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

November 28, 2025 updated by: Insmed Incorporated

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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1767

Phase

  • Phase 3

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Córdoba, Argentina, X5003DCE
        • ARG005
      • Mendoza, Argentina, M5500CCG
        • ARG007
      • Rosario, Argentina, S2000JKR
        • ARG011
      • Santa Fe, Argentina, 3000
        • ARG019
    • Buenos Aires
      • Bahía 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
      • La Plata, Buenos Aires, Argentina, B1902COS
        • ARG006
      • Mar del Plata, Buenos Aires, Argentina, B7600FYK
        • ARG013
      • Mar del Plata, Buenos Aires, Argentina, CP 7600
        • ARG017
      • Villa Vatteone, Buenos Aires, Argentina, B1853AIK
        • ARG009
    • Ciudad Autónoma de BuenosAires
      • Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C10227AAP
        • ARG012
      • Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1060
        • ARG018
      • Recoleta, Ciudad Autónoma de BuenosAires, Argentina, C1425EFD
        • ARG026
    • Córdoba Province
      • Río Cuarto, Córdoba Province, Argentina, 5800
        • ARG023
    • Mendoza Province
      • Vistalba, Mendoza Province, Argentina, M5544
        • ARG014
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000DTC
        • ARG010
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000IFL
        • ARG015
      • San Miguel de Tucumán, Tucumán Province, 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
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • BEL002
      • Ghent, 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
      • Rousse, 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 Region
      • Valdivia, Los Ríos Region, Chile, 5110683
        • CHL007
    • Maule Region
      • Curicó, Maule Region, Chile, 3440000
        • CHL005
      • Talca, Maule Region, 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
    • Bogota D.C.
      • Bogotá, Bogota D.C., Colombia, 111211
        • COL001
    • Cundinamarca
      • Zipaquirá, Cundinamarca, Colombia, 250252
        • COL006
    • Santander Department
      • Floridablanca, Santander Department, Colombia, 681004
        • COL005
    • Valle del Cauca Department
      • Cali, Valle del Cauca Department, 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
    • Region Syddanmark
      • Odense C, Region Syddanmark, Denmark, 5000
        • DNK005
      • Vejle, Region Syddanmark, Denmark, 7100
        • DNK006
  • France
      • Amiens, France, 80054
        • FRA004
      • Créteil, 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
      • Hanover, Germany, 30625
        • DEU015
      • Mainz, Germany, 55128
        • DEU023
      • Münster, Germany, 48149
        • DEU029
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Germany, 69126
        • DEU009
    • Bavaria
      • München, Bavaria, Germany, 80336
        • DEU025
    • Brandenburg
      • Potsdam, Brandenburg, Germany, 14467
        • DEU027
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60590
        • DEU008
      • Marburg, Hesse, Germany, 35037
        • DEU005
    • Lower Saxony
      • Hanover, Lower Saxony, Germany, 30625
        • DEU031
    • North Rhine-Westphalia
      • Essen, North Rhine-Westphalia, Germany, 45239
        • DEU013
    • Saxony
      • Leipzig, Saxony, Germany, 04347
        • DEU003
    • Saxony-Anhalt
      • Halle, Saxony-Anhalt, Germany, 06120
        • DEU016
    • Schleswig-Holstein
      • Geesthacht, Schleswig-Holstein, Germany, 21502
        • DEU020
  • Greece
      • Heraklion, 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
      • Beersheba, Israel, 84101
        • ISR010
      • Haifa, Israel, 34362
        • ISR008
      • Jerusalem, Israel, 91031
        • ISR006
      • Jerusalem, Israel, 91120
        • ISR002
      • Kefar Sava, Israel, 44281
        • ISR009
      • Petah Tikva, Israel, 49100
        • ISR011
      • Ramat Gan, Israel, 52621
        • ISR007
      • Rehovot, Israel, 76100
        • ISR003
      • Ẕerifin, Israel, 70300
        • ISR004
  • Italy
      • Milan, 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
    • Lombardy
      • Milan, Lombardy, Italy, 20122
        • ITA006
      • Milan, Lombardy, Italy, 20122
        • ITA012
      • Rozzano, Lombardy, Italy, 20089
        • ITA011
    • Tuscany
      • Siena, Tuscany, Italy, 53100
        • ITA004
  • Japan
      • Fukuoka, Japan, 8408571
        • JPN030
      • Hamamatsu, Japan, 434-8511
        • JPN003
      • Kita Kyushu-shi, Japan, 807-8556
        • JPN004
      • Matsue, 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, Hukuoka, Japan, 815-0032
        • JPN027
      • Iizuka-Shi, Hukuoka, Japan, 820-0018
        • JPN023
    • Hyôgo
      • Kobe, Hyôgo, Japan, 650-0047
        • JPN009
    • Ibaraki
      • Kasama-Shi, Ibaraki, Japan, 309-1703
        • JPN020
      • Naka-gun, Ibaraki, Japan, 319-1113
        • JPN001
    • Kagawa-ken
      • Takamatsu, Kagawa-ken, Japan, 761-8073
        • JPN022
    • Kanagawa
      • Yokohama-Shi Konan-Ku, Kanagawa, Japan, 234-0054
        • JPN028
    • Kumamoto
      • Koshi Shi, Kumamoto, Japan, 861-1196
        • JPN005
    • Mie-ken
      • Matsusaka-shi, Mie-ken, Japan, 515-8544
        • JPN008
      • Tsu, Mie-ken, Japan, 514-1101
        • JPN011
    • Miyagi
      • Sendai, Miyagi, Japan, 981-0914
        • JPN034
    • Nagasaki
      • Nagasaki, Nagasaki, Japan, 852-8501
        • JPN013
    • Niigata
      • Chuo-ku, Niigata, Japan, 951-8510
        • JPN012
    • Shimane
      • Matsue, Shimane, Japan, 690-8556
        • JPN015
    • Tokyo
      • Kiyose, Tokyo, Japan, 204-8522
        • JPN007
      • 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
      • Ōta-ku, Tokyo, Japan, 143-8541
        • JPN014
    • Yamaguchi
      • Shimonoseki-Shi, Yamaguchi, Japan, 750-0041
        • JPN019
  • Latvia
      • Jūrmala, Latvia, LV-2015
        • LVA005
    • Daugavpils Aprinkis
      • Daugavpils, Daugavpils Aprinkis, Latvia, LV-5401
        • LVA002
  • Malaysia
      • Kota Bharu, 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 City, 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
    • North Holland
      • Alkmaar, North Holland, Netherlands, 1815 JD
        • NLD001
      • Amsterdam, North 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 Region
      • Hamilton, Waikato Region, New Zealand, 3204
        • NZL002
    • Wellington Region
      • Paraparaumu, Wellington Region, 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
      • Ksawerów, Poland, 95-054
        • POL018
      • Rabka-Zdrój, 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
      • Tarnów, Poland, 33-100
        • POL009
    • Świętokrzyskie Voivodeship
      • Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland, 27-400
        • POL012
  • Portugal
      • Aveiro, Portugal, 3814-501
        • PRT005
      • Braga, Portugal, 4710-243
        • PRT009
      • Guarda, Portugal, 6300-858
        • PRT006
      • Guimarães, Portugal, 4835-044
        • PRT002
      • Lisbon, Portugal, 1649-035
        • PRT003
  • Serbia
      • Belgrade, Serbia, 11000
        • SRB001
      • Belgrade, Serbia, 11000
        • SRB003
      • Niš, Serbia, 18000
        • SRB007
      • Sombor, Serbia, 25000
        • SRB014
      • Užice, Serbia, 31000
        • SRB010
  • Slovakia
      • Bardejov, Slovakia, 085 01
        • SVK002
      • Spisská Nová Ves, Slovakia, 052 01
        • SVK003
  • South Korea
      • Incheon, South Korea, 21431
        • KOR004
      • Seoul, South Korea, 02447
        • KOR012
      • Seoul, South Korea, 02841
        • KOR011
      • Seoul, South Korea, 03312
        • KOR009
      • Seoul, South Korea, 03722
        • KOR013
      • Seoul, South Korea, 06273
        • KOR010
      • Seoul, South Korea, 06591
        • KOR005
    • Gyeonggido
      • Ansan-si, Gyeonggido, South Korea, 15355
        • KOR015
      • Bucheon-si, Gyeonggido, South Korea, 14584
        • KOR008
      • Seongnam-si, Gyeonggido, South Korea, 13620
        • KOR007
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, South Korea, 05030
        • KOR003
  • 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
    • Barcelona
      • Badalona, Barcelona, Spain, 08036
        • ESP013
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • ESP012
    • Madrid
      • Pozuelo de Alarcón, Madrid, Spain, 28223
        • ESP015
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • ESP011
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spain, 33011
        • ESP008
  • Taiwan
      • Kaohsiung City, Taiwan, 80756
        • TWN003
      • Kaohsiung City, Taiwan, 82544
        • TWN002
      • Kaohsiung City, Taiwan, 833
        • TWN001
      • New Taipei City, Taiwan, 22060
        • TWN005
      • Taipei, Taiwan, 10002
        • TWN007
      • Taipei, Taiwan, 11217
        • TWN004
      • Taipei, Taiwan, 11490
        • TWN006
  • Thailand
      • Khon Kaen, Thailand, 40002
        • THA003
    • Changwat Nakhon Nayok
      • Nakhonnayok, Changwat Nakhon Nayok, Thailand, 26120
        • THA004
    • Changwat Nonthaburi
      • Muang, Changwat Nonthaburi, Thailand, 11000
        • THA002
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 6010
        • TUR010
      • Ankara, Turkey (Türkiye), 6340
        • TUR011
      • Izmir, Turkey (Türkiye), 35100
        • TUR008
      • Izmir, Turkey (Türkiye), 35110
        • TUR004
      • Kocaeli, Turkey (Türkiye), 41380
        • TUR009
      • Konya, Turkey (Türkiye), 42075
        • TUR005
      • Mersin, Turkey (Türkiye), 33079
        • TUR001
      • Çanakkale, Turkey (Türkiye), 17110
        • TUR003
    • Samsun
      • Atakum, Samsun, Turkey (Türkiye), 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
    • Kherson Oblast
      • Kherson, Kherson Oblast, Ukraine, 73003
        • UKR007
    • Poltava Oblast
      • Poltava, Poltava 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, 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
        • 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
        • USA102
      • Palm Springs, California, United States, 92262
        • USA022
      • Sacramento, California, United States, 95817
        • USA024
      • San Diego, California, United States, 92120
        • USA035
      • Santa Barbara, California, United States, 93105
        • USA078
      • Ventura, California, United States, 93003
        • USA027
    • Colorado
      • Denver, Colorado, United States, 80206
        • USA075
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • USA017
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • USA001
    • Florida
      • Clearwater, Florida, United States, 33765
        • USA015
      • Gainesville, Florida, United States, 32610
        • USA076
      • Jacksonville, Florida, United States, 32224
        • USA082
      • Kissimmee, Florida, United States, 34746
        • USA039
      • Leesburg, Florida, United States, 34748
        • USA072
      • Miami, Florida, United States, 33126
        • USA037
      • Miami Lakes, Florida, United States, 33014
        • USA019
      • Naples, Florida, United States, 34102
        • USA049
      • Orlando, Florida, United States, 32825
        • USA052
      • Plantation, Florida, United States, 33324
        • USA103
      • Sarasota, Florida, United States, 34239
        • USA084
      • St. Petersburg, Florida, United States, 33704
        • USA089
      • St. Petersburg, Florida, United States, 33707
        • USA074
      • 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
        • USA073
      • Maywood, Illinois, United States, 60153
        • USA061
    • Indiana
      • Hammond, Indiana, United States, 46324
        • 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
        • 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
      • St 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
        • USA066
      • New York, New York, United States, 10017
        • USA021
      • New York, New York, United States, 10032
        • USA085
    • North Carolina
      • Gastonia, North Carolina, United States, 28054
        • USA033
      • Huntersville, North Carolina, United States, 28078
        • 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
        • USA109
    • Texas
      • Dallas, Texas, United States, 75246
        • USA097
      • McKinney, Texas, United States, 75069
        • 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
        • USA088

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Experimental: Brensocatib 10 milligrams (mg)
Participants will receive brensocatib 10 mg, tablets orally, once daily, for 52 weeks.
Drug: Brensocatib 10 mg
Oral tablet.
Other Names:
  • INS1007

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annualized Rate of Pulmonary Exacerbations (PEs)
Time Frame: Up to Week 52
PE was defined as having 3 or more of these symptoms for at least 48 hours resulting in a physician's decision to prescribe antibiotics: 1. Increased cough 2. Increased sputum volume or change in sputum consistency 3. Increased sputum purulence 4. Increased breathlessness and/or decreased exercise tolerance 5. Fatigue and/or malaise 6. Hemoptysis. A severe pulmonary exacerbation was that required intravenous (IV) antibacterial drug treatment and/or hospitalization. A minimum of 14 days must have occurred between one exacerbation onset and the next. Any exacerbation that occurred less than 14 days from the prior exacerbation was not considered a new exacerbation. Independent adjudication committee with pulmonary physicians adjudicated reported PE events to see if they fulfil the protocol definition. The rate of PE was analyzed using the negative binomial model.
Up to Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First PE
Time Frame: Up to Week 52
PE was defined as having 3 or more of following symptoms for at least 48 hours resulting in physician's decision to prescribe antibiotics:1.Increased cough2.Increased sputum volume or change in sputum consistency3.Increased sputum purulence4.Increased breathlessness &/or decreased exercise tolerance5.Fatigue &/or malaise6.Hemoptysis.Severe PE were those requiring IV antibacterial drug treatment &/or hospitalization. Minimum of 14 days must have occurred between one exacerbation onset and next. Any exacerbation that occurred within 14 days of prior exacerbation was not considered a new exacerbation. Time to first PE was calculated from randomization date to onset date of the first exacerbation. Participants who did not have exacerbation at end of 52-week treatment period were considered as censored at date of Week 52 in Cox proportional hazard model. Independent adjudication committee with pulmonary physicians adjudicated reported PE events to see if they fulfil protocol definition.
Up to Week 52
Responder Status for Exacerbation-Free Over the 52-Week Treatment Period
Time Frame: Up to Week 52
Responder status was based on percentage of participants who were exacerbation free over 52-weeks of treatment period. Pulmonary exacerbation was defined as having 3 or more of the following symptoms for at least 48 hours resulting in a physician's decision to prescribe antibiotics: 1. Increased cough 2. Increased sputum volume or change in sputum consistency 3. Increased sputum purulence 4. Increased breathlessness and/or decreased exercise tolerance 5. Fatigue and/or malaise 6. Hemoptysis. A minimum of 14 days must have occurred between one exacerbation onset and the next. Any exacerbation that occurred less than 14 days from the prior exacerbation was not considered a new exacerbation. Independent adjudication committee of pulmonary physicians adjudicated reported PE events to see if they fulfill protocol definition. For discontinuation prior to Week 52 without having experienced a confirmed PE, responder status was imputed by multiple imputation.
Up to Week 52
Change From Baseline at Week 52 in Postbronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Time Frame: Baseline, Week 52
FEV1 was used to assess lung function and is the maximum amount of air that can be forced out in one second after first second after taking a forced expiration as measured by spirometer. Postbronchodilator FEV1 tests included spirometry tests performed referred to the spirometry performed within 30 minutes after administration of bronchodilator (4 puffs of salbutamol/albuterol, terbutaline or ipratropium). A positive change from baseline indicates an improvement in lung function. Baseline was the most recent non-missing assessment determined as best effort prior to the first dose of the investigational product.
Baseline, Week 52
Annualized Rate of Severe PEs
Time Frame: Up to Week 52
Pulmonary exacerbation was defined as having 3 or more of the following symptoms for at least 48 hours resulting in a physician's decision to prescribe antibiotics: 1. Increased cough 2. Increased sputum volume or change in sputum consistency 3. Increased sputum purulence 4. Increased breathlessness and/or decreased exercise tolerance 5. Fatigue and/or malaise 6. Hemoptysis. A severe PE was defined as those requiring IV antibacterial drug treatment and/or hospitalization. A minimum of 14 days must have occurred between one exacerbation onset and the next. Any exacerbation that occurred less than 14 days from the prior exacerbation was not considered a new exacerbation. Independent adjudication committee with pulmonary physicians adjucated reported PE events to see if they fulfil the protocol definition. The rate of PE was analyzed using the negative binomial model.
Up to Week 52
Change From Baseline at Week 52 in Quality of Life Questionnaire - Bronchiectasis (QOL-B) Respiratory Symptoms Domain Score in Adult Participants
Time Frame: Baseline, Week 52
The QOL-B is a validated, self-administered patient-reported outcome (PRO) that assesses symptoms, functioning, and health-related quality of life for participants with non-cystic fibrosis bronchiectasis (NCFBE). It contains 37 items in 8 domains (Respiratory Symptoms, Physical Functioning, Role Functioning, Emotional Functioning, Social Functioning, Vitality, Health Perceptions and Treatment Burden). Each of the 37 items is scored from 1 to 4, and each of the 8 domains scale scores is standardized on a 0-100 point scale, with higher scores representing fewer symptoms or better functioning. A positive change from Baseline indicates improvement in symptoms. For this outcome measure, change in the respiratory symptoms domain score from Baseline was reported. Baseline refers to most recent assessment on or before study Day 1.
Baseline, Week 52
Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Up to Week 56
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs are AEs that occurred on or after the date of first dose of study drugs and within 28 days after the end of treatment.
Up to Week 56
Plasma Concentration of Brensocatib in Adults (Main Study)
Time Frame: 2 hours (h) post-dose on Day 1; Pre-dose and 2 h post-dose at Weeks 4, 28 and 40; Pre-dose at Weeks 16 and 52
2 hours (h) post-dose on Day 1; Pre-dose and 2 h post-dose at Weeks 4, 28 and 40; Pre-dose at Weeks 16 and 52
Plasma Concentration of Brensocatib in Adults (PK Substudy)
Time Frame: 0.5 h, 2 h, and 4 to 8 h post-dose on Day 1and at Week 28; Pre-dose and 2 h post-dose at Weeks 4 and 48; Pre-dose at Weeks 16 and 52
0.5 h, 2 h, and 4 to 8 h post-dose on Day 1and at Week 28; Pre-dose and 2 h post-dose at Weeks 4 and 48; Pre-dose at Weeks 16 and 52
Plasma Concentration of Brensocatib in Adolescents (Main Study)
Time Frame: 0.5 h, 2 h, and 4 to 8 h post-dose on Day 1 and at Week 28; Pre-dose and 2 h post-dose at Weeks 4 and 48; Pre-dose at Weeks 16 and 52
0.5 h, 2 h, and 4 to 8 h post-dose on Day 1 and at Week 28; Pre-dose and 2 h post-dose at Weeks 4 and 48; Pre-dose at Weeks 16 and 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Insmed Incorporated

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

October 28, 2024

Study Completion (Actual)

October 28, 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 (Estimated)

December 16, 2025

Last Update Submitted That Met QC Criteria

November 28, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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