A Prospective, Multi-Center Registry Study of Progressive Pulmonary Fibrosis (PPF) in China (PROFINA)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Progressive Pulmonary Fibrosis. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Absolute change in FVC (mL) [Time frame: at 1-year and 2-year follow-up]
Secondary outcome measures (10)
- CTD-ILD, HP, iNSIP, exposure-related ILD, sarcoidosis, unclassified ILD, and other ILDs [Time frame: 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 [Time frame: 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 [Time frame: during the 2-year follow-up period]
- Change in absolute DLCO of pulmonary function expressed as percent predicted [Time frame: after 1 year and 2 years of follow-up]
- Changes in the absolute score of the dyspnea severity questionnaire [Time frame: at 1-year and 2-year follow-up]
- Changes in the absolute score of the Cough Severity Numerical Rating Scale (CNSRS) [Time frame: at 1-year and 2-year follow-up]
- Frequency of acute exacerbations of ILD [Time frame: during the 2-year follow-up]
- Time to first acute exacerbation [Time frame: during the 2-year follow-up]
- The percentage of patients with acute exacerbations, lung transplantation, or death [Time frame: at 2-year follow-up]
- The percentage of patients with ILD progression (FVC decline >10% of predicted value) [Time frame: at 2-year follow-up]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Peking Union Medical College Hospital — Beijing
Identifiers
NCT: NCT07683728 · PROFINA