A Study to Test Whether Different Doses of BI 1291583 Help People With Bronchiectasis
- Registration Number
- NCT05238675
- Lead Sponsor
- Boehringer Ingelheim
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 322
- 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.
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Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation.
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Age of patients when signing the informed consent ≥18 (for Korea: ≥19) and ≤85 years.
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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.
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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.
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
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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.
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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.
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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.
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Received any live attenuated vaccine within 4 weeks prior to Visit 2.
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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.
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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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - BI 1291583: Medium dose group BI 1291583 - BI 1291583: High dose group BI 1291583 - BI 1291583: Low dose group BI 1291583 -
- Primary Outcome Measures
Name Time Method Time to first pulmonary exacerbation up to 48 weeks after first drug administration Up to week 48
- Secondary Outcome Measures
Name Time Method Occurrence of an exacerbation by week 24 after first drug administration Up to week 24 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 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 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 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
Trial Locations
- Locations (110)
Amsterdam UMC, location VUMC
🇳🇱Amsterdam, Netherlands
Hospital de Mérida
🇪🇸Mérida, Spain
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
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
New York University Langone Medical Center
🇺🇸New York, New York, United States
Hospital Quirónsalud Madrid
🇪🇸Pozuelo de Alarcón, Spain
Uludag Universitesi Tip Fakultesi
🇹🇷Bursa, Turkey
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
Sureyyapasa Egitim ve Arastirma Hastanesi
🇹🇷Istanbul, Turkey
Pulmonary Private Practice Kralupy
🇨🇿Kralupy nad Vltavou, Czechia
The First Pulmonary Private Practice
🇨🇿Prague 9, Czechia
Centre Hospitalier de l'Universite de Montreal (CHUM)
🇨🇦Montreal, Quebec, Canada
Matsusaka City Hospital
🇯🇵Mie, Matsusaka, Japan
IUCPQ (Laval University)
🇨🇦Quebec, Canada
Niigata University Medical and Dental Hospital
🇯🇵Niigata, Niigata, Japan
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
🇧🇪Gent, 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"
🇧🇬Ruse, Bulgaria
Medical Center Hera EOOD
🇧🇬Sofia, Bulgaria
Jewish General Hospital
🇨🇦Montreal, Migration Data, Canada
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
Aalborg Sygehus Syd
🇩🇰Ålborg, 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
🇩🇪Wiesbaden, Germany
Lungenfachklinik Immenhausen
🇩🇪Immenhausen, Germany
Klinikum Konstanz
🇩🇪Konstanz, Germany
Klinikum der Universität München - Campus Innenstadt
🇩🇪München, Germany
Univ. Gen. Hosp. of Ioannina
🇬🇷Ioannina, Greece
Semmelweis University
🇭🇺Budapest, Hungary
Da Vinci Private Clinic
🇭🇺Pecs, Hungary
Soroka Univ. Medical Center
🇮🇱Beer Sheva, 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
Chungbuk National University Hospital
🇰🇷Cheongju, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
SMG-SNU Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Daugavpils Regional Hospital LTD Centre Outpatient Clinic
🇱🇻Daugavpils, Latvia
Med.Center OLVI Health Center Assotiation,Private Practice
🇱🇻Daugavpils, Latvia
VCA Dubultu Medical center
🇱🇻Jurmala, 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, Mexico
Hospital Universitario Nuevo de Nuevo León - CEPREP
🇲🇽Monterrey, Nuevo León, Mexico
Accelerium S de RL de CV
🇲🇽Monterrey, Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
🇲🇽Nuevo Leon, Mexico
Oaxaca Site Management Organization, S.C.
🇲🇽Oaxaca, Mexico
Clinical Research Institute S.C.
🇲🇽Tlalnepantla, Mexico
Gelre Ziekenhuis Zutphen
🇳🇱Zutphen, Netherlands
Respiratory Medicine Centre, private prac., Bialystok
🇵🇱Bialystok, Poland
Screenmed Sp. z o.o.
🇵🇱Piaseczno, Poland
Alergopneuma Medical Center
🇵🇱Swidnik, Poland
Altamed Specjalistyczna Praktyka Lekarska Pawel Siwinski
🇵🇱Warszawa, Poland
Dr. Piotr Napora, Center of Clinical Research
🇵🇱Wroclaw, Poland
ULS de Santa Maria, E.P.E
🇵🇹Lisboa, Portugal
Hospital Clínic de Barcelona
🇪🇸Barcelona, Spain
Hospital de Bellvitge
🇪🇸L'Hospitalet de Llobregat, Spain
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Marmara University Pendik Training and Research Hospital
🇹🇷Istanbul, Turkey
Royal Papworth Hospital
🇬🇧Cambridge, United Kingdom
Ninewells Hospital & Medical School
🇬🇧Dundee, Scotland, United Kingdom
Liverpool Heart & Chest Hospital
🇬🇧Liverpool, United Kingdom