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New pill for cystic fibrosis lung disease tested in small trial

NCT ID NCT05865886

Disease control 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested a new medicine called BI 1291583 in 22 adults with cystic fibrosis bronchiectasis, a lung condition that causes coughing and infections. Participants took one tablet daily for 12 weeks, and the study checked if the medicine was safe and well-tolerated. The trial was completed and aimed to gather early safety data.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

22 people

The number who actually took part.

Started

Apr 2024

Finished

Oct 2024

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.

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: 1. Age of patients when signing the informed consent ≥18 years 2. Historical clinical diagnosis of Cystic fibrosis (CF) (symptoms of CF and sweat chloride ≥ 60 mmol/L and/or 2 CF-causing Cystic fibrosis transmembrane conductance regulator (CFTR) mutations) 3. Investigator-confirmed diagnosis of Bronchiectasis (BE) by Computed tomography (CT) scan and clinical history consistent with BE (e.g., cough, chronic sputum production, recurrent respiratory infections). Subjects whose past chest CT records are not available will undergo a chest CT scan during Screening. Historical scans must not be older than 5 years 4. History of pulmonary exacerbations requiring antibiotic treatment. In the 12 months before Visit 1, patients must have had either: 1. at least 2 exacerbations, or 2. at least 1 exacerbation and an St. George's Respiratory Questionnaire (SGRQ) Symptoms score of \>40 at screening visit 1 For patients on stable oral or inhaled antibiotics as chronic treatment for BE, at least one exacerbation must have occurred while on stable antibiotics. 5. Patients must be able to provide spontaneous or induced sputum samples. Further inclusion criteria apply. Exclusion Criteria: 1. Moderate or severe liver disease (defined by Child-Pugh score B or C hepatic impairment) or Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT) \> 3.0x Upper limit of normal (ULN) at Visit 1 2. Estimated glomerular filtration rate (eGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula \< 30 mL/min at Visit 1 3. Absolute blood neutrophil count \< 1,000/mm\^3 (equivalent to \< 1000 cells/μL or \< 10\^9 cells/L) at Visit 1 4. Any findings in the medical examination (including blood pressure (BP), pulse rate (PR), or electrocardiogram (ECG)) and/or laboratory value assessed at Visit 1 or during screening period that in the opinion of the investigator may put the patient at risk by participating in the trial 5. Positive serological tests for hepatitis B, hepatitis C (also confirmed with Hepatitis C virus ribonucleic acid (HCV RNA)), or human immunodeficiency virus (HIV) infection, or known infection status. Further exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

bronchiectasis cystic fibrosis

As listed by the trial registrant

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

Bronchiectasis Cystic fibrosis

Contacts and locations

Locations

  • AOU San Luigi Gonzaga

    Orbassano (TO), 10043, Italy

  • Amsterdam UMC, location VUMC

    Amsterdam, 1081 HV, Netherlands

  • Azienda Ospedaliera Meyer

    Florence, 50139, Italy

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona, 37126, Italy

  • Brussels - UNIV UZ Brussel

    Brussels, 1090, Belgium

  • Central Florida Pulmonary Group

    Altamonte Springs, Florida, 32701, United States

  • Charité - Universitätsmedizin Berlin

    Berlin, 13353, Germany

  • Chest Medicine Associates

    South Portland, Maine, 04106, United States

  • Columbia University Medical Center-New York Presbyterian Hospital

    New York, New York, 10032, United States

  • HOP Arnaud de Villeneuve

    Montpellier, 34295, France

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28049, Spain

  • Hôpital Charles Nicolle

    Rouen, 76031, France

  • Hôpital Cochin

    Paris, 75679, France

  • IRCCS Fondazione Ospedale Maggiore

    Milan, 20122, Italy

  • Istituto G. Gaslini

    Genova, 16147, Italy

  • Klinikum der Universität München AÖR

    München, 80336, Germany

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • National Jewish Health

    Denver, Colorado, 80206, United States

  • Northwell Health Physician Partners

    New York, New York, 10028, United States

  • Oregon Health and Sciences University

    Portland, Oregon, 97239, United States

  • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

    Essen, 45239, Germany

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX, Netherlands

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