Клинические исследование Бронхоэктазы без кистозного фиброза: Brensocatib 10 mg, Бренсокатиб 25 мг, Плацебо

Спонсоры	Ведущий спонсор: Insmed Incorporated
Источник	Insmed Incorporated
Краткое содержание	Основная цель этого исследования - оценить эффект бренсокатиба в дозе 10 мг и 25 мг. мг по сравнению с плацебо в отношении частоты обострений легких (ПЭ) в течение 52 недель период лечения.

Общий статус

Рекрутинг

Дата начала

2020-12-01

Дата завершения

2024-03-31

Дата первичного завершения

2024-03-31

Фаза

Фаза 3

Тип исследования

Интервенционный

Первичный результат

Мера	Временное ограничение
Частота легочных обострений (ПЭ)	52 недели

Вторичный результат

Мера	Временное ограничение
Time to First Pulmonary Exacerbation (PE)	52 Weeks
Процент участников, у которых не было обострения легких (ПЭ)	52 недели
Изменение объема форсированного выдоха после введения бронходилататора за 1 секунду (ОФВ1) по сравнению с исходным уровнем	Исходный уровень до 52 недели
Частота тяжелых обострений легких (ТЭЛА)	52 недели
Изменение по сравнению с исходным уровнем до 52 недели в вопроснике по качеству жизни - балл по шкале респираторных симптомов бронхоэктаза (QOL-B) у взрослых участников	Исходный уровень до 52 недели
Частота и тяжесть нежелательных явлений, вызванных лечением	56 недель
Максимальная наблюдаемая концентрация (Cmax) Brensocatib в устойчивом состоянии	56 недель
Время достижения максимальной концентрации (Tmax) Brensocatib в устойчивом состоянии	56 недель
Площадь под кривой зависимости концентрации от времени (AUC) Brensocatib в устойчивом состоянии	56 недель
Изменение по сравнению с исходным уровнем до 52 недели в вопроснике по качеству жизни - Бронхоэктаз (QOL-B) Оценка области респираторных симптомов	Исходный уровень до 52 недели
Частота и тяжесть нежелательных явлений, связанных с лечением	До 56 недели

Регистрация

1620

Состояние	Бронхоэктазы без кистозного фиброза
Вмешательство	Тип вмешательства: Drug Название вмешательства: Brensocatib 10 mg Описание: Oral tablet. Этикетка Arm Group: Brensocatib 10 mg Другое имя: INS1007 Тип вмешательства: Препарат, средство, медикамент Название вмешательства: Бренсокатиб 25 мг Описание: Таблетка для перорального применения. Этикетка Arm Group: Бренсокатиб 25 мг Другое имя: INS1007 Тип вмешательства: Препарат, средство, медикамент Название вмешательства: Плацебо Описание: Таблетка для приема внутрь, соответствующая Brensocatib. Этикетка Arm Group: Плацебо
Приемлемость	Критерии: Критерии включения: - Предоставить подписанное ими информированное участие в исследовании. - Клинический анамнез соответствует бронхоэктазам без кистозного фиброза (кашель, хронический выделение мокроты и / или рецидивирующие респираторные инфекции), что подтверждено грудной клеткой компьютерная томография (КТ). - По крайней мере, 2 легочных обострения, обусловленная необходимостью назначения антибиотиков врачом. врач по поводу признаков и симптомов респираторных инфекций за последние 12 месяцев перед отборочным визитом. - Женщины должны находиться в постменопаузе (подразумевается отсутствие менструаций в течение 12 месяцев без альтернативная медицинская причина), стерильно хирургически или с использованием высокоэффективных контрацепция (т. е. методы, которые позволяют снизить частоту неудач) Пол: Все Минимальный возраст: 18 лет Максимальный возраст: 85 лет Здоровые волонтеры: Нет

Состояние

Бронхоэктазы без кистозного фиброза

Вмешательство

Тип вмешательства: Drug

Название вмешательства: Brensocatib 10 mg

Описание: Oral tablet.

Этикетка Arm Group: Brensocatib 10 mg

Другое имя: INS1007

Тип вмешательства: Препарат, средство, медикамент

Название вмешательства: Бренсокатиб 25 мг

Описание: Таблетка для перорального применения.

Этикетка Arm Group: Бренсокатиб 25 мг

Другое имя: INS1007

Тип вмешательства: Препарат, средство, медикамент

Название вмешательства: Плацебо

Описание: Таблетка для приема внутрь, соответствующая Brensocatib.

Этикетка Arm Group: Плацебо

Приемлемость

Критерии:

Критерии включения: - Предоставить подписанное ими информированное участие в исследовании. - Клинический анамнез соответствует бронхоэктазам без кистозного фиброза (кашель, хронический выделение мокроты и / или рецидивирующие респираторные инфекции), что подтверждено грудной клеткой компьютерная томография (КТ). - По крайней мере, 2 легочных обострения, обусловленная необходимостью назначения антибиотиков врачом. врач по поводу признаков и симптомов респираторных инфекций за последние 12 месяцев перед отборочным визитом. - Женщины должны находиться в постменопаузе (подразумевается отсутствие менструаций в течение 12 месяцев без альтернативная медицинская причина), стерильно хирургически или с использованием высокоэффективных контрацепция (т. е. методы, которые позволяют снизить частоту неудач)

Пол:

Все

Минимальный возраст:

18 лет

Максимальный возраст:

85 лет

Здоровые волонтеры:

Нет

Общий контакт

Фамилия: Insmed Medical Information

Телефон: 844-4-INSMED

Расположение

Объект:	Положение дел:
USA013 \| Birmingham, Alabama, 35233, United States	Recruiting
USA044 \| Little Rock, Arkansas, 72205, United States	Recruiting
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USA022 \| Palm Springs, California, 92262, United States	Recruiting
USA042 \| Palm Springs, California, 92262, United States	Recruiting
USA035 \| San Diego, California, 92120, United States	Recruiting
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USA027 \| Ventura, California, 93303, United States	Recruiting
USA008 \| Lafayette, Colorado, 80026, United States	Recruiting
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USA001 \| Washington, District of Columbia, 20007, United States	Recruiting
USA054 \| Brandon, Florida, 33511, United States	Recruiting
USA015 \| Clearwater, Florida, 33765, United States	Recruiting
USA032 \| Jacksonville, Florida, 32204, United States	Recruiting
USA007 \| Kissimmee, Florida, 34741, United States	Recruiting
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USA019 \| Miami Lakes, Florida, 33014, United States	Recruiting
USA037 \| Miami, Florida, 33126, United States	Recruiting
USA049 \| Naples, Florida, 34102, United States	Recruiting
USA052 \| Orlando, Florida, 32825, United States	Recruiting
USA053 \| Augusta, Georgia, 30912, United States	Recruiting
USA061 \| Maywood, Illinois, 60153, United States	Recruiting
USA063 \| Iowa City, Iowa, 52242-1009, United States	Recruiting
USA031 \| Kansas City, Kansas, 66160, United States	Recruiting
USA020 \| New Orleans, Louisiana, 70112, United States	Recruiting
USA051 \| New Orleans, Louisiana, 70112, United States	Recruiting
USA003 \| Baltimore, Maryland, 21205, United States	Recruiting
USA047 \| Columbia, Maryland, 21044-3078, United States	Recruiting
USA025 \| Towson, Maryland, 21286, United States	Recruiting
USA064 \| Springfield, Massachusetts, 01199, United States	Recruiting
USA010 \| Rochester, Minnesota, 55905, United States	Recruiting
USA006 \| Chesterfield, Missouri, 63017, United States	Recruiting
USA059 \| Saint Louis, Missouri, 63110, United States	Recruiting
USA009 \| Omaha, Nebraska, 68131, United States	Recruiting
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USA023 \| Portland, Oregon, 97239, United States	Recruiting
USA038 \| DuBois, Pennsylvania, 15801, United States	Recruiting
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USA005 \| Charleston, South Carolina, 29425, United States	Recruiting
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USA036 \| Rock Hill, South Carolina, 29732, United States	Recruiting
USA041 \| Franklin, Tennessee, 37067, United States	Recruiting
USA043 \| Cypress, Texas, 77429, United States	Recruiting
USA087 \| Galveston, Texas, 77555, United States	Recruiting
USA050 \| McKinney, Texas, 75069, United States	Recruiting
USA018 \| Mesquite, Texas, 75149, United States	Recruiting
USA011 \| San Antonio, Texas, 78258, United States	Recruiting
USA002 \| Tyler, Texas, 75708, United States	Recruiting
USA034 \| Williamsburg, Virginia, 23188, United States	Recruiting
ARG007 \| Ciudad Autonoma de Buenos Aires, Buenos Aires, C1122AAK, Argentina	Recruiting
ARG022 \| Ciudad Autonoma de Buenos Aires, Buenos Aires, C1122AAK, Argentina	Recruiting
ARG009 \| Florencio Varela, Buenos Aires, B1853AIK, Argentina	Recruiting
ARG006 \| La Plata, Buenos Aires, B1902COS, Argentina	Recruiting
ARG017 \| Mar Del Plata, Buenos Aires, 7600, Argentina	Recruiting
ARG013 \| Mar Del Plata, Buenos Aires, B7600FYK, Argentina	Recruiting
ARG002 \| Ciudad Autonoma de Buenos Aires, Ciudad Autonoma De BuenosAires, C1414AIF, Argentina	Recruiting
ARG003 \| Ciudad Autonoma de Buenos Aires, Ciudad Autonoma De BuenosAires, C1425BEN, Argentina	Recruiting
ARG008 \| Ciudad Autonoma de Buenos Aires, Ciudad Autonoma De BuenosAires, C1425BEN, Argentina	Recruiting
ARG015 \| Ciudad Autonoma de Buenos Aires, Ciudad Autonoma De BuenosAires, C1425BEN, Argentina	Recruiting
ARG016 \| Rosario, Santa Fe, S2000AJU, Argentina	Recruiting
ARG010 \| Rosario, Santa Fe, S2013DTC, Argentina	Recruiting
ARG012 \| Ciudad Autonoma de Buenos Aires, C10227AAP, Argentina	Recruiting
ARG001 \| Ciudad Autonoma de Buenos Aires, C1425AZB, Argentina	Recruiting
ARG018 \| Ciudad Autonoma de BuenosAires, C1425DES, Argentina	Recruiting
ARG005 \| Cordoba, X5003DCE, Argentina	Recruiting
ARG004 \| Mendoza, M5500GPD, Argentina	Recruiting
ARG011 \| Mendoza, M5500GPD, Argentina	Recruiting
ARG014 \| Mendoza, M5500GPD, Argentina	Recruiting
ARG021 \| Mendoza, M5500GPD, Argentina	Recruiting
ARG019 \| Santa Fe, 3000, Argentina	Recruiting
AUS003 \| Concord, New South Wales, 2139, Australia	Recruiting
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AUS008 \| New Lambton, New South Wales, 2305, Australia	Recruiting
AUS012 \| Cairns North, Queensland, 4870, Australia	Recruiting
AUS001 \| Chermside, Queensland, 4032, Australia	Recruiting
AUS010 \| Greenslopes, Queensland, 4120, Australia	Recruiting
AUS006 \| South Brisbane, Queensland, 4101, Australia	Recruiting
AUS011 \| Adelaide, South Australia, 5000, Australia	Recruiting
AUS017 \| Bedford Park, South Australia, 5042, Australia	Recruiting
AUS004 \| Kent Town, South Australia, 5067, Australia	Recruiting
AUS009 \| Woodville South, South Australia, 5011, Australia	Recruiting
AUS002 \| Boxhill, Victoria, 3128, Australia	Recruiting
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AUS018 \| Murdoch, Western Australia, 6961, Australia	Recruiting
AUS005 \| Nedlands, Western Australia, 6009, Australia	Recruiting
AUS015 \| Spearwood, Western Australia, 6163, Australia	Recruiting
AUS007 \| Westmead, 2145, Australia	Recruiting
AUT001 \| Graz, Steiermark, 8036, Austria	Recruiting
BEL005 \| Edegem, Antwerpen, 2650, Belgium	Recruiting
BEL004 \| Mechelen, Antwerpen, 2800, Belgium	Recruiting
BEL002 \| Gent, Oost-Vlaanderen, 9000, Belgium	Recruiting
BEL001 \| Leuven, Vlaams Brabant, 3000, Belgium	Recruiting
BEL003 \| Roeselare, West-Vlaanderen, 8800, Belgium	Recruiting
BEL006 \| Bruxelles, 1000, Belgium	Recruiting
BEL007 \| Liege, 4000, Belgium	Recruiting
BRA004 \| Sao Bernardo do Campo, Sao Paulo, 09715-090, Brazil	Recruiting
BGR011 \| Sofia, Sofia-Grad, 1336, Bulgaria	Recruiting
BGR009 \| Sofia, Sofia-Grad, 1510, Bulgaria	Recruiting
BGR002 \| Sofia, Sofia-Grad, 1680, Bulgaria	Recruiting
BGR005 \| Blagoevgrad, 2700, Bulgaria	Recruiting
BGR014 \| Kozloduy, 3320, Bulgaria	Recruiting
BGR015 \| Lovech, 5500, Bulgaria	Recruiting
BGR007 \| Montana, 3400, Bulgaria	Recruiting
BGR018 \| Pazardzhik, 4400, Bulgaria	Recruiting
BGR019 \| Plevan, 5800, Bulgaria	Recruiting
BGR004 \| Plovdiv, 4023, Bulgaria	Recruiting
BGR008 \| Ruse, 7002, Bulgaria	Recruiting
BGR017 \| Sliven, 8800, Bulgaria	Recruiting
BGR010 \| Sofia, 1233, Bulgaria	Recruiting
BGR012 \| Veliko Tarnovo, 5000, Bulgaria	Recruiting
BGR013 \| Vidin, 3700, Bulgaria	Recruiting
BGR006 \| Vratsa, 3000, Bulgaria	Recruiting
BGR016 \| Vratsa, 3000, Bulgaria	Recruiting
CAN004 \| Toronto, Ontario, M5T 3A9, Canada	Recruiting
CAN002 \| Montreal, Quebec, HX1P1, Canada	Recruiting
CAN003 \| Saint-Charles-Borromee, Quebec, J6E 2B4, Canada	Recruiting
CHL007 \| Nunoa, Los Rios, 5110683, Chile	Recruiting
CHL010 \| Talca, Maule, 3465586, Chile	Recruiting
CHL006 \| Nunoa, Region-MetropolitanadeSantiago, 7750495, Chile	Recruiting
CHL002 \| Santiago, Region-MetropolitanadeSantiago, 7500010, Chile	Recruiting
CHL008 \| Santiago, Region-MetropolitanadeSantiago, 7500588, Chile	Recruiting
CHL001 \| Santiago, Region-MetropolitanadeSantiago, 7500800, Chile	Recruiting
CHL005 \| Curico, 3341643, Chile	Recruiting
CHL004 \| Quillota, 2260000, Chile	Recruiting
COL006 \| Zipaquira, Cundinamarca, 250252, Colombia	Recruiting
COL005 \| Bogota, Distrito Capital De Bogota, 80CO, Colombia	Recruiting
COL004 \| Cali, 760042, Colombia	Recruiting
COL007 \| Medellin, 50012, Colombia	Recruiting
DNK001 \| Hvidovre, Hovedstaden, 2650, Denmark	Recruiting
DNK002 \| Roskilde, Sjalland, 4000, Denmark	Recruiting
DNK003 \| Aalborg, 9100, Denmark	Recruiting
DNK007 \| Aarhus, 8200, Denmark	Recruiting
DNK004 \| Hellerup, 2900, Denmark	Recruiting
DNK005 \| Odense, 5000, Denmark	Recruiting
DNK006 \| Vejle, 7100, Denmark	Recruiting
FRA004 \| Amiens, 80054, France	Recruiting
FRA003 \| Nantes, 44093, France	Recruiting
DEU001 \| Donaustauf, Bayern, 93093, Germany	Recruiting
DEU025 \| Munchen, Bayern, 80336, Germany	Recruiting
DEU004 \| Frankfurt am Main, Hessen, 60596, Germany	Recruiting
DEU021 \| Frankfurt, Hessen, 60389, Germany	Recruiting
DEU005 \| Marburg, Hessen, 35037, Germany	Recruiting
DEU018 \| Neu-Isenburg, Hessen, 63263, Germany	Recruiting
DEU024 \| Homburg, Saarland, 66421, Germany	Recruiting
DEU003 \| Leipzig, Sachsen, ?04357, Germany	Recruiting
DEU022 \| Berlin, 10717, Germany	Recruiting
DEU006 \| Berlin, 13125, Germany	Recruiting
DEU011 \| Berlin, 13353, Germany	Recruiting
DEU010 \| Borstel, 23845, Germany	Recruiting
DEU014 \| Dresden, ?01307, Germany	Recruiting
DEU013 \| Essen, 45239, Germany	Recruiting
DEU008 \| Frankfurt Am Man, 60590, Germany	Recruiting
DEU019 \| Geesthacht, 21502, Germany	Recruiting
DEU020 \| Geesthacht, 21502, Germany	Recruiting
DEU016 \| Halle (Saale), 06120, Germany	Recruiting
DEU002 \| Hannover, 30173, Germany	Recruiting
DEU015 \| Hannover, 30625, Germany	Recruiting
DEU009 \| Heidelberg, 69126, Germany	Recruiting
DEU007 \| Lubeck, 23552, Germany	Recruiting
DEU023 \| Mainz, 55128, Germany	Recruiting
DEU012 \| Munchen, 81925, Germany	Recruiting
GRC007 \| Heraklion, Irakleio, 711 10, Greece	Recruiting
GRC002 \| Larisa, 411 10, Greece	Recruiting
GRC006 \| Thessaloniki, 57010, Greece	Recruiting
HUN005 \| Tatabanya, Komarom-Esztergom, 2800, Hungary	Recruiting
IRL003 \| Dublin, 15, Ireland	Recruiting
IRL004 \| Dublin, 24, Ireland	Recruiting
IRL002 \| Dublin, Dublin 8, Ireland	Recruiting
IRL001 \| Limerick, V94 F858, Ireland	Recruiting
ISR009 \| Kfar Saba, HaMerkaz, 44281, Israel	Recruiting
ISR001 \| Ashkelon, 78278, Israel	Recruiting
ISR010 \| Beer Sheva, 84100, Israel	Recruiting
ISR008 \| Haifa, 34362, Israel	Recruiting
ISR005 \| Holon, 58100, Israel	Recruiting
ISR006 \| Jerusalem, 91031, Israel	Recruiting
ISR002 \| Jerusalem, 91120, Israel	Recruiting
ISR011 \| Petah Tikva, 49100, Israel	Recruiting
ISR007 \| Ramat-Gan, 52621, Israel	Recruiting
ISR003 \| Rehovot, 7661041, Israel	Recruiting
ITA008 \| Cona, Ferrara, 44124, Italy	Recruiting
ITA004 \| Pavia, Lombardia, 27100, Italy	Recruiting
ITA007 \| Pavia, Lombardia, 27100, Italy	Recruiting
ITA010 \| Bologna, 40138, Italy	Recruiting
ITA003 \| Milano, 20157, Italy	Recruiting
ITA001 \| Palermo, 90127, Italy	Recruiting
ITA002 \| Reggio Emilia, 42123, Italy	Recruiting
ITA006 \| Roma, 00168, Italy	Recruiting
ITA009 \| Roma, 00168, Italy	Recruiting
JPN009 \| Kobe-Shi, Hyogo, 650-0047, Japan	Recruiting
JPN011 \| Tsu shi, Mie, 514-1101, Japan	Recruiting
JPN013 \| Nagasaki-Shi, Nagasaki, 852-8501, Japan	Recruiting
JPN012 \| Chuo ku, Niigata, 951-8520, Japan	Recruiting
JPN018 \| Toyonaka-shi, Osaka, 560-8552, Japan	Recruiting
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JPN015 \| Matsue shi, Simane, 690-8556, Japan	Recruiting
JPN003 \| Hamamatsu-shi, Sizuoka, 434-8511, Japan	Recruiting
JPN007 \| Kiyose shi, Tokyo, 204-8522, Japan	Recruiting
JPN010 \| Meguro-ku, Tokyo, 152-8902, Japan	Recruiting
JPN014 \| Ota-ku, Tokyo, 143-8541, Japan	Recruiting
JPN006 \| Shinagawa-ku, Tokyo, 140-8522, Japan	Recruiting
JPN017 \| Shinagawa-ku, Tokyo, 141-8625, Japan	Recruiting
JPN002 \| Shinjuku-ku, Tokyo, 160-8582, Japan	Recruiting
JPN019 \| Shimonoseki-Shi, Yamaguti, 750-0041, Japan	Recruiting
JPN004 \| Kita Kyushu-shi, 807-8556, Japan	Recruiting
JPN005 \| Koshi shi, 861-1196, Japan	Recruiting
JPN008 \| Matsusaka-shi, 515-8544, Japan	Recruiting
JPN001 \| Naka-gun, 319-1113, Japan	Recruiting
KOR008 \| Bucheon-si, Gyeonggido, 14584, Korea, Republic of	Recruiting
KOR004 \| Incheon, 21431, Korea, Republic of	Recruiting
KOR001 \| Incheon, 21565, Korea, Republic of	Recruiting
KOR002 \| Incheon, 400-711, Korea, Republic of	Recruiting
KOR007 \| Seongnam, 13620, Korea, Republic of	Recruiting
KOR012 \| Seoul, 02447, Korea, Republic of	Recruiting
KOR006 \| Seoul, 110744, Korea, Republic of	Recruiting
KOR005 \| Seoul, 137-701, Korea, Republic of	Recruiting
KOR013 \| Seoul, 3722, Korea, Republic of	Recruiting
KOR010 \| Seoul, 6273, Korea, Republic of	Recruiting
KOR011 \| Seoul, ?02841, Korea, Republic of	Recruiting
KOR009 \| Seoul, ?03312, Korea, Republic of	Recruiting
KOR003 \| Seoul, ?05030, Korea, Republic of	Recruiting
KOR014 \| Uijeongbu-Si, Gyeonggido, 11765, Korea, Republic of	Recruiting
LVA002 \| Daugavpils, Daugavpils Aprinkis, LV-5401, Latvia	Recruiting
LVA005 \| Jurmala, LV-2015, Latvia	Recruiting
MYS003 \| Kota Bharu, Kelantan, 15586, Malaysia	Recruiting
MYS004 \| Kuantan, Pahang, 25100, Malaysia	Recruiting
MYS006 \| Kuching, Sarawak, 93586, Malaysia	Recruiting
MYS002 \| Batu Caves, Selangor, 68100, Malaysia	Recruiting
MYS005 \| Kuala Lumpur, Wilayah Persekutuan, 50590, Malaysia	Recruiting
MYS001 \| Kuala Lumpur, Wilayah Persekutuan, 59100, Malaysia	Recruiting
MEX004 \| Guadalajara, Jalisco, 44130, Mexico	Recruiting
MEX007 \| Guadalajara, Jalisco, 44160, Mexico	Recruiting
MEX008 \| Guadalajara, Jalisco, 44160, Mexico	Recruiting
MEX003 \| Monterrey, Nuevo Leon, 64460, Mexico	Recruiting
MEX001 \| Monterrey, Nuevo Leon, 64718, Mexico	Recruiting
MEX002 \| Oaxaca, 68000, Mexico	Recruiting
NLD003 \| Arnhem, Gelderland, 6815 AD, Netherlands	Recruiting
NLD005 \| Heerlen, Limburg, 6419 PC, Netherlands	Recruiting
NLD001 \| Alkmaar, Noord-Holland, 1815 JD, Netherlands	Recruiting
NLD002 \| Amsterdam, Noord-Holland, 1105 AZ, Netherlands	Recruiting
NLD004 \| Denhaag, Zuid-Holland, 2545 CH, Netherlands	Recruiting
NLD006 \| Rotterdam, Zuid-Holland, 3015 GD Rotterdam, Netherlands	Recruiting
NZL008 \| Auckland, North Island, 1051, New Zealand	Recruiting
NZL004 \| Auckland, North Island, 1144, New Zealand	Recruiting
NZL006 \| Auckland, North Island, 1640, New Zealand	Recruiting
NZL009 \| Havelock North, North Island, 4130, New Zealand	Recruiting
NZL007 \| Taurunga, North Island, 3110, New Zealand	Recruiting
NZL010 \| Wellington, North Island, 6021, New Zealand	Recruiting
NZL011 \| Wellington, North Island, 6021, New Zealand	Recruiting
NZL005 \| Christchurch, South Island, 8011, New Zealand	Recruiting
NZL001 \| Dunedin, South Island, 9001, New Zealand	Recruiting
NZL002 \| Hamilton, Waikato, 3204, New Zealand	Recruiting
NZL003 \| Auckland, 1051, New Zealand	Recruiting
PER001 \| Cercado De Lima, Lima 01, Peru	Recruiting
PER005 \| Chancay, 15131, Peru	Recruiting
PER002 \| Lima, 15084, Peru	Recruiting
PER003 \| Lima, Lima 27, Peru	Recruiting
PER006 \| Piura, 20001, Peru	Recruiting
POL011 \| Ciudad Autonoma De BuenosAires, Ciudad Autonoma De Buenos Aires, C1121ABE, Poland	Recruiting
POL016 \| Katowice, Slaskie, 40-081, Poland	Recruiting
POL007 \| Sosnowiec, Slaskie, 41-200, Poland	Recruiting
POL005 \| Bialystok, 15-044, Poland	Recruiting
POL006 \| Bielsko Biala, 43-300, Poland	Recruiting
POL012 \| Kielce, 25-751, Poland	Recruiting
POL015 \| Kielce, 25-751, Poland	Recruiting
POL017 \| Krakow, 30-510, Poland	Recruiting
POL018 \| Ksawerow, 95-054, Poland	Recruiting
POL008 \| Rabka-Zdroj, 34-700, Poland	Recruiting
POL010 \| Siedlce, ?08-110, Poland	Recruiting
POL001 \| Sucha Beskidzka, 34-200, Poland	Recruiting
POL014 \| Szczecin, 70-111, Poland	Recruiting
POL009 \| Tarnow, 33-100, Poland	Recruiting
PRT007 \| Vila Nova de Gaia, Porto, 4434-502, Portugal	Recruiting
PRT005 \| Aveiro, 3814-5001, Portugal	Recruiting
PRT009 \| Braga, 4710-243, Portugal	Recruiting
PRT001 \| Covilha, 6200-251, Portugal	Recruiting
PRT006 \| Guarda, 6300-858, Portugal	Recruiting
PRT002 \| Guimaraes, 4835-044, Portugal	Recruiting
PRT003 \| Lisboa, 1649-035, Portugal	Recruiting
SRB004 \| Kragujevac, Aumadijski Okrug, 34000, Serbia	Recruiting
SRB001 \| Belgrade, 11000, Serbia	Recruiting
SRB003 \| Belgrade, 11000, Serbia	Recruiting
SRB007 \| Nis, 18000, Serbia	Recruiting
SRB014 \| Sombor, 25000, Serbia	Recruiting
SRB010 \| Uzice, 31000, Serbia	Recruiting
SVK002 \| Bardejov, ?085 01, Slovakia	Recruiting
SVK003 \| Spisska Nova Ves, 085 01, Slovakia	Recruiting
ESP008 \| Oviedo, Asturias, 33011, Spain	Recruiting
ESP006 \| LHospitalet de LLobregat, Barcelona, ?08907, Spain	Recruiting
ESP009 \| Santander, Cantabria, 39008, Spain	Recruiting
ESP012 \| Santander, Cantabria, 39008, Spain	Recruiting
ESP010 \| Pozuelo de Alarcon, Madrid, 28223, Spain	Recruiting
ESP015 \| Pozuelo de Alarcon, Madrid, 28223, Spain	Recruiting
ESP011 \| Pamplona, Navarra, 31008, Spain	Recruiting
ESP016 \| Barcelona, 8036, Spain	Recruiting
ESP013 \| Barcelona, ?08036, Spain	Recruiting
ESP001 \| Girona, 17007, Spain	Recruiting
ESP007 \| Madrid, 28007, Spain	Recruiting
ESP002 \| Madrid, 28046, Spain	Recruiting
TWN003 \| Kaohsiung City, 80756, Taiwan	Recruiting
TWN002 \| Kaohsiung, 82445, Taiwan	Recruiting
TWN001 \| Kaohsiung, 833, Taiwan	Recruiting
TWN005 \| New Taipei City, 22060, Taiwan	Recruiting
TWN007 \| Taipei City, 10002, Taiwan	Recruiting
TWN004 \| Taipei, 11217, Taiwan	Recruiting
TWN006 \| Taipei, 11490, Taiwan	Recruiting
THA003 \| Mueang Khon Kaen, Khon Kaen, 40000, Thailand	Recruiting
THA001 \| Bangkok, Krung Thep Maha Nakhon, 10400, Thailand	Recruiting
THA004 \| Nakhonnayok, Nakhon Nayok, 26120, Thailand	Recruiting
THA002 \| Muang, Nonthaburi, 11000, Thailand	Recruiting
TUR010 \| Ankara, 06010, Turkey	Recruiting
TUR003 \| Canakkale, 17110, Turkey	Recruiting
TUR008 \| Izmir, 35100, Turkey	Recruiting
TUR004 \| Izmir, 35110, Turkey	Recruiting
TUR005 \| Konya, 42075, Turkey	Recruiting
TUR011 \| Mamak, 06340, Turkey	Recruiting
TUR001 \| Mersin, 33079, Turkey	Recruiting
TUR006 \| Samsun, 55139, Turkey	Recruiting
TUR009 \| Umuttepe, 41380, Turkey	Recruiting
UKR001 \| Kharkiv, Kharkivs'ka Oblast', 61124, Ukraine	Recruiting
UKR010 \| Vinnytsia, Vinnyts'ka Oblast', 21018, Ukraine	Recruiting
UKR012 \| Dnipro, 49000, Ukraine	Recruiting
UKR002 \| Dnipro, 49027, Ukraine	Recruiting
UKR009 \| Ivano-Frankivsk, 76018, Ukraine	Recruiting
UKR007 \| Kherson, 73000, Ukraine	Recruiting
UKR008 \| Kyiv, ?01033, Ukraine	Recruiting
UKR004 \| Kyiv, ?03038, Ukraine	Recruiting
UKR003 \| Odesa, 65025, Ukraine	Recruiting
UKR005 \| Poltava, 36010, Ukraine	Recruiting
GBR004 \| Liverpool, Merseyside, L14 3PE, United Kingdom	Recruiting
GBR007 \| Dundee, DD2 4BF, United Kingdom	Recruiting
GBR014 \| Londonderry, BT47 1SB, United Kingdom	Recruiting
GBR009 \| London, SW3 6NP, United Kingdom	Recruiting
GBR008 \| Manchester, M23 9LT, United Kingdom	Recruiting
GBR011 \| Manchester, M8 5RB, United Kingdom	Recruiting
GBR017 \| Norwich, NR4 7UY, United Kingdom	Recruiting
GBR002 \| Surrey, KT16 0PZ, United Kingdom	Recruiting

Расположение Страны	Argentina Australia Austria Belgium Brazil Bulgaria Canada Chile Colombia Denmark France Germany Greece Hungary Ireland Israel Italy Japan Korea, Republic of Latvia Malaysia Mexico Netherlands New Zealand Peru Poland Portugal Serbia Slovakia Spain Taiwan Thailand Turkey Ukraine United Kingdom United States
Дата проверки	2021-12-01
Ответственная сторона	Тип: Спонсор
Ключевые слова	ASPEN Brensocatib INS1007
Имеет расширенный доступ	Нет
Количество рук	3
Группа вооружений	Метка: Brensocatib 10 mg Тип: Experimental Описание: Participants will receive brensocatib 10 mg once daily, for 52 weeks. Метка: Бренсокатиб 25 мг Тип: Экспериментальный Описание: Участники будут получать 25 мг бренсокатиба один раз в день в течение 52 недель. Метка: Плацебо Тип: Компаратор плацебо Описание: Участники будут получать плацебо, соответствующее бренсокатибу, один раз в день.
Акроним	ASPEN
Информация о дизайне исследования	Распределение: Рандомизированный Модель вмешательства: Параллельное присвоение Первичное назначение: Уход Маскировка: Двойник (участник, исследователь)

Исследование эффективности, безопасности и переносимости у пациентов с бронхоэктазами без кистозного фиброза.