Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

A Study to Learn How Well People With Bronchiectasis Tolerate Continued Treatment With Verducatib After Earlier Studies (AIRTIVITY®-ON)

30. oktober 2026 oppdatert av: Boehringer Ingelheim

An Open-label, Roll-over Study Evaluating the Long-term Safety and Efficacy of an Oral Dose of Verducatib q.d. in Patients With Bronchiectasis (AIRTIVITY®-ON)

This study is for adults and adolescents who are at least 12 years old and have bronchiectasis. People can participate if they completed a previous study with the study medicine called verducatib. The purpose of this study is to find out how well verducatib is tolerated when people with bronchiectasis take it for a long time. The study also looks at breathing problems, how often lung flare-ups happen, and how quickly lung function changes.

This is a roll-over study for participants who completed a previous study with verducatib: AIRTIVITY® (1397-0014) or CLAIRLEAF® (1397-0017). All participants receive verducatib. Participants take verducatib as tablets once a day at home. They may continue their usual treatment for bronchiectasis during the study.

Participants can stay in the study for up to 1 year and 9 months. Treatment with verducatib can continue for up to 1 year and 6 months. About 6 study visits are done at the study site and about 4 are done by phone. At all visits, the doctors check participants' health and collect information on any health problems that occur during the study. The doctors also look at lung flare-ups and measure lung function over time.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

1500

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Argentina
      • Alberdi Sur, Argentina, X5003DCE
        • Instituto de Medicina Respiratoria (IMeR)
        • Ta kontakt med:
      • Buenos Aires, Argentina, C1128AAF
      • CABA, Argentina, C1428BNF
      • CABA, Argentina, 1425
        • Centro de Investigacion Clinica Belgrano
        • Ta kontakt med:
      • CABA, Argentina, 1182
        • Fundacion NIBA Neurologia Infantil Buenos Aires
        • Ta kontakt med:
      • Capital Federal, Argentina, C1118AAT
      • Ciudad Autonoma Buenos Aires, Argentina, C1046AAQ
      • Mar del Plata, Argentina, 7600
        • Instituto Ave Pulmo - Fundacion Enfisema
        • Ta kontakt med:
      • Quilmes, Argentina, B1878FNR
      • Rosario, Argentina, 2000
        • Instituto de Especialidades de la Salud Rosario
        • Ta kontakt med:
      • Santa Fe, Argentina, 3000
  • Belgia
      • Brussels, Belgia, 1200
      • Ghent, Belgia, 9000
      • Leuven, Belgia, 3000
      • Sint-Niklaas, Belgia, 9100
  • Brasil
      • Barra Mansa, Brasil, 27323240
        • Serviços Medicos Respirar Sul Fluminense
        • Ta kontakt med:
      • Botucatu, Brasil, 18618-687
        • Faculdade de Medicina de Botucatu - UNESP
        • Ta kontakt med:
      • Brasília, Brasil, 72145-450
      • Goiânia, Brasil, 74605-020
        • HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
        • Ta kontakt med:
      • Porto Alegre, Brasil, 90035-074
        • Irmandade da Santa Casa de Misericórdia de Porto Alegre
        • Ta kontakt med:
      • São Bernardo do Campo, Brasil, 09750-420
        • Netspiro Clinica Medica Ltda - Respsono
        • Ta kontakt med:
      • São Paulo, Brasil, 05403-000
        • INCOR e Hospital das Clínicas da Universidade de São Paulo
        • Ta kontakt med:
  • Bulgaria
      • Kozloduy, Bulgaria, 3320
      • Montana, Bulgaria, 3400
      • Pernik, Bulgaria, 2300
      • Plovdiv, Bulgaria, 4023
      • Razgrad, Bulgaria, 7200
      • Rousse, Bulgaria, 7002
        • Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov-Ruse
        • Ta kontakt med:
      • Sofia, Bulgaria, 1510
      • Sofia, Bulgaria, 1606
        • University Medical Center "N. I. Pirogov"
        • Ta kontakt med:
      • Sofia, Bulgaria, 1680
        • Diagnostics And Consultation Center Convex Ltd.
        • Ta kontakt med:
      • Sofia, Bulgaria, 1756
      • Veliko Tarnovo, Bulgaria, 5000
      • Vidin, Bulgaria, 3700
      • Vratsa, Bulgaria, 3001
        • Specialized Hospital For Active Treatment Of Pneumo-Physiatiric Diseases Vraca /Sbalpfz Vratsa EOOD
        • Ta kontakt med:
  • Canada
      • Québec, Canada, G1V 4G5
        • Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
        • Ta kontakt med:
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St. Paul's Hospital (Vancouver)
        • Ta kontakt med:
    • Ontario
      • Burlington, Ontario, Canada, L7N 3V2
    • Quebec
      • Montreal, Quebec, Canada, H2X 0A9
        • Centre Hospitalier de l'Universite de Montreal (CHUM)
        • Ta kontakt med:
  • Chile
      • Santiago, Chile, 7750000
        • Centro de Estudios Clinicos CEC
        • Ta kontakt med:
      • Talca, Chile, 3465586
        • Centro de Investigacion del Maule
        • Ta kontakt med:
  • Danmark
      • Aalborg, Danmark, 9000
      • Aarhus N, Danmark, 8200
      • Hvidovre, Danmark, 2650
      • Københagen Ø, Danmark, 2100
        • Copenhagen University Hospital, Rigshospitalet
        • Ta kontakt med:
      • Odense C, Danmark, 5000
      • Vejle, Danmark, 7100
  • Filippinene
      • Iloilo City, Filippinene, 5000
        • West Visayas State University Medical Center
        • Ta kontakt med:
      • Iloilo City, Filippinene, 5000
      • Mandaluyong, Filippinene, 1552
      • Quezon City, Filippinene, 1109
      • Taft, Manila, Filippinene, 1000
  • Finland
      • Helsinki, Finland, 00290 HUS
        • Helsinki University Hospital
        • Ta kontakt med:
      • Oulu, Finland, 90150
        • Northern Clinical Trial Coordinators
        • Ta kontakt med:
      • Tampere, Finland, 33520
        • Tampere University Hospital
        • Ta kontakt med:
      • Turku, Finland, 20521
        • Turku University Hospital / TYKS
        • Ta kontakt med:
  • Forente stater
    • Arizona
      • Tucson, Arizona, Forente stater, 85724
    • California
      • Newport Beach, California, Forente stater, 92663
      • Redding, California, Forente stater, 96001
      • Sacramento, California, Forente stater, 95817
    • Colorado
      • Denver, Colorado, Forente stater, 80206
    • Florida
      • Brandon, Florida, Forente stater, 33511
      • Jacksonville, Florida, Forente stater, 32224
      • Jacksonville, Florida, Forente stater, 32209
      • Naples, Florida, Forente stater, 34102
      • Tampa, Florida, Forente stater, 33614
      • Weston, Florida, Forente stater, 33331
    • Georgia
      • Augusta, Georgia, Forente stater, 30912
    • Kansas
      • Kansas City, Kansas, Forente stater, 66160
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109
    • Minnesota
      • Rochester, Minnesota, Forente stater, 55905
      • Saint Paul, Minnesota, Forente stater, 55130
    • Missouri
      • St Louis, Missouri, Forente stater, 63110
    • Nebraska
      • Omaha, Nebraska, Forente stater, 68198-5910
    • New York
      • Hawthorne, New York, Forente stater, 10532
      • New Hyde Park, New York, Forente stater, 11040
      • New York, New York, Forente stater, 10029
      • New York, New York, Forente stater, 10017
      • New York, New York, Forente stater, 10032
        • New York Presbyterian Hospital -Columbia University
        • Ta kontakt med:
    • North Carolina
      • Huntersville, North Carolina, Forente stater, 28078
      • Pinehurst, North Carolina, Forente stater, 28374
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45267
      • Cleveland, Ohio, Forente stater, 44106
    • Pennsylvania
      • DuBois, Pennsylvania, Forente stater, 15801
      • Philadelphia, Pennsylvania, Forente stater, 19104
      • Philadelphia, Pennsylvania, Forente stater, 19107
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29425
      • Rock Hill, South Carolina, Forente stater, 29732
    • Texas
      • Cypress, Texas, Forente stater, 77429
      • Dallas, Texas, Forente stater, 75390
      • Dallas, Texas, Forente stater, 75246
      • El Paso, Texas, Forente stater, 79902
      • Galveston, Texas, Forente stater, 77555
      • Houston, Texas, Forente stater, 77030
      • McKinney, Texas, Forente stater, 75069
      • San Antonio, Texas, Forente stater, 78229
      • Tyler, Texas, Forente stater, 75708
        • University of Texas Health Science Center at Tyler
        • Ta kontakt med:
    • Utah
      • Murray, Utah, Forente stater, 84107-4107
    • Vermont
      • Colchester, Vermont, Forente stater, 05446
    • Virginia
      • Falls Church, Virginia, Forente stater, 22042
      • Richmond, Virginia, Forente stater, 23219
    • Washington
      • Seattle, Washington, Forente stater, 98195
      • Spokane, Washington, Forente stater, 99204
    • Wisconsin
      • Madison, Wisconsin, Forente stater, 53792
  • Frankrike
      • Amiens, Frankrike, 80054
      • Créteil, Frankrike, 94000
      • Lille, Frankrike, 59037
      • Lyon, Frankrike, 69004
        • Hopital De La Croix-Rousse
        • Ta kontakt med:
      • Montpellier, Frankrike, 34295
      • Nice, Frankrike, 06001
      • Paris, Frankrike, 75014
      • Pessac, Frankrike, 33604
      • Rennes, Frankrike, 35000
      • Saint-Herblain, Frankrike, 44093
      • Tououse, Frankrike, 31059
        • Hôpital Larrey - CHU de Toulouse
        • Ta kontakt med:
  • Hong Kong
      • Hong Kong, Hong Kong, 999077
      • Hong Kong, Hong Kong, 999077
  • Irland
  • Israel
      • Beersheba, Israel, 8410101
        • Soroka Univ. Medical Center
        • Ta kontakt med:
      • Haifa, Israel, 3436212
        • Lady Davis Carmel Medical Center
        • Ta kontakt med:
      • Jerusalem, Israel, 9112001
        • Hadassah Medical Center, Ein-Karem
        • Ta kontakt med:
      • Jerusalem, Israel, 9765422
        • Hadassah Medical Center, Ein-Karem
        • Ta kontakt med:
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center Beilinson
        • Ta kontakt med:
      • Tel Aviv, Israel, 6093246
  • Italia
      • Bologna, Italia, 40138
        • Policlinico S. Orsola-Malpighi
        • Ta kontakt med:
      • Catania, Italia, 95121
        • Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
        • Ta kontakt med:
      • Florence, Italia, 50139
      • Genova, Italia, 16147
      • Genova, Italia, 16132
        • Azienda Ospedaliera San Martino
        • Ta kontakt med:
      • Messina, Italia, 98124
        • A.O.U.Policlinico G.Martino
        • Ta kontakt med:
      • Milan, Italia, 20122
        • Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
        • Ta kontakt med:
      • Monza (MB), Italia, 20900
        • Azienda Socio Sanitaria Territoriale Di Monza
        • Ta kontakt med:
      • Naples, Italia, 80131
        • Azienda Ospedaliera Universitaria "Federico II"
        • Ta kontakt med:
      • Padova, Italia, 35128
        • Azienda Ospedaliera Universitaria di Padova
        • Ta kontakt med:
      • Palermo, Italia, 90127
        • Policlinico "Paolo Giaccone"
        • Ta kontakt med:
      • Pavia, Italia, 27100
        • Fondazione IRCCS Policlinico S. Matteo
        • Ta kontakt med:
      • Roma, Italia, 00165
        • Ospedale Pediatrico Bambino Gesù
        • Ta kontakt med:
      • Rozzano (MI), Italia, 20089
      • Verona, Italia, 37126
        • Azienda Ospedaliera Universitaria Integrata Verona
        • Ta kontakt med:
  • Japan
      • Aichi, Nagoya, Japan, 466-8560
        • Nagoya University Hospital
        • Ta kontakt med:
      • Aomori, Hirosaki, Japan, 036-8563
        • Hirosaki University Hospital
        • Ta kontakt med:
      • Chiba, Chiba, Japan, 260-8677
        • Chiba University Hospital
        • Ta kontakt med:
      • Chiba, Kamogawa, Japan, 296-0041
      • Fukuoka, Fukuoka, Japan, 812-8582
        • Kyushu University Hospital
        • Ta kontakt med:
      • Fukuoka, Fukuoka, Japan, 814-0180
        • Fukuoka University Hospital
        • Ta kontakt med:
      • Hyogo, Himeji, Japan, 670-0849
        • Terada Clinic, Respiratory Medicine & General practice
        • Ta kontakt med:
      • Ibaraki, Naka-gun, Japan, 319-1113
        • Ibarakihigashi National Hospial
        • Ta kontakt med:
      • Ibaraki, Tsukuba, Japan, 305-8576
        • University of Tsukuba Hospital
        • Ta kontakt med:
      • Kagoshima, Kagoshima, Japan, 890-8520
        • Kagoshima University Hospital
        • Ta kontakt med:
      • Kanagawa, Yokohama, Japan, 236-0051
        • Kanagawa Cardiovascular and Respiratory Center
        • Ta kontakt med:
      • Kyoto, Joyo, Japan, 610-0113
      • Kyoto, Kyoto, Japan, 606-8507
        • Kyoto University Hospital
        • Ta kontakt med:
      • Mie, Matsusaka, Japan, 515-8544
      • Miyagi, Sendai, Japan, 980-8574
        • Tohoku University Hospital
        • Ta kontakt med:
      • Nagasaki, Nagasaki, Japan, 852-8501
        • Nagasaki University Hospital
        • Ta kontakt med:
      • Niigata, Niigata, Japan, 951-8520
        • Niigata University Medical and Dental Hospital
        • Ta kontakt med:
      • Oita, Yufu, Japan, 879-5593
      • Okayama, Kurashiki, Japan, 710-8602
        • Kurashiki Central Hospital
        • Ta kontakt med:
      • Osaka, Sakai, Japan, 591-8555
        • National Hospital Organization Kinki-Chuo Chest Medical Center
        • Ta kontakt med:
      • Osaka, Toyonaka, Japan, 560-8552
        • Osaka Toneyama Medical Center
        • Ta kontakt med:
      • Saga, Saga, Japan, 849-8501
      • Saitama, Kumagaya, Japan, 360-0197
        • Saitama Cardiovascular and Respiratory Center
        • Ta kontakt med:
      • Shiga, Otsu, Japan, 520-2192
        • Shiga University of Medical Science Hospital
        • Ta kontakt med:
      • Shimane, Matsue, Japan, 690-8556
      • Shizuoka, Hamamatsu, Japan, 431-3192
        • Hamamatsu University Hospital
        • Ta kontakt med:
      • Shizuoka, Hamamatsu, Japan, 434-8511
      • Tokushima, Tokushima, Japan, 770-8503
        • Tokushima University Hospital
        • Ta kontakt med:
      • Tokyo, Bunkyo-ku, Japan, 113-8519
        • Institute of Science Tokyo Hospital
        • Ta kontakt med:
      • Tokyo, Itabashi-ku, Japan, 173-8610
        • Nihon University Itabashi Hospital
        • Ta kontakt med:
      • Tokyo, Kiyose, Japan, 204-8522
      • Tokyo, Minato-ku, Japan, 105-8470
      • Tokyo, Shinjuku-ku, Japan, 162-8666
        • Tokyo Women's Medical University Hospital
        • Ta kontakt med:
      • Tokyo, Shinjuku-ku, Japan, 160-8582
      • Yamaguchi, Ube, Japan, 755-8505
        • Yamaguchi University Hospital
        • Ta kontakt med:
  • Kasakhstan
      • Astana, Kasakhstan, 010000
        • Multidisciplinary City Hospital №1 of the Akimat of Astana
        • Ta kontakt med:
      • Karaganda, Kasakhstan, 100019
        • Regional Clinical Hospital of the Health Department of the Karaganda Region
        • Ta kontakt med:
  • Kina
      • Beijing, Kina, 100730
        • Peking Union Medical College Hospital
        • Ta kontakt med:
      • Beijing, Kina, 100191
        • Peking University Third Hospital
        • Ta kontakt med:
      • Beijing, Kina, 100029
        • China-Japan Friendship Hospital
        • Ta kontakt med:
      • Beijing, Kina, 100045
        • Beijing Children's Hospital, Capital Medical University
        • Ta kontakt med:
      • Changchun, Kina, 130000
        • The Second Hospital of Jilin University
        • Ta kontakt med:
      • Changchun, Kina, 130000
        • The First Hospital of Jilin University
        • Ta kontakt med:
      • Changsha, Kina, 410011
        • The Second Xiangya Hospital Of Central South University
        • Ta kontakt med:
      • Chengdu, Kina, 610041
        • West China Hospital, Sichuan University
        • Ta kontakt med:
      • Guangzhou, Kina, 510080
        • Guangdong Provincial People's Hospital
        • Ta kontakt med:
      • Guangzhou, Kina, 510000
        • First Affiliated Hospital of Guangzhou Medical University
        • Ta kontakt med:
      • Guiyang, Kina, 550002
        • Guizhou Provincial People's Hospital
        • Ta kontakt med:
      • Hangzhou, Kina, 310009
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Ta kontakt med:
      • Hangzhou, Kina, 310006
        • Hangzhou First People's Hospital
        • Ta kontakt med:
      • Hangzhou, Kina, 310016
        • Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
        • Ta kontakt med:
      • Hangzhou, Kina, 310030
      • Hefei, Kina, 230022
        • The First Affiliated Hospital of Anhui Medical University
        • Ta kontakt med:
      • Huzhou, Kina, 313000
        • Huzhou Central Hospital
        • Ta kontakt med:
      • Jiangmen, Kina, 529030
        • Jiangmen Central Hospital
        • Ta kontakt med:
      • Nanchang, Kina, 330006
        • The Second Affiliated Hospital to Nanchang University
        • Ta kontakt med:
      • Nanchang, Kina, 330000
        • The First Affiliated Hospital of Nanchang University
        • Ta kontakt med:
      • Nanjing, Kina, 210008
        • Nanjing Drum Tower Hospital
        • Ta kontakt med:
      • Nanjing, Kina, 210006
        • Nanjing First Hospital
        • Ta kontakt med:
      • Nantong, Kina, 226001
        • Affiliated Hospital of Nantong University
        • Ta kontakt med:
      • Ningbo, Kina, 315000
        • Ningbo Medical Center Lihuili Hospital
        • Ta kontakt med:
      • Ningbo, Kina, 315010
        • The First Affiliated Hospital of Ningbo University
        • Ta kontakt med:
      • Pingxiang, Kina, 337000
        • Pingxiang People's Hospital
        • Ta kontakt med:
      • Qingdao, Kina, 266011
        • Qingdao Municipal Hospital
        • Ta kontakt med:
      • Quanzhou, Kina, 362000
        • The Second Affiliated Hospital of Fujian Medical University
        • Ta kontakt med:
      • Shanghai, Kina, 200240
        • Shanghai Fifth People's Hospital affiliated to Fudan University
        • Ta kontakt med:
      • Shanghai, Kina, 200433
        • Shanghai Pulmonary Hospital
        • Ta kontakt med:
      • Shanghai, Kina, 200032
        • Zhongshan Hospital Affiliated to Fudan University
        • Ta kontakt med:
      • Shanghai, Kina, 200080
        • Shanghai General Hospital
        • Ta kontakt med:
      • Shanghai, Kina, 200040
        • Huadong Hospital affiliated to Fudan University
        • Ta kontakt med:
      • Shanghai, Kina, 200025
        • Ruijin Hospital Shanghai Jiao Tong University School of Medicine
        • Ta kontakt med:
      • Shanghai, Kina, 201700
        • Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University
        • Ta kontakt med:
      • Shanghai, Kina, 201102
        • The Children's Hospital of Fudan University
        • Ta kontakt med:
      • Shenzhen, Kina, 518020
        • Shenzhen People's Hospital
        • Ta kontakt med:
      • Suzhou, Kina, 215006
        • The First Affiliated Hospital of Soochow University
        • Ta kontakt med:
      • Tianjin, Kina, 300052
        • Tianjin Medical University General Hospital
        • Ta kontakt med:
      • Wenzhou, Kina, 325000
        • The First Affiliated Hospital of Wenzhou Medical University
        • Ta kontakt med:
      • Wenzhou, Kina, 325006
        • Wenzhou People's Hospital
        • Ta kontakt med:
      • Wuhan, Kina, 430030
        • Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
        • Ta kontakt med:
      • Wuhan, Kina, 430022
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
        • Ta kontakt med:
      • Wuxi, Kina, 214043
        • Wuxi People's Hospital
        • Ta kontakt med:
      • Xi'an, Kina, 710061
        • First Affiliated Hospital of Xi'an JiaoTong University
        • Ta kontakt med:
      • Xuzhou, Kina, 221006
        • The Affiliated Hospital of Xuzhou Medical College
        • Ta kontakt med:
      • Yangzhou, Kina, 225001
        • Northern Jiangsu People's Hospital
        • Ta kontakt med:
      • Yixing, Kina, 214258
        • Yixing People'S Hospital
        • Ta kontakt med:
  • Latvia
      • Daugavpils, Latvia, 5401
        • Daugavpils regionala slimnica SIA
        • Ta kontakt med:
      • Daugavpils, Latvia, LV-5410
        • Veselibas centru apvieniba AS
        • Ta kontakt med:
      • Jūrmala, Latvia, 2015
      • Riga, Latvia, LV-1002
        • Pauls Stradins Clinical University Hospital
        • Ta kontakt med:
      • Riga, Latvia, 1001
      • Riga, Latvia, 2118
        • Rigas Austrumu kliniska universitates slimnica SIA
        • Ta kontakt med:
      • Riga, Latvia, LV-1011
        • Mediciniskas pecdiploma izglitibas instituts SIA
        • Ta kontakt med:
  • Litauen
      • Kaunas, Litauen, 50161
        • Hospital of Lithuanian University of Health Sciences Kauno Klinikos
        • Ta kontakt med:
      • Klaipėda, Litauen, 92231
      • Vilnius, Litauen, 08406
        • Vilnius University Hospital, Santariskiu
        • Ta kontakt med:
  • Malaysia
      • Kajang, Malaysia, 43000
        • Hospital Sultan Idris Shah Serdang
        • Ta kontakt med:
      • Kelantan, Malaysia, 15586
      • Kuala Lumpur, Malaysia, 59100
      • Kuching, Malaysia, 93586
  • Mexico
      • Chihuahua City, Mexico, 31203
        • Centro de Investigacion Integral MEDIVEST S.C
        • Ta kontakt med:
      • Chihuahua City, Mexico, 31203
        • Mediadvance Clinical S.A.P.I de C.V.
        • Ta kontakt med:
      • León, Mexico, 37160
        • Centro de Investigacion Farmacologica del Bajío, S.C.
        • Ta kontakt med:
      • Mexico City, Mexico, 03650
        • Soluciones terapeuticas medico quirurgicas S de RL de CV
        • Ta kontakt med:
      • Monterrey, Nuevo León, Mexico, C.P. 64460
        • Hospital Universitario Nuevo de Nuevo León - CEPREP
        • Ta kontakt med:
      • Oaxaca City, Mexico, 68000
        • Oaxaca Site Management Organization, S.C.
        • Ta kontakt med:
      • Tlalnepantla, Mexico, 54055
        • Clinical Research Institute S.C.
        • Ta kontakt med:
  • Nederland
      • Alkmaar, Nederland, 1815 JD
      • Amsterdam, Nederland, 1081HV
      • Rotterdam, Nederland, 3015 GD
      • The Hague, Nederland, 2545 AA
      • Utrecht, Nederland, 3584 CX
      • Zutphen, Nederland, 7207 AE
  • Polen
      • Bialystok, Polen, 15-044
        • Respiratory Medicine Centre, private prac., Bialystok
        • Ta kontakt med:
      • Chorzów, Polen, 41-500
        • M2M Med. Badania Sp. z o.o.
        • Ta kontakt med:
      • Piaseczno, Polen, 05500
      • Rzeszów, Polen, 35205
        • EMED, Center of Medical Services,Private Prac,Rzeszow
        • Ta kontakt med:
      • Warsaw, Polen, 01-456
        • Altamed Specjalistyczna Praktyka Lekarska Pawel Sliwinski
        • Ta kontakt med:
      • Wroclaw, Polen, 51-162
        • Centrum Badan Klinicznych Piotr Napora Lekarze sp.p.
        • Ta kontakt med:
      • Świdnik, Polen, 21040
        • Przychodnia Alergologiczno-Pulmonologiczna Alergopneuma Sp. z o.o.
        • Ta kontakt med:
  • Portugal
      • Aveiro, Portugal, 3814-501
      • Braga, Portugal, 4710-243
      • Coimbra, Portugal, 3004-561
        • CHUC - Centro Hospitalar e Universitario de Coimbra, EPE
        • Ta kontakt med:
      • Guimarães, Portugal, 4835-045
      • Leiria, Portugal, 2410-197
      • Lisbon, Portugal, 1649-035
      • Porto, Portugal, 4202-451
        • Centro Hospitalar Universitário São João,EPE
        • Ta kontakt med:
  • Romania
      • Bucharest, Romania, 050159
        • Institutul De Pneumoftiziologie Marius Nasta
        • Ta kontakt med:
      • Cluj-Napoca, Romania, 400003
      • Cluj-Napoca, Romania, 400371
        • Spitalul Clinic De Pneumoftiziologie Leon Daniello
        • Ta kontakt med:
      • Timișoara, Romania, 300310
        • Clinical Hospital Of Infectious Diseases And Pneumophysiology Dr.Victor Babes Timisoara
        • Ta kontakt med:
  • Singapore
      • Singapore, Singapore, 169608
      • Singapore, Singapore, 308433
      • Singapore, Singapore, 529905
  • Slovakia
      • Martin, Slovakia, 036 01
      • Spišská Nová Ves, Slovakia, 05201
  • Spania
      • A Coruña, Spania, 15006
        • Complejo Hospitalario Universitario A Coruña
        • Ta kontakt med:
      • Badalona, Spania, 08916
        • Hospital Germans Trias i Pujol
        • Ta kontakt med:
      • Barcelona, Spania, 08035
        • Hospital Universitari Vall d'Hebron
        • Ta kontakt med:
      • Barcelona, Spania, 08036
        • Hospital Clínic de Barcelona
        • Ta kontakt med:
      • El Palmar, Spania, 30120
        • Hospital Universitario Virgen de la Arrixaca
        • Ta kontakt med:
      • Girona, Spania, 17007
        • Hospital Universitari de Girona Doctor Josep Trueta
        • Ta kontakt med:
      • Huelva, Spania, 21080
      • Huelva, Spania, 21005
        • Hospital Juan Ramón Jimenez
        • Ta kontakt med:
      • Jerez de la Frontera, Spania, 11407
        • Hospital Jerez de la Frontera
        • Ta kontakt med:
      • L'Hospitalet Del Llobregat, Spania, 08907
        • Hospital Universitari de Bellvitge
        • Ta kontakt med:
      • Madrid, Spania, 28046
        • Hospital Universitario La Paz
        • Ta kontakt med:
      • Mérida, Spania, 06800
      • Oviedo, Spania, 33011
        • Hospital Central de Asturias
        • Ta kontakt med:
      • Palma de Mallorca, Spania, 07120
      • Pamplona, Spania, 31008
        • Hospital Universitario de Navarra
        • Ta kontakt med:
      • Pozuelo de Alarcón, Spania, 28223
        • Hospital Memorial Publio Cordon
        • Ta kontakt med:
      • Santander, Spania, 39008
        • Hospital Universitario Marqués de Valdecilla
        • Ta kontakt med:
      • Santiago, Spania, 15706
        • Complexo Hospitalario Universitario De Santiago
        • Ta kontakt med:
      • Seville, Spania, 41009
        • Hospital Universitario Virgen De La Macarena
        • Ta kontakt med:
      • Seville, Spania, 41013
      • Valencia, Spania, 46026
        • Hospital Universitari i Politècnic La Fe
        • Ta kontakt med:
  • Storbritannia
      • Birmingham, Storbritannia, B9 5SS
      • Blackpool, Storbritannia, FY3 8NR
      • Bradford, Storbritannia, BD9 6RJ
      • Bristol, Storbritannia, BS8 2RA
      • Cambridge, Storbritannia, CB2 0AY
      • Cardiff, Storbritannia, CF64 2XX
      • Dundee, Scotland, Storbritannia, DD1 9SY
      • Edinburgh, Storbritannia, EH4 2XU
      • Edinburgh, Storbritannia, EH16 4SA
      • Edinburgh, Storbritannia, EH16 4TJ
      • High Heaton, Storbritannia, NE7 7DN
      • Lancaster, Storbritannia, LA1 4RP
      • Leeds, Storbritannia, LS9 7TF
      • Liverpool, Storbritannia, L14 3PE
      • London, Storbritannia, SE5 9RS
      • London, Storbritannia, SW3 6NP
      • Portadown, Storbritannia, BT63 5QQ
      • Sheffield, Storbritannia, S5 7AU
      • Southampton, Storbritannia, SO16 6YD
      • Stoke-on-Trent, Storbritannia, ST4 6QG
      • Torquay, Storbritannia, TQ2 7AA
  • Sveits
      • Basel, Sveits, 4031
      • Lausanne, Sveits
        • University Hospital of Lausanne
        • Ta kontakt med:
  • Sverige
      • Stockholm, Sverige, SE-171 64
        • Karolinska University Hospital
        • Ta kontakt med:
      • Uppsala, Sverige, 752 37
        • CTC Clinical Trial Consultants AB
        • Ta kontakt med:
      • Örebro, Sverige, 703 82
        • Universitetssjukhuset, Örebro
        • Ta kontakt med:
  • Sør -Korea
      • Anyang, Sør -Korea, 14068
        • Hallym University Sacred Heart Hospital
        • Ta kontakt med:
      • Cheongju-si, Sør -Korea, 28644
        • Chungbuk National University Hospital
        • Ta kontakt med:
      • Daegu, Sør -Korea, 42415
        • Yeongnam University Hospital
        • Ta kontakt med:
      • Dong-gu Ulsan, Sør -Korea, 44033
      • Incheon, Sør -Korea, 21431
        • The Catholic University of Korea, Incheon St. Mary's Hospital
        • Ta kontakt med:
      • Seoul, Sør -Korea, 05505
      • Seoul, Sør -Korea, 06351
      • Seoul, Sør -Korea, 03722
      • Seoul, Sør -Korea, 08308
        • Korea University Guro Hospital
        • Ta kontakt med:
      • Seoul, Sør -Korea, 05030
        • Konkuk University Medical Center
        • Ta kontakt med:
      • Seoul, Sør -Korea, 137-701
        • The Catholic University of Korea, Seoul St.Mary's Hospital
        • Ta kontakt med:
      • Seoul, Sør -Korea, 03312
        • The Catholic University of Korea, Eunpyeong St. Mary's Hospital
        • Ta kontakt med:
      • Seoul, Sør -Korea, 07071
        • SMG-SNU Boramae Medical Center
        • Ta kontakt med:
      • Seoul, Sør -Korea, 150-950
        • Hallym University Kangnam Sacred Heart Hospital
        • Ta kontakt med:
      • Seoul, Sør -Korea, 54907
        • Jeonbuk National University Hospital
        • Ta kontakt med:
      • Wŏnju, Sør -Korea, 26426
        • Yonsei University Wonju Severance Christian Hospital
        • Ta kontakt med:
  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • Kaohsiung Chang Gung Memorial Hospital
        • Ta kontakt med:
      • Kaohsiung City, Taiwan, 807
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
        • Ta kontakt med:
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital
        • Ta kontakt med:
      • Taoyuan City, Taiwan, 333
        • Chang Gung Memorial Hospital, Linkou
        • Ta kontakt med:
  • Thailand
      • Bangkok, Thailand, 10700
      • Ratchathewi, Thailand, 10400
        • Ramathibodi Hospital
        • Ta kontakt med:
  • Tsjekkia
      • Jindřichův Hradec, Tsjekkia, 377 01
      • Prague, Tsjekkia, 19000
        • The First Pulmonary Private Practice
        • Ta kontakt med:
  • Tyskland
      • Aachen, Tyskland, 52074
      • Ahrensburg, Tyskland, 22926
        • Velocity Clinical Research Germany GmbH, Ahrensburg
        • Ta kontakt med:
      • Bamberg, Tyskland, 96049
      • Berlin, Tyskland, 12351
      • Berlin, Tyskland, 13353
      • Berlin, Tyskland, 10117
      • Bochum, Tyskland, 44791
      • Bonn, Tyskland, 53127
      • Cologne, Tyskland, 50937
      • Cologne, Tyskland, 50678
      • Donaustauf, Tyskland, 93093
      • Dortmund, Tyskland, 44145
      • Dresden, Tyskland, 01307
      • Essen, Tyskland, 45239
        • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
        • Ta kontakt med:
      • Frankfurt, Tyskland, 60590
      • Frankfurt, Tyskland, 60596
      • Freiburg im Breisgau, Tyskland, 79106
      • Gauting, Tyskland, 82131
      • Halle, Tyskland, 06120
      • Hanover, Tyskland, 30625
      • Heidelberg, Tyskland, 69126
        • Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
        • Ta kontakt med:
      • Jena, Tyskland, 07747
      • Kiel, Tyskland, 24105
        • Universitätsklinikum Schleswig-Holstein, Campus Kiel
        • Ta kontakt med:
      • Lübeck, Tyskland, 23552
      • Mainz, Tyskland, 55131
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
        • Ta kontakt med:
      • München, Tyskland, 80336
      • München, Tyskland, 81241
      • Münster, Tyskland, 48149
      • Potsdam, Tyskland, 14467
        • Klinikum Ernst von Bergmann GmbH, CF-Zentrum Potsdam
        • Ta kontakt med:
      • Stralstund, Tyskland, 18435
      • Wiesbaden, Tyskland, 65183
  • Ungarn
  • Østerrike
      • Graz, Østerrike, 8036
      • Innsbruck, Østerrike, 6020

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

12 år og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion criteria:

  1. Participants (adults and adolescents ≥12 years of age) who completed the treatment period in trials 1397-0014 or 1397-0017 as planned per protocol and did not discontinue trial treatment prematurely.
  2. Male or female participants. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Council of Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the participant information.
  3. Signed and dated written informed consent and assent, if applicable, prior to admission to the trial, in accordance with Good Clinical Practice (GCP) and local legislation.

Exclusion criteria:

  1. Moderate or severe liver disease (defined by Child-Pugh score B or C hepatic impairment), unless the investigator determines it is in the best interest of the participant to enrol in the trial.
  2. Estimated glomerular filtration rate (eGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula (adults) and Chronic Kidney Disease Under 25 (CKiD-U25) (adolescents) <30 mL/min at Visit 1 (or at the last safety assessment in the parent trial, if no more than 6 weeks passed since then), unless the investigator determines it is in the best interest of the participant to enrol in the trial.
  3. An absolute blood neutrophil count <1000/mm^3 (equivalent to <1000 cells/µL or <10^9 cells/L) at Visit 1 (or at the last safety assessment in the parent trial, if no more than 6 weeks passed since then).
  4. Any findings in the medical examination and/or laboratory value assessed at Visit 1 (or at the last safety assessment in the parent trial, concerning the laboratory tests, if no more than 6 weeks passed since then), that in the opinion of the investigator may put the participant at risk by participating in the trial.
  5. Diagnosis of primary or secondary immunodeficiency made after end of treatment in preceding trial.
  6. Any relevant pulmonary, gastrointestinal, hepatic, renal, cardiovascular, metabolic, immunological, hormonal, or other disorder that, in the opinion of the investigator, may put the participant at risk by participating in the study.
  7. Participants 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.
  8. Participants not expected to comply with the protocol requirements or not expected to complete the trial as scheduled, i.e. chronic alcohol or drug abuse or any other condition that, in the investigator's opinion, makes the participant an unreliable trial participant.

Further exclusion criteria apply.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Participants with bronchiectasis rolling over from parent trials

Participants with bronchiectasis who completed parent trials AIRTIVITY® (1397-0014) or CLAIRLEAF® (1397-0017) and did not prematurely discontinue the trial drug.
Legemiddel: verducatib

verducatib

Andre navn:
  • BI 1291583

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Occurrence of treatment-emergent adverse events (TEAEs) over the course of this trial
Tidsramme: up to 78 weeks
up to 78 weeks

Sekundære resultatmål

Resultatmål
Tidsramme
Annualised rate of pulmonary exacerbations (number of events per person-time) up to Week 78
Tidsramme: up to 78 weeks
up to 78 weeks
Time to first pulmonary exacerbation from first drug administration up to Week 78
Tidsramme: up to 78 weeks
up to 78 weeks
Absolute change from baseline in post-bronchodilator forced expiratory volume in the first second (FEV1) %pred up to Week 78
Tidsramme: at baseline, at week 78
at baseline, at week 78
Absolute change from baseline in post-bronchodilator forced vital capacity (FVC) %pred up to Week 78
Tidsramme: at baseline, at week 78
at baseline, at week 78
High-resolution computed tomography (HRCT) substudy: Change from baseline (52-week HRCT from the parent trial) in total number of mucus plugs at Week 78
Tidsramme: at baseline, at week 78
at baseline, at week 78
HRCT substudy: Change from baseline (52-week HRCT from the parent trial) in volume of mucus plugs at Week 78
Tidsramme: at baseline, at week 78
at baseline, at week 78
HRCT substudy: Change from baseline (52-week HRCT from the parent trial) in bronchial wall area over bronchial outer area (Bwa/Boa) at Week 78
Tidsramme: at baseline, at week 78
at baseline, at week 78

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Boehringer Ingelheim

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

11. januar 2027

Primær fullføring (Antatt)

31. juli 2029

Studiet fullført (Antatt)

10. september 2029

Datoer for studieregistrering

Først innsendt

30. oktober 2026

Først innsendt som oppfylte QC-kriteriene

30. oktober 2026

Først lagt ut (Faktiske)

4. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 1397-0018
  • U1111-1341-3104 (Registeridentifikator: WHO International Clinical Trials Registry Platform (ICTRP))
  • 2026-527086-30-00 (Ctis)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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 on the website.

IPD-delingstidsramme

One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

Tilgangskriterier for IPD-deling

For study documents - upon signing of a "Document Sharing Agreement". For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere