A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis
NCT ID: NCT04594369
Last Updated: 2025-12-16
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
1767 participants
INTERVENTIONAL
2020-12-01
2024-10-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Brensocatib 10 milligrams (mg)
Participants will receive brensocatib 10 mg, tablets orally, once daily, for 52 weeks.
Brensocatib 10 mg
Oral tablet.
Brensocatib 25 mg
Participants will receive brensocatib 25 mg, tablets orally, once daily, for 52 weeks.
Brensocatib 25 mg
Oral tablet.
Placebo
Participants will receive a brensocatib-matching placebo, tablets orally, once daily, for 52 weeks.
Placebo
Brensocatib-matching oral tablet.
Interventions
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Brensocatib 10 mg
Oral tablet.
Brensocatib 25 mg
Oral tablet.
Placebo
Brensocatib-matching oral tablet.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
a. Adolescent participants must have signed study assent form to participate, and the adolescent's parent or legal guardian must have provided signed informed consent for the adolescent to participate.
2. Clinical history consistent with non-cystic fibrosis bronchiectasis (NCFBE) (cough, chronic sputum production and/or recurrent respiratory infections) that is confirmed by chest computerized tomography (CT) scan.
3. At least 2 PEs defined by need for antibiotic prescription by a physician for the signs and symptoms of respiratory infections in the past 12 months before the Screening Visit.
a. Adolescent participants are required to have at least 1 pulmonary exacerbation in the prior 12 months.
4. Women must be postmenopausal (defined as no menses for 12 months without an alternative medical cause), surgically sterile, or using highly effective contraception (ie, methods that can achieve a failure rate \<1% per year when used consistently and correctly) from Day 1 to at least 90 days after the last dose.
5. Male participants with female partners of childbearing potential must be using effective contraception from Day 1 to at least 90 days after the last dose.
6. Male participants with pregnant or non-pregnant women of child-bearing potential partners must use condoms to avoid potential exposure to the embryo/fetus.
Exclusion Criteria
2. Bronchiectasis due to cystic fibrosis.
3. Current smokers as defined per Centers for Disease Control (CDC).
4. Known or suspected immunodeficiency disorder, including history of invasive opportunistic infections.
5. Known history of human immunodeficiency virus (HIV) infection.
6. Currently being treated for nontuberculous mycobacteria (NTM) lung infection, allergic bronchopulmonary aspergillosis, or tuberculosis (TB).
7. Active and current symptomatic infection by 2019 corona virus disease (COVID-19).
8. Inability to follow the procedures of the study (eg, due to language problems or psychological disorders).
9. Receiving medications or therapy that are prohibited as concomitant medications.
10. Previously participated in a clinical trial for brensocatib.
11. Received any live attenuated vaccine within 4 weeks prior to the first administration of brensocatib.
12. Suffering an exacerbation 4 weeks before Screening or during the Screening period.
13. Adult participants only: Have compliance issues with completion of electronic diary entries during the Screening Period and in the opinion of the Investigator, compliance is unlikely to improve during the study.
14. Participated in any other interventional clinical studies within 3 months before Screening Visit.
15. History of alcohol or drug abuse within 6 months prior to the Screening Visit.
16. Is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the study.
17. Known history of hypersensitivity to brensocatib or any of its excipients.
12 Years
85 Years
ALL
No
Sponsors
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Insmed Incorporated
INDUSTRY
Responsible Party
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Locations
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USA013
Birmingham, Alabama, United States
USA080
Conway, Arkansas, United States
USA044
Little Rock, Arkansas, United States
USA104
Fresno, California, United States
USA055
Los Angeles, California, United States
USA029
Newport Beach, California, United States
USA102
Northridge, California, United States
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Palm Springs, California, United States
USA024
Sacramento, California, United States
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San Diego, California, United States
USA078
Santa Barbara, California, United States
USA027
Ventura, California, United States
USA075
Denver, Colorado, United States
USA017
Farmington, Connecticut, United States
USA001
Washington D.C., District of Columbia, United States
USA015
Clearwater, Florida, United States
USA076
Gainesville, Florida, United States
USA082
Jacksonville, Florida, United States
USA039
Kissimmee, Florida, United States
USA072
Leesburg, Florida, United States
USA037
Miami, Florida, United States
USA019
Miami Lakes, Florida, United States
USA049
Naples, Florida, United States
USA052
Orlando, Florida, United States
USA103
Plantation, Florida, United States
USA084
Sarasota, Florida, United States
USA089
St. Petersburg, Florida, United States
USA074
St. Petersburg, Florida, United States
USA120
Tampa, Florida, United States
USA012
Atlanta, Georgia, United States
USA053
Augusta, Georgia, United States
USA073
Chicago, Illinois, United States
USA061
Maywood, Illinois, United States
USA115
Hammond, Indiana, United States
USA063
Iowa City, Iowa, United States
USA031
Kansas City, Kansas, United States
USA020
New Orleans, Louisiana, United States
USA051
New Orleans, Louisiana, United States
USA003
Baltimore, Maryland, United States
USA079
Boston, Massachusetts, United States
USA064
Springfield, Massachusetts, United States
USA010
Rochester, Minnesota, United States
USA006
Chesterfield, Missouri, United States
USA059
St Louis, Missouri, United States
USA110
Lincoln, Nebraska, United States
USA065
Toms River, New Jersey, United States
USA066
New Hyde Park, New York, United States
USA021
New York, New York, United States
USA085
New York, New York, United States
USA033
Gastonia, North Carolina, United States
USA096
Huntersville, North Carolina, United States
USA026
Winston-Salem, North Carolina, United States
USA067
Cincinnati, Ohio, United States
USA093
Cleveland, Ohio, United States
USA023
Portland, Oregon, United States
USA038
DuBois, Pennsylvania, United States
USA046
Philadelphia, Pennsylvania, United States
USA005
Charleston, South Carolina, United States
USA036
Rock Hill, South Carolina, United States
USA041
Franklin, Tennessee, United States
USA109
Nashville, Tennessee, United States
USA097
Dallas, Texas, United States
USA050
McKinney, Texas, United States
USA011
San Antonio, Texas, United States
USA002
Tyler, Texas, United States
USA034
Williamsburg, Virginia, United States
USA088
Vancouver, Washington, United States
ARG027
Bahía Blanca, Buenos Aires, Argentina
ARG021
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
ARG022
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
ARG002
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
ARG001
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
ARG003
Ciudad Autónoma de BuenosAires, Buenos Aires, Argentina
ARG004
Ciudad Autónoma de BuenosAires, Buenos Aires, Argentina
ARG006
La Plata, Buenos Aires, Argentina
ARG013
Mar del Plata, Buenos Aires, Argentina
ARG017
Mar del Plata, Buenos Aires, Argentina
ARG009
Villa Vatteone, Buenos Aires, Argentina
ARG012
Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina
ARG018
Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina
ARG026
Recoleta, Ciudad Autónoma de BuenosAires, Argentina
ARG023
Río Cuarto, Córdoba Province, Argentina
ARG014
Vistalba, Mendoza Province, Argentina
ARG010
Rosario, Santa Fe Province, Argentina
ARG015
San Miguel de Tucumán, Tucumán Province, Argentina
ARG025
San Miguel de Tucumán, Tucumán Province, Argentina
ARG005
Córdoba, , Argentina
ARG007
Mendoza, , Argentina
ARG011
Rosario, , Argentina
ARG019
Santa Fe, , Argentina
AUS013
Kogarah, New South Wales, Australia
AUS008
New Lambton Heights, New South Wales, Australia
AUS007
Westmead, New South Wales, Australia
AUS012
Cairns North, Queensland, Australia
AUS001
Chermside, Queensland, Australia
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Greenslopes, Queensland, Australia
AUS006
South Brisbane, Queensland, Australia
AUS019
South Brisbane, Queensland, Australia
AUS011
Adelaide, South Australia, Australia
AUS017
Bedford Park, South Australia, Australia
AUS022
North Adelaide, South Australia, Australia
AUS009
Woodville South, South Australia, Australia
AUS002
Box Hill, Victoria, Australia
AUS014
Clayton, Victoria, Australia
AUS018
Murdoch, Western Australia, Australia
AUS005
Nedlands, Western Australia, Australia
AUS003
Concord, , Australia
AUS015
Spearwood, , Australia
AUT002
Linz, , Austria
BEL002
Ghent, Oost-Vlaanderen, Belgium
BEL009
Ghent, Oost-Vlaanderen, Belgium
BEL004
Roeselare, West-Vlaanderen, Belgium
BEL001
Leuven, , Belgium
BEL007
Liège, , Belgium
BEL003
Mechelen, , Belgium
BEL008
Sint-Niklaas, , Belgium
BRA009
Passo Fundo, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
BRA001
Blumenau, Santa Catarina, Brazil
BRA006
Santo André, São Paulo, Brazil
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Botucatu, , Brazil
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São Bernardo do Campo, , Brazil
BRA011
São Paulo, , Brazil
BGR011
Sofia, Sofia-Grad, Bulgaria
BGR009
Sofia, Sofia-Grad, Bulgaria
BGR002
Sofia, Sofia-Grad, Bulgaria
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Blagoevgrad, , Bulgaria
BGR006
Gabrovo, , Bulgaria
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Kozloduy, , Bulgaria
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Lovech, , Bulgaria
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Montana, , Bulgaria
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Pazardzhik, , Bulgaria
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Pleven, , Bulgaria
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Plovdiv, , Bulgaria
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Rousse, , Bulgaria
BGR017
Sliven, , Bulgaria
BGR010
Sofia, , Bulgaria
BGR012
Veliko Tarnovo, , Bulgaria
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Vidin, , Bulgaria
BGR016
Vratsa, , Bulgaria
CAN004
Toronto, Ontario, Canada
CAN002
Montreal, Quebec, Canada
CHL007
Valdivia, Los Ríos Region, Chile
CHL005
Curicó, Maule Region, Chile
CHL010
Talca, Maule Region, Chile
CHL001
Providencia, Región-MetropolitanadeSantiago, Chile
CHL002
Providencia, Región-MetropolitanadeSantiago, Chile
CHL008
Providencia, Región-MetropolitanadeSantiago, Chile
CHL004
Quillota, , Chile
COL001
Bogotá, Bogota D.C., Colombia
COL006
Zipaquirá, Cundinamarca, Colombia
COL005
Floridablanca, Santander Department, Colombia
COL003
Cali, Valle del Cauca Department, Colombia
COL002
Bogota DC, , Colombia
COL004
Santiago de Cali, , Colombia
DNK008
Copenhagen O, Capital, Denmark
DNK001
Hvidovre, Capital, Denmark
DNK005
Odense C, Region Syddanmark, Denmark
DNK006
Vejle, Region Syddanmark, Denmark
DNK003
Aalborg, , Denmark
DNK007
Aarhus, , Denmark
DNK004
Hellerup, , Denmark
DNK002
Roskilde, , Denmark
FRA002
Strasbourg, Bas-Rhin, France
FRA005
Montpellier, Hérault, France
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Amiens, , France
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Créteil, , France
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Nantes, , France
FRA009
Nice, , France
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Paris, , France
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Toulouse, , France
DEU009
Heidelberg, Baden-Wurttemberg, Germany
DEU025
München, Bavaria, Germany
DEU027
Potsdam, Brandenburg, Germany
DEU008
Frankfurt am Main, Hesse, Germany
DEU005
Marburg, Hesse, Germany
DEU031
Hanover, Lower Saxony, Germany
DEU013
Essen, North Rhine-Westphalia, Germany
DEU003
Leipzig, Saxony, Germany
DEU016
Halle, Saxony-Anhalt, Germany
DEU020
Geesthacht, Schleswig-Holstein, Germany
DEU002
Berlin, , Germany
DEU019
Berlin, , Germany
DEU006
Berlin, , Germany
DEU011
Berlin, , Germany
DEU014
Dresden, , Germany
DEU021
Frankfurt, , Germany
DEU015
Hanover, , Germany
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Mainz, , Germany
DEU029
Münster, , Germany
GRC003
Alexandroupoli, Evros, Greece
GRC007
Heraklion, , Greece
GRC006
Thessaloniki, , Greece
HUN005
Tatabánya, Komárom-Esztergom, Hungary
IRL003
Dublin, , Ireland
IRL002
Dublin, , Ireland
IRL001
Limerick, , Ireland
ISR001
Ashkelon, , Israel
ISR010
Beersheba, , Israel
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Haifa, , Israel
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Jerusalem, , Israel
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Jerusalem, , Israel
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Kefar Sava, , Israel
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Petah Tikva, , Israel
ISR007
Ramat Gan, , Israel
ISR003
Rehovot, , Israel
ISR004
Ẕerifin, , Israel
ITA010
Bologna, Emilia-Romagna, Italy
ITA008
Ferrara, Emilia-Romagna, Italy
ITA002
Reggio Emilia, Emilia-Romagna, Italy
ITA006
Milan, Lombardy, Italy
ITA012
Milan, Lombardy, Italy
ITA011
Rozzano, Lombardy, Italy
ITA004
Siena, Tuscany, Italy
ITA003
Milan, , Italy
ITA001
Palermo, , Italy
ITA007
Pavia, , Italy
ITA009
Roma, , Italy
JPN029
Toyoake, Aiti, Japan
JPN031
Toon-Shi, Ehime, Japan
JPN027
Fukuoka, Hukuoka, Japan
JPN023
Iizuka-Shi, Hukuoka, Japan
JPN009
Kobe, Hyôgo, Japan
JPN020
Kasama-Shi, Ibaraki, Japan
JPN001
Naka-gun, Ibaraki, Japan
JPN022
Takamatsu, Kagawa-ken, Japan
JPN028
Yokohama-Shi Konan-Ku, Kanagawa, Japan
JPN005
Koshi Shi, Kumamoto, Japan
JPN008
Matsusaka-shi, Mie-ken, Japan
JPN011
Tsu, Mie-ken, Japan
JPN034
Sendai, Miyagi, Japan
JPN013
Nagasaki, Nagasaki, Japan
JPN012
Chuo-ku, Niigata, Japan
JPN015
Matsue, Shimane, Japan
JPN007
Kiyose, Tokyo, Japan
JPN014
Ōta-ku, Tokyo, Japan
JPN006
Shinagawa-ku, Tokyo, Japan
JPN017
Shinagawa-ku, Tokyo, Japan
JPN002
Shinjuku-ku, Tokyo, Japan
JPN032
Shinjuku-ku, Tokyo, Japan
JPN019
Shimonoseki-Shi, Yamaguchi, Japan
JPN030
Fukuoka, , Japan
JPN003
Hamamatsu, , Japan
JPN004
Kita Kyushu-shi, , Japan
JPN016
Matsue, , Japan
JPN010
Meguro-ku, , Japan
JPN018
Toyonaka-shi, , Japan
LVA002
Daugavpils, Daugavpils Aprinkis, Latvia
LVA005
Jūrmala, , Latvia
MYS004
Kuantan, Pahang, Malaysia
MYS001
Kuala Lumpur, WilayahPersekutuan KualaLumpur, Malaysia
MYS003
Kota Bharu, , Malaysia
MYS005
Kuala Lumpur, , Malaysia
MEX007
Guadalajara, Jalisco, Mexico
MEX008
Guadalajara, Jalisco, Mexico
MEX005
Guadalajara, Jalisco, Mexico
MEX004
Guadalajara, Jalisco, Mexico
MEX003
Monterrey, Nuevo León, Mexico
MEX006
Durango, , Mexico
MEX001
Monterrey, , Mexico
MEX002
Oaxaca City, , Mexico
NLD003
Arnhem, Gelderland, Netherlands
NLD001
Alkmaar, North Holland, Netherlands
NLD002
Amsterdam, North Holland, Netherlands
NLD006
Rotterdam, , Netherlands
NZL006
Otahuhu, Auckland, New Zealand
NZL009
Hastings, Hawkes's Bay, New Zealand
NZL005
Christchurch, South Island, New Zealand
NZL001
Dunedin, South Island, New Zealand
NZL002
Hamilton, Waikato Region, New Zealand
NZL011
Paraparaumu, Wellington Region, New Zealand
NZL003
Auckland, , New Zealand
NZL008
Auckland, , New Zealand
NZL007
Tauranga, , New Zealand
NZL010
Wellington, , New Zealand
PER005
Chancay, , Peru
PER001
Lima, , Peru
PER003
Lima, , Peru
PER002
Lima, , Peru
PER006
Piura, , Peru
POL005
Bialystok, , Poland
POL006
Bielsko-Biala, , Poland
POL016
Katowice, , Poland
POL015
Kielce, , Poland
POL017
Krakow, , Poland
POL018
Ksawerów, , Poland
POL008
Rabka-Zdrój, , Poland
POL011
Rzeszów, , Poland
POL010
Siedlce, , Poland
POL007
Sosnowiec, , Poland
POL001
Sucha Beskidzka, , Poland
POL014
Szczecin, , Poland
POL009
Tarnów, , Poland
POL012
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland
PRT005
Aveiro, , Portugal
PRT009
Braga, , Portugal
PRT006
Guarda, , Portugal
PRT002
Guimarães, , Portugal
PRT003
Lisbon, , Portugal
SRB001
Belgrade, , Serbia
SRB003
Belgrade, , Serbia
SRB007
Niš, , Serbia
SRB014
Sombor, , Serbia
SRB010
Užice, , Serbia
SVK002
Bardejov, , Slovakia
SVK003
Spisská Nová Ves, , Slovakia
KOR015
Ansan-si, Gyeonggido, South Korea
KOR008
Bucheon-si, Gyeonggido, South Korea
KOR007
Seongnam-si, Gyeonggido, South Korea
KOR003
Seoul, Seoul Teugbyeolsi, South Korea
KOR004
Incheon, , South Korea
KOR012
Seoul, , South Korea
KOR011
Seoul, , South Korea
KOR009
Seoul, , South Korea
KOR013
Seoul, , South Korea
KOR010
Seoul, , South Korea
KOR005
Seoul, , South Korea
ESP009
Santiago de Compostela, A Coruña, Spain
ESP013
Badalona, Barcelona, Spain
ESP012
Santander, Cantabria, Spain
ESP015
Pozuelo de Alarcón, Madrid, Spain
ESP011
Pamplona, Navarre, Spain
ESP008
Oviedo, Principality of Asturias, Spain
ESP003
Barcelona, , Spain
ESP016
Barcelona, , Spain
ESP001
Girona, , Spain
ESP006
L'Hospitalet de Llobregat, , Spain
ESP007
Madrid, , Spain
ESP002
Madrid, , Spain
TWN003
Kaohsiung City, , Taiwan
TWN002
Kaohsiung City, , Taiwan
TWN001
Kaohsiung City, , Taiwan
TWN005
New Taipei City, , Taiwan
TWN007
Taipei, , Taiwan
TWN004
Taipei, , Taiwan
TWN006
Taipei, , Taiwan
THA004
Nakhonnayok, Changwat Nakhon Nayok, Thailand
THA002
Muang, Changwat Nonthaburi, Thailand
THA003
Khon Kaen, , Thailand
TUR006
Atakum, Samsun, Turkey (Türkiye)
TUR010
Ankara, , Turkey (Türkiye)
TUR011
Ankara, , Turkey (Türkiye)
TUR003
Çanakkale, , Turkey (Türkiye)
TUR008
Izmir, , Turkey (Türkiye)
TUR004
Izmir, , Turkey (Türkiye)
TUR009
Kocaeli, , Turkey (Türkiye)
TUR005
Konya, , Turkey (Türkiye)
TUR001
Mersin, , Turkey (Türkiye)
UKR001
Kharkiv, Kharkivs’ka Oblast’, Ukraine
UKR007
Kherson, Kherson Oblast, Ukraine
UKR005
Poltava, Poltava Oblast, Ukraine
UKR012
Dnipro, , Ukraine
UKR009
Ivano-Frankivsk, , Ukraine
UKR008
Kyiv, , Ukraine
UKR004
Kyiv, , Ukraine
UKR003
Odesa, , Ukraine
UKR010
Vinnytsia, , Ukraine
GBR001
Cambridge, Cambridgeshire, United Kingdom
GBR015
Exeter, Devon, United Kingdom
GBR017
Norwich, Norfolk, United Kingdom
GBR013
Llandough, Vale of Glamorgan, the, United Kingdom
GBR016
Bradford, Yorkshire, United Kingdom
GBR006
Birmingham, , United Kingdom
GBR002
Chertsey, , United Kingdom
GBR007
Dundee, , United Kingdom
GBR004
Liverpool, , United Kingdom
GBR009
London, , United Kingdom
GBR008
Manchester, , United Kingdom
GBR011
Manchester, , United Kingdom
GBR003
Newcastle upon Tyne, , United Kingdom
GBR012
Salford, , United Kingdom
GBR018
Southampton, , United Kingdom
GBR010
Swansea, , United Kingdom
Countries
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References
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Chalmers JD, Burgel PR, Daley CL, De Soyza A, Haworth CS, Mauger D, Loebinger MR, McShane PJ, Ringshausen FC, Blasi F, Shteinberg M, Mange K, Teper A, Fernandez C, Zambrano M, Fan C, Zhang X, Metersky ML; ASPEN Investigators. Phase 3 Trial of the DPP-1 Inhibitor Brensocatib in Bronchiectasis. N Engl J Med. 2025 Apr 24;392(16):1569-1581. doi: 10.1056/NEJMoa2411664.
Chalmers JD, Burgel PR, Daley CL, De Soyza A, Haworth CS, Mauger D, Mange K, Teper A, Fernandez C, Conroy D, Metersky M. Brensocatib in non-cystic fibrosis bronchiectasis: ASPEN protocol and baseline characteristics. ERJ Open Res. 2024 Jul 22;10(4):00151-2024. doi: 10.1183/23120541.00151-2024. eCollection 2024 Jul.
Chalmers JD, Usansky H, Rubino CM, Teper A, Fernandez C, Zou J, Mange KC. Pharmacokinetic/Pharmacodynamic Evaluation of the Dipeptidyl Peptidase 1 Inhibitor Brensocatib for Non-cystic Fibrosis Bronchiectasis. Clin Pharmacokinet. 2022 Oct;61(10):1457-1469. doi: 10.1007/s40262-022-01147-w. Epub 2022 Jul 25.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2020-003688-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
INS1007-301
Identifier Type: -
Identifier Source: org_study_id