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BronchiectasisPhase 2NCT05238675

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

A Phase 2 study testing BI 1291583 in people with Bronchiectasis, run by Boehringer Ingelheim at 112 sites in 23 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Bronchiectasis
What is being tested?
BI 1291583
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
322 participants
Where
112 sitesin 23 countries
Study dates
28 Apr 2022to 30 May 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.
Show all 32Show fewer
  • 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

Trial locations and contacts

112 sites in 23 countries.

112 sites in 23 countries

United States16 sites

  • Central Florida Pulmonary Group

    Altamonte Springs, Florida, 32701

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Malcom Randall VA Medical Center

    Gainesville, Florida, 32608

  • Institute for Translational Oncology Research

    Greenville, South Carolina, 29605

  • University of Florida College of Medicine

    Jacksonville, Florida, 32209

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Metroplex Pulmonary & Sleep Center

    McKinney, Texas, 75069

  • New York University Langone Medical Center

    New York, New York, 10016

  • NewYork-Presbyterian/Weill Cornell Medical Center

    New York, New York, 10065

  • Newport Native MD, Inc

    Newport Beach, California, 92663

  • Phoenix Medical Group

    Peoria, Arizona, 85381

  • University of California Davis

    Sacramento, California, 95817

  • Diagnostics Research Group

    San Antonio, Texas, 78229

  • University of Texas Health Science Center at Tyler

    Tyler, Texas, 75708

  • Southeastern Research Center

    Winston-Salem, North Carolina, 27103

Other trials in United States

Japan13 sites

  • Nagoya University Hospital

    Aichi, Nagoya, 466-8560

  • Hirosaki University Hospital

    Aomori, Hirosaki, 036-8563

  • Kameda Clinic

    Chiba, Kamogawa, 296-0041

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812-8582

  • Fukuoka University Hospital

    Fukuoka, Fukuoka, 814-0180

  • Ibarakihigashi National Hospial

    Ibaraki, Naka-gun, 319-1113

  • Kagoshima University Hospital

    Kagoshima, Kagoshima, 890-8520

  • Matsusaka City Hospital

    Mie, Matsusaka, 515-8544

  • Niigata University Medical and Dental Hospital

    Niigata, Niigata, 951-8520

  • Osaka Toneyama Medical Center

    Osaka, Toyonaka, 560-8552

  • Saga University Hospital

    Saga, Saga, 849-8501

  • Fukujuji Hospital

    Tokyo, Kiyose, 204-8522

  • Kitasato Institute Hospital

    Tokyo, Minato-ku, 108-8642

Other trials in Japan

Germany9 sites

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117

  • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

    Essen, 45239

  • IKF Pneumologie GmbH & Co. KG

    Frankfurt, 60596

  • Velocity Clinical Research Germany GmbH

    Großhansdorf, 22927

  • Lungenfachklinik Immenhausen

    Immenhausen, 34376

  • Klinikum Konstanz

    Konstanz, 78464

  • Velocity Clinical Research Germany GmbH

    Lübeck, 23552

  • Klinikum der Universität München - Campus Innenstadt

    München, 80336

  • Velocity Clinical Research Germany GmbH

    Wiesbaden, 65189

Other trials in Germany

Australia6 sites

  • Lung Research Queensland

    Chermside, Queensland, 4032

  • Institute for Respiratory Health

    Nedlands, Western Australia, 6009

  • Macquarie University

    North Ryde, New South Wales, 2109

  • Mater Research Institute

    South Brisbane, Queensland, 4101

  • Trialswest

    Spearwood, Western Australia, 6153

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Denmark6 sites

  • Aalborg Sygehus Syd

    Aalborg, 9000

  • Hvidovre Hospital

    Hvidovre, 2650

  • Copenhagen University Hospital, Rigshospitalet

    København Ø, 2100

  • Odense University Hospital

    Odense, 5000 C

  • Sjællands Universitetshospital

    Roskilde, 4000

  • Vejle University Hospital

    Vejle, 7100

Other trials in Denmark

Latvia6 sites

  • Daugavpils Regional Hospital LTD Centre Outpatient Clinic

    Daugavpils, 5401

  • Med.Center OLVI Health Center Assotiation,Private Practice

    Daugavpils, 5410

  • VCA Dubultu Medical center

    Jūrmala, 2015

  • Riga 1st Hospital

    Riga, 1001

  • Pauls Stradins Clinical University Hospital

    Riga, 1002

  • LUMPII Doctors practice

    Riga, 1011

Other trials in Latvia

Mexico6 sites

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

    Chihuahua City, 31203

  • Accelerium S de RL de CV

    Monterrey, 64000

  • Hospital Universitario Nuevo de Nuevo León - CEPREP

    Monterrey, Nuevo León, C.P. 64460

  • Hospital Universitario Dr Jose Eleuterio Gonzalez

    Nuevo León, 64460

  • Oaxaca Site Management Organization, S.C.

    Oaxaca City, 68000

  • Clinical Research Institute S.C.

    Tlalnepantla, 54055

Other trials in Mexico

Bulgaria5 sites

  • Medical Center "Zdrave-1"

    Kozloduy, 3320

  • Medica Center Hera - Montana Branch

    Montana, 3400

  • Medical Center ReSpiro Ltd

    Razgrad, 7200

  • SHATPFD "Dr. Dimitar Gramatikov"

    Rousse, 7002

  • Medical Center Hera EOOD

    Sofia, 1510

Other trials in Bulgaria

Poland5 sites

  • Respiratory Medicine Centre, private prac., Bialystok

    Bialystok, 15044

  • Screenmed Sp. z o.o.

    Piaseczno, 05500

  • Alergopneuma Medical Center

    Świdnik, 21040

  • Altamed Specjalistyczna Praktyka Lekarska Pawel Siwinski

    Warsaw, 01-456

  • Dr. Piotr Napora, Center of Clinical Research

    Wroclaw, 51162

Other trials in Poland

South Korea5 sites

  • Chungbuk National University Hospital

    Cheongju-si, 28644

  • Asan Medical Center

    Seoul, 05505

  • Korea University Guro Hospital

    Seoul, 08308

  • SMG-SNU Boramae Medical Center

    Seoul, 156-707

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

    Seoul, 22711

Other trials in South Korea

Spain5 sites

  • Hospital Clínic de Barcelona

    Barcelona, 08036

  • Hospital de Bellvitge

    L'Hospitalet de Llobregat, 08907

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital de Mérida

    Mérida, 06800

  • Hospital Quirónsalud Madrid

    Pozuelo de Alarcón, 28223

Other trials in Spain

France4 sites

  • HOP Amiens-Picardie Sud

    Amiens, 80054

  • HOP Arnaud de Villeneuve

    Montpellier, 34295

  • HOP Cochin

    Paris, 75679

  • HOP Pontchaillou

    Rennes, 35033

Other trials in France

Israel4 sites

  • Soroka Univ. Medical Center

    Beersheba, 8410101

  • Lady Davis Carmel Medical Center

    Haifa, 3436212

  • Hadassah Medical Center, Ein-Karem

    Jerusalem, 9112001

  • Sourasky Medical Center

    Tel Aviv, 6093246

Other trials in Israel

Canada3 sites

  • Jewish General Hospital

    Montreal, Migration Data, H3T 1E2

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

    Montreal, Quebec, H2X 0A9

  • IUCPQ (Laval University)

    Québec, Quebec, G1V 4G5

Other trials in Canada

Italy3 sites

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

    Palermo, 90127

  • Fondazione IRCCS Policlinico S. Matteo

    Pavia, 27100

  • Istituto Clinico Humanitas

    Rozzano (MI), 20089

Other trials in Italy

Turkey (Türkiye)3 sites

  • Uludag Universitesi Tip Fakultesi

    Bursa, 16120

  • Marmara University Pendik Training and Research Hospital

    Istanbul, 34890

  • Sureyyapasa Egitim ve Arastirma Hastanesi

    Istanbul, 34890

Other trials in Turkey (Türkiye)

United Kingdom3 sites

  • Royal Papworth Hospital

    Cambridge, CB2 0AY

  • Ninewells Hospital & Medical School

    Dundee, Scotland, DD1 9SY

  • Liverpool Heart & Chest Hospital

    Liverpool, L14 3PE

Other trials in United Kingdom

Belgium2 sites

  • UNIV UZ Gent

    Ghent, 9000

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

Czechia2 sites

  • Pulmonary Private Practice Kralupy

    Kralupy nad Vltavou, 27801

  • The First Pulmonary Private Practice

    Prague, 19000

Other trials in Czechia

Hungary2 sites

  • Semmelweis University

    Budapest, 1083

  • Da Vinci Private Clinic

    Pécs, 7635

Other trials in Hungary

Netherlands2 sites

  • Amsterdam UMC, location VUMC

    Amsterdam, 1081 HV

  • Gelre Ziekenhuis Zutphen

    Zutphen, 7207 AE

Other trials in Netherlands

Greece1 site

  • Univ. Gen. Hosp. of Ioannina

    Ioannina, 45 500

Other trials in Greece

Portugal1 site

  • ULS de Santa Maria, E.P.E

    Lisbon, 1064-035

Other trials in Portugal

About this study

Official title: 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.

Read more

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.

Conditions
Bronchiectasis
Being tested
BI 1291583, Placebo
Medical subject headings
Bronchiectasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BI 1291583Drug

    Also called Verducatib

    BI 1291583

  • PlaceboDrug

    Placebo

Study groups in NCT05238675
Study groupRoleWhat they receive
BI 1291583: Low dose groupExperimentalNot described
Receives: Drug: BI 1291583
BI 1291583: Medium dose groupExperimentalNot described
Receives: Drug: BI 1291583
BI 1291583: High dose groupExperimentalNot described
Receives: Drug: BI 1291583
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to first pulmonary exacerbation up to 48 weeks after first drug administration

    Measured: Up to week 48

Secondary outcomes (6)

  1. Key secondary: Rate of pulmonary exacerbations (number of events per person-time) up to week 48 after first drug administration

    Measured: Up to week 48

  2. Absolute change from baseline in Quality of Life Questionnaire - Bronchiectasis (QOLB) respiratory symptoms domain score at week 24 after first drug administration

    Measured: At baseline and at week 24

  3. Relative change from baseline in neutrophil elastase (NE) activity in sputum at week 12 after first drug administration

    Measured: At baseline and at week 12

  4. Absolute change from baseline in St. George's Respiratory Questionnaire (SGRQ) Symptoms score at week 24 after first drug administration

    Measured: At baseline and at week 24

  5. Absolute change from baseline in percent predicted post-bronchodilator forced expiratory volume in one second (FEV1%pred) at week 24 after first drug administration

    Measured: At baseline and at week 24

  6. Occurrence of an exacerbation by week 24 after first drug administration

    Measured: Up to week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2022
  2. Study start28 Apr 2022
  3. Primary completion1 May 2024
  4. Study completion30 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
322 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05238675
Sponsor's protocol ID
1397-0012
Other IDs
2021-003304-41
Status last verified
Aug 2025
First submitted
3 Feb 2022
Last updated
28 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can 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.

Publications

  • Chalmers JD, Shteinberg M, Mall MA, O'Donnell AE, Watz H, Gupta A, Frahm E, Eleftheraki A, Rauch J, Chotirmall SH, Armstrong AW, Eickholz P, Hasegawa N, Sauter W, McShane PJ. Cathepsin C (dipeptidyl peptidase 1) inhibition in adults with bronchiectasis: AIRLEAF, a phase II randomised, double-blind, placebo-controlled, dose-finding study. Eur Respir J. 2025 Jan 2;65(1):2401551. doi: 10.1183/13993003.01551-2024. Print 2025 Jan.

    PubMed 39255990

  • Badorrek P, Diefenbach C, Kogler H, Eleftheraki A, Seitz F, Hohlfeld JM. Novel cathepsin C inhibitor, BI 1291583, intended for treatment of bronchiectasis: Phase I characterization in healthy volunteers. Clin Transl Sci. 2024 Aug;17(8):e13891. doi: 10.1111/cts.13891.

    PubMed 39175217

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BI 1291583 in people with Bronchiectasis, run by Boehringer Ingelheim at 112 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 112 sites in United States, Japan, Germany, Australia, Denmark and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to first pulmonary exacerbation up to 48 weeks after first drug administration (time frame: Up to week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05238675, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.

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