A Study to Test Whether Different Doses of BI 1291583 Help People With Bronchiectasis
Bronchiectasis
About this trial
This is an interventional treatment trial for Bronchiectasis
Eligibility Criteria
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.
- Acute respiratory infection (including SARS-CoV-2 infection), or any other acute infection requiring systemic or inhaled therapy within 4 weeks prior Visit 1 and throughout screening.
- 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
Sites / Locations
- Phoenix Medical Group
- Newport Native MD, Inc
- University of California Davis
- Central Florida Pulmonary Group
- Malcom Randall VA Medical Center
- University of Florida College of Medicine
- New York University Langone Medical Center
- NewYork-Presbyterian/Weill Cornell Medical Center
- Southeastern Research Center
- University of Cincinnati
- Medical University of South Carolina
- Institute for Translational Oncology Research
- Metroplex Pulmonary & Sleep Center
- Diagnostics Research Group
- University of Texas Health Science Center at Tyler
- Macquarie University
- Westmead Hospital
- Lung Research Queensland
- Mater Research Institute
- Institute for Respiratory Health
- Trialswest
- AZ Sint-Jan Brugge
- UNIV UZ Gent
- UZ Leuven
- Medical Center "Zdrave-1"
- Medica Center Hera - Montana Branch
- Medical Center ReSpiro Ltd
- SHATPFD "Dr. Dimitar Gramatikov"
- Medical Center Hera EOOD
- Jewish General Hospital
- Centre Hospitalier de l'Universite de Montreal (CHUM)
- IUCPQ (Laval University)
- Pulmonary Private Practice Kralupy
- The First Pulmonary Private Practice
- Hvidovre Hospital
- Copenhagen University Hospital, Rigshospitalet
- Odense University Hospital
- Sjællands Universitetshospital
- Vejle University Hospital
- Aalborg Sygehus Syd
- HOP Amiens-Picardie Sud
- HOP Arnaud de Villeneuve
- HOP Cochin
- HOP Pontchaillou
- HOP Perharidy
- Charité - Universitätsmedizin Berlin
- Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
- IKF Pneumologie GmbH & Co. KG
- Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
- Lungenfachklinik Immenhausen
- Klinikum Konstanz
- KLB Gesundheitsforschung Lübeck GmbH
- Klinikum der Universität München - Campus Innenstadt
- Velocity Clinical Research Germany GmbH
- Univ. Gen. Hosp. of Ioannina
- Univ. Gen. Hosp. of Patras
- Semmelweis University
- Pulmonology Institute of Veszprem County, Farkasgyepu
- Da Vinci Private Clinic
- Soroka Univ. Medical Center
- Lady Davis Carmel Medical Center
- Hadassah Medical Center, Ein-Karem
- Tel Aviv Sourasky Medical Center
- A.O. Univ. Policlinico "Paolo Giaccone"
- Fondazione IRCCS Policlinico S. Matteo
- Istituto Clinico Humanitas
- Nagoya University Hospital
- Hirosaki University Hospital
- Kameda Clinic
- Kyushu University Hospital
- Fukuoka University Hospital
- Ibarakihigashi National Hospial
- Kagoshima University Hospital
- Kochi Medical School Hospital
- Matsusaka City Hospital
- Niigata University Medical and Dental Hospital
- Osaka Toneyama Medical Center
- Saga University Hospital
- Tokyo Medical and Dental University Hospital
- Fukujuji Hospital
- Kitasato Institute Hospital
- Chungbuk National University Hospital
- Asan Medical Center
- Korea University Guro Hospital
- SMG-SNU Boramae Medical Center
- The Catholic University of Korea, Eunpyeong St. Mary's Hospital
- Daugavpils Regional Hospital LTD Centre Outpatient Clinic
- Med.Center OLVI Health Center Assotiation,Private Practice
- VCA Dubultu Medical center
- Riga 1st Hospital
- Pauls Stradins Clinical University Hospital
- LUMPII Doctors practice
- Mediadvance Clinical S.A.P.I de C.V.
- Hospital Universitario Nuevo de Nuevo León - CEPREP
- Accelerium S de RL de CV
- Hospital Universitario Dr Jose Eleuterio Gonzalez
- Oaxaca Site Management Organization, S.C.
- Clinical Research Institute S.C.
- Amsterdam UMC, Locatie AMC
- Gelre Ziekenhuis Zutphen
- Respiratory Medicine Centre, private prac., Bialystok
- Screenmed Sp. z o.o.
- Alergopneuma Medical Center
- Altamed Specjalistyczna Praktyka Lekarska Pawel Siwinski
- Dr. Piotr Napora, Center of Clinical Research
- Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital Santa Maria
- Hospital Clínic de Barcelona
- Hospital de Bellvitge
- Hospital General Universitario Gregorio Marañón
- Hospital de Mérida
- Hospital Quirónsalud Madrid
- Uludag Universitesi Tip Fakultesi
- Marmara University Pendik Training and Research Hospital
- Sureyyapasa Egitim ve Arastirma Hastanesi
- Royal Papworth Hospital
- Ninewells Hospital & Medical School
- Liverpool Heart & Chest Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
BI 1291583: Low dose group
BI 1291583: Medium dose group
BI 1291583: High dose group
Placebo