Idiopathic Pulmonary FibrosisNCT04614441
NICEFIT-ON: A Study Under Routine Clinical Practice in Taiwan to Observe the Long-term Outcome of People With Certain Types of Lung Disease (PF-ILD, SSc-ILD, IPF) Who Start Treatment With Nintedanib
An observational study of Idiopathic Pulmonary Fibrosis, run by Boehringer Ingelheim at 26 sites in Taiwan.
Trial summary
To better understand the clinical characteristics of Idiopathic Pulmonary Fibrosis (IPF) / Systemic Sclerosis-associated-Interstitial Lung Disease (SSc-ILD)/ Progressive Fibrosing Interstitial Lung Disease (PF-ILD) patients treated with nintedanib and biomarkers associated with the disease course, a… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- OFEV®
- How many people
- 214 participants
- Where
- 26 sitesTaiwan
- Study dates
- 21 Jan 2021to 14 May 2025
- Phase
- Observational
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study plans to enroll approximately 500 patients with Idiopathic Pulmonary Fibrosis (IPF) / Systemic Sclerosis-associated-Interstitial Lung Disease (SSc-ILD)/ Progressive Fibrosing Interstitial Lung Disease (PF-ILD) who newly initiate nintedanib per physicians' discretion within 6 months before participating in the study.
Who may be able to join
- This study plans to enroll approximately 500 patients with IPF/SSc-ILD/PF-ILD who newly initiate nintedanib per physicians' discretion within 6 months before participating in the study.
- IPF cohort:
- Diagnosed with IPF during the prior 6 months before study enrollment, based on the 2018 ATS/ERS/JRS/ALAT guideline
- Patient ≥ 40 years of age
- Newly initiating nintedanib within 6 months prior to participating in the study
- Providing written informed consent prior to participating in the study
Show all 23Show fewer
- Having further follow-up possibility with participating physician during the planned study period
- Ability to read and write in local language
- SSc-ILD cohort:
- Diagnosed with SSc-ILD during the prior 6 months before study enrollment, based on 2013 ACR/EULAR
- Patient ≥ 20 years of age
- Newly initiating nintedanib OR not receiving nintedanib per physician's discretion (For patients who diagnosed with SSc-ILD but are not treated with nintedanib on physician's discretion, they will apply the same inclusion criteria, with baseline characteristics collected only) within 6 months prior to participating in the study
- Providing written informed consent prior to participating in the study
- Having further follow-up possibility with participating physician during the planned study period
- Ability to read and write in local language
- PF-ILD cohort:
- Diagnosed with PF-ILD (PF-ILD patients will be enrolled only after nintedanib acquires the label approval from TFDA) during the prior 6 months before study enrollment. The definition of PF-ILD diagnosis is as follows:
- --Patients who have ILD with a progressive phenotype, but are not diagnosed with IPF, per physician's judgment. The pathophysiology in these patients is characterized by self-sustaining fibrosis and a deterioration in lung function over time, with worsening respiratory symptoms, resistance to immune-modulatory therapies, and ultimately early mortality.
- Patient ≥ 20 years of age
- Newly initiating nintedanib OR not receiving nintedanib per physician's discretion (For patients who diagnosed with PF-ILD but are not treated with nintedanib on physician's discretion, they will apply the same inclusion criteria, with baseline characteristics collected only) within 6 months prior to participating in the study
- Providing written informed consent prior to participating in the study
- Having further follow-up possibility with participating physician during the planned study period
- Ability to read and write in local language
Who cannot join
- Lung transplantation expected within the next 6 months.
- --Included in ongoing interventional trials
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
Taiwan26 sites
Chang-Hua Christian Hospital
Changhua, 500
Chang Gung Memorial Hospital Chiayi
Chiayi City, 613
National Taiwan University Hospital-Hsin-Chu Branch
Hsinchu, 300
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807
Kaohsiung Veterans General Hospital
Kaohsiung City, 81362
E-Da Hospital
Kaohsiung City, 824
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
Taipei Tzu Chi General Hospital
New Taipei City, 231
Taipei Medical University-Shuang Ho Hospital
New Taipei City, 235
Chung Shan Medical University Hospital
Taichung, 40201
China Medical University Hospital
Taichung, 404327
Taichung Veterans General Hospital
Taichung, 40705
Cheng Ching Hospital
Taichung, 407
Asia University Hospital
Taichung, 413
National Taiwan University Hospital
Taipei, 100
Mackay Memorial Hospital
Taipei, 10449
Taipei Medical University Hospital
Taipei, 110
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, 111
Taipei Veterans General Hospital
Taipei, 11217
Tri-Service General Hospital
Taipei, 114
Cheng Hsin Rehabilitation Medical Center
Taipei
Taitung MacKay Memorial Hospital
Taitung, 950
Chang Gung Memorial Hospital(Linkou)
Taoyuan, 330
TaoYuan General Hospital
Taoyuan County
National Yang-Ming University Hospital
Yilan, 26058
National Taiwan University Hospital Yun-Lin Branch
Yunlin County, 632
About this study
Official title: Non-Interventional Collecting Evidences For ILD in Taiwan: Optimized Novel Therapy
To better understand the clinical characteristics of Idiopathic Pulmonary Fibrosis (IPF) / Systemic Sclerosis-associated-Interstitial Lung Disease (SSc-ILD)/ Progressive Fibrosing Interstitial Lung Disease (PF-ILD) patients treated with nintedanib and biomarkers associated with the disease course, a non-interventional, 3-year, prospective study will be conducted to collect the long-term real-world clinical data on IPF/SSc-ILD/PF-ILD patients newly administered with nintedanib in Taiwan
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- OFEV®
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OFEV®Drug
nintedanib
| Study group | Role | What they receive |
|---|---|---|
| Idiopathic Pulmonary Fibrosis (IPF) | Not described Receives: Drug: OFEV® | |
| Progressive Fibrosing Interstitial Lung Disease (PF-ILD) | Not described Receives: Drug: OFEV® | |
| Systemic Sclerosis-associated-Interstitial Lung Disease (SSc-ILD) | Not described Receives: Drug: OFEV® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual percentage of decline from baseline in Forced Vital Capacity (FVC, %) per cohort of IPF, SSc-ILD, or PF-ILD
IPF: Idiopathic Pulmonary Fibrosis PF-ILD: Progressive Fibrosing Interstitial Lung Disease SSc-ILD: Systemic Sclerosis-associated-Interstitial Lung Disease
Measured: Up to 5 years
Annual decline from baseline in Diffusing capacity of the Lungs for Carbon monoxide (DLco, %)
Measured: Up to 5 years
Annual decline from baseline in resting and exercise Oxygen Saturation (SpO2, %)
Measured: Up to 5 years
Secondary outcomes (7)
Time to first acute exacerbation (AE) of IPF; or time to ILD worsening for SSc-ILD/PF-ILD after study enrollment
Measured: Up to 5 years
Annual change from baseline in St George's Respiratory Questionnaire (SGRQ) for IPF or King's Brief Interstitial Lung (K-BILD) for other ILDs
IPF: Idiopathic Pulmonary Fibrosis ILD: Interstitial Lung Disease
Measured: Up to 5 years
Annual change from baseline in Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT)
Measured: Up to 5 years
Annual change from baseline in Six-Minutes Walking Test (6MWT)
Measured: Up to 5 years
Annual change from baseline in Berlin questionnaire
Measured: Up to 5 years
Change from baseline in quantification of biomarkers
Biomarkers include but not limited to Platelet Derived Growth Factor (PDGF), Vascular Endothelial Growth Factor (VEGF), Fibroblast Growth Factor (FGF), Transforming Growth Factor β1 (TGF-β1), Hepatocyte Growth Factor (HGF), Matrix Metalloproteinase (MMP): MMP-1, MMP-7, MMP-9, α-defensin 1, High Mobility Group Box 1 (HMGB1), Tissue of Metalloproteinase (TIMP), Heat-Shock Protein (HSP): HSP-27, bile acid conjugated, Lysophosphatidic Acid (LPA), Lysophosphatidic Acid Receptor 1 (LPAR1), Prostagladin E2 (PGE2), Interleukin (IL): IL-1β, IL-4, IL-18, IL-13, IL-17, Monocyte Chemoattractant Protein 1 (MCP-1), Macrophage Inflammatory Protein 2 (MIP-2), periostin, osteopontin, Surfactant Protein A (SPA), Surfactant Protein D (SPD), Krebs von den Lungen 6 / Mucin 1 (KL-6/MUC1), anti-HSP70 Immunoglobolin (IgG), Bone Morphogenic Protein (BMP), Carbonhydrate Antigen-199 (CA-199), C-Reaktiv Protein degraded by MMPs (CRPM), chemokine ligand (CCL): CCL 2, CCL-18
Measured: Up to 5 years
Mortality (with cause of death): respiratory- and non-respiratory-related death
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start21 Jan 2021
- Primary completion14 May 2025
- Study completion14 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614441
- Sponsor's protocol ID
- 1199-0393
- Status last verified
- Aug 2025
- First submitted
- 29 Oct 2020
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets. .
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Interventional Collecting Evidences For ILD in Taiwan: Optimized Novel Therapy
- ClinicalTrials.gov ID
- NCT04614441
- Acronym / sponsor ID
- 1199-0393
- Conditions
- Idiopathic Pulmonary Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 14 May 2025 (actual)
- Study completion
- 14 May 2025 (actual)
- First posted
- 4 Nov 2020 (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.
To better understand the clinical characteristics of Idiopathic Pulmonary Fibrosis (IPF) / Systemic Sclerosis-associated-Interstitial Lung Disease (SSc-ILD)/ Progressive Fibrosing Interstitial Lung Disease (PF-ILD) patients treated with nintedanib and biomarkers associated with the disease course, a non-interventional, 3-year, prospective study will be conducted to collect the long-term real-world clinical data on IPF/SSc-ILD/PF-ILD patients newly administered with nintedanib in Taiwan
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Idiopathic Pulmonary Fibrosis (IPF) | – | Drug: OFEV® |
| Progressive Fibrosing Interstitial Lung Disease (PF-ILD) | – | Drug: OFEV® |
| Systemic Sclerosis-associated-Interstitial Lung Disease (SSc-ILD) | – | Drug: OFEV® |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study plans to enroll approximately 500 patients with Idiopathic Pulmonary Fibrosis (IPF) / Systemic Sclerosis-associated-Interstitial Lung Disease (SSc-ILD)/ Progressive Fibrosing Interstitial Lung Disease (PF-ILD) who newly initiate nintedanib per physicians' discretion within 6 months before participating in the study.
Key inclusion criteria (23 listed)
- This study plans to enroll approximately 500 patients with IPF/SSc-ILD/PF-ILD who newly initiate nintedanib per physicians' discretion within 6 months before participating in the study.
- Diagnosed with IPF during the prior 6 months before study enrollment, based on the 2018 ATS/ERS/JRS/ALAT guideline
- Patient ≥ 40 years of age
- Newly initiating nintedanib within 6 months prior to participating in the study
- Providing written informed consent prior to participating in the study
Key exclusion criteria (2 listed)
- Lung transplantation expected within the next 6 months.
- --Included in ongoing interventional trials
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 |
|---|---|---|
| OFEV®nintedanib | Drug | Idiopathic Pulmonary Fibrosis (IPF), Progressive Fibrosing Interstitial Lung Disease (PF-ILD), Systemic Sclerosis-associated-Interstitial Lung Disease (SSc-ILD) |
Primary outcome
Annual percentage of decline from baseline in Forced Vital Capacity (FVC, %) per cohort of IPF, SSc-ILD, or PF-ILD
Time frame: Up to 5 years
IPF: Idiopathic Pulmonary Fibrosis PF-ILD: Progressive Fibrosing Interstitial Lung Disease SSc-ILD: Systemic Sclerosis-associated-Interstitial Lung Disease
Annual decline from baseline in Diffusing capacity of the Lungs for Carbon monoxide (DLco, %)
Time frame: Up to 5 years
Annual decline from baseline in resting and exercise Oxygen Saturation (SpO2, %)
Time frame: Up to 5 years
7 secondary outcomes
Time to first acute exacerbation (AE) of IPF; or time to ILD worsening for SSc-ILD/PF-ILD after study enrollment
Time frame: Up to 5 years
Annual change from baseline in St George's Respiratory Questionnaire (SGRQ) for IPF or King's Brief Interstitial Lung (K-BILD) for other ILDs
Time frame: Up to 5 years
Annual change from baseline in Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT)
Time frame: Up to 5 years
Annual change from baseline in Six-Minutes Walking Test (6MWT)
Time frame: Up to 5 years
Annual change from baseline in Berlin questionnaire
Time frame: Up to 5 years
Change from baseline in quantification of biomarkers
Time frame: Up to 5 years
Mortality (with cause of death): respiratory- and non-respiratory-related death
Time frame: Up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets. .
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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.
The record lists no contact. Use the official record to reach the sponsor.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Pulmonary Fibrosis, run by Boehringer Ingelheim at 26 sites in Taiwan.
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 23 inclusion and 2 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: finished, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Taiwan. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annual percentage of decline from baseline in Forced Vital Capacity (FVC, %) per cohort of IPF, SSc-ILD, or PF-ILD (time frame: Up to 5 years). The study lists 3 primary outcomes in all. 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 19 Aug 2025.