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

A Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose-finding Study Evaluating Efficacy, Safety and Tolerability of BI 1291583 qd Over at Least 24 Weeks in Patients With Bronchiectasis (AirleafTM)

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.

Study Overview

• Status: Completed
• Conditions: Bronchiectasis
• Intervention / Treatment: Drug: Placebo; Drug: BI 1291583

• Study Type: Interventional
• Enrollment (Actual): 322
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • North Ryde, New South Wales, Australia, 2109
      • Macquarie University
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital
  • Queensland
    • Chermside, Queensland, Australia, 4032
      • Lung Research Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Mater Research Institute
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Institute for Respiratory Health
    • Spearwood, Western Australia, Australia, 6153
      • TrialsWest
• Belgium
  • Gent, Belgium, 9000
    • UNIV UZ Gent
  • Leuven, Belgium, 3000
    • UZ Leuven
• Bulgaria
  • Kozloduy, Bulgaria, 3320
    • Medical Center "Zdrave-1"
  • Montana, Bulgaria, 3400
    • Medica Center Hera - Montana Branch
  • Razgrad, Bulgaria, 7200
    • Medical Center ReSpiro Ltd
  • Ruse, Bulgaria, 7002
    • SHATPFD "Dr. Dimitar Gramatikov"
  • Sofia, Bulgaria, 1510
    • Medical Center Hera EOOD
• Canada
  • Quebec, Canada, G1V 4G5
    • IUCPQ (Laval University)
  • Migration Data
    • Montreal, Migration Data, Canada, H3T 1E2
      • Jewish General Hospital
  • Quebec
    • Montreal, Quebec, Canada, H2X 0A9
      • Centre Hospitalier de l'Universite de Montreal (CHUM)
• Czechia
  • Kralupy nad Vltavou, Czechia, 27801
    • Pulmonary Private Practice Kralupy
  • Prague 9, Czechia, 19000
    • The First Pulmonary Private Practice
• Denmark
  • Hvidovre, Denmark, 2650
    • Hvidovre Hospital
  • København Ø, Denmark, 2100
    • Copenhagen University Hospital, Rigshospitalet
  • Odense, Denmark, 5000 C
    • Odense University Hospital
  • Roskilde, Denmark, 4000
    • Sjællands Universitetshospital
  • Vejle, Denmark, 7100
    • Vejle University Hospital
  • Ålborg, Denmark, 9000
    • Aalborg Sygehus Syd
• France
  • Amiens, France, 80054
    • HOP Amiens-Picardie Sud
  • Montpellier, France, 34295
    • HOP Arnaud de Villeneuve
  • Paris, France, 75679
    • HOP Cochin
  • Rennes, France, 35033
    • HOP Pontchaillou
• Germany
  • Berlin, Germany, 10117
    • Charité - Universitätsmedizin Berlin
  • Essen, Germany, 45239
    • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
  • Frankfurt, Germany, 60596
    • IKF Pneumologie GmbH & Co. KG
  • Großhansdorf, Germany, 22927
    • Velocity Clinical Research Germany GmbH
  • Immenhausen, Germany, 34376
    • Lungenfachklinik Immenhausen
  • Konstanz, Germany, 78464
    • Klinikum Konstanz
  • Lübeck, Germany, 23552
    • Velocity Clinical Research Germany GmbH
  • München, Germany, 80336
    • Klinikum der Universität München - Campus Innenstadt
  • Wiesbaden, Germany, 65189
    • Velocity Clinical Research Germany GmbH
• Greece
  • Ioannina, Greece, 45 500
    • Univ. Gen. Hosp. of Ioannina
• Hungary
  • Budapest, Hungary, 1083
    • Semmelweis University
  • Pecs, Hungary, 7635
    • Da Vinci Private Clinic
• Israel
  • Beer Sheva, Israel, 8410101
    • Soroka Univ. Medical Center
  • Haifa, Israel, 3436212
    • Lady Davis Carmel Medical Center
  • Jerusalem, Israel, 9112001
    • Hadassah Medical Center, Ein-Karem
  • Tel Aviv, Israel, 6093246
    • Sourasky Medical Center
• Italy
  • Palermo, Italy, 90127
    • A.O. Univ. Policlinico "Paolo Giaccone"
  • Pavia, Italy, 27100
    • Fondazione IRCCS Policlinico S. Matteo
  • Rozzano (MI), Italy, 20089
    • Istituto Clinico Humanitas
• Japan
  • Aichi, Nagoya, Japan, 466-8560
    • Nagoya University Hospital
  • Aomori, Hirosaki, Japan, 036-8563
    • Hirosaki University Hospital
  • Chiba, Kamogawa, Japan, 296-0041
    • Kameda Clinic
  • Fukuoka, Fukuoka, Japan, 814-0180
    • Fukuoka University Hospital
  • Fukuoka, Fukuoka, Japan, 812-8582
    • Kyushu University Hospital
  • Ibaraki, Naka-gun, Japan, 319-1113
    • Ibarakihigashi National Hospial
  • Kagoshima, Kagoshima, Japan, 890-8520
    • Kagoshima University Hospital
  • Mie, Matsusaka, Japan, 515-8544
    • Matsusaka City Hospital
  • Niigata, Niigata, Japan, 951-8520
    • Niigata University Medical And Dental Hospital
  • Osaka, Toyonaka, Japan, 560-8552
    • Osaka Toneyama Medical Center
  • Saga, Saga, Japan, 849-8501
    • Saga University Hospital
  • Tokyo, Kiyose, Japan, 204-8522
    • Fukujuji Hospital
  • Tokyo, Minato-ku, Japan, 108-8642
    • Kitasato Institute Hospital
• Korea, Republic of
  • Cheongju, Korea, Republic of, 28644
    • Chungbuk National University Hospital
  • Seoul, Korea, Republic of, 156-707
    • SMG-SNU Boramae Medical Center
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 08308
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of, 22711
    • The Catholic University of Korea, Eunpyeong St. Mary's Hospital
• Latvia
  • Daugavpils, Latvia, 5401
    • Daugavpils Regional Hospital LTD Centre Outpatient Clinic
  • Daugavpils, Latvia, 5410
    • Med.Center OLVI Health Center Assotiation,Private Practice
  • Jurmala, Latvia, 2015
    • VCA Dubultu Medical center
  • Riga, Latvia, 1002
    • Pauls Stradins Clinical University Hospital
  • Riga, Latvia, 1001
    • Riga 1st Hospital
  • Riga, Latvia, 1011
    • LUMPII Doctors practice
• Mexico
  • Chihuahua, Mexico, 31203
    • Mediadvance Clinical S.A.P.I de C.V.
  • Monterrey, Mexico, 64000
    • Accelerium S de RL de CV
  • Monterrey, Nuevo León, Mexico, C.P. 64460
    • Hospital Universitario Nuevo de Nuevo León - CEPREP
  • Nuevo Leon, Mexico, 64460
    • Hospital Universitario Dr Jose Eleuterio Gonzalez
  • Oaxaca, Mexico, 68000
    • Oaxaca Site Management Organization, S.C.
  • Tlalnepantla, Mexico, 54055
    • Clinical Research Institute S.C.
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • Amsterdam UMC, location VUmc
  • Zutphen, Netherlands, 7207 AE
    • Gelre Ziekenhuis Zutphen
• Poland
  • Bialystok, Poland, 15044
    • Respiratory Medicine Centre, private prac., Bialystok
  • Piaseczno, Poland, 05500
    • Screenmed Sp. z o.o.
  • Swidnik, Poland, 21040
    • Alergopneuma Medical Center
  • Warszawa, Poland, 01-456
    • Altamed Specjalistyczna Praktyka Lekarska Pawel Siwinski
  • Wroclaw, Poland, 51162
    • Dr. Piotr Napora, Center of Clinical Research
• Portugal
  • Lisboa, Portugal, 1064-035
    • ULS de Santa Maria, E.P.E
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona
  • L'Hospitalet de Llobregat, Spain, 08907
    • Hospital De Bellvitge
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañon
  • Mérida, Spain, 06800
    • Hospital de Merida
  • Pozuelo de Alarcón, Spain, 28223
    • Hospital Quironsalud Madrid
• Turkey
  • Bursa, Turkey, 16120
    • Uludag Universitesi Tip Fakultesi
  • Istanbul, Turkey, 34890
    • Marmara University Pendik Training and Research Hospital
  • Istanbul, Turkey, 34890
    • Sureyyapasa Egitim ve Arastirma Hastanesi
• United Kingdom
  • Cambridge, United Kingdom, CB2 0AY
    • Royal Papworth Hospital
  • Dundee, Scotland, United Kingdom, DD1 9SY
    • Ninewells Hospital & Medical School
  • Liverpool, United Kingdom, L14 3PE
    • Liverpool Heart & Chest Hospital
• United States
  • Arizona
    • Peoria, Arizona, United States, 85381
      • Phoenix Medical Group
  • California
    • Newport Beach, California, United States, 92663
      • Newport Native MD, Inc
    • Sacramento, California, United States, 95817
      • University of California Davis
  • Florida
    • Altamonte Springs, Florida, United States, 32701
      • Central Florida Pulmonary Group
    • Gainesville, Florida, United States, 32608
      • Malcom Randall VA Medical Center
    • Jacksonville, Florida, United States, 32209
      • University of Florida College of Medicine
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • New York
    • New York, New York, United States, 10016
      • New York University Langone Medical Center
    • New York, New York, United States, 10065
      • NewYork-Presbyterian/Weill Cornell Medical Center
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Southeastern Research Center
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Greenville, South Carolina, United States, 29605
      • Institute for Translational Oncology Research
  • Texas
    • McKinney, Texas, United States, 75069
      • Metroplex Pulmonary & Sleep Center
    • San Antonio, Texas, United States, 78229
      • Diagnostics Research Group
    • Tyler, Texas, United States, 75708
      • University of Texas Health Science Center at Tyler

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo
Experimental: BI 1291583: Low dose group	Drug: BI 1291583; BI 1291583; Other Names: Verducatib
Experimental: BI 1291583: Medium dose group	Drug: BI 1291583; BI 1291583; Other Names: Verducatib
Experimental: BI 1291583: High dose group	Drug: BI 1291583; BI 1291583; Other Names: Verducatib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to first pulmonary exacerbation up to 48 weeks after first drug administration	Up to week 48

Secondary Outcome Measures

Outcome Measure	Time Frame
Key secondary: Rate of pulmonary exacerbations (number of events per person-time) up to week 48 after first drug administration	Up to week 48
Absolute change from baseline in Quality of Life Questionnaire - Bronchiectasis (QOLB) respiratory symptoms domain score at week 24 after first drug administration	At baseline and at week 24
Relative change from baseline in neutrophil elastase (NE) activity in sputum at week 12 after first drug administration	At baseline and at week 12
Absolute change from baseline in St. George's Respiratory Questionnaire (SGRQ) Symptoms score at week 24 after first drug administration	At baseline and at week 24
Absolute change from baseline in percent predicted post-bronchodilator forced expiratory volume in one second (FEV1%pred) at week 24 after first drug administration	At baseline and at week 24
Occurrence of an exacerbation by week 24 after first drug administration	Up to week 24

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2022
• Primary Completion (Actual): May 1, 2024
• Study Completion (Actual): May 30, 2024

Study Registration Dates

• First Submitted: February 3, 2022
• First Submitted That Met QC Criteria: February 3, 2022
• First Posted (Actual): February 14, 2022

Study Record Updates

• Last Update Posted (Actual): August 14, 2025
• Last Update Submitted That Met QC Criteria: August 12, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis
• Other Study ID Numbers: 1397-0012; 2021-003304-41 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link http://trials.boehringeringelheim.com/ to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

• IPD Sharing Time Frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
• IPD Sharing Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No