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

30. oktober 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

1500

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

12 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: verducatib

verducatib

Andre navne:
  • BI 1291583

Hvad måler undersøgelsen?

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Boehringer Ingelheim

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

11. januar 2027

Primær færdiggørelse (Anslået)

31. juli 2029

Studieafslutning (Anslået)

10. september 2029

Datoer for studieregistrering

Først indsendt

30. oktober 2026

Først indsendt, der opfyldte QC-kriterier

30. oktober 2026

Først opslået (Faktiske)

4. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (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.

IPD-delingsadgangskriterier

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 Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner