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

NCT07683728 | Recruiting

• 1 other identifier: PROFINA
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Progressive Pulmonary Fibrosis

Keywords

Progressive Pulmonary Fibrosis; Registry Study

Outcome Measures

Primary Outcomes (1)

• Absolute change in FVC (mL)

  Absolute change in FVC (mL) at 1-year and 2-year follow-up.

  at 1-year and 2-year follow-up

Secondary Outcomes (10)

• 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

Study Arms (1)

Chinese PPF Prospective Registry Cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with PPF in China

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Zuojun Xu: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

Central Study Contacts

Zuojun Xu Zuojun Xu

CONTACT

+86 13671345136; xuzi@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 6, 2026
• Study Start: September 23, 2025
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): October 31, 2029
• Last Updated: July 6, 2026

Record last verified: 2026-07

Locations

CN (1)