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Observational Study for Progressive Pulmonary Fibrosis

This is an observational study for people with progressive pulmonary fibrosis (PPF) or interstitial lung disease (ILD) that is not idiopathic pulmonary fibrosis (non-IPF ILD). The study aims to better understand and classify PPF, and to see how often it occurs in different types of ILD. Researchers will collect clinical information, images, and blood samples over 24 months. The main goal is to see if a decline in lung function over 12 months is linked to how long people live without needing a lung transplant. You can join if you are between 18 and 80 years old, have a diagnosis of non-IPF fibrosing ILD, and are willing to follow study procedures. The study is currently recruiting 500 participants.

Study design
This is an observational study, meaning no new treatments are given. It will follow 500 participants over 24 months.
What's involved
You will have protocolized follow-up visits over 24 months, where clinical data and blood samples will be collected.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 months, with the primary outcome measured at 12-24 months after an initial 12-month observation period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06855329

PRospective phenotypIng and Multi-omic Endotyping of Progressive Pulmonary Fibrosis

Recruiting
Not specifiedAges 18–80Observational
University of Massachusetts, Worcester
~500 participants
Updated 2026-08-18 on ClinicalTrials.gov

At a glance

Recruiting sites
9 of 24 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Transplant-free survival (TFS)
Measured over 12-months to 24-months (following an observation period from 0 months to 12 months)

Conditions

Progressive Pulmonary Fibrosis
Interstitial Lung Disease

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Interstitial Lung Disease

Where it's being run

24 sites across 22 states
France2
Germany2
Colorado1
Massachusetts1
Michigan1
New York1
Texas1
Virginia1

Study leadership

  • Fernando J Martinez, MD, MS · PRINCIPAL_INVESTIGATOR · University of Massachusetts, Worcester
  • Justin Oldham, MD, MS · PRINCIPAL_INVESTIGATOR · University of Michigan
  • Cathie Spino, DSc · PRINCIPAL_INVESTIGATOR · University of Michigan
  • Imre Noth, MD, MS · PRINCIPAL_INVESTIGATOR · University of Virginia
  • Michael Kreuter, MD · PRINCIPAL_INVESTIGATOR · Johannes Gutenberg University Mainz
  • Dinesh Khanna, MD, MS · PRINCIPAL_INVESTIGATOR · University of Michigan
  • Luca Richeldi, MD, PhD · PRINCIPAL_INVESTIGATOR · Policlinico Gemelli

Who to contact

Fernando J Martinez, MD, MS
[email protected]
508-334-8685
Email the study team

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Eligibility criteria

Inclusion

Age 18-80 years with a diagnosis of non-IPF fibrosing ILD due to CTD-ILD, fHP, or non-IPF IIP based on central review
Diagnosis of Fibrotic ILD as determined by site investigator.
Willingness to comply with study procedures and follow-up.
Provide written informed consent.

Exclusion

Site diagnosis of fibrosing ILD \>5 years prior to Visit 1 (Screening and Baseline Visit).
Minimal ILD, defined as reticular opacities and/or ground-glass opacities without architectural distortion (traction bronchiolectasis/bronchiectasis or honeycombing) affecting \< 5% of the lung on centralized evaluation of HRCT at Visit 1 (Screening and Baseline Visit). High quality historical chest HRCT may be used if performed within 90 days prior to Visit 1.
Extent of emphysema \>15% of total lung volume or greater than extent of fibrosis based on central, qualitative assessment of HRCT at Visit 1. High quality historical chest HRCT may be used if performed within 90 days prior to Visit 1.
Active malignancy within one year prior to Visit 1 (except for non-melanoma skin cancer requiring local treatment).
Inability to complete full PFT (spirometry and DLCO) at Visit 1. Historical PFT may be used if performed within 90 days prior to Visit 1.
Taking nintedanib or nerandomilast at Visit 1.
Pregnancy at screening or plans to become pregnant during follow-up.
Participation in an interventional clinical trial for fibrotic ILD at the time of Visit 1, or receipt of an investigational drug within the previous 4 weeks of the enrollment visit (Visit 1) or 5 times the half-life, if longer.

What this trial measures

  • Transplant-free survival (TFS)12-months to 24-months (following an observation period from 0 months to 12 months)

    TFS is defined as the time from the 12-month pulmonary function tests to death or lung transplant. Censoring will occur at 12-months or earlier if lost to follow-up.