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NCT Number: NCT07683728

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

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.

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Key information

Conditions

Progressive Pulmonary Fibrosis

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Primary outcomes

  1. Absolute change in FVC (mL)

    Time frame: at 1-year and 2-year follow-up

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

Secondary outcomes

  1. 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 with CTD-ILD, HP, iNSIP, exposure-related ILD, sarcoidosis, unclassified ILD, and other ILDs at baseline and following 2 years of follow-up.

  2. 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 who meet at least two of the following three inclusion criteria for PPF at baseline, 1-year, and 2-year follow-up:

    • Worsening respiratory symptoms;
    • Physiological evidence of disease progression (FVC decline >5% or DLCO
    • Imaging evidence of disease progression (e.g., increased or worsened traction bronchiectasis, new ground-glass opacities with traction bronchiectasis, new reticular patterns, or new honeycombing).

  3. 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

    The percentage of patients receiving treatment with corticosteroids, immunosuppressive agents (including cyclophosphamide, mycophenolate mofetil, azathioprine, and other commonly used immunosuppressants for ILDs), and antifibrotic drugs (nintedanib, pirfenidone) or PDE4B inhibitors (e.g., nerandomilast) during the 2-year follow-up period.

  4. Change in absolute DLCO of pulmonary function expressed as percent predicted

    Time frame: after 1 year and 2 years of follow-up

    Change in absolute DLCO of pulmonary function expressed as percent predicted after 1 year and 2 years of follow-up.

  5. 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 dyspnea severity questionnaire at 1-year and 2-year follow-up.

  6. Changes in the absolute score of the Cough Severity Numerical Rating Scale (CNSRS)

    Time frame: 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.

  7. Frequency of acute exacerbations of ILD

    Time frame: during the 2-year follow-up

    Frequency of acute exacerbations of ILD during the 2-year follow-up.

  8. Time to first acute exacerbation

    Time frame: during the 2-year follow-up

    Time to first acute exacerbation during the 2-year follow-up.

  9. The percentage of patients with acute exacerbations, lung transplantation, or death

    Time frame: at 2-year follow-up

    The percentage of patients with acute exacerbations, lung transplantation, or death at 2-year follow-up.

  10. The percentage of patients with ILD progression (FVC decline >10% of predicted value)

    Time frame: at 2-year follow-up

    The percentage of patients with ILD progression (FVC decline >10% of predicted value) at 2-year follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Zuojun Xu Zuojun Xu

CONTACT

[email protected]

+86 13671345136

Sponsors and collaborators

Lead sponsor

Zuojun Xu

Other

Collaborators

  • Boehringer Ingelheim

Registry information

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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