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P4O2 ILD Extension

Recruitingn/aAges 18 Years - 80 YearsAllAmsterdam UMC, location VUmc
NCT06644144 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • No Interventions
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Where

1 site
Amsterdam UMC, locatie VUmc
Amsterdam, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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