Phase
Condition
Scar Tissue
Cystic Fibrosis
Lung Injury
Treatment
OFEV®
Clinical Study ID
Ages > 20 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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
Having further follow-up possibility with participating physician during the plannedstudy 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 onphysician's discretion, they will apply the same inclusion criteria, with baselinecharacteristics 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 plannedstudy period
Ability to read and write in local language
PF-ILD cohort:
- Diagnosed with PF-ILD (PF-ILD patients will be enrolled only after nintedanibacquires the label approval from TFDA) during the prior 6 months before studyenrollment. The definition of PF-ILD diagnosis is as follows:
--Patients who have ILD with a progressive phenotype, but are not diagnosed withIPF, per physician's judgment. The pathophysiology in these patients ischaracterized by self-sustaining fibrosis and a deterioration in lung function overtime, with worsening respiratory symptoms, resistance to immune-modulatorytherapies, 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 onphysician's discretion, they will apply the same inclusion criteria, with baselinecharacteristics 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 plannedstudy period
Ability to read and write in local language
Exclusion
Exclusion Criteria:
- Lung transplantation expected within the next 6 months.
--Included in ongoing interventional trials
Study Design
Connect with a study center
Chang-Hua Christian Hospital
Changhua, 500
TaiwanSite Not Available
Chang Gung Memorial Hospital Chiayi
Chiayi, 613
TaiwanSite Not Available
National Taiwan University Hospital-Hsin-Chu Branch
Hsinchu, 300
TaiwanSite Not Available
Buddhist Tzu Chi General Hospital
Hualien, 970
TaiwanSite Not Available
E-Da Hospital
Kaohsiung, 824
TaiwanSite Not Available
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, 83301
TaiwanSite Not Available
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, 807
TaiwanSite Not Available
Kaohsiung Veterans General Hospital
Kaohsiung, 81362
TaiwanSite Not Available
Far Eastern Memorial Hospital
New Taipei City, 220
TaiwanSite Not Available
Taipei Medical University-Shuang Ho Hospital
New Taipei City, 235
TaiwanSite Not Available
Taipei Tzu Chi General Hospital
New Taipei City, 231
TaiwanSite Not Available
Asia University Hospital
Taichung, 413
TaiwanSite Not Available
Cheng Ching Hospital
Taichung, 407
TaiwanSite Not Available
China Medical University Hospital
Taichung, 404327
TaiwanSite Not Available
Chung Shan Medical University Hospital
Taichung, 40201
TaiwanSite Not Available
Taichung Veterans General Hospital
Taichung, 40705
TaiwanSite Not Available
Cheng Hsin Rehabilitation Medical Center
Taipei,
TaiwanSite Not Available
Mackay Memorial Hospital
Taipei, 10449
TaiwanSite Not Available
National Taiwan University Hospital
Taipei, 100
TaiwanSite Not Available
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, 111
TaiwanSite Not Available
Taipei Veterans General Hospital
Taipei, 11217
TaiwanSite Not Available
Tri-Service General Hospital
Taipei, 114
TaiwanSite Not Available
Taipei Medical University Hospital
Taipei City, 110
TaiwanSite Not Available
Taitung MacKay Memorial Hospital
Taitung, 950
TaiwanSite Not Available
Chang Gung Memorial Hospital(Linkou)
Taoyuan, 330
TaiwanSite Not Available
TaoYuan General Hospital
Taoyuan County,
TaiwanSite Not Available
National Yang-Ming University Hospital
Yilan, 26058
TaiwanSite Not Available
National Taiwan University Hospital Yun-Lin Branch
Yunlin County, 632
TaiwanSite Not Available

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