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Can a daily pill cut dangerous lung Flare-Ups in bronchiectasis?

NCT ID NCT05238675

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time

Summary

This trial tests an experimental drug, BI 1291583, in adults with bronchiectasis who produce sputum and have a history of flare-ups. Participants are randomly assigned to one of three doses of the drug or a placebo, taken once daily for at least 24 weeks. The study measures how long it takes for the first flare-up to occur and tracks overall health and side effects.

What this could mean

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

Active substance
an experimental drug called BI 1291583 (verducatib)
What this could lead to
If it works, this could point toward a new treatment to reduce dangerous lung flare-ups in people with bronchiectasis.
What could go wrong
This is an early phase 2 trial, so the drug may not prove effective or could have side effects. Results may not apply to all 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.

Phase

Phase 2

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

Participants

322 people

The number who actually took part.

Started

Apr 2022

Finished

May 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 to 85 years

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: \- Male or female patients: Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly, as well as one barrier method. A list of contraception methods meeting these criteria is provided in the patient information. Men participating in this clinical trial must use male contraception (condom or sexual abstinence) if their sexual partner is a WOCBP. * Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation. * Age of patients when signing the informed consent ≥18 (for Korea: ≥19) and ≤85 years. * Clinical history consistent with bronchiectasis (e.g., cough, chronic sputum production and/or recurrent respiratory infections) and investigator confirmed diagnosis of bronchiectasis by computed tomography (CT) scan. Subjects whose past chest radiographic image records are not available will undergo a chest CT scan during Screening. Historical scans must not be older than 5 years. * History of pulmonary exacerbations requiring antibiotic treatment. In the 12 months before Visit 1, patients must have had either: * at least 2 exacerbations, or * at least 1 exacerbation and a 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 bronchiectasis, at least one exacerbation must have occurred since initiation of stable antibiotics. \- Current sputum producers with a history of chronic expectoration who are able to provide a spontaneous (not induced) sputum sample at Screening Visit 1. Exclusion Criteria: Laboratory and medical examination * Aspartate Aminotransferase (AST) and / or Alanine Aminotransferase (ALT) \>3.0 x upper limit of normal (ULN) at Visit 1, or moderate or severe liver disease (defined by Child-Pugh score B or C hepatic impairment). * Estimated glomerular filtration rate (eGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula \< 30 mL/min at Visit 1. * An absolute blood neutrophil count \<1,000/mm\^3 at Visit 1 (equivalent to \<1,000 cells/µL or \<109 cells/L). * Any findings in the medical examination and/or laboratory value assessed at Screening Visit 1 or during screening period, that in the opinion of the investigator may put the patient at risk by participating in the trial. * Positive serological tests for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection, or known infection status. Concomitant diagnosis and therapy * A current diagnosis of: * Cystic Fibrosis * Hypogammaglobulinemia * Common variable immunodeficiency * α1-antitrypsin deficiency being treated with augmentation therapy * Allergic bronchopulmonary aspergillosis being treated or requiring treatment * Tuberculosis or non-tuberculous mycobacterial infection being treated or requiring treatment according to local guidelines * Palmoplantar keratosis; or keratoderma climactericum * Hypothyroidism, myxedema, chronic lymphedema with associated hyperkeratosis of the skin, acrocyanosis. If a subject has hypothyroidism but is treated and compensated, the subject is allowed into the trial * Psoriasis affecting palms and soles; or body surface area for psoriasis ≥ 10% * Reactive arthritis (Reiter's syndrome); keratoderma blennorrhagicum * Pityriasis rubra pilaris * Atopic dermatitis affecting palms and soles; or body surface area for atopic dermatitis ≥ 10% * Active extensive verruca vulgaris, as per investigator's discretion * Active fungal infection of hand and/or feet not adequately treated, or not responsive to antifungal therapy, as per investigator's discretion. * Any clinically relevant (at the discretion of the investigator) acute respiratory infection within 4 weeks prior Visit 2, or any other acute infection requiring systemic or inhaled anti-infective therapy within 4 weeks prior Visit 2. * Any evidence of a concomitant disease, such as Papillon-Lefevre Syndrome, relevant pulmonary, gastrointestinal, hepatic, renal, cardiovascular, metabolic, immunological, hormonal disorders, or patients who are immunocompromised with a higher risk of invasive pneumococcal disease or other invasive opportunistic infections (such as histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis), that in the opinion of the investigator, may put the patient at risk by participating in the study. * Received any live attenuated vaccine within 4 weeks prior to Visit 2. * Medical conditions associated with periodontal disease (to be evaluated by a periodontist or dentist): * Any tooth that can potentially cause pain or infection as noted in the oral exam unless they are corrected before the study (e.g. pulp necrosis). * Severe periodontal disease defined as with pocket depth measurements ≥ 6 mm on 2 or more teeth. * Class-3 mobility or Class-3 furcation involvement. * Scheduled tooth extraction during the study period. * Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial. Further exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

bronchiectasis

As listed by the trial registrant

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

Bronchiectasis

Contacts and locations

Locations

  • A.O. Univ. Policlinico "Paolo Giaccone"

    Palermo, 90127, Italy

  • Aalborg Sygehus Syd

    Aalborg, 9000, Denmark

  • Accelerium S de RL de CV

    Monterrey, 64000, Mexico

  • Alergopneuma Medical Center

    Świdnik, 21040, Poland

  • Altamed Specjalistyczna Praktyka Lekarska Pawel Siwinski

    Warsaw, 01-456, Poland

  • Amsterdam UMC, location VUMC

    Amsterdam, 1081 HV, Netherlands

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Central Florida Pulmonary Group

    Altamonte Springs, Florida, 32701, United States

  • Centre Hospitalier de l'Universite de Montreal (CHUM)

    Montreal, Quebec, H2X 0A9, Canada

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117, Germany

  • Chungbuk National University Hospital

    Cheongju-si, 28644, South Korea

  • Clinical Research Institute S.C.

    Tlalnepantla, 54055, Mexico

  • Copenhagen University Hospital, Rigshospitalet

    København Ø, 2100, Denmark

  • Da Vinci Private Clinic

    Pécs, 7635, Hungary

  • Daugavpils Regional Hospital LTD Centre Outpatient Clinic

    Daugavpils, 5401, Latvia

  • Diagnostics Research Group

    San Antonio, Texas, 78229, United States

  • Dr. Piotr Napora, Center of Clinical Research

    Wroclaw, 51162, Poland

  • Fondazione IRCCS Policlinico S. Matteo

    Pavia, 27100, Italy

  • Fukujuji Hospital

    Tokyo, Kiyose, 204-8522, Japan

  • Fukuoka University Hospital

    Fukuoka, Fukuoka, 814-0180, Japan

  • Gelre Ziekenhuis Zutphen

    Zutphen, 7207 AE, Netherlands

  • HOP Amiens-Picardie Sud

    Amiens, 80054, France

  • HOP Arnaud de Villeneuve

    Montpellier, 34295, France

  • HOP Cochin

    Paris, 75679, France

  • HOP Pontchaillou

    Rennes, 35033, France

  • Hadassah Medical Center, Ein-Karem

    Jerusalem, 9112001, Israel

  • Hirosaki University Hospital

    Aomori, Hirosaki, 036-8563, Japan

  • Hospital Clínic de Barcelona

    Barcelona, 08036, Spain

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007, Spain

  • Hospital Quirónsalud Madrid

    Pozuelo de Alarcón, 28223, Spain

  • Hospital Universitario Dr Jose Eleuterio Gonzalez

    Nuevo León, 64460, Mexico

  • Hospital Universitario Nuevo de Nuevo León - CEPREP

    Monterrey, Nuevo León, C.P. 64460, Mexico

  • Hospital de Bellvitge

    L'Hospitalet de Llobregat, 08907, Spain

  • Hospital de Mérida

    Mérida, 06800, Spain

  • Hvidovre Hospital

    Hvidovre, 2650, Denmark

  • IKF Pneumologie GmbH & Co. KG

    Frankfurt, 60596, Germany

  • IUCPQ (Laval University)

    Québec, Quebec, G1V 4G5, Canada

  • Ibarakihigashi National Hospial

    Ibaraki, Naka-gun, 319-1113, Japan

  • Institute for Respiratory Health

    Nedlands, Western Australia, 6009, Australia

  • Institute for Translational Oncology Research

    Greenville, South Carolina, 29605, United States

  • Istituto Clinico Humanitas

    Rozzano (MI), 20089, Italy

  • Jewish General Hospital

    Montreal, Migration Data, H3T 1E2, Canada

  • Kagoshima University Hospital

    Kagoshima, Kagoshima, 890-8520, Japan

  • Kameda Clinic

    Chiba, Kamogawa, 296-0041, Japan

  • Kitasato Institute Hospital

    Tokyo, Minato-ku, 108-8642, Japan

  • Klinikum Konstanz

    Konstanz, 78464, Germany

  • Klinikum der Universität München - Campus Innenstadt

    München, 80336, Germany

  • Korea University Guro Hospital

    Seoul, 08308, South Korea

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812-8582, Japan

  • LUMPII Doctors practice

    Riga, 1011, Latvia

  • Lady Davis Carmel Medical Center

    Haifa, 3436212, Israel

  • Liverpool Heart & Chest Hospital

    Liverpool, L14 3PE, United Kingdom

  • Lung Research Queensland

    Chermside, Queensland, 4032, Australia

  • Lungenfachklinik Immenhausen

    Immenhausen, 34376, Germany

  • Macquarie University

    North Ryde, New South Wales, 2109, Australia

  • Malcom Randall VA Medical Center

    Gainesville, Florida, 32608, United States

  • Marmara University Pendik Training and Research Hospital

    Istanbul, 34890, Turkey (Türkiye)

  • Mater Research Institute

    South Brisbane, Queensland, 4101, Australia

  • Matsusaka City Hospital

    Mie, Matsusaka, 515-8544, Japan

  • Med.Center OLVI Health Center Assotiation,Private Practice

    Daugavpils, 5410, Latvia

  • Mediadvance Clinical S.A.P.I de C.V.

    Chihuahua City, 31203, Mexico

  • Medica Center Hera - Montana Branch

    Montana, 3400, Bulgaria

  • Medical Center "Zdrave-1"

    Kozloduy, 3320, Bulgaria

  • Medical Center Hera EOOD

    Sofia, 1510, Bulgaria

  • Medical Center ReSpiro Ltd

    Razgrad, 7200, Bulgaria

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Metroplex Pulmonary & Sleep Center

    McKinney, Texas, 75069, United States

  • Nagoya University Hospital

    Aichi, Nagoya, 466-8560, Japan

  • New York University Langone Medical Center

    New York, New York, 10016, United States

  • NewYork-Presbyterian/Weill Cornell Medical Center

    New York, New York, 10065, United States

  • Newport Native MD, Inc

    Newport Beach, California, 92663, United States

  • Niigata University Medical and Dental Hospital

    Niigata, Niigata, 951-8520, Japan

  • Ninewells Hospital & Medical School

    Dundee, Scotland, DD1 9SY, United Kingdom

  • Oaxaca Site Management Organization, S.C.

    Oaxaca City, 68000, Mexico

  • Odense University Hospital

    Odense, 5000 C, Denmark

  • Osaka Toneyama Medical Center

    Osaka, Toyonaka, 560-8552, Japan

  • Pauls Stradins Clinical University Hospital

    Riga, 1002, Latvia

  • Phoenix Medical Group

    Peoria, Arizona, 85381, United States

  • Pulmonary Private Practice Kralupy

    Kralupy nad Vltavou, 27801, Czechia

  • Respiratory Medicine Centre, private prac., Bialystok

    Bialystok, 15044, Poland

  • Riga 1st Hospital

    Riga, 1001, Latvia

  • Royal Papworth Hospital

    Cambridge, CB2 0AY, United Kingdom

  • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

    Essen, 45239, Germany

  • SHATPFD "Dr. Dimitar Gramatikov"

    Rousse, 7002, Bulgaria

  • SMG-SNU Boramae Medical Center

    Seoul, 156-707, South Korea

  • Saga University Hospital

    Saga, Saga, 849-8501, Japan

  • Screenmed Sp. z o.o.

    Piaseczno, 05500, Poland

  • Semmelweis University

    Budapest, 1083, Hungary

  • Sjællands Universitetshospital

    Roskilde, 4000, Denmark

  • Soroka Univ. Medical Center

    Beersheba, 8410101, Israel

  • Sourasky Medical Center

    Tel Aviv, 6093246, Israel

  • Southeastern Research Center

    Winston-Salem, North Carolina, 27103, United States

  • Sureyyapasa Egitim ve Arastirma Hastanesi

    Istanbul, 34890, Turkey (Türkiye)

  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital

    Seoul, 22711, South Korea

  • The First Pulmonary Private Practice

    Prague, 19000, Czechia

  • Trialswest

    Spearwood, Western Australia, 6153, Australia

  • ULS de Santa Maria, E.P.E

    Lisbon, 1064-035, Portugal

  • UNIV UZ Gent

    Ghent, 9000, Belgium

  • UZ Leuven

    Leuven, 3000, Belgium

  • Uludag Universitesi Tip Fakultesi

    Bursa, 16120, Turkey (Türkiye)

  • Univ. Gen. Hosp. of Ioannina

    Ioannina, 45 500, Greece

  • University of California Davis

    Sacramento, California, 95817, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45267, United States

  • University of Florida College of Medicine

    Jacksonville, Florida, 32209, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Texas Health Science Center at Tyler

    Tyler, Texas, 75708, United States

  • VCA Dubultu Medical center

    Jūrmala, 2015, Latvia

  • Vejle University Hospital

    Vejle, 7100, Denmark

  • Velocity Clinical Research Germany GmbH

    Großhansdorf, 22927, Germany

  • Velocity Clinical Research Germany GmbH

    Lübeck, 23552, Germany

  • Velocity Clinical Research Germany GmbH

    Wiesbaden, 65189, Germany

  • Westmead Hospital

    Westmead, New South Wales, 2145, Australia

More trials for these conditions

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