Phase
Condition
Bronchiectasis
Treatment
BI 1291583
Placebo
Clinical Study ID
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or female patients: Women of childbearing potential (WOCBP) must be ready andable to use highly effective methods of birth control per ICH M3 (R2) that result ina low failure rate of less than 1% per year when used consistently and correctly, aswell as one barrier method. A list of contraception methods meeting these criteriais 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, inaccordance with Good Clinical Practice (GCP) and local legislation.
Age of patients when signing the informed consent ≥18 (for Korea: ≥19) and ≤85years.
Clinical history consistent with bronchiectasis (e.g., cough, chronic sputumproduction and/or recurrent respiratory infections) and investigator confirmeddiagnosis of bronchiectasis by computed tomography (CT) scan. Subjects whose pastchest radiographic image records are not available will undergo a chest CT scanduring Screening. Historical scans must not be older than 5 years.
History of pulmonary exacerbations requiring antibiotic treatment. In the 12 monthsbefore 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 toprovide a spontaneous (not induced) sputum sample at Screening Visit 1.
Exclusion
Exclusion Criteria:
Laboratory and medical examination
Aspartate Aminotransferase (AST) and / or Alanine Aminotransferase (ALT) >3.0 xupper limit of normal (ULN) at Visit 1, or moderate or severe liver disease (definedby Child-Pugh score B or C hepatic impairment).
Estimated glomerular filtration rate (eGFR) according to Chronic Kidney DiseaseEpidemiology Collaboration (CKD-EPI) formula < 30 mL/min at Visit 1.
An absolute blood neutrophil count <1,000/mm^3 at Visit 1 (equivalent to <1,000cells/µL or <109 cells/L).
Any findings in the medical examination and/or laboratory value assessed atScreening Visit 1 or during screening period, that in the opinion of theinvestigator may put the patient at risk by participating in the trial.
Positive serological tests for hepatitis B, hepatitis C, or human immunodeficiencyvirus (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 orrequiring treatment according to local guidelines
Palmoplantar keratosis; or keratoderma climactericum
Hypothyroidism, myxedema, chronic lymphedema with associated hyperkeratosis ofthe skin, acrocyanosis. If a subject has hypothyroidism but is treated andcompensated, 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 atopicdermatitis ≥ 10%
Active extensive verruca vulgaris, as per investigator's discretion
Active fungal infection of hand and/or feet not adequately treated, or notresponsive to antifungal therapy, as per investigator's discretion.
Any clinically relevant (at the discretion of the investigator) acute respiratoryinfection within 4 weeks prior Visit 2, or any other acute infection requiringsystemic or inhaled anti-infective therapy within 4 weeks prior Visit 2.
Any evidence of a concomitant disease, such as Papillon-Lefevre Syndrome, relevantpulmonary, gastrointestinal, hepatic, renal, cardiovascular, metabolic,immunological, hormonal disorders, or patients who are immunocompromised with ahigher risk of invasive pneumococcal disease or other invasive opportunisticinfections (such as histoplasmosis, listeriosis, coccidioidomycosis,pneumocystosis), that in the opinion of the investigator, may put the patient atrisk 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 aperiodontist or dentist):
Any tooth that can potentially cause pain or infection as noted in the oralexam 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 anydrug considered likely to interfere with the safe conduct of the trial.
Further exclusion criteria apply
Study Design
Connect with a study center
Macquarie University
North Ryde, New South Wales 2109
AustraliaSite Not Available
Westmead Hospital
Westmead, New South Wales 2145
AustraliaSite Not Available
Lung Research Queensland
Chermside, Queensland 4032
AustraliaSite Not Available
Mater Research Institute
South Brisbane, Queensland 4101
AustraliaSite Not Available
Institute for Respiratory Health
Nedlands, Western Australia 6009
AustraliaSite Not Available
Trialswest
Spearwood, Western Australia 6153
AustraliaSite Not Available
AZ Sint-Jan Brugge
Brugge, 8000
BelgiumSite Not Available
UNIV UZ Gent
Gent, 9000
BelgiumSite Not Available
UZ Leuven
Leuven, 3000
BelgiumSite Not Available
Medical Center "Zdrave-1"
Kozloduy, 3320
BulgariaSite Not Available
Medica Center Hera - Montana Branch
Montana, 3400
BulgariaSite Not Available
Medical Center ReSpiro Ltd
Razgrad, 7200
BulgariaSite Not Available
SHATPFD "Dr. Dimitar Gramatikov"
Ruse, 7002
BulgariaSite Not Available
Medical Center Hera EOOD
Sofia, 1510
BulgariaSite Not Available
Cardio 1 Medical Clinic
Winnipeg, Manitoba R3L 1Z5
CanadaSite Not Available
Jewish General Hospital
Montreal, Migration Data H3T 1E2
CanadaSite Not Available
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec H2X 0A9
CanadaSite Not Available
IUCPQ (Laval University)
Quebec, G1V 4G5
CanadaSite Not Available
Pulmonary Private Practice Kralupy
Kralupy nad Vltavou, 27801
CzechiaSite Not Available
The First Pulmonary Private Practice
Prague 9, 19000
CzechiaSite Not Available
Hvidovre Hospital
Hvidovre, 2650
DenmarkSite Not Available
Copenhagen University Hospital, Rigshospitalet
København Ø, 2100
DenmarkSite Not Available
Odense University Hospital
Odense, 5000 C
DenmarkSite Not Available
Sjællands Universitetshospital
Roskilde, 4000
DenmarkSite Not Available
Vejle University Hospital
Vejle, 7100
DenmarkSite Not Available
Aalborg Sygehus Syd
Ålborg, 9000
DenmarkSite Not Available
HOP Amiens-Picardie Sud
Amiens, 80054
FranceSite Not Available
HOP Arnaud de Villeneuve
Montpellier, 34295
FranceSite Not Available
HOP Cochin
Paris, 75679
FranceSite Not Available
HOP Pontchaillou
Rennes, 35033
FranceSite Not Available
HOP Perharidy
Roscoff, 29680
FranceSite Not Available
Charité - Universitätsmedizin Berlin
Berlin, 10117
GermanySite Not Available
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, 45239
GermanySite Not Available
IKF Pneumologie GmbH & Co. KG
Frankfurt, 60596
GermanySite Not Available
Universitätsklinikum Freiburg
Freiburg, 79106
GermanySite Not Available
Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
Großhansdorf, 22927
GermanySite Not Available
Velocity Clinical Research Germany GmbH
Großhansdorf, 22927
GermanySite Not Available
Lungenfachklinik Immenhausen
Immenhausen, 34376
GermanySite Not Available
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Kiel, 24105
GermanySite Not Available
Klinikum Konstanz
Konstanz, 78464
GermanySite Not Available
KLB Gesundheitsforschung Lübeck GmbH
Lübeck, 23552
GermanySite Not Available
Velocity Clinical Research Germany GmbH
Lübeck, 23552
GermanySite Not Available
Klinikum der Universität München - Campus Innenstadt
München, 80336
GermanySite Not Available
Intermed - Institut für med. Forschung u. Arzneimittelsicherheit GmbH
Wiesbaden, 65189
GermanyActive - Recruiting
Velocity Clinical Research Germany GmbH
Wiesbaden, 65189
GermanySite Not Available
Univ. Gen. Hosp. of Ioannina
Ioannina, 45 500
GreeceSite Not Available
Univ. Gen. Hosp. of Patras
Patras, 26504
GreeceSite Not Available
Semmelweis University
Budapest, 1083
HungarySite Not Available
Pulmonology Institute of Veszprem County, Farkasgyepu
Farkasgyepu, 8582
HungarySite Not Available
Da Vinci Private Clinic
Pecs, 7635
HungarySite Not Available
Soroka Univ. Medical Center
Beer Sheva, 8410101
IsraelSite Not Available
Lady Davis Carmel Medical Center
Haifa, 3436212
IsraelSite Not Available
Hadassah Medical Center, Ein-Karem
Jerusalem, 9112001
IsraelSite Not Available
Rabin Medical Center Beilinson
Petah Tikva, 4941492
IsraelSite Not Available
Sourasky Medical Center
Tel Aviv, 6093246
IsraelSite Not Available
Tel Aviv Sourasky Medical Center
Tel Aviv, 6093246
IsraelSite Not Available
Università degli Studi di Genova
Genova, 16132
ItalySite Not Available
A.O. Univ. Policlinico "Paolo Giaccone"
Palermo, 90127
ItalySite Not Available
Fondazione IRCCS Policlinico S. Matteo
Pavia, 27100
ItalySite Not Available
Istituto Clinico Humanitas
Rozzano (MI), 20089
ItalySite Not Available
Nagoya University Hospital
Aichi, Nagoya, 466-8560
JapanSite Not Available
Hirosaki University Hospital
Aomori, Hirosaki, 036-8563
JapanSite Not Available
Kameda Clinic
Chiba, Kamogawa, 296-0041
JapanSite Not Available
Fukuoka University Hospital
Fukuoka, Fukuoka, 814-0180
JapanSite Not Available
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582
JapanSite Not Available
Ibarakihigashi National Hospial
Ibaraki, Naka-gun, 319-1113
JapanSite Not Available
Kagoshima University Hospital
Kagoshima, Kagoshima, 890-8520
JapanSite Not Available
Kochi Medical School Hospital
Kochi, Nankoku, 783-8505
JapanSite Not Available
Matsusaka City Hospital
Mie, Matsusaka, 515-8544
JapanSite Not Available
Niigata University Medical and Dental Hospital
Niigata, Niigata, 951-8520
JapanSite Not Available
Osaka Toneyama Medical Center
Osaka, Toyonaka, 560-8552
JapanSite Not Available
Saga University Hospital
Saga, Saga, 849-8501
JapanSite Not Available
Tokyo Medical and Dental University Hospital
Tokyo, Bunkyo-ku, 113-8519
JapanSite Not Available
Fukujuji Hospital
Tokyo, Kiyose, 204-8522
JapanSite Not Available
Kitasato Institute Hospital
Tokyo, Minato-ku, 108-8642
JapanSite Not Available
Chungbuk National University Hospital
Cheongju, 28644
Korea, Republic ofSite Not Available
Asan Medical Center
Seoul, 05505
Korea, Republic ofSite Not Available
Korea University Guro Hospital
Seoul, 08308
Korea, Republic ofSite Not Available
SMG-SNU Boramae Medical Center
Seoul, 156-707
Korea, Republic ofSite Not Available
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, 22711
Korea, Republic ofSite Not Available
Daugavpils Regional Hospital LTD Centre Outpatient Clinic
Daugavpils, 5401
LatviaSite Not Available
Med.Center OLVI Health Center Assotiation,Private Practice
Daugavpils, 5410
LatviaSite Not Available
VCA Dubultu Medical center
Jurmala, 2015
LatviaSite Not Available
LUMPII Doctors practice
Riga, 1011
LatviaSite Not Available
Pauls Stradins Clinical University Hospital
Riga, 1002
LatviaSite Not Available
Riga 1st Hospital
Riga, 1001
LatviaSite Not Available
Mediadvance Clinical S.A.P.I de C.V.
Chihuahua, 31203
MexicoSite Not Available
Accelerium S de RL de CV
Monterrey, 64000
MexicoSite Not Available
Hospital Universitario Nuevo de Nuevo León - CEPREP
Monterrey, Nuevo León, C.P. 64460
MexicoSite Not Available
Hospital Universitario Dr Jose Eleuterio Gonzalez
Nuevo Leon, 64460
MexicoSite Not Available
Oaxaca Site Management Organization, S.C.
Oaxaca, 68000
MexicoSite Not Available
Clinical Research Institute S.C.
Tlalnepantla, 54055
MexicoSite Not Available
Amsterdam UMC, Locatie AMC
Amsterdam, 1105 AZ
NetherlandsSite Not Available
Amsterdam UMC, location VUMC
Amsterdam, 1081 HV
NetherlandsSite Not Available
Gelre Ziekenhuis Zutphen
Zutphen, 7207 AE
NetherlandsSite Not Available
Respiratory Medicine Centre, private prac., Bialystok
Bialystok, 15044
PolandSite Not Available
Screenmed Sp. z o.o.
Piaseczno, 05500
PolandSite Not Available
Alergopneuma Medical Center
Swidnik, 21040
PolandSite Not Available
Altamed Specjalistyczna Praktyka Lekarska Pawel Siwinski
Warszawa, 01-456
PolandSite Not Available
Dr. Piotr Napora, Center of Clinical Research
Wroclaw, 51162
PolandSite Not Available
Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital Santa Maria
Lisboa, 1064-035
PortugalSite Not Available
ULS de Santa Maria, E.P.E
Lisboa, 1064-035
PortugalSite Not Available
Hospital Clínic de Barcelona
Barcelona, 08036
SpainSite Not Available
Hospital de Bellvitge
L'Hospitalet de Llobregat, 08907
SpainSite Not Available
Hospital General Universitario Gregorio Marañón
Madrid, 28007
SpainSite Not Available
Hospital de Mérida
Mérida, 06800
SpainSite Not Available
Hospital Quirónsalud Madrid
Pozuelo de Alarcón, 28223
SpainSite Not Available
Uludag Universitesi Tip Fakultesi
Bursa, 16120
TurkeySite Not Available
Marmara University Pendik Training and Research Hospital
Istanbul, 34890
TurkeySite Not Available
Sureyyapasa Egitim ve Arastirma Hastanesi
Istanbul, 34890
TurkeySite Not Available
Royal Papworth Hospital
Cambridge, CB2 0AY
United KingdomSite Not Available
Ninewells Hospital & Medical School
Dundee, Scotland, DD1 9SY
United KingdomSite Not Available
Liverpool Heart & Chest Hospital
Liverpool, L14 3PE
United KingdomSite Not Available
University Hospital Llandough
Penarth, CF64 2XX
United KingdomSite Not Available
Jasper Summit Research, LLC
Jasper, Alabama 35501
United StatesSite Not Available
Phoenix Medical Group
Peoria, Arizona 85381
United StatesSite Not Available
Phoenix Medical Group, PC
Peoria, Arizona 85381
United StatesActive - Recruiting
Newport Native MD, Inc
Newport Beach, California 92663
United StatesSite Not Available
University of California Davis
Sacramento, California 95817
United StatesSite Not Available
Georgetown University
Washington, District of Columbia 20007
United StatesSite Not Available
Central Florida Pulmonary Group
Altamonte Springs, Florida 32701
United StatesSite Not Available
Malcom Randall VA Medical Center
Gainesville, Florida 32608
United StatesSite Not Available
University of Florida College of Medicine
Jacksonville, Florida 32209
United StatesSite Not Available
University of Kansas Medical Center
Kansas City, Kansas 66160
United StatesSite Not Available
Lenox Hill Hospital
New York, New York 10075
United StatesActive - Recruiting
New York University Langone Medical Center
New York, New York 10016
United StatesSite Not Available
NewYork-Presbyterian/Weill Cornell Medical Center
New York, New York 10065
United StatesSite Not Available
Southeastern Research Center
Winston-Salem, North Carolina 27103
United StatesSite Not Available
University of Cincinnati
Cincinnati, Ohio 45267
United StatesSite Not Available
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
Institute for Translational Oncology Research
Greenville, South Carolina 29605
United StatesSite Not Available
Metroplex Pulmonary & Sleep Center
McKinney, Texas 75069
United StatesSite Not Available
Diagnostics Research Group
San Antonio, Texas 78229
United StatesSite Not Available
University of Texas Health Science Center at Tyler
Tyler, Texas 75708
United StatesSite Not Available
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