Non-Interventional Study (NIS) Collecting Experiences For IPF in Taiwan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 10
- 主要终点
- Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 52
研究概览
简要总结
This is a non-interventional, multi-center study to collect data from patients with idiopathic pulmonary fibrosis (IPF) in clinical practice in Taiwan. The study will be carried out at 10 medical centers, the expert centers where IPF patients are mainly managed in Taiwan.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients can be included if ALL the following criteria are met:
- •1.Newly diagnosed with IPF within 6 months based upon recent ATS/ERS/JRS/ALAT IPF guideline (Ref 1, Raghu G, et al. 2011).
- •Exclusion of other known causes of ILD (e.g. domestic and occupational environmental exposures, connective tissue disease, and drug toxicity).
- •Assessment of IPF based on HRCT or HRCT and surgical lung biopsy, if available. 2.Patient ≥ 20 years of age 3.Written informed consent prior to participation 4.Patients with further follow-up possible with participating physician during planned study period 5.Ability to read and write in the local language
排除标准
- •Patients should not be included if ANY of the following criteria is met:
- •Lung transplantation expected within next 6 months.
- •Inclusion in ongoing clinical trials.
研究组 & 干预措施
patients with idiopathic pulmonary fibrosis (IPF)
干预措施: nintedanib (Drug)
patients with idiopathic pulmonary fibrosis (IPF)
干预措施: pirfenidone (Drug)
结局指标
主要结局
Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 52
时间窗: At baseline and Week 52.
Annual Change from Baseline in percentage of predicted Forced Vital Capacity (FVC) at Week 52 was reported.
Annual Change From Baseline in Percentage of Predicted Forced Vital Capacity (FVC) at Week 100
时间窗: At baseline and Week 100.
Annual Change from Baseline in percentage of predicted Forced Vital Capacity (FVC) at Week 100 was reported.
Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 52
时间窗: At baseline and Week 52.
Annual Change from Baseline in percentage of predicted Diffusing capacity of the Lungs for Carbon monoxide (DLco) at Week 52 was reported
Annual Change From Baseline in Percentage of Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLco) at Week 100
时间窗: At baseline and Week 100.
Annual Change from Baseline in percentage of predicted Diffusing capacity of the Lungs for Carbon monoxide (DLco) at Week 100 was reported.
Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 52
时间窗: At baseline and Week 52.
Annual Change from Baseline in percentage of predicted oxygen saturation (SpO2) at Week 52 was reported.
Annual Change From Baseline in Percentage of Predicted Oxygen Saturation (SpO2) at Week 100
时间窗: At baseline and Week 100.
Annual Change from Baseline in percentage of predicted oxygen saturation (SpO2) at Week 100 was reported.
Annual Change From Baseline in Percentage of Predicted Total Lung Capacity (TLC) at Week 52
时间窗: At baseline and Week 52.
Annual Change from Baseline in percentage of predicted Total Lung Capacity (TLC) at Week 52was reported.
Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 52
时间窗: At baseline and Week 52.
Annual Change from Baseline in percentage of predicted Inspiratory Capacity (IC) at Week 52 was reported.
Annual Change From Baseline in Percentage of Predicted Total Lung Capacity (TLC) at Week 100
时间窗: At baseline and Week 100.
Annual Change from Baseline in percentage of predicted Total Lung Capacity (TLC) at Week 100 was reported.
Annual Change From Baseline in Percentage of Predicted Inspiratory Capacity (IC) at Week 100
时间窗: At baseline and Week 100.
Annual Change from Baseline in percentage of predicted Inspiratory Capacity (IC) at Week 100 was reported.
次要结局
- Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 52(At baseline and Week 52.)
- Annual Change in Score of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 100(At baseline and Week 100)
- Annual Change in Six-Minute Walk Test (6MWT) at Week 52(At baseline and Week 52.)
- Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis(From baseline until end of follow-up, up to 899 days.)
- Annual Change in Total Score of St. Georges Respiratory Questionnaire (SGRQ) at Week 100(At baseline and Week 100.)
- Number of Participants Per Death Reason Categories(From baseline until end of follow-up, up to 899 days.)
- Annual Change in Score of Chronic Obstructive Pulmonary Disease Assessment Test (CAT) at Week 52(At baseline and Week 52)
- Annual Change in Six-Minute Walk Test (6MWT) at Week 100(At baseline and Week 100.)
- Overall Survival(From baseline until end of follow-up, up to 899 days.)