P4O2 ILD Extension

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.

Conditions

• Interstitial Lung Disease
• Pulmonary Fibrosis
• Interstitial Lung Fibrosis
• IPF
• Pulmonary Fibrosis, Idiopathic
• Pulmonary Fibrosis Idiopathic Familial
• Chronic Hypersensitivity Pneumonitis
• Unclassifiable ILD
• Idiopathic NSIP
• CTD-ILD

Interventions

OTHER

No Interventions

No intervention so not applicable.

Sponsors & Collaborators

• AbbVie

  collaborator INDUSTRY

• Boehringer Ingelheim

  collaborator INDUSTRY

• Amsterdam UMC, location VUmc

  lead OTHER

Principal Investigators

• Esther Nossent, MD · Amsterdam UMC, locatie VUmc

• Jan Willem Duitman, PhD · Amsterdam UMC, locatie VUmc

• Anke-Hilse Maitland-van der Zee, PhD · Amsterdam UMC, locatie VUmc

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-01

Primary Completion

2028-10-01

Completion

2031-10-01

Countries

• Netherlands

Study Locations