A Prospective, Multi-Center Registry Study of Progressive Pulmonary Fibrosis (PPF) in China (PROFINA)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorZuojun Xu

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.)

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

600 Participants
are grouped into 1 trial group

Sponsors and collaborators

Zuojun Xu

Lead sponsor

Peking Union Medical College Hospital

Sponsor institution

Boehringer Ingelheim

Collaborator