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

1. juli 2026 opdateret af: Zuojun Xu
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.

Studieoversigt

Status

Rekruttering

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Anslået)

600

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Zuojun Xu Zuojun Xu
  • Telefonnummer: +86 13671345136
  • E-mail: xuzi@hotmail.com

Studiesteder

  • Kina
      • Beijing, Kina
        • Rekruttering
        • Peking Union Medical College Hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients diagnosed with PPF in China

Beskrivelse

Inclusion Criteria:

  1. Diagnosis of PPF within the past year, according to the 2022 ATS/ERS/JRS/ALAT guidelines;
  2. Patients who are willing to participate in the study and have signed an informed consent form.

Exclusion Criteria:

  1. Patients diagnosed with IPF.
  2. Patients without baseline chest HRCT.
  3. Patients who refuse to sign the informed consent form.
  4. 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.)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Chinese PPF Prospective Registry Cohort

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
CTD-ILD, HP, iNSIP, exposure-related ILD, sarcoidosis, unclassified ILD, and other ILDs
Tidsramme: 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.
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
Tidsramme: 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:

  1. Worsening respiratory symptoms;
  2. Physiological evidence of disease progression (FVC decline >5% or DLCO
  3. 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).
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
Tidsramme: 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.
during the 2-year follow-up period
Change in absolute DLCO of pulmonary function expressed as percent predicted
Tidsramme: 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.
after 1 year and 2 years of follow-up
Changes in the absolute score of the dyspnea severity questionnaire
Tidsramme: 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.
at 1-year and 2-year follow-up
Changes in the absolute score of the Cough Severity Numerical Rating Scale (CNSRS)
Tidsramme: 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.
at 1-year and 2-year follow-up
Frequency of acute exacerbations of ILD
Tidsramme: during the 2-year follow-up
Frequency of acute exacerbations of ILD during the 2-year follow-up.
during the 2-year follow-up
Time to first acute exacerbation
Tidsramme: during the 2-year follow-up
Time to first acute exacerbation during the 2-year follow-up.
during the 2-year follow-up
The percentage of patients with acute exacerbations, lung transplantation, or death
Tidsramme: at 2-year follow-up
The percentage of patients with acute exacerbations, lung transplantation, or death at 2-year follow-up.
at 2-year follow-up
The percentage of patients with ILD progression (FVC decline >10% of predicted value)
Tidsramme: at 2-year follow-up
The percentage of patients with ILD progression (FVC decline >10% of predicted value) at 2-year follow-up
at 2-year follow-up

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Zuojun Xu

Samarbejdspartnere

Boehringer Ingelheim

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

23. september 2025

Primær færdiggørelse (Anslået)

31. juli 2029

Studieafslutning (Anslået)

31. oktober 2029

Datoer for studieregistrering

Først indsendt

25. juni 2026

Først indsendt, der opfyldte QC-kriterier

1. juli 2026

Først opslået (Faktiske)

6. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • PROFINA

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

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