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Breath test reveals hidden lung damage in IPF patients

NCT ID NCT07312305

Knowledge-focused Sponsor: University of Milan 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study looks at whether people newly diagnosed with idiopathic pulmonary fibrosis (IPF) have problems in their small airways, which are tiny air passages in the lungs. Researchers will use a simple breath test called nitrogen washout to check for these issues before starting any medication. About 100 adults with IPF and a group of healthy volunteers will take part, and the results will help doctors better understand how IPF affects the lungs.

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 100 people

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

Started

May 2025

Expected to finish

May 2027

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

Patients with IPF of any severity diagnosed according to the 2022 ATS/ERS/JRS/ALAT guidelines, attending the specialist outpatient clinics of the Pulmonology Units of ASST Santi Paolo e Carlo and ASST Fatebenefratelli-Sacco (Milan, Italy).

Ages

18 years and older

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: * Age over 18 years * IPF of any degree of severity, diagnosed according to the 2022 ATS/ERS/JRS/ALAT guidelines Exclusion Criteria: * Refusal to participate in the study * Patients unable to provide informed consent for participation in the study * IPF exacerbation in the 6 months prior to enrollment * Previous diagnosis of chronic airway disease (e.g., bronchial asthma, chronic obstructive bronchitis, bronchiectasis with a cause other than IPF) * Presence of bronchial obstruction defined by an FEV1/FVC (or FEV1/VC) ratio below the lower limit of normal * Chronic therapy with long-acting bronchodilators or combinations of bronchodilators and inhaled corticosteroids * Inability of the patient to perform reproducible pulmonary function tests * Chronic treatment with systemic corticosteroids or immunosuppressants * Concomitant lung or pleural cancer * Pregnancy or breastfeeding women

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease idiopathic pulmonary fibrosis

As listed by the trial registrant

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

Idiopathic pulmonary fibrosis Small airways disease

How to take part

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

  1. The places running it

    2 sites. 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

  • Division of Respiratory Diseases, L. Sacco University Hospital, ASST Fatebenefratelli-Sacco, Milan, Italy. Department of Biomedical and Clinical Sciences, Università Degli Studi di Milano, Milano, Italy

    RECRUITING

    Milan, Lombardy, Italy

  • Pulmonology Unit, ASST Santi Paolo e Carlo. Department of Health Sciences, University of Milan, Milan (Italy)

    RECRUITING

    Milan, Lombardy, 20142, Italy

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