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

1 juli 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Studietyp

Observationell

Inskrivning (Beräknad)

600

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

  • Namn: Zuojun Xu Zuojun Xu
  • Telefonnummer: +86 13671345136
  • E-post: xuzi@hotmail.com

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Patients diagnosed with PPF in China

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Chinese PPF Prospective Registry Cohort

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Absolute change in FVC (mL)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
CTD-ILD, HP, iNSIP, exposure-related ILD, sarcoidosis, unclassified ILD, and other ILDs
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Zuojun Xu

Samarbetspartners

Boehringer Ingelheim

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

23 september 2025

Primärt slutförande (Beräknad)

31 juli 2029

Avslutad studie (Beräknad)

31 oktober 2029

Studieregistreringsdatum

Först inskickad

25 juni 2026

Först inskickad som uppfyllde QC-kriterierna

1 juli 2026

Första postat (Faktisk)

6 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • PROFINA

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

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