumoconiosis Coal, Asbestosis, Silicosis
- What is being tested?
- Nintedanib 150 MG [Ofev]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteAustralia
- Study dates
- 9 Oct 2020to Feb 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Holdsworth House Medical Practice
Sydney, New South Wales, 2010
Trina Vincent, RN, 0280381044, trina.vincent@holdsworthhouse.com.au
About this study
Prospective clinical pilot study for subjects diagnosed with Occupational Progressive Pneumoconiosis.
Subjects will be treated with Nintedanib 150mg twice daily for 3 years.
Read the detailed 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.
- Conditions
- Pneumoconiosis Coal, Asbestosis, Silicosis
- Being tested
- Nintedanib 150 MG [Ofev]
- Medical subject headings
- Anthracosis, Asbestosis, Silicosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nintedanib 150 MG [Ofev]Drug
Nintedanib 150mg twice daily for 3 years
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Other | Nintedanib 150mg twice daily for 3 years Receives: Drug: Nintedanib 150 MG [Ofev] |
What is being measured
The primary outcome is the main question the study is designed to answer.
annual decline in FVC
measured in millilitres per year, calculated from serial measurements
Measured: 36 months
Secondary outcomes (4)
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
Measured: week 52
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.
Measured: 36 months
Time to referral for Lung transplantation
Respiratory deterioration which necessitates a referral for lung transplant
Measured: 36 months
Time to death
Respiratory deterioration leading to death
Measured: 12, 24 and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start9 Oct 2020
- Primary completionDec 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumoconiosis CoalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective clinical pilot study
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Holdsworth House Medical Practice
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Principal investigator, Deborah Yates, Holdsworth House Medical Practice
- Investigators
- Deborah Yates, A/Prof, Principal investigator, Holdsworth House Medical Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161014
- Sponsor's protocol ID
- NiPPs
- Acronym
- NiPPs
- Status last verified
- Feb 2021
- First submitted
- 7 Nov 2019
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Nintedanib in Progressive Pneumoconiosis Study (NiPPS): a Collaborative NSW Treatment Trial
- ClinicalTrials.gov ID
- NCT04161014
- Acronym / sponsor ID
- NiPPs / NiPPs
- Conditions
- Pneumoconiosis Coal, Asbestosis, Silicosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Holdsworth House Medical PracticeUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- 9 Oct 2020 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 13 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective clinical pilot study for subjects diagnosed with Occupational Progressive Pneumoconiosis.
Subjects will be treated with Nintedanib 150mg twice daily for 3 years.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective clinical pilot study
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Other | Drug: Nintedanib 150 MG [Ofev]Nintedanib 150mg twice daily for 3 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nintedanib 150 MG [Ofev]Nintedanib 150mg twice daily for 3 years | Drug | Treatment Arm |
Primary outcome
annual decline in FVC
Time frame: 36 months
measured in millilitres per year, calculated from serial measurements
4 secondary outcomes
K-BILD score
Time frame: week 52
Time to acute exacerbation
Time frame: 36 months
Time to referral for Lung transplantation
Time frame: 36 months
Time to death
Time frame: 12, 24 and 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Yates, A/Prof principal investigator
Holdsworth House Medical Practice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nintedanib 150 MG [Ofev] in people with Pneumoconiosis Coal and Asbestosis, run by Holdsworth House Medical Practice at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Trina Vincent, RN (0280381044, trina.vincent@holdsworthhouse.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
annual decline in FVC (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.