NCT06644144Recruiting
P4O2 ILD Extension
Early Identification of Progressive Pulmonary Fibrosis, Precision Medicine for More Oxygen - ILD Extension.
Source: ClinicalTrials.gov · Last updated 11 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 450 (estimated)
- First submitted
- 23 Sept 2024
- Start date
- 1 Nov 2024
- Primary completion date
- 1 Oct 2028
- Lead sponsor
- Amsterdam UMC, location VUmc
- Diseases
- Idiopathic pulmonary fibrosis
- NCT number
- NCT06644144
What you commit to
- Study type: Observational
- Planned participants: 450
- From 1 Nov 2024 to the primary completion date, 1 Oct 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Chronic obstructive lung disease (COPD) with an FEV1/FVC \<70%.
- Active malignancy, except for squamous cell carcinoma of the skin, low-risk breast cancer, and low-risk prostate cancer.
Other
- Combined pulmonary fibrosis and emphysema (CPFE) diagnosis
- Uncontrolled severe asthma.
- Pregnancy or lactating.
Who the study is looking for
- 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:
- FVC ≥45% predicted.
- FEV1/FVC ≥0.7.
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC Locatie VUMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.