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Lung function vs. symptoms: new study explores Nintedanib's Real-World impact

NCT ID NCT05151640

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 followed 158 adults with chronic fibrosing interstitial lung disease (a type of progressive lung scarring) who were starting treatment with nintedanib. Researchers wanted to see if changes in lung function (measured by forced vital capacity) over 52 weeks were linked to changes in cough and breathlessness, as reported by patients on a questionnaire. The goal is to better understand how nintedanib affects symptoms in everyday life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Nintedanib
What this could lead to
If successful, this could help doctors better understand how nintedanib affects symptoms like cough and breathlessness in people with progressive lung scarring.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may not apply to all patients with this condition.

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

158 people

The number who actually took part.

Started

Feb 2023

Finished

Sep 2025

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 chronic fibrosing Interstitial lung disease (ILD) with a progressive phenotype excluding Idiopathic Pulmonary Fibrosis (IPF) patients.

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: * Adults ≥ 18 years at Visit 1 * Subjects must be contractually capable and mentally able to understand and follow the instructions of the study personnel * Physician's diagnosis of chronic fibrosing Interstitial lung disease (ILD) with a progressive phenotype, except Idiopathic pulmonary fibrosis (IPF) * Initiation of nintedanib as first antifibrotic therapy according to physician´s decision which has been made as part of routine care prior to and independent of study inclusion * Outpatients not currently hospitalized with a life expectancy \> 12 months per investigator's assessment * Written informed consent prior to study participation * Current Forced vital capacity (FVC) measurement (taken within the last 3 months) available in the patient file * Women of childbearing potential must take appropriate precautions against getting pregnant during the intake of nintedanib. Exclusion Criteria: * Patients with contraindications according to Summary of product characteristics (SmPC) * Prior use of any antifibrotic treatment * Lack of informed consent * Pregnant or lactating females * Any physician diagnosed exacerbation of Interstitial lung disease (ILD) in the patient's history file, irrespective of time since event * Current diagnosis of lung cancer * Respiratory failure (pH \< 7,35 and/ or respiratory rate \> 30/min) in the patient's history * Participation in a parallel interventional clinical trial * Patients being spouse or lateral relatives to the second degree or economically dependent from the investigator

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Conditions

The condition(s) this trial relates to.

idiopathic pulmonary fibrosis 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

  • Acibadem City Clinic Tokuda University Hospital EAD

    Sofia, 1407, Bulgaria

  • Biomedical Centers Sp. z o.o.

    Warsaw, 00-844, Poland

  • Bronz Media SRL

    Cluj-Napoca, 400015, Romania

  • Centre Hospitalier Universitaire Vaudois (CHUV)

    Lausanne, 1011, Switzerland

  • Doctor 4 Sim Srl

    Cluj-Napoca, 400428, Romania

  • Dr. Belaconi I. Ionela-Nicoleta - Medic Specialist Pneumologie

    Bucharest, 32582, Romania

  • Dr. Fira-Mladinescu SRL

    Timișoara, 300451, Romania

  • Dr. Ion Cantacuzino Clinical Hospital

    Bucharest, 020475, Romania

  • Dr. Toma Claudia Lucia - Medic Primar Pneumologie

    Bucharest, 41651, Romania

  • Fakultni Nemocnice Plzen

    Pilsen, 30100, Czechia

  • HOCH Health Ostschweiz

    Sankt Gallen, CH-9007, Switzerland

  • Hanna Jagielska Len IPL

    Zielona Góra, 65-101, Poland

  • IPL Michał Krawczyk

    Lodz, 94-053, Poland

  • Iasis Srl

    Timișoara, 300708, Romania

  • Indywidualna SPL Małgorzata Noceń-Piskorowska

    Szczecin, 70-205, Poland

  • Medical Military Academy MHAT Sofia

    Sofia, 1606, Bulgaria

  • Mirosław Nęcki SPL

    Krakow, 31-618, Poland

  • Nemocnice AGEL Novy Jicin a.s.

    Nový Jičín, 74101, Czechia

  • PFI Ramazan Ana-Maria

    Constanța, 900377, Romania

  • Pneumo Research Srl

    Moşniţa Nouă, 307285, Romania

  • Prywatna Praktyka Lekarska Paweł Piesiak

    Wroclaw, 50-521, Poland

  • Sc Pneumo Clinic Dantes Srl

    Constanța, 900629, Romania

  • Somed Cr Sp. z o.o. sp.k.

    Lodz, 90-368, Poland

  • Spital De Pneumologie Dr. Lavinia Davidescu S.R.L.

    Oradea, 410155, Romania

  • Strambu I. Irina-Ruxandra - Activitate Medicala

    Bucharest, 10991, Romania

  • Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy

    Bydgoszcz, 85-168, Poland

  • Thomayer University Hospital

    Prague, 140 59, Czechia

  • University Hospital Brno

    Brno, 625 00, Czechia

  • University Hospital Brno

    Brno, 62500, Czechia

  • University Hospital Ostrava

    Ostrava-Poruba, 708 52, Czechia

  • Universitätsspital Basel

    Basel, CH - 4031, Switzerland

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