P4O2 ILD Extension

Last updated: March 28, 2025
Sponsor: Amsterdam UMC, location VUmc
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pneumonia

Idiopathic Pulmonary Fibrosis

Scar Tissue

Treatment

No Interventions

Clinical Study ID

NCT06644144
2023.0591
NL84006.018.23
  • Ages 18-80
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of (1) idiopathic pulmonary fibrosis (IPF), familial pulmonary fibrosis (FPF), (2) other fibrotic ILDs (fILD), including fibrotic hypersensitivitypneumonitis (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 ethicscommittee.

  • Able to undergo a CT scan and perform PFT.

  • Age > 18 years and < 80 years.

  • Understanding of the Dutch or English language.

Exclusion

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 breastcancer, and low-risk prostate cancer.

  • Pregnancy or lactating.

Study Design

Total Participants: 450
Treatment Group(s): 1
Primary Treatment: No Interventions
Phase:
Study Start date:
November 01, 2024
Estimated Completion Date:
October 01, 2031

Study Description

Included participants will complete several study visits to collect clinical data and biological samples. Study visits will be performed at baseline, 3, 6, 12, 24, 36, 48 and 60 months, with a 2-month time window for follow-up visits. These time points are aligned with the standard clinical follow-up visits outlined in the ILD Care Path Protocol of Amsterdam UMC.

Connect with a study center

  • Amsterdam UMC, locatie VUmc

    Amsterdam, Noord-Holland 1081 HV
    Netherlands

    Active - Recruiting

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