Actively Recruiting
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
Eligibility Criteria
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
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
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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