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NCT05238675

PHASE2

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

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

322

Start Date

2022-04-28

Completion Date

2024-05-30

Last Updated

2026-07-28

Healthy Volunteers

Conditions

Bronchiectasis

Interventions

DRUG

BI 1291583

DRUG

Placebo

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

Locations (112)

Phoenix Medical Group

Peoria, Arizona, United States

Newport Native MD, Inc

Newport Beach, California, United States

University of California Davis

Sacramento, California, United States

Central Florida Pulmonary Group

Altamonte Springs, Florida, United States

Malcom Randall VA Medical Center

Gainesville, Florida, United States

University of Florida College of Medicine

Jacksonville, Florida, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

New York University Langone Medical Center

New York, New York, United States

NewYork-Presbyterian/Weill Cornell Medical Center

New York, New York, United States

Southeastern Research Center

Winston-Salem, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Institute for Translational Oncology Research

Greenville, South Carolina, United States

Metroplex Pulmonary & Sleep Center

McKinney, Texas, United States

Diagnostics Research Group

San Antonio, Texas, United States

University of Texas Health Science Center at Tyler

Tyler, Texas, United States

Macquarie University

North Ryde, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Lung Research Queensland

Chermside, Queensland, Australia

Mater Research Institute

South Brisbane, Queensland, Australia

Institute for Respiratory Health

Nedlands, Western Australia, Australia

Trialswest

Spearwood, Western Australia, Australia

UNIV UZ Gent

Ghent, Belgium

UZ Leuven

Leuven, Belgium

Medical Center "Zdrave-1"

Kozloduy, Bulgaria

Medica Center Hera - Montana Branch

Montana, Bulgaria

Medical Center ReSpiro Ltd

Razgrad, Bulgaria

SHATPFD "Dr. Dimitar Gramatikov"

Rousse, Bulgaria

Medical Center Hera EOOD

Sofia, Bulgaria

Jewish General Hospital

Montreal, Migration Data, Canada

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, Canada

IUCPQ (Laval University)

Québec, Quebec, Canada

Pulmonary Private Practice Kralupy

Kralupy nad Vltavou, Czechia

The First Pulmonary Private Practice

Prague, Czechia

Aalborg Sygehus Syd

Aalborg, Denmark

Hvidovre Hospital

Hvidovre, Denmark

Copenhagen University Hospital, Rigshospitalet

København Ø, Denmark

Odense University Hospital

Odense, Denmark

Sjællands Universitetshospital

Roskilde, Denmark

Vejle University Hospital

Vejle, Denmark

HOP Amiens-Picardie Sud

Amiens, France

HOP Arnaud de Villeneuve

Montpellier, France

HOP Cochin

Paris, France

HOP Pontchaillou

Rennes, France

Charité - Universitätsmedizin Berlin

Berlin, Germany

Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH

Essen, Germany

IKF Pneumologie GmbH & Co. KG

Frankfurt, Germany

Velocity Clinical Research Germany GmbH

Großhansdorf, Germany

Lungenfachklinik Immenhausen

Immenhausen, Germany

Klinikum Konstanz

Konstanz, Germany

Velocity Clinical Research Germany GmbH

Lübeck, Germany

Klinikum der Universität München - Campus Innenstadt

München, Germany

Velocity Clinical Research Germany GmbH

Wiesbaden, Germany

Univ. Gen. Hosp. of Ioannina

Ioannina, Greece

Semmelweis University

Budapest, Hungary

Da Vinci Private Clinic

Pécs, Hungary

Soroka Univ. Medical Center

Beersheba, Israel

Lady Davis Carmel Medical Center

Haifa, Israel

Hadassah Medical Center, Ein-Karem

Jerusalem, Israel

Sourasky Medical Center

Tel Aviv, Israel

A.O. Univ. Policlinico "Paolo Giaccone"

Palermo, Italy

Fondazione IRCCS Policlinico S. Matteo

Pavia, Italy

Istituto Clinico Humanitas

Rozzano (MI), Italy

Nagoya University Hospital

Aichi, Nagoya, Japan

Hirosaki University Hospital

Aomori, Hirosaki, Japan

Kameda Clinic

Chiba, Kamogawa, Japan

Kyushu University Hospital

Fukuoka, Fukuoka, Japan

Fukuoka University Hospital

Fukuoka, Fukuoka, Japan

Ibarakihigashi National Hospial

Ibaraki, Naka-gun, Japan

Kagoshima University Hospital

Kagoshima, Kagoshima, Japan

Matsusaka City Hospital

Mie, Matsusaka, Japan

Niigata University Medical and Dental Hospital

Niigata, Niigata, Japan

Osaka Toneyama Medical Center

Osaka, Toyonaka, Japan

Saga University Hospital

Saga, Saga, Japan

Fukujuji Hospital

Tokyo, Kiyose, Japan

Kitasato Institute Hospital

Tokyo, Minato-ku, Japan

Daugavpils Regional Hospital LTD Centre Outpatient Clinic

Daugavpils, Latvia

Med.Center OLVI Health Center Assotiation,Private Practice

Daugavpils, Latvia

VCA Dubultu Medical center

Jūrmala, Latvia

Riga 1st Hospital

Riga, Latvia

Pauls Stradins Clinical University Hospital

Riga, Latvia

LUMPII Doctors practice

Riga, Latvia

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

Chihuahua City, Mexico

Accelerium S de RL de CV

Monterrey, Mexico

Hospital Universitario Nuevo de Nuevo León - CEPREP

Monterrey, Nuevo León, Mexico

Hospital Universitario Dr Jose Eleuterio Gonzalez

Nuevo León, Mexico

Oaxaca Site Management Organization, S.C.

Oaxaca City, Mexico

Clinical Research Institute S.C.

Tlalnepantla, Mexico

Amsterdam UMC, location VUMC

Amsterdam, Netherlands

Gelre Ziekenhuis Zutphen

Zutphen, Netherlands

Respiratory Medicine Centre, private prac., Bialystok

Bialystok, Poland

Screenmed Sp. z o.o.

Piaseczno, Poland

Alergopneuma Medical Center

Świdnik, Poland

Altamed Specjalistyczna Praktyka Lekarska Pawel Siwinski

Warsaw, Poland

Dr. Piotr Napora, Center of Clinical Research

Wroclaw, Poland

ULS de Santa Maria, E.P.E

Lisbon, Portugal

Chungbuk National University Hospital

Cheongju-si, South Korea

Asan Medical Center

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

SMG-SNU Boramae Medical Center

Seoul, South Korea

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

Seoul, South Korea

Hospital Clínic de Barcelona

Barcelona, Spain

Hospital de Bellvitge

L'Hospitalet de Llobregat, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Hospital de Mérida

Mérida, Spain

Hospital Quirónsalud Madrid

Pozuelo de Alarcón, Spain

Uludag Universitesi Tip Fakultesi

Bursa, Turkey (Türkiye)

Marmara University Pendik Training and Research Hospital

Istanbul, Turkey (Türkiye)

Sureyyapasa Egitim ve Arastirma Hastanesi

Istanbul, Turkey (Türkiye)

Royal Papworth Hospital

Cambridge, United Kingdom

Ninewells Hospital & Medical School

Dundee, Scotland, United Kingdom

Liverpool Heart & Chest Hospital

Liverpool, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (112)