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Search / Trial NCT06644144

P4O2 ILD Extension

Launched by AMSTERDAM UMC, LOCATION VUMC · Oct 13, 2024

Trial Information

Current as of November 10, 2025

Recruiting

Keywords

Interstitial Lung Disease Interstitial Lung Abnormalities Progressive Pulmonary Fibrosis

ClinConnect Summary

The P4O2 ILD Extension study is researching ways to identify early signs, called biomarkers, that could help predict how quickly certain lung diseases, particularly types of interstitial lung disease (ILD) like idiopathic pulmonary fibrosis (IPF) and familial pulmonary fibrosis (FPF), might worsen over time. The goal is to find out what factors could indicate rapid deterioration in these patients and to learn more about how different forms of ILD might behave. This study is important because it could lead to better treatment approaches and help doctors understand who might develop more serious lung issues.

To participate in this study, individuals aged 18 to 80 who have been diagnosed with IPF, FPF, or other fibrotic lung diseases are eligible, provided they meet specific health criteria. Participants will undergo a series of tests, including blood samples, lung function tests, CT scans, and questionnaires, to gather detailed information about their condition. Some participants may also have a bronchoscopy, a procedure to look inside the lungs. This study is currently recruiting participants, and it aims to provide valuable insights into managing and treating these challenging lung diseases.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Diagnosis of (1) idiopathic pulmonary fibrosis (IPF), familial pulmonary fibrosis (FPF), (2) other fibrotic ILDs (fILD), including fibrotic hypersensitivity pneumonitis (fHP), idiopathic non-specific interstitial pneumonia (iNSIP), connective tissue disease (CTD)-ILD, and unclassifiable ILD (uILD); or (3) interstitial lung abnormalities (ILA).
  • * Meeting all the following criteria during the screening period:
  • 1. FVC ≥45% predicted.
  • 2. FEV1/FVC ≥0.7.
  • 3. DLco corrected for Hb ≥40% predicted.
  • Able to provide written informed consent as approved by the independent ethics committee.
  • Able to undergo a CT scan and perform PFT.
  • Age \> 18 years and \< 80 years.
  • Understanding of the Dutch or English language.
  • Exclusion Criteria:
  • Combined pulmonary fibrosis and emphysema (CPFE) diagnosis
  • Chronic obstructive lung disease (COPD) with an FEV1/FVC \<70%.
  • Uncontrolled severe asthma.
  • Active malignancy, except for squamous cell carcinoma of the skin, low-risk breast cancer, and low-risk prostate cancer.
  • Pregnancy or lactating.

About Amsterdam Umc, Location Vumc

Amsterdam UMC, located at VU Medical Center (VUmc), is a leading academic medical center in the Netherlands dedicated to advancing healthcare through innovative research and clinical trials. With a strong emphasis on translating scientific discoveries into practical applications, Amsterdam UMC collaborates closely with researchers, healthcare professionals, and industry partners to enhance patient outcomes. The institution is committed to rigorous ethical standards and regulatory compliance, ensuring the integrity and reliability of its clinical research initiatives across various medical disciplines.

Locations

Amsterdam, Noord Holland, Netherlands

Patients applied

0 patients applied

Trial Officials

Esther Nossent, MD

Principal Investigator

Amsterdam UMC, locatie VUmc

Jan Willem Duitman, PhD

Principal Investigator

Amsterdam UMC, locatie VUmc

Anke-Hilse Maitland-van der Zee, PhD

Principal Investigator

Amsterdam UMC, locatie VUmc

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported