Non-Interventional Collecting Evidences For ILD in Taiwan: Optimized Novel Therapy
Overview
- Phase
- Not Applicable
- Intervention
- OFEV®
- Conditions
- Idiopathic Pulmonary Fibrosis
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 214
- Locations
- 26
- Primary Endpoint
- Annual percentage of decline from baseline in Forced Vital Capacity (FVC, %) per cohort of IPF, SSc-ILD, or PF-ILD
- Status
- Completed
- Last Updated
- 8 months ago
Overview
Brief 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 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
Investigators
Eligibility Criteria
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 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
Exclusion Criteria
- •Lung transplantation expected within the next 6 months.
- •-Included in ongoing interventional trials
Arms & Interventions
Idiopathic Pulmonary Fibrosis (IPF)
Intervention: OFEV®
Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
Intervention: OFEV®
Systemic Sclerosis-associated-Interstitial Lung Disease (SSc-ILD)
Intervention: OFEV®
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Time to first acute exacerbation (AE) of IPF; or time to ILD worsening for SSc-ILD/PF-ILD after study enrollment(Up to 5 years)
- Annual change from baseline in Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT)(Up to 5 years)
- Annual change from baseline in Six-Minutes Walking Test (6MWT)(Up to 5 years)
- Annual change from baseline in Berlin questionnaire(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(Up to 5 years)
- Mortality (with cause of death): respiratory- and non-respiratory-related death(Up to 5 years)
- Change from baseline in quantification of biomarkers(Up to 5 years)