A Study to Test Whether Different Doses of BI 1291583 Help People With Bronchiectasis

Last updated: August 12, 2025
Sponsor: Boehringer Ingelheim
Overall Status: Completed

Phase

2

Condition

Bronchiectasis

Treatment

BI 1291583

Placebo

Clinical Study ID

NCT05238675
1397-0012
2021-003304-41
  • Ages 18-85
  • All Genders

Study Summary

This study is open to adults with bronchiectasis. People can join the study if they produce sputum and have a history of flare-ups (also called exacerbations).

The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis.

Participants are put into 4 groups randomly, which means by chance. Participants in groups 1, 2, and 3 get different doses of BI 1291583. Participants in group 4 get placebo. Placebo tablets look like BI 1291583 tablets, but do not contain any medicine. Participants take the tablets once a day.

Participants are in the study for between 6 months and 1 year. During this time, they visit the study site about 10 times and get about 5 phone calls from the site staff.

The doctors document when participants experience flare-ups during the study. The time to the first flare-ups is compared between the treatment groups. Doctors also regularly check participants' health and take note of any unwanted effects.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female patients: Women of childbearing potential (WOCBP) must be ready andable to use highly effective methods of birth control per ICH M3 (R2) that result ina low failure rate of less than 1% per year when used consistently and correctly, aswell as one barrier method. A list of contraception methods meeting these criteriais 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, inaccordance with Good Clinical Practice (GCP) and local legislation.

  • Age of patients when signing the informed consent ≥18 (for Korea: ≥19) and ≤85years.

  • Clinical history consistent with bronchiectasis (e.g., cough, chronic sputumproduction and/or recurrent respiratory infections) and investigator confirmeddiagnosis of bronchiectasis by computed tomography (CT) scan. Subjects whose pastchest radiographic image records are not available will undergo a chest CT scanduring Screening. Historical scans must not be older than 5 years.

  • History of pulmonary exacerbations requiring antibiotic treatment. In the 12 monthsbefore 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 toprovide a spontaneous (not induced) sputum sample at Screening Visit 1.

Exclusion

Exclusion Criteria:

Laboratory and medical examination

  • Aspartate Aminotransferase (AST) and / or Alanine Aminotransferase (ALT) >3.0 xupper limit of normal (ULN) at Visit 1, or moderate or severe liver disease (definedby Child-Pugh score B or C hepatic impairment).

  • Estimated glomerular filtration rate (eGFR) according to Chronic Kidney DiseaseEpidemiology Collaboration (CKD-EPI) formula < 30 mL/min at Visit 1.

  • An absolute blood neutrophil count <1,000/mm^3 at Visit 1 (equivalent to <1,000cells/µL or <109 cells/L).

  • Any findings in the medical examination and/or laboratory value assessed atScreening Visit 1 or during screening period, that in the opinion of theinvestigator may put the patient at risk by participating in the trial.

  • Positive serological tests for hepatitis B, hepatitis C, or human immunodeficiencyvirus (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 orrequiring treatment according to local guidelines

  • Palmoplantar keratosis; or keratoderma climactericum

  • Hypothyroidism, myxedema, chronic lymphedema with associated hyperkeratosis ofthe skin, acrocyanosis. If a subject has hypothyroidism but is treated andcompensated, 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 atopicdermatitis ≥ 10%

  • Active extensive verruca vulgaris, as per investigator's discretion

  • Active fungal infection of hand and/or feet not adequately treated, or notresponsive to antifungal therapy, as per investigator's discretion.

  • Any clinically relevant (at the discretion of the investigator) acute respiratoryinfection within 4 weeks prior Visit 2, or any other acute infection requiringsystemic or inhaled anti-infective therapy within 4 weeks prior Visit 2.

  • Any evidence of a concomitant disease, such as Papillon-Lefevre Syndrome, relevantpulmonary, gastrointestinal, hepatic, renal, cardiovascular, metabolic,immunological, hormonal disorders, or patients who are immunocompromised with ahigher risk of invasive pneumococcal disease or other invasive opportunisticinfections (such as histoplasmosis, listeriosis, coccidioidomycosis,pneumocystosis), that in the opinion of the investigator, may put the patient atrisk 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 aperiodontist or dentist):

  • Any tooth that can potentially cause pain or infection as noted in the oralexam 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 anydrug considered likely to interfere with the safe conduct of the trial.

Further exclusion criteria apply

Study Design

Total Participants: 322
Treatment Group(s): 2
Primary Treatment: BI 1291583
Phase: 2
Study Start date:
April 28, 2022
Estimated Completion Date:
May 30, 2024

Connect with a study center

  • Macquarie University

    North Ryde, New South Wales 2109
    Australia

    Site Not Available

  • Westmead Hospital

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • Lung Research Queensland

    Chermside, Queensland 4032
    Australia

    Site Not Available

  • Mater Research Institute

    South Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Institute for Respiratory Health

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Trialswest

    Spearwood, Western Australia 6153
    Australia

    Site Not Available

  • AZ Sint-Jan Brugge

    Brugge, 8000
    Belgium

    Site Not Available

  • UNIV UZ Gent

    Gent, 9000
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven, 3000
    Belgium

    Site Not Available

  • Medical Center "Zdrave-1"

    Kozloduy, 3320
    Bulgaria

    Site Not Available

  • Medica Center Hera - Montana Branch

    Montana, 3400
    Bulgaria

    Site Not Available

  • Medical Center ReSpiro Ltd

    Razgrad, 7200
    Bulgaria

    Site Not Available

  • SHATPFD "Dr. Dimitar Gramatikov"

    Ruse, 7002
    Bulgaria

    Site Not Available

  • Medical Center Hera EOOD

    Sofia, 1510
    Bulgaria

    Site Not Available

  • Cardio 1 Medical Clinic

    Winnipeg, Manitoba R3L 1Z5
    Canada

    Site Not Available

  • Jewish General Hospital

    Montreal, Migration Data H3T 1E2
    Canada

    Site Not Available

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

    Montreal, Quebec H2X 0A9
    Canada

    Site Not Available

  • IUCPQ (Laval University)

    Quebec, G1V 4G5
    Canada

    Site Not Available

  • Pulmonary Private Practice Kralupy

    Kralupy nad Vltavou, 27801
    Czechia

    Site Not Available

  • The First Pulmonary Private Practice

    Prague 9, 19000
    Czechia

    Site Not Available

  • Hvidovre Hospital

    Hvidovre, 2650
    Denmark

    Site Not Available

  • Copenhagen University Hospital, Rigshospitalet

    København Ø, 2100
    Denmark

    Site Not Available

  • Odense University Hospital

    Odense, 5000 C
    Denmark

    Site Not Available

  • Sjællands Universitetshospital

    Roskilde, 4000
    Denmark

    Site Not Available

  • Vejle University Hospital

    Vejle, 7100
    Denmark

    Site Not Available

  • Aalborg Sygehus Syd

    Ålborg, 9000
    Denmark

    Site Not Available

  • HOP Amiens-Picardie Sud

    Amiens, 80054
    France

    Site Not Available

  • HOP Arnaud de Villeneuve

    Montpellier, 34295
    France

    Site Not Available

  • HOP Cochin

    Paris, 75679
    France

    Site Not Available

  • HOP Pontchaillou

    Rennes, 35033
    France

    Site Not Available

  • HOP Perharidy

    Roscoff, 29680
    France

    Site Not Available

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117
    Germany

    Site Not Available

  • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

    Essen, 45239
    Germany

    Site Not Available

  • IKF Pneumologie GmbH & Co. KG

    Frankfurt, 60596
    Germany

    Site Not Available

  • Universitätsklinikum Freiburg

    Freiburg, 79106
    Germany

    Site Not Available

  • Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH

    Großhansdorf, 22927
    Germany

    Site Not Available

  • Velocity Clinical Research Germany GmbH

    Großhansdorf, 22927
    Germany

    Site Not Available

  • Lungenfachklinik Immenhausen

    Immenhausen, 34376
    Germany

    Site Not Available

  • Universitätsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, 24105
    Germany

    Site Not Available

  • Klinikum Konstanz

    Konstanz, 78464
    Germany

    Site Not Available

  • KLB Gesundheitsforschung Lübeck GmbH

    Lübeck, 23552
    Germany

    Site Not Available

  • Velocity Clinical Research Germany GmbH

    Lübeck, 23552
    Germany

    Site Not Available

  • Klinikum der Universität München - Campus Innenstadt

    München, 80336
    Germany

    Site Not Available

  • Intermed - Institut für med. Forschung u. Arzneimittelsicherheit GmbH

    Wiesbaden, 65189
    Germany

    Active - Recruiting

  • Velocity Clinical Research Germany GmbH

    Wiesbaden, 65189
    Germany

    Site Not Available

  • Univ. Gen. Hosp. of Ioannina

    Ioannina, 45 500
    Greece

    Site Not Available

  • Univ. Gen. Hosp. of Patras

    Patras, 26504
    Greece

    Site Not Available

  • Semmelweis University

    Budapest, 1083
    Hungary

    Site Not Available

  • Pulmonology Institute of Veszprem County, Farkasgyepu

    Farkasgyepu, 8582
    Hungary

    Site Not Available

  • Da Vinci Private Clinic

    Pecs, 7635
    Hungary

    Site Not Available

  • Soroka Univ. Medical Center

    Beer Sheva, 8410101
    Israel

    Site Not Available

  • Lady Davis Carmel Medical Center

    Haifa, 3436212
    Israel

    Site Not Available

  • Hadassah Medical Center, Ein-Karem

    Jerusalem, 9112001
    Israel

    Site Not Available

  • Rabin Medical Center Beilinson

    Petah Tikva, 4941492
    Israel

    Site Not Available

  • Sourasky Medical Center

    Tel Aviv, 6093246
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6093246
    Israel

    Site Not Available

  • Università degli Studi di Genova

    Genova, 16132
    Italy

    Site Not Available

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

    Palermo, 90127
    Italy

    Site Not Available

  • Fondazione IRCCS Policlinico S. Matteo

    Pavia, 27100
    Italy

    Site Not Available

  • Istituto Clinico Humanitas

    Rozzano (MI), 20089
    Italy

    Site Not Available

  • Nagoya University Hospital

    Aichi, Nagoya, 466-8560
    Japan

    Site Not Available

  • Hirosaki University Hospital

    Aomori, Hirosaki, 036-8563
    Japan

    Site Not Available

  • Kameda Clinic

    Chiba, Kamogawa, 296-0041
    Japan

    Site Not Available

  • Fukuoka University Hospital

    Fukuoka, Fukuoka, 814-0180
    Japan

    Site Not Available

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812-8582
    Japan

    Site Not Available

  • Ibarakihigashi National Hospial

    Ibaraki, Naka-gun, 319-1113
    Japan

    Site Not Available

  • Kagoshima University Hospital

    Kagoshima, Kagoshima, 890-8520
    Japan

    Site Not Available

  • Kochi Medical School Hospital

    Kochi, Nankoku, 783-8505
    Japan

    Site Not Available

  • Matsusaka City Hospital

    Mie, Matsusaka, 515-8544
    Japan

    Site Not Available

  • Niigata University Medical and Dental Hospital

    Niigata, Niigata, 951-8520
    Japan

    Site Not Available

  • Osaka Toneyama Medical Center

    Osaka, Toyonaka, 560-8552
    Japan

    Site Not Available

  • Saga University Hospital

    Saga, Saga, 849-8501
    Japan

    Site Not Available

  • Tokyo Medical and Dental University Hospital

    Tokyo, Bunkyo-ku, 113-8519
    Japan

    Site Not Available

  • Fukujuji Hospital

    Tokyo, Kiyose, 204-8522
    Japan

    Site Not Available

  • Kitasato Institute Hospital

    Tokyo, Minato-ku, 108-8642
    Japan

    Site Not Available

  • Chungbuk National University Hospital

    Cheongju, 28644
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Korea University Guro Hospital

    Seoul, 08308
    Korea, Republic of

    Site Not Available

  • SMG-SNU Boramae Medical Center

    Seoul, 156-707
    Korea, Republic of

    Site Not Available

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

    Seoul, 22711
    Korea, Republic of

    Site Not Available

  • Daugavpils Regional Hospital LTD Centre Outpatient Clinic

    Daugavpils, 5401
    Latvia

    Site Not Available

  • Med.Center OLVI Health Center Assotiation,Private Practice

    Daugavpils, 5410
    Latvia

    Site Not Available

  • VCA Dubultu Medical center

    Jurmala, 2015
    Latvia

    Site Not Available

  • LUMPII Doctors practice

    Riga, 1011
    Latvia

    Site Not Available

  • Pauls Stradins Clinical University Hospital

    Riga, 1002
    Latvia

    Site Not Available

  • Riga 1st Hospital

    Riga, 1001
    Latvia

    Site Not Available

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

    Chihuahua, 31203
    Mexico

    Site Not Available

  • Accelerium S de RL de CV

    Monterrey, 64000
    Mexico

    Site Not Available

  • Hospital Universitario Nuevo de Nuevo León - CEPREP

    Monterrey, Nuevo León, C.P. 64460
    Mexico

    Site Not Available

  • Hospital Universitario Dr Jose Eleuterio Gonzalez

    Nuevo Leon, 64460
    Mexico

    Site Not Available

  • Oaxaca Site Management Organization, S.C.

    Oaxaca, 68000
    Mexico

    Site Not Available

  • Clinical Research Institute S.C.

    Tlalnepantla, 54055
    Mexico

    Site Not Available

  • Amsterdam UMC, Locatie AMC

    Amsterdam, 1105 AZ
    Netherlands

    Site Not Available

  • Amsterdam UMC, location VUMC

    Amsterdam, 1081 HV
    Netherlands

    Site Not Available

  • Gelre Ziekenhuis Zutphen

    Zutphen, 7207 AE
    Netherlands

    Site Not Available

  • Respiratory Medicine Centre, private prac., Bialystok

    Bialystok, 15044
    Poland

    Site Not Available

  • Screenmed Sp. z o.o.

    Piaseczno, 05500
    Poland

    Site Not Available

  • Alergopneuma Medical Center

    Swidnik, 21040
    Poland

    Site Not Available

  • Altamed Specjalistyczna Praktyka Lekarska Pawel Siwinski

    Warszawa, 01-456
    Poland

    Site Not Available

  • Dr. Piotr Napora, Center of Clinical Research

    Wroclaw, 51162
    Poland

    Site Not Available

  • Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital Santa Maria

    Lisboa, 1064-035
    Portugal

    Site Not Available

  • ULS de Santa Maria, E.P.E

    Lisboa, 1064-035
    Portugal

    Site Not Available

  • Hospital Clínic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital de Bellvitge

    L'Hospitalet de Llobregat, 08907
    Spain

    Site Not Available

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital de Mérida

    Mérida, 06800
    Spain

    Site Not Available

  • Hospital Quirónsalud Madrid

    Pozuelo de Alarcón, 28223
    Spain

    Site Not Available

  • Uludag Universitesi Tip Fakultesi

    Bursa, 16120
    Turkey

    Site Not Available

  • Marmara University Pendik Training and Research Hospital

    Istanbul, 34890
    Turkey

    Site Not Available

  • Sureyyapasa Egitim ve Arastirma Hastanesi

    Istanbul, 34890
    Turkey

    Site Not Available

  • Royal Papworth Hospital

    Cambridge, CB2 0AY
    United Kingdom

    Site Not Available

  • Ninewells Hospital & Medical School

    Dundee, Scotland, DD1 9SY
    United Kingdom

    Site Not Available

  • Liverpool Heart & Chest Hospital

    Liverpool, L14 3PE
    United Kingdom

    Site Not Available

  • University Hospital Llandough

    Penarth, CF64 2XX
    United Kingdom

    Site Not Available

  • Jasper Summit Research, LLC

    Jasper, Alabama 35501
    United States

    Site Not Available

  • Phoenix Medical Group

    Peoria, Arizona 85381
    United States

    Site Not Available

  • Phoenix Medical Group, PC

    Peoria, Arizona 85381
    United States

    Active - Recruiting

  • Newport Native MD, Inc

    Newport Beach, California 92663
    United States

    Site Not Available

  • University of California Davis

    Sacramento, California 95817
    United States

    Site Not Available

  • Georgetown University

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Central Florida Pulmonary Group

    Altamonte Springs, Florida 32701
    United States

    Site Not Available

  • Malcom Randall VA Medical Center

    Gainesville, Florida 32608
    United States

    Site Not Available

  • University of Florida College of Medicine

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Lenox Hill Hospital

    New York, New York 10075
    United States

    Active - Recruiting

  • New York University Langone Medical Center

    New York, New York 10016
    United States

    Site Not Available

  • NewYork-Presbyterian/Weill Cornell Medical Center

    New York, New York 10065
    United States

    Site Not Available

  • Southeastern Research Center

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • University of Cincinnati

    Cincinnati, Ohio 45267
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Institute for Translational Oncology Research

    Greenville, South Carolina 29605
    United States

    Site Not Available

  • Metroplex Pulmonary & Sleep Center

    McKinney, Texas 75069
    United States

    Site Not Available

  • Diagnostics Research Group

    San Antonio, Texas 78229
    United States

    Site Not Available

  • University of Texas Health Science Center at Tyler

    Tyler, Texas 75708
    United States

    Site Not Available

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