Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New study tracks lung function and symptoms in fibrosis patients on nintedanib

NCT ID NCT05503030

Knowledge-focused Sponsor: Boehringer Ingelheim 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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 looked at 88 adults with connective tissue disease-related lung scarring who were prescribed nintedanib. Researchers measured changes in lung function and tracked cough and breathlessness using a questionnaire over 24 months. The goal was to see if improvements in lung function matched up with fewer symptoms in everyday life.

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

88 people

The number who actually took part.

Started

Dec 2022

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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 physician-diagnosed interstitial lung disease (ILD) must fulfil at least one of the following criteria for progressive fibrosing (PF)-ILD within the previous period and up to two years before the screening, despite standard treatment to treat ILD: * Clinically significant decline in forced vital capacity (FVC) percentage (%) predicted based on a relative decline of ≥ 10% * The marginal decline in FVC % predicted based on a relative decline of ≥ 5-\< 10% combined with worsening respiratory symptoms * The marginal decline in FVC % predicted based on a relative decline of ≥ 5-\< 10% combined with increasing extent of fibrotic changes on chest imaging * Worsening of respiratory symptoms as well as increasing extent of fibrotic changes on chest imaging All patients will need to be treatment naïve concerning antifibrotic treatments (i.e., nintedanib or pirfenidone) before initiating nintedanib. Enrolment period will be 24 months, and each participant will be observed for 24 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: * Age ≥18 years with a confirmed physician diagnosis of connective tissue disease (CTD) associated Progressive Fibrosing Interstitial Lung Disease (PF-ILD) * Have been prescribed nintedanib according to the local Summary of Product Characteristics (SmPC) and clinical judgment. Therapy with nintedanib must have been started for clinical reasons independently from the intended patient enrolment into the study at a maximum of 15 days before enrolment into the trial. Exclusion Criteria: * Patients currently receiving treatment with any investigational drug/device/intervention or who have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) before the commencement of therapy with nintedanib * Patients at baseline with a known condition or reason that will result in withdrawal from the study before the 24-month time point * Pregnancy or lactation

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Lung diseases, interstitial are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

interstitial lung disease

As listed by the trial registrant

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

Lung diseases, interstitial

Contacts and locations

Locations

  • "ATTIKON" University General Hospital

    Athens, 12462, Greece

  • "G. Gennimatas" General Hospital of Athens

    Athens, 11527, Greece

  • "G. Papanikolaou" General University of Thessaloniki

    Thessaloniki, 57010, Greece

  • "Hippokration" General Hospital of Thessaloniki

    Thessaloniki, 54642, Greece

  • "Ippokration" General Hospital of Athens

    Athens, 11527, Greece

  • "KAT" General Hospital

    Athens, 14561, Greece

  • "Laiko" General Hospital of Athens

    Athens, 11527, Greece

  • Private physician

    Athens, 10676, Greece

  • Private physician

    Athens, 11362, Greece

  • Private physician

    Athens, 11634, Greece

  • Private physician

    Ioannina, 45332, Greece

  • Private physician

    Larissa, 41222, Greece

  • Private physician

    Nea Smirni, Athens, 17121, Greece

  • Private physician

    Pátrai, 26504, Greece

  • Private physician

    Thessaloniki, 54622, Greece

  • University General Hospital of Heraklion

    Heraklion, 71003, Greece

  • University General Hospital of Heraklion

    Heraklion, 71110, Greece

  • University General Hospital of Ioannina

    Ioannina, 45500, Greece

  • University General Hospital of Larisa

    Larissa, 41334, Greece

  • University General Hospital of Patra

    Pátrai, 26504, Greece

More trials for these conditions

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