A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis (ASPEN)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects With Non-Cystic Fibrosis Bronchiectasis - The ASPEN Study

The primary objective of this study is to evaluate the effect of brensocatib at 10 mg and 25 mg compared with placebo on the rate of pulmonary exacerbations (PEs) over the 52-week treatment period.

Study Overview

• Status: Active, not recruiting
• Conditions: Non-Cystic Fibrosis Bronchiectasis
• Intervention / Treatment: Drug: Brensocatib 10 mg; Drug: Brensocatib 25 mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 1767
• Phase: Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

• Study Contact: Name: Insmed Medical Information; Phone Number: 1-844-446-7633; Email: medicalinformation@insmed.com

Study Locations

• Argentina
  • Córdoba, Argentina, X5003DCE
    • ARG005
  • Mendoza, Argentina, M5500CCG
    • ARG007
  • Rosario, Argentina, S2000JKR
    • ARG011
  • Santa Fe, Argentina, 3000
    • ARG019
  • Buenos Aires
    • Bahia Blanca, Buenos Aires, Argentina, 8000
      • ARG027
    • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1121ABE
      • ARG021
    • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1122AAK
      • ARG022
    • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1414AIF
      • ARG002
    • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1425AZB
      • ARG001
    • Ciudad Autónoma de BuenosAires, Buenos Aires, Argentina, C1425BEN
      • ARG003
    • Ciudad Autónoma de BuenosAires, Buenos Aires, Argentina, C1426ABP
      • ARG004
    • Mar Del Plata, Buenos Aires, Argentina, CP 7600
      • ARG017
    • Mar del Plata, Buenos Aires, Argentina, B7600FYK
      • ARG013
    • Villa Vatteone, Buenos Aires, Argentina, B1853AIK
      • ARG009
    • la Plata, Buenos Aires, Argentina, B1902COS
      • ARG006
  • Ciudad Autónoma De BuenosAires
    • Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina, C10227AAP
      • ARG012
    • Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina, C1060
      • ARG018
    • Recoleta, Ciudad Autónoma De BuenosAires, Argentina, C1425EFD
      • ARG026
  • Córdoba
    • Río Cuarto, Córdoba, Argentina, 5800
      • ARG023
  • Mendoza
    • Vistalba, Mendoza, Argentina, M5544
      • ARG014
  • Santa Fe
    • Rosario, Santa Fe, Argentina, S2000DTC
      • ARG010
  • Tucumán
    • San Miguel De Tucumán, Tucumán, Argentina, T4000IFL
      • ARG015
    • San Miguel de Tucumán, Tucumán, Argentina, T4000IHE
      • ARG025
• Australia
  • Concord, Australia, NSW 2139
    • AUS003
  • Spearwood, Australia, 6163
    • AUS015
  • New South Wales
    • Kogarah, New South Wales, Australia, 2217
      • AUS013
    • New Lambton Heights, New South Wales, Australia, 2305
      • AUS008
    • Westmead, New South Wales, Australia, 2145
      • AUS007
  • Queensland
    • Cairns North, Queensland, Australia, 4870
      • AUS012
    • Chermside, Queensland, Australia, 4032
      • AUS001
    • Greenslopes, Queensland, Australia, 4120
      • AUS010
    • South Brisbane, Queensland, Australia, 4101
      • AUS006
    • South Brisbane, Queensland, Australia, 4101
      • AUS019
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • AUS011
    • Bedford Park, South Australia, Australia, 5042
      • AUS017
    • North Adelaide, South Australia, Australia, 5006
      • AUS022
    • Woodville South, South Australia, Australia, 5011
      • AUS009
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • AUS002
    • Clayton, Victoria, Australia, 3168
      • AUS014
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • AUS018
    • Nedlands, Western Australia, Australia, 6009
      • AUS005
• Austria
  • Linz, Austria, 4021
    • AUT002
• Belgium
  • Leuven, Belgium, 3000
    • BEL001
  • Liège, Belgium, 4000
    • BEL007
  • Mechelen, Belgium, 2800
    • BEL003
  • Sint-Niklaas, Belgium, 9100
    • BEL008
  • Oost-Vlaanderen
    • Gent, Oost-Vlaanderen, Belgium, 9000
      • BEL002
    • Gent, Oost-Vlaanderen, Belgium, 9000
      • BEL009
  • West-Vlaanderen
    • Roeselare, West-Vlaanderen, Belgium, 8800
      • BEL004
• Brazil
  • Botucatu, Brazil, 18618-686
    • BRA003
  • São Bernardo do Campo, Brazil, 09715-090
    • BRA004
  • São Paulo, Brazil, 05403-000
    • BRA011
  • Rio Grande Do Sul
    • Passo Fundo, Rio Grande Do Sul, Brazil, 99010-120
      • BRA009
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-074
      • BRA005
  • Santa Catarina
    • Blumenau, Santa Catarina, Brazil, 89030-240
      • BRA001
  • São Paulo
    • Santo André, São Paulo, Brazil, 09090-790
      • BRA006
• Bulgaria
  • Blagoevgrad, Bulgaria, 2700
    • BGR005
  • Gabrovo, Bulgaria, 5300
    • BGR006
  • Kozloduy, Bulgaria, 3320
    • BGR014
  • Lovech, Bulgaria, 5500
    • BGR015
  • Montana, Bulgaria, 3400
    • BGR007
  • Pazardzhik, Bulgaria, 4400
    • BGR018
  • Pleven, Bulgaria, 5800
    • BGR019
  • Plovdiv, Bulgaria, 4023
    • BGR004
  • Ruse, Bulgaria, 7002
    • BGR008
  • Sliven, Bulgaria, 8800
    • BGR017
  • Sofia, Bulgaria, 1233
    • BGR010
  • Veliko Tarnovo, Bulgaria, 5000
    • BGR012
  • Vidin, Bulgaria, 3700
    • BGR013
  • Vratsa, Bulgaria, 3000
    • BGR016
  • Sofia-Grad
    • Sofia, Sofia-Grad, Bulgaria, 1336
      • BGR011
    • Sofia, Sofia-Grad, Bulgaria, 1510
      • BGR009
    • Sofia, Sofia-Grad, Bulgaria, 1680
      • BGR002
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 3A9
      • CAN004
  • Quebec
    • Montreal, Quebec, Canada, H2X 0A9
      • CAN002
• Chile
  • Quillota, Chile, 2260000
    • CHL004
  • Los Ríos
    • Valdivia, Los Ríos, Chile, 5110683
      • CHL007
  • Maule
    • Curicó, Maule, Chile, 3440000
      • CHL005
    • Talca, Maule, Chile, 3481349
      • CHL010
  • Región-MetropolitanadeSantiago
    • Providencia, Región-MetropolitanadeSantiago, Chile, 7500000
      • CHL001
    • Providencia, Región-MetropolitanadeSantiago, Chile, 7500000
      • CHL002
    • Providencia, Región-MetropolitanadeSantiago, Chile, 7500587
      • CHL008
• Colombia
  • Bogota DC, Colombia, 110131
    • COL002
  • Santiago de Cali, Colombia, 076001
    • COL004
  • Cundinamarca
    • Zipaquira, Cundinamarca, Colombia, 250252
      • COL006
  • Distrito Capital De Bogotá
    • Bogotá, Distrito Capital De Bogotá, Colombia, 111211
      • COL001
  • Santander
    • Floridablanca, Santander, Colombia, 681004
      • COL005
  • Valle Del Cauca
    • Cali, Valle Del Cauca, Colombia, 760026
      • COL003
• Denmark
  • Aalborg, Denmark, 9000
    • DNK003
  • Aarhus, Denmark, DK-8200
    • DNK007
  • Hellerup, Denmark, 2900
    • DNK004
  • Roskilde, Denmark, 4000
    • DNK002
  • Capital
    • Copenhagen O, Capital, Denmark, 2100
      • DNK008
    • Hvidovre, Capital, Denmark, DK-2650
      • DNK001
  • South Denmark
    • Odense C, South Denmark, Denmark, 5000
      • DNK005
    • Vejle, South Denmark, Denmark, 7100
      • DNK006
• France
  • Amiens cedex 1, France, 80054
    • FRA004
  • Creteil, France, 94010
    • FRA011
  • Nantes, France, 44093
    • FRA003
  • Nice, France, 6002
    • FRA009
  • Paris, France, 75014
    • FRA010
  • Toulouse, France, 31400
    • FRA006
  • Bas-Rhin
    • Strasbourg, Bas-Rhin, France, 67091
      • FRA002
  • Hérault
    • Montpellier, Hérault, France, 34295
      • FRA005
• Germany
  • Berlin, Germany, 10717
    • DEU002
  • Berlin, Germany, 10961
    • DEU019
  • Berlin, Germany, 13125
    • DEU006
  • Berlin, Germany, 13353
    • DEU011
  • Dresden, Germany, 01307
    • DEU014
  • Frankfurt, Germany, 60389
    • DEU021
  • Hannover, Germany, 30625
    • DEU015
  • Mainz, Germany, 55128
    • DEU023
  • Muenster, Germany, 48149
    • DEU029
  • Baden-Württemberg
    • Heidelberg, Baden-Württemberg, Germany, 69126
      • DEU009
  • Bayern
    • München, Bayern, Germany, 80336
      • DEU025
  • Brandenburg
    • Potsdam, Brandenburg, Germany, 14467
      • DEU027
  • Hessen
    • Frankfurt am Main, Hessen, Germany, 60590
      • DEU008
    • Marburg, Hessen, Germany, 35037
      • DEU005
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30625
      • DEU031
  • Nordrhein-Westfalen
    • Essen, Nordrhein-Westfalen, Germany, 45239
      • DEU013
  • Sachsen
    • Leipzig, Sachsen, Germany, 04347
      • DEU003
  • Sachsen-Anhalt
    • Halle, Sachsen-Anhalt, Germany, 06120
      • DEU016
  • Schleswig-Holstein
    • Geesthacht, Schleswig-Holstein, Germany, 21502
      • DEU020
• Greece
  • Herakleion, Greece, 71110
    • GRC007
  • Thessaloniki, Greece, 57010
    • GRC006
  • Evros
    • Alexandroupoli, Evros, Greece, 681 00
      • GRC003
• Hungary
  • Komárom-Esztergom
    • Tatabánya, Komárom-Esztergom, Hungary, 2800
      • HUN005
• Ireland
  • Dublin, Ireland, 15
    • IRL003
  • Dublin, Ireland, Dublin 8
    • IRL002
  • Limerick, Ireland, V94 F858
    • IRL001
• Israel
  • Ashkelon, Israel, 78278
    • ISR001
  • Beer Sheva, Israel, 84101
    • ISR010
  • Haifa, Israel, 34362
    • ISR008
  • Jerusalem, Israel, 91031
    • ISR006
  • Jerusalem, Israel, 91120
    • ISR002
  • Kefar-Sava, Israel, 44281
    • ISR009
  • Petach Tikva, Israel, 49100
    • ISR011
  • Ramat Gan, Israel, 52621
    • ISR007
  • Rehovot, Israel, 76100
    • ISR003
  • Zerifin, Israel, 70300
    • ISR004
• Italy
  • Milano, Italy, 20157
    • ITA003
  • Palermo, Italy, 90127
    • ITA001
  • Pavia, Italy, 27100
    • ITA007
  • Roma, Italy, 00168
    • ITA009
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • ITA010
    • Ferrara, Emilia-Romagna, Italy, 44124
      • ITA008
    • Reggio Emilia, Emilia-Romagna, Italy, 42100
      • ITA002
  • Lombardia
    • Milano, Lombardia, Italy, 20122
      • ITA006
    • Milano, Lombardia, Italy, 20122
      • ITA012
    • Rozzano, Lombardia, Italy, 20089
      • ITA011
  • Toscana
    • Siena, Toscana, Italy, 53100
      • ITA004
• Japan
  • Fukuoka-shi, Japan, 8408571
    • JPN030
  • Hamamatsu-Shi, Japan, 434-8511
    • JPN003
  • Kita Kyushu-shi, Japan, 807-8556
    • JPN004
  • Matsue-shi, Japan, 690-8504
    • JPN016
  • Meguro-ku, Japan, 152-0021
    • JPN010
  • Toyonaka-shi, Japan, 560-8552
    • JPN018
  • Aiti
    • Toyoake, Aiti, Japan, 470-1192
      • JPN029
  • Ehime
    • Toon-Shi, Ehime, Japan, 791-0203
      • JPN031
  • Hukuoka
    • Fukuoka-Shi, Hukuoka, Japan, 815-0032
      • JPN027
    • Iizuka-Shi, Hukuoka, Japan, 820-0018
      • JPN023
  • Hyôgo
    • Kobe-City, Hyôgo, Japan, 650-0047
      • JPN009
  • Ibaraki
    • Kasama-Shi, Ibaraki, Japan, 309-1703
      • JPN020
    • Naka-gun, Ibaraki, Japan, 319-1113
      • JPN001
  • Kagawa
    • Takamatsu-Shi, Kagawa, Japan, 761-8073
      • JPN022
  • Kanagawa
    • Yokohama-Shi Konan-Ku, Kanagawa, Japan, 234-0054
      • JPN028
  • Kumamoto
    • Koshi shi, Kumamoto, Japan, 861-1196
      • JPN005
  • Mie
    • Matsusaka-shi, Mie, Japan, 515-8544
      • JPN008
    • Tsu, Mie, Japan, 514-1101
      • JPN011
  • Miyagi
    • Sendai-shi, Miyagi, Japan, 980-0873
      • JPN034
  • Nagasaki
    • Nagasaki-Shi, Nagasaki, Japan, 852-8501
      • JPN013
  • Niigata
    • Chuo-ku, Niigata, Japan, 951-8510
      • JPN012
  • Simane
    • Matsue, Simane, Japan, 690-8556
      • JPN015
  • Tokyo
    • Kiyose, Tokyo, Japan, 204-8522
      • JPN007
    • Ota-Ku, Tokyo, Japan, 143-8541
      • JPN014
    • Shinagawa-ku, Tokyo, Japan, 140-8522
      • JPN006
    • Shinagawa-ku, Tokyo, Japan, 141-8625
      • JPN017
    • Shinjuku-ku, Tokyo, Japan, 160-8582
      • JPN002
    • Shinjuku-ku, Tokyo, Japan, 1628655
      • JPN032
  • Yamaguti
    • Shimonoseki-Shi, Yamaguti, Japan, 750-0041
      • JPN019
• Korea, Republic of
  • Incheon, Korea, Republic of, 21431
    • KOR004
  • Seoul, Korea, Republic of, 02447
    • KOR012
  • Seoul, Korea, Republic of, 02841
    • KOR011
  • Seoul, Korea, Republic of, 03312
    • KOR009
  • Seoul, Korea, Republic of, 03722
    • KOR013
  • Seoul, Korea, Republic of, 06273
    • KOR010
  • Seoul, Korea, Republic of, 06591
    • KOR005
  • Gyeonggido
    • Ansan-si, Gyeonggido, Korea, Republic of, 15355
      • KOR015
    • Bucheon-si, Gyeonggido, Korea, Republic of, 14584
      • KOR008
    • Seongnam-si, Gyeonggido, Korea, Republic of, 13620
      • KOR007
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05030
      • KOR003
• Latvia
  • Jurmala, Latvia, LV-2015
    • LVA005
  • Daugavpils Aprinkis
    • Daugavpils, Daugavpils Aprinkis, Latvia, LV-5401
      • LVA002
• Malaysia
  • Kota Bahru, Malaysia, 16150
    • MYS003
  • Kuala Lumpur, Malaysia, 50590
    • MYS005
  • Pahang
    • Kuantan, Pahang, Malaysia, 25100
      • MYS004
  • WilayahPersekutuan KualaLumpur
    • Kuala Lumpur, WilayahPersekutuan KualaLumpur, Malaysia, 50603
      • MYS001
• Mexico
  • Durango, Mexico, 34080
    • MEX006
  • Monterrey, Mexico, 64718
    • MEX001
  • Oaxaca, Mexico, 68000
    • MEX002
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44160
      • MEX007
    • Guadalajara, Jalisco, Mexico, 44160
      • MEX008
    • Guadalajara, Jalisco, Mexico, 44220
      • MEX005
    • Guadalajara, Jalisco, Mexico, 44700
      • MEX004
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64460
      • MEX003
• Netherlands
  • Rotterdam, Netherlands, 3015 GD
    • NLD006
  • Gelderland
    • Arnhem, Gelderland, Netherlands, 6815 AD
      • NLD003
  • Noord-Holland
    • Alkmaar, Noord-Holland, Netherlands, 1815 JD
      • NLD001
    • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
      • NLD002
• New Zealand
  • Auckland, New Zealand, 1051
    • NZL003
  • Auckland, New Zealand, 1051
    • NZL008
  • Tauranga, New Zealand, 3110
    • NZL007
  • Wellington, New Zealand, 6021
    • NZL010
  • Auckland
    • Otahuhu, Auckland, New Zealand, 1640
      • NZL006
  • Hawkes's Bay
    • Hastings, Hawkes's Bay, New Zealand, 4122
      • NZL009
  • South Island
    • Christchurch, South Island, New Zealand, 8011
      • NZL005
    • Dunedin, South Island, New Zealand, 9001
      • NZL001
  • Waikato
    • Hamilton, Waikato, New Zealand, 3204
      • NZL002
  • Wellington
    • Paraparaumu, Wellington, New Zealand, 5032
      • NZL011
• Peru
  • Chancay, Peru, 15131
    • PER005
  • Lima, Peru, 15001
    • PER001
  • Lima, Peru, 15036
    • PER003
  • Lima, Peru, 15084
    • PER002
  • Piura, Peru, 20001
    • PER006
• Poland
  • Bialystok, Poland, 15-044
    • POL005
  • Bielsko Biala, Poland, 43-300
    • POL006
  • Katowice, Poland, 40-081
    • POL016
  • Kielce, Poland, 25-751
    • POL015
  • Krakow, Poland, 30-510
    • POL017
  • Ksawerow, Poland, 95-054
    • POL018
  • Rabka-Zdroj, Poland, 34-700
    • POL008
  • Rzeszów, Poland, 35-051
    • POL011
  • Siedlce, Poland, 08-110
    • POL010
  • Sosnowiec, Poland, 41-208
    • POL007
  • Sucha Beskidzka, Poland, 34-200
    • POL001
  • Szczecin, Poland, 70-111
    • POL014
  • Tarnow, Poland, 33-100
    • POL009
  • Swietokrzyskie
    • Ostrowiec Swietokrzyski, Swietokrzyskie, Poland, 27-400
      • POL012
• Portugal
  • Aveiro, Portugal, 3814-501
    • PRT005
  • Braga, Portugal, 4710-243
    • PRT009
  • Guarda, Portugal, 6300-858
    • PRT006
  • Guimaraes, Portugal, 4835-044
    • PRT002
  • Lisboa, Portugal, 1649-035
    • PRT003
• Serbia
  • Belgrade, Serbia, 11000
    • SRB001
  • Belgrade, Serbia, 11000
    • SRB003
  • Nis, Serbia, 18000
    • SRB007
  • Sombor, Serbia, 25000
    • SRB014
  • Uzice, Serbia, 31000
    • SRB010
• Slovakia
  • Bardejov, Slovakia, 085 01
    • SVK002
  • Spisská Nová Ves, Slovakia, 052 01
    • SVK003
• Spain
  • Barcelona, Spain, 08035
    • ESP003
  • Barcelona, Spain, 8036
    • ESP016
  • Girona, Spain, 17007
    • ESP001
  • L´Hospitalet de Llobregat, Spain, 08907
    • ESP006
  • Madrid, Spain, 28007
    • ESP007
  • Madrid, Spain
    • ESP002
  • A Coruña
    • Santiago de Compostela, A Coruña, Spain, 15706
      • ESP009
  • Asturias
    • Oviedo, Asturias, Spain, 33011
      • ESP008
  • Barcelona
    • Badalona, Barcelona, Spain, 08036
      • ESP013
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • ESP012
  • Madrid
    • Pozuelo de Alarcon, Madrid, Spain, 28223
      • ESP015
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • ESP011
• Taiwan
  • Kaohsiung, Taiwan, 82544
    • TWN002
  • Kaohsiung, Taiwan, 833
    • TWN001
  • Kaohsiung City, Taiwan, 80756
    • TWN003
  • New Taipei City, Taiwan, 22060
    • TWN005
  • Taipei, Taiwan, 10002
    • TWN007
  • Taipei, Taiwan, 11217
    • TWN004
  • Taipei City, Taiwan, 11490
    • TWN006
• Thailand
  • Khon Kaen, Thailand, 40002
    • THA003
  • Nakhon Nayok
    • Nakhonnayok, Nakhon Nayok, Thailand, 26120
      • THA004
  • Nonthaburi
    • Muang, Nonthaburi, Thailand, 11000
      • THA002
• Turkey
  • Ankara, Turkey, 6010
    • TUR010
  • Ankara, Turkey, 6340
    • TUR011
  • Canakkale, Turkey, 17110
    • TUR003
  • Izmir, Turkey, 35100
    • TUR008
  • Izmir, Turkey, 35110
    • TUR004
  • Kocaeli, Turkey, 41380
    • TUR009
  • Konya, Turkey, 42075
    • TUR005
  • Mersin, Turkey, 33079
    • TUR001
  • Samsun
    • Atakum, Samsun, Turkey, 55270
      • TUR006
• Ukraine
  • Dnipro, Ukraine, 49102
    • UKR012
  • Ivano-Frankivsk, Ukraine, 76018
    • UKR009
  • Kyiv, Ukraine, 01033
    • UKR008
  • Kyiv, Ukraine, 03038
    • UKR004
  • Odesa, Ukraine, 65025
    • UKR003
  • Vinnytsia, Ukraine, 21018
    • UKR010
  • Kharkivs'ka Oblast
    • Kharkiv, Kharkivs'ka Oblast, Ukraine, 61124
      • UKR001
  • Khersons'ka Oblast
    • Kherson, Khersons'ka Oblast, Ukraine, 73003
      • UKR007
  • Poltavs'ka Oblast
    • Poltava, Poltavs'ka Oblast, Ukraine, 36010
      • UKR005
• United Kingdom
  • Birmingham, United Kingdom, B9 5SS
    • GBR006
  • Chertsey, United Kingdom, KT16 0PZ
    • GBR002
  • Dundee, United Kingdom, DDI 9SY
    • GBR007
  • Liverpool, United Kingdom, L14 3PE
    • GBR004
  • London, United Kingdom, SW3 6NP
    • GBR009
  • Manchester, United Kingdom, M23 9LT
    • GBR008
  • Manchester, United Kingdom, M8 5RB
    • GBR011
  • Newcastle upon Tyne, United Kingdom, NE7 7DN
    • GBR003
  • Salford, United Kingdom, M6 8HD
    • GBR012
  • Southampton, United Kingdom, SO16 6YD
    • GBR018
  • Swansea, United Kingdom, SA6 6NL
    • GBR010
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB23 3RE
      • GBR001
  • Devon
    • Exeter, Devon, United Kingdom, EX2 5DW
      • GBR015
  • Norfolk
    • Norwich, Norfolk, United Kingdom, NR4 7UY
      • GBR017
  • Vale Of Glamorgan, The
    • Llandough, Penarth, Vale Of Glamorgan, The, United Kingdom, CF64 2XX
      • GBR013
  • Yorkshire
    • Bradford, Yorkshire, United Kingdom, BD9 6RJ
      • GBR016
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233-1711
      • USA013
  • Arkansas
    • Conway, Arkansas, United States, 72032
      • USA080
    • Little Rock, Arkansas, United States, 72205
      • USA044
  • California
    • Fresno, California, United States, 93702
      • USA104
    • Los Angeles, California, United States, 90048
      • USA055
    • Newport Beach, California, United States, 92663
      • USA029
    • Northridge, California, United States, 91324-3138
      • USA102
    • Palm Springs, California, United States, 92262
      • USA022
    • Sacramento, California, United States, 95817-1460
      • USA024
    • San Diego, California, United States, 92120
      • USA035
    • Santa Barbara, California, United States, 93105-4353
      • USA078
    • Ventura, California, United States, 93003
      • USA027
  • Colorado
    • Denver, Colorado, United States, 80206-2761
      • USA075
  • Connecticut
    • Farmington, Connecticut, United States, 06030
      • USA017
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • USA001
  • Florida
    • Clearwater, Florida, United States, 33765
      • USA015
    • Gainesville, Florida, United States, 32610-0001
      • USA076
    • Jacksonville, Florida, United States, 32224-1865
      • USA082
    • Kissimmee, Florida, United States, 34746
      • USA039
    • Leesburg, Florida, United States, 34748-5077
      • USA072
    • Miami, Florida, United States, 33126
      • USA037
    • Miami Lakes, Florida, United States, 33014
      • USA019
    • Naples, Florida, United States, 34102-5444
      • USA049
    • Orlando, Florida, United States, 32825
      • USA052
    • Plantation, Florida, United States, 33324
      • USA103
    • Saint Petersburg, Florida, United States, 33704
      • USA089
    • Saint Petersburg, Florida, United States, 33707
      • USA074
    • Sarasota, Florida, United States, 34239-3502
      • USA084
    • Tampa, Florida, United States, 33606
      • USA120
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • USA012
    • Augusta, Georgia, United States, 30912
      • USA053
  • Illinois
    • Chicago, Illinois, United States, 60611-2951
      • USA073
    • Maywood, Illinois, United States, 60153
      • USA061
  • Indiana
    • Hammond, Indiana, United States, 46324-2213
      • USA115
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • USA063
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • USA031
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • USA020
    • New Orleans, Louisiana, United States, 70112
      • USA051
  • Maryland
    • Baltimore, Maryland, United States, 21224-3057
      • USA003
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • USA079
    • Springfield, Massachusetts, United States, 01199
      • USA064
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • USA010
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • USA006
    • Saint Louis, Missouri, United States, 63110
      • USA059
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • USA110
  • New Jersey
    • Toms River, New Jersey, United States, 08755
      • USA065
  • New York
    • New Hyde Park, New York, United States, 11042-1102
      • USA066
    • New York, New York, United States, 10017-6739
      • USA021
    • New York, New York, United States, 10032-3729
      • USA085
  • North Carolina
    • Gastonia, North Carolina, United States, 28054
      • USA033
    • Huntersville, North Carolina, United States, 28078-5082
      • USA096
    • Winston-Salem, North Carolina, United States, 27103
      • USA026
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • USA067
    • Cleveland, Ohio, United States, 44195
      • USA093
  • Oregon
    • Portland, Oregon, United States, 97239
      • USA023
  • Pennsylvania
    • DuBois, Pennsylvania, United States, 15801
      • USA038
    • Philadelphia, Pennsylvania, United States, 19104
      • USA046
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • USA005
    • Rock Hill, South Carolina, United States, 29732
      • USA036
  • Tennessee
    • Franklin, Tennessee, United States, 37067
      • USA041
    • Nashville, Tennessee, United States, 37232-0028
      • USA109
  • Texas
    • Dallas, Texas, United States, 75246-2081
      • USA097
    • McKinney, Texas, United States, 75069-8085
      • USA050
    • San Antonio, Texas, United States, 78258
      • USA011
    • Tyler, Texas, United States, 75708
      • USA002
  • Virginia
    • Williamsburg, Virginia, United States, 23188
      • USA034
  • Washington
    • Vancouver, Washington, United States, 98664-1913
      • USA088

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 85 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Provide their signed study informed consent to participate.

   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:

1. A primary diagnosis of chronic obstructive pulmonary disease (COPD) or asthma as judged by the Investigator.
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brensocatib 10 mg; Participants will receive brensocatib 10 mg, tablets orally, once daily, for 52 weeks.	Drug: Brensocatib 10 mg; Oral tablet.; Other Names: INS1007
Experimental: Brensocatib 25 mg; Participants will receive brensocatib 25 mg, tablets orally, once daily, for 52 weeks.	Drug: Brensocatib 25 mg; Oral tablet.; Other Names: INS1007
Placebo Comparator: Placebo; Participants will receive a brensocatib-matching placebo, tablets orally, once daily, for 52 weeks.	Drug: Placebo; Brensocatib-matching oral tablet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of Adjudicated Pulmonary Exacerbations (PEs)	52 Weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to First Adjudicated Pulmonary Exacerbation (PE)	52 Weeks
Percentage of Participants who are Pulmonary Exacerbation (PE) Free	52 Weeks
Change From Baseline in Postbronchodilator Forced Expiratory Volume in 1 Second (FEV1)	Baseline, at Week 52
Rate of Severe Adjudicated Pulmonary Exacerbations (PEs)	52 Weeks
Change from Baseline to Week 52 in Quality of Life Questionnaire - Bronchiectasis (QOL-B) Respiratory Symptoms Domain Score in Adult Participants	Baseline to Week 52
Number of Participants who Experience at Least one Treatment-Emergent Adverse Events (TEAEs)	56 Weeks
Plasma Concentration of Brensocatib at Select Time Points	Pre-dose and post-dose at multiple time points up to Week 52

Collaborators and Investigators

• Sponsor: Insmed Incorporated

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Estimated): March 22, 2024
• Study Completion (Estimated): March 22, 2024

Study Registration Dates

• First Submitted: October 14, 2020
• First Submitted That Met QC Criteria: October 14, 2020
• First Posted (Actual): October 20, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Brensocatib; INS1007; ASPEN
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Bronchial Diseases; Fibrosis; Bronchiectasis
• Other Study ID Numbers: INS1007-301; 2020-003688-25 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No