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New study aims to tame Nintedanib's gut side effects in lung disease

NCT ID NCT06714812

Knowledge-focused Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 observes 100 adults with idiopathic pulmonary fibrosis (IPF) who are taking the drug nintedanib. The goal is to understand who is more likely to get diarrhea as a side effect and to see if lowering the dose helps. Researchers will track diarrhea severity and how dose changes affect patients.

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

100 people

The number who actually took part.

Started

Aug 2023

Expected to finish

Dec 2025

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 treated with Nintedanib for IPF who are seen at the Interstitial Lung Disease Outpatient Clinic of the Pneumology and Respiratory Intensive Care Unit at the IRCCS Azienda Ospedaliero-Universitaria of Bologna, Policlinico di Sant'Orsola, and who have received the treatment for at least 12 consecutive months.

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: * Caucasian ethnicity; * Age ≥ 18 years; * Subjects with a diagnosis of IPF who started antifibrotic therapy with nintedanib on or after 01/06/2020. * Obtaining written informed consent Exclusion Criteria: * clinical and functional data not availbale

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Conditions

The condition(s) this trial relates to.

idiopathic pulmonary fibrosis

As listed by the trial registrant

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

IPF

Contacts and locations

Locations

  • IRCCS Azienda Ospedaliera-Universitaria di Bologna

    Bologna, Bologna, 40138, Italy

More trials for these conditions

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