Identifying biomarkers for progressive pulmonary fibrosis in lung disease patients

Early Identification of Progressive Pulmonary Fibrosis, Precision Medicine for More Oxygen - ILD Extension.

This study is trying to find early signs that can help predict if adults with certain lung diseases will develop progressive pulmonary fibrosis over the next five years.

Quick facts

• Study type: Observational
• Enrollment: 450 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Amsterdam UMC, location VUmc (Academic / other)
• Locations: 1 site (Amsterdam, North Holland)
• Trial ID: NCT06644144 on ClinicalTrials.gov

What this trial studies

This observational study aims to identify early biomarkers that can predict the development of progressive pulmonary fibrosis (PPF) in adults diagnosed with various interstitial lung diseases (ILDs), including idiopathic pulmonary fibrosis (IPF) and familial pulmonary fibrosis (FPF). Participants will undergo multiple study visits over five years to collect clinical data and biological samples, allowing researchers to analyze risk factors and biomarkers associated with fibrosis progression and treatment response. The study will compare outcomes among different types of ILD to enhance understanding of disease progression.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 80 with a diagnosis of IPF, FPF, other fibrotic ILDs, or interstitial lung abnormalities.

Not a fit: Patients with combined pulmonary fibrosis and emphysema or chronic obstructive lung disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier identification of patients at risk for rapid disease progression, allowing for timely interventions.

How similar studies have performed: While this approach is observational and builds on existing knowledge, similar studies have shown promise in identifying biomarkers for lung diseases.

Eligibility criteria

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.

Where this trial is running

Amsterdam, North Holland

• Amsterdam UMC, locatie VUmc — Amsterdam, North Holland, Netherlands (Recruiting)

Study contacts

• Principal investigator: Esther Nossent, MD — Amsterdam UMC, locatie VUmc
• Study coordinator: Jan Willem Duitman, PhD

Conditions Interstitial Lung Disease; Pulmonary Fibrosis; Interstitial Lung Fibrosis; IPF; Pulmonary Fibrosis, Idiopathic; Pulmonary Fibrosis Idiopathic Familial; Chronic Hypersensitivity Pneumonitis; Unclassifiable ILD