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Can a breath test predict lung scarring? new study seeks answers

NCT ID NCT06644144

Knowledge-focused Sponsor: Amsterdam UMC, location VUmc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This observational study aims to find early biomarkers that can predict if a person's lung scarring (pulmonary fibrosis) will get worse quickly. Researchers will follow 450 adults with various types of interstitial lung disease, including IPF and other fibrotic conditions. Participants will provide blood samples, lung function tests, CT scans, and breath analysis over time. The goal is to better understand who is at risk for rapid decline and to improve personalized treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 450 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Oct 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The P4O2 ILD-extension is a non-interventional prospective observational cohort study that will include a minimum of 450 participants, divided intro three groups (1) 150 participants diagnosed with idiopathic pulmonary fibrosis (IPF) or familial pulmonary fibrosis (FPF); (2) 150 participants diagnosed with other fibrotic ILDs (fILD), including fibrotic hypersensitivity pneumonitis (fHP), idiopathic non-specific interstitial pneumonia (iNSIP), connective tissue disease (CTD)-ILD, and unclassifiable ILD (uILD); and (3) 150 participants diagnosed with interstitial lung abnormalities (ILA).

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

fibrotic hypersensitivity pneumonitis hypersensitivity pneumonitis idiopathic pulmonary fibrosis interstitial lung disease interstitial lung disease 2 non-specific interstitial pneumonia pulmonary fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic hypersensitivity pneumonitis CTD-ild Idiopathic nsip Interstitial lung disease Interstitial lung fibrosis IPF Pulmonary fibrosis Pulmonary fibrosis idiopathic familial Pulmonary fibrosis, idiopathic Unclassifiable ild

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Amsterdam UMC, locatie VUmc

    RECRUITING

    Amsterdam, North Holland, 1081 HV, Netherlands

More trials for these conditions

Other studies related to the condition(s) this trial covers.