Actively Recruiting

Age: 18Years - 80Years
All Genders
NCT06644144

P4O2 ILD Extension

Led by Amsterdam UMC, location VUmc · Updated on 2026-05-11

450

Participants Needed

1

Research Sites

360 weeks

Total Duration

On this page

Sponsors

A

Amsterdam UMC, location VUmc

Lead Sponsor

A

AbbVie

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this observational study is to identify early biomarkers that can predict the development of progressive pulmonary fibrosis (PPF) in participants with interstitial lung diseases (ILDs). The participant population includes adults diagnosed with idiopathic pulmonary fibrosis (IPF), familial pulmonary fibrosis (FPF), other fibrotic ILDs, and interstitial lung abnormalities (ILA). The main questions it aims to answer are: * What biomarkers and risk factors are linked to fibrosis progression or can predict rapid worsening and sudden flare-ups in IPF and FPF patients? * What biomarkers and risk factors can predict the development of a PPF phenotype in different types of ILD? * What biomarkers and risk factors can help identify ILA patients who may develop significant ILD? * What biomarkers and risk factors can predict how well ILD patients will respond to treatment? Researchers will compare the outcomes between participants diagnosed with IPF/FPF, other fibrotic ILDs, and ILA to see if early detection biomarkers differ among these groups. Participants will: * Undergo blood sampling. * Perform lung function tests. * Have CT scans. * Perform breath analysis * Participate in exposome and microbiome analyses. * Complete questionnaires. * A subgroup of participants will be offered bronchoscopy.

CONDITIONS

Official Title

P4O2 ILD Extension

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of idiopathic pulmonary fibrosis (IPF), familial pulmonary fibrosis (FPF), other fibrotic interstitial lung diseases (including fibrotic hypersensitivity pneumonitis, idiopathic non-specific interstitial pneumonia, connective tissue disease-associated ILD, and unclassifiable ILD), or interstitial lung abnormalities (ILA)
  • Forced vital capacity (FVC) of 45% or higher predicted at screening
  • Forced expiratory volume in one second/forced vital capacity (FEV1/FVC) ratio of 0.7 or higher at screening
  • Diffusing capacity of the lungs for carbon monoxide (DLco) corrected for hemoglobin of 40% or higher predicted at screening
  • Able to provide written informed consent
  • Able to undergo a CT scan and perform pulmonary function tests
  • Age greater than 18 years and less than 80 years
  • Able to understand Dutch or English
Not Eligible

You will not qualify if you...

  • Diagnosis of combined pulmonary fibrosis and emphysema (CPFE)
  • Chronic obstructive pulmonary disease (COPD) with an FEV1/FVC ratio less than 70%
  • Uncontrolled severe asthma
  • Active cancer, except for squamous cell carcinoma of the skin, low-risk breast cancer, and low-risk prostate cancer
  • Pregnant or breastfeeding

AI-Screening

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Trial Site Locations

Total: 1 location

1

Amsterdam UMC, locatie VUmc

Amsterdam, North Holland, Netherlands, 1081 HV

Actively Recruiting

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Research Team

J

Jan Willem Duitman, PhD

CONTACT

I

Iris Simons, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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