A Prospective, Multi-Center Registry Study of Progressive Pulmonary Fibrosis (PPF) in China (PROFINA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Absolute change in FVC (mL)
研究概览
简要总结
This is a nationwide multicenter prospective non-interventional registry study enrolling 600 Chinese patients diagnosed with PPF over a 3-year period (9-month enrollment, 2-year follow-up, and 3 months for data analysis and publication). Eligible participants must meet the PPF criteria defined by the 2022 ATS/ERS/JRS/ALAT guidelines, while patients with IPF, no baseline chest HRCT, or refusal to sign informed consent will be excluded. The primary endpoint is the absolute change in FVC (mL) at 1- and 2-year follow-ups. The core objective is to investigate real-world disease progression in Chinese PPF patients, with secondary objectives to analyze their clinical characteristics, current treatment status, and unmet clinical needs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of PPF within the past year, according to the 2022 ATS/ERS/JRS/ALAT guidelines;
- •Patients who are willing to participate in the study and have signed an informed consent form.
排除标准
- •Patients diagnosed with IPF.
- •Patients without baseline chest HRCT.
- •Patients who refuse to sign the informed consent form.
- •Patients participating in other clinical trials for medications. (Patients who have completed other trials or are in an unblinded phase after a washout period of 2 weeks are eligible for enrollment.)
结局指标
主要结局
Absolute change in FVC (mL)
时间窗: at 1-year and 2-year follow-up
Absolute change in FVC (mL) at 1-year and 2-year follow-up.
次要结局
- CTD-ILD, HP, iNSIP, exposure-related ILD, sarcoidosis, unclassified ILD, and other ILDs(at baseline and after 2 years of follow-up)
- The percentage of patients who meet at least two of the following three inclusion criteria for PPF(at baseline, 1-year, and 2-year follow-up)
- The percentage of patients receiving treatment with corticosteroids, immunosuppressive agents, and antifibrotic drugs or PDE4B inhibitors(during the 2-year follow-up period)
- Change in absolute DLCO of pulmonary function expressed as percent predicted(after 1 year and 2 years of follow-up)
- Changes in the absolute score of the dyspnea severity questionnaire(at 1-year and 2-year follow-up)
- Changes in the absolute score of the Cough Severity Numerical Rating Scale (CNSRS)(at 1-year and 2-year follow-up)
- Frequency of acute exacerbations of ILD(during the 2-year follow-up)
- Time to first acute exacerbation(during the 2-year follow-up)
- The percentage of patients with acute exacerbations, lung transplantation, or death(at 2-year follow-up)
- The percentage of patients with ILD progression (FVC decline >10% of predicted value)(at 2-year follow-up)
研究者
Zuojun Xu
Chief Physician
Peking Union Medical College Hospital