Non-Cystic Fibrosis BronchiectasisPhase 3ASPENNCT04594369
A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis
A Phase 3 study testing Brensocatib 10 mg and Brensocatib 25 mg in people with Non-Cystic Fibrosis Bronchiectasis, run by Insmed Incorporated at 373 sites in 36 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 85 years
- Conditions the study is for
- Non-Cystic Fibrosis Bronchiectasis
- What is being tested?
- Brensocatib 10 mg and Brensocatib 25 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,767 participants
- Where
- 373 sitesin 36 countries
- Study dates
- 1 Dec 2020to 28 Oct 2024
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Provide their signed study informed consent to participate.
- 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.
- 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.
- 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.
- Adolescent participants are required to have at least 1 pulmonary exacerbation in the prior 12 months.
- 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.
- 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.
- Male participants with pregnant or non-pregnant women of child-bearing potential partners must use condoms to avoid potential exposure to the embryo/fetus.
Who cannot join
- A primary diagnosis of chronic obstructive pulmonary disease (COPD) or asthma as judged by the Investigator.
- Bronchiectasis due to cystic fibrosis.
- Current smokers as defined per Centers for Disease Control (CDC).
- Known or suspected immunodeficiency disorder, including history of invasive opportunistic infections.
- Known history of human immunodeficiency virus (HIV) infection.
- Currently being treated for nontuberculous mycobacteria (NTM) lung infection, allergic bronchopulmonary aspergillosis, or tuberculosis (TB).
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- Active and current symptomatic infection by 2019 corona virus disease (COVID-19).
- Inability to follow the procedures of the study (eg, due to language problems or psychological disorders).
- Receiving medications or therapy that are prohibited as concomitant medications.
- Previously participated in a clinical trial for brensocatib.
- Received any live attenuated vaccine within 4 weeks prior to the first administration of brensocatib.
- Suffering an exacerbation 4 weeks before Screening or during the Screening period.
- 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.
- Participated in any other interventional clinical studies within 3 months before Screening Visit.
- History of alcohol or drug abuse within 6 months prior to the Screening Visit.
- 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.
- Known history of hypersensitivity to brensocatib or any of its excipients.
Trial locations and contacts
373 sites in 36 countries.
373 sites in 36 countries
United States67 sites
USA012
Atlanta, Georgia, 30342
USA053
Augusta, Georgia, 30912
USA003
Baltimore, Maryland, 21224
USA013
Birmingham, Alabama, 35233
USA079
Boston, Massachusetts, 02114
USA005
Charleston, South Carolina, 29425
USA006
Chesterfield, Missouri, 63017
USA073
Chicago, Illinois, 60611
USA067
Cincinnati, Ohio, 45267
USA015
Clearwater, Florida, 33765
USA093
Cleveland, Ohio, 44195
USA080
Conway, Arkansas, 72032
USA097
Dallas, Texas, 75246
USA075
Denver, Colorado, 80206
USA038
DuBois, Pennsylvania, 15801
USA017
Farmington, Connecticut, 06030
USA041
Franklin, Tennessee, 37067
USA104
Fresno, California, 93702
USA076
Gainesville, Florida, 32610
USA033
Gastonia, North Carolina, 28054
USA115
Hammond, Indiana, 46324
USA096
Huntersville, North Carolina, 28078
USA063
Iowa City, Iowa, 52242
USA082
Jacksonville, Florida, 32224
USA031
Kansas City, Kansas, 66160
USA039
Kissimmee, Florida, 34746
USA072
Leesburg, Florida, 34748
USA110
Lincoln, Nebraska, 68510
USA044
Little Rock, Arkansas, 72205
USA055
Los Angeles, California, 90048
USA061
Maywood, Illinois, 60153
USA050
McKinney, Texas, 75069
USA037
Miami, Florida, 33126
USA019
Miami Lakes, Florida, 33014
USA049
Naples, Florida, 34102
USA109
Nashville, Tennessee, 37232
USA066
New Hyde Park, New York, 11042
USA020
New Orleans, Louisiana, 70112
USA051
New Orleans, Louisiana, 70112
USA021
New York, New York, 10017
USA085
New York, New York, 10032
USA029
Newport Beach, California, 92663
USA102
Northridge, California, 91324
USA052
Orlando, Florida, 32825
USA022
Palm Springs, California, 92262
USA046
Philadelphia, Pennsylvania, 19104
USA103
Plantation, Florida, 33324
USA023
Portland, Oregon, 97239
USA010
Rochester, Minnesota, 55905
USA036
Rock Hill, South Carolina, 29732
USA024
Sacramento, California, 95817
USA011
San Antonio, Texas, 78258
USA035
San Diego, California, 92120
USA078
Santa Barbara, California, 93105
USA084
Sarasota, Florida, 34239
USA064
Springfield, Massachusetts, 01199
USA059
St Louis, Missouri, 63110
USA089
St. Petersburg, Florida, 33704
USA074
St. Petersburg, Florida, 33707
USA120
Tampa, Florida, 33606
USA065
Toms River, New Jersey, 08755
USA002
Tyler, Texas, 75708
USA088
Vancouver, Washington, 98664
USA027
Ventura, California, 93003
USA001
Washington D.C., District of Columbia, 20007
USA034
Williamsburg, Virginia, 23188
USA026
Winston-Salem, North Carolina, 27103
Japan29 sites
JPN012
Chuo-ku, Niigata, 951-8510
JPN027
Fukuoka, Hukuoka, 815-0032
JPN030
Fukuoka, 8408571
JPN003
Hamamatsu, 434-8511
JPN023
Iizuka-Shi, Hukuoka, 820-0018
JPN020
Kasama-Shi, Ibaraki, 309-1703
JPN004
Kita Kyushu-shi, 807-8556
JPN007
Kiyose, Tokyo, 204-8522
JPN009
Kobe, Hyôgo, 650-0047
JPN005
Koshi Shi, Kumamoto, 861-1196
JPN015
Matsue, Shimane, 690-8556
JPN016
Matsue, 690-8504
JPN008
Matsusaka-shi, Mie-ken, 515-8544
JPN010
Meguro-ku, 152-0021
JPN013
Nagasaki, Nagasaki, 852-8501
JPN001
Naka-gun, Ibaraki, 319-1113
JPN014
Ōta-ku, Tokyo, 143-8541
JPN034
Sendai, Miyagi, 981-0914
JPN019
Shimonoseki-Shi, Yamaguchi, 750-0041
JPN006
Shinagawa-ku, Tokyo, 140-8522
JPN017
Shinagawa-ku, Tokyo, 141-8625
JPN002
Shinjuku-ku, Tokyo, 160-8582
JPN032
Shinjuku-ku, Tokyo, 1628655
JPN022
Takamatsu, Kagawa-ken, 761-8073
JPN031
Toon-Shi, Ehime, 791-0203
JPN029
Toyoake, Aiti, 470-1192
JPN018
Toyonaka-shi, 560-8552
JPN011
Tsu, Mie-ken, 514-1101
JPN028
Yokohama-Shi Konan-Ku, Kanagawa, 234-0054
Argentina23 sites
ARG027
Bahía Blanca, Buenos Aires, 8000
ARG012
Buenos Aires, Ciudad Autónoma de BuenosAires, C10227AAP
ARG018
Buenos Aires, Ciudad Autónoma de BuenosAires, C1060
ARG021
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1121ABE
ARG022
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1122AAK
ARG002
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1414AIF
ARG001
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1425AZB
ARG003
Ciudad Autónoma de BuenosAires, Buenos Aires, C1425BEN
ARG004
Ciudad Autónoma de BuenosAires, Buenos Aires, C1426ABP
ARG005
Córdoba, X5003DCE
ARG006
La Plata, Buenos Aires, B1902COS
ARG013
Mar del Plata, Buenos Aires, B7600FYK
ARG017
Mar del Plata, Buenos Aires, CP 7600
ARG007
Mendoza, M5500CCG
ARG026
Recoleta, Ciudad Autónoma de BuenosAires, C1425EFD
ARG023
Río Cuarto, Córdoba Province, 5800
ARG010
Rosario, Santa Fe Province, S2000DTC
ARG011
Rosario, S2000JKR
ARG015
San Miguel de Tucumán, Tucumán Province, T4000IFL
ARG025
San Miguel de Tucumán, Tucumán Province, T4000IHE
ARG019
Santa Fe, 3000
ARG009
Villa Vatteone, Buenos Aires, B1853AIK
ARG014
Vistalba, Mendoza Province, M5544
Germany19 sites
DEU002
Berlin, 10717
DEU019
Berlin, 10961
DEU006
Berlin, 13125
DEU011
Berlin, 13353
DEU014
Dresden, 01307
DEU013
Essen, North Rhine-Westphalia, 45239
DEU021
Frankfurt, 60389
DEU008
Frankfurt am Main, Hesse, 60590
DEU020
Geesthacht, Schleswig-Holstein, 21502
DEU016
Halle, Saxony-Anhalt, 06120
DEU031
Hanover, Lower Saxony, 30625
DEU015
Hanover, 30625
DEU009
Heidelberg, Baden-Wurttemberg, 69126
DEU003
Leipzig, Saxony, 04347
DEU023
Mainz, 55128
DEU005
Marburg, Hesse, 35037
DEU025
München, Bavaria, 80336
DEU029
Münster, 48149
DEU027
Potsdam, Brandenburg, 14467
Australia18 sites
AUS011
Adelaide, South Australia, 5000
AUS017
Bedford Park, South Australia, 5042
AUS002
Box Hill, Victoria, 3128
AUS012
Cairns North, Queensland, 4870
AUS001
Chermside, Queensland, 4032
AUS014
Clayton, Victoria, 3168
AUS003
Concord, NSW 2139
AUS010
Greenslopes, Queensland, 4120
AUS013
Kogarah, New South Wales, 2217
AUS018
Murdoch, Western Australia, 6150
AUS005
Nedlands, Western Australia, 6009
AUS008
New Lambton Heights, New South Wales, 2305
AUS022
North Adelaide, South Australia, 5006
AUS006
South Brisbane, Queensland, 4101
AUS019
South Brisbane, Queensland, 4101
AUS015
Spearwood, 6163
AUS007
Westmead, New South Wales, 2145
AUS009
Woodville South, South Australia, 5011
Bulgaria17 sites
BGR005
Blagoevgrad, 2700
BGR006
Gabrovo, 5300
BGR014
Kozloduy, 3320
BGR015
Lovech, 5500
BGR007
Montana, 3400
BGR018
Pazardzhik, 4400
BGR019
Pleven, 5800
BGR004
Plovdiv, 4023
BGR008
Rousse, 7002
BGR017
Sliven, 8800
BGR011
Sofia, Sofia-Grad, 1336
BGR009
Sofia, Sofia-Grad, 1510
BGR002
Sofia, Sofia-Grad, 1680
BGR010
Sofia, 1233
BGR012
Veliko Tarnovo, 5000
BGR013
Vidin, 3700
BGR016
Vratsa, 3000
United Kingdom16 sites
GBR006
Birmingham, B9 5SS
GBR016
Bradford, Yorkshire, BD9 6RJ
GBR001
Cambridge, Cambridgeshire, CB23 3RE
GBR002
Chertsey, KT16 0PZ
GBR007
Dundee, DDI 9SY
GBR015
Exeter, Devon, EX2 5DW
GBR004
Liverpool, L14 3PE
GBR013
Llandough, Vale of Glamorgan, the, CF64 2XX
GBR009
London, SW3 6NP
GBR008
Manchester, M23 9LT
GBR011
Manchester, M8 5RB
GBR003
Newcastle upon Tyne, NE7 7DN
GBR017
Norwich, Norfolk, NR4 7UY
GBR012
Salford, M6 8HD
GBR018
Southampton, SO16 6YD
GBR010
Swansea, SA6 6NL
Poland14 sites
POL005
Bialystok, 15-044
POL006
Bielsko-Biala, 43-300
POL016
Katowice, 40-081
POL015
Kielce, 25-751
POL017
Krakow, 30-510
POL018
Ksawerów, 95-054
POL012
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400
POL008
Rabka-Zdrój, 34-700
POL011
Rzeszów, 35-051
POL010
Siedlce, 08-110
POL007
Sosnowiec, 41-208
POL001
Sucha Beskidzka, 34-200
POL014
Szczecin, 70-111
POL009
Tarnów, 33-100
Spain12 sites
ESP013
Badalona, Barcelona, 08036
ESP003
Barcelona, 08035
ESP016
Barcelona, 8036
ESP001
Girona, 17007
ESP006
L'Hospitalet de Llobregat, 08907
ESP007
Madrid, 28007
ESP002
Madrid
ESP008
Oviedo, Principality of Asturias, 33011
ESP011
Pamplona, Navarre, 31008
ESP015
Pozuelo de Alarcón, Madrid, 28223
ESP012
Santander, Cantabria, 39008
ESP009
Santiago de Compostela, A Coruña, 15706
Italy11 sites
ITA010
Bologna, Emilia-Romagna, 40138
ITA008
Ferrara, Emilia-Romagna, 44124
ITA006
Milan, Lombardy, 20122
ITA012
Milan, Lombardy, 20122
ITA003
Milan, 20157
ITA001
Palermo, 90127
ITA007
Pavia, 27100
ITA002
Reggio Emilia, Emilia-Romagna, 42100
ITA009
Roma, 00168
ITA011
Rozzano, Lombardy, 20089
ITA004
Siena, Tuscany, 53100
South Korea11 sites
KOR015
Ansan-si, Gyeonggido, 15355
KOR008
Bucheon-si, Gyeonggido, 14584
KOR004
Incheon, 21431
KOR007
Seongnam-si, Gyeonggido, 13620
KOR003
Seoul, Seoul Teugbyeolsi, 05030
KOR012
Seoul, 02447
KOR011
Seoul, 02841
KOR009
Seoul, 03312
KOR013
Seoul, 03722
KOR010
Seoul, 06273
KOR005
Seoul, 06591
Israel10 sites
ISR001
Ashkelon, 78278
ISR010
Beersheba, 84101
ISR008
Haifa, 34362
ISR006
Jerusalem, 91031
ISR002
Jerusalem, 91120
ISR009
Kefar Sava, 44281
ISR011
Petah Tikva, 49100
ISR007
Ramat Gan, 52621
ISR003
Rehovot, 76100
ISR004
Ẕerifin, 70300
New Zealand10 sites
NZL003
Auckland, 1051
NZL008
Auckland, 1051
NZL005
Christchurch, South Island, 8011
NZL001
Dunedin, South Island, 9001
NZL002
Hamilton, Waikato Region, 3204
NZL009
Hastings, Hawkes's Bay, 4122
NZL006
Otahuhu, Auckland, 1640
NZL011
Paraparaumu, Wellington Region, 5032
NZL007
Tauranga, 3110
NZL010
Wellington, 6021
Turkey (Türkiye)9 sites
TUR010
Ankara, 6010
TUR011
Ankara, 6340
TUR006
Atakum, Samsun, 55270
TUR003
Çanakkale, 17110
TUR008
Izmir, 35100
TUR004
Izmir, 35110
TUR009
Kocaeli, 41380
TUR005
Konya, 42075
TUR001
Mersin, 33079
Ukraine9 sites
UKR012
Dnipro, 49102
UKR009
Ivano-Frankivsk, 76018
UKR001
Kharkiv, Kharkiv Oblast, 61124
UKR007
Kherson, Kherson Oblast, 73003
UKR008
Kyiv, 01033
UKR004
Kyiv, 03038
UKR003
Odesa, 65025
UKR005
Poltava, Poltava Oblast, 36010
UKR010
Vinnytsia, 21018
Denmark8 sites
DNK003
Aalborg, 9000
DNK007
Aarhus, DK-8200
DNK008
Copenhagen O, Capital, 2100
DNK004
Hellerup, 2900
DNK001
Hvidovre, Capital, DK-2650
DNK005
Odense C, Region Syddanmark, 5000
DNK002
Roskilde, 4000
DNK006
Vejle, Region Syddanmark, 7100
France8 sites
FRA004
Amiens, 80054
FRA011
Créteil, 94010
FRA005
Montpellier, Hérault, 34295
FRA003
Nantes, 44093
FRA009
Nice, 6002
FRA010
Paris, 75014
FRA002
Strasbourg, Bas-Rhin, 67091
FRA006
Toulouse, 31400
Mexico8 sites
MEX006
Durango, 34080
MEX007
Guadalajara, Jalisco, 44160
MEX008
Guadalajara, Jalisco, 44160
MEX005
Guadalajara, Jalisco, 44220
MEX004
Guadalajara, Jalisco, 44700
MEX003
Monterrey, Nuevo León, 64460
MEX001
Monterrey, 64718
MEX002
Oaxaca City, 68000
Belgium7 sites
BEL002
Ghent, Oost-Vlaanderen, 9000
BEL009
Ghent, Oost-Vlaanderen, 9000
BEL001
Leuven, 3000
BEL007
Liège, 4000
BEL003
Mechelen, 2800
BEL004
Roeselare, West-Vlaanderen, 8800
BEL008
Sint-Niklaas, 9100
Brazil7 sites
BRA001
Blumenau, Santa Catarina, 89030-240
BRA003
Botucatu, 18618-686
BRA009
Passo Fundo, Rio Grande do Sul, 99010-120
BRA005
Porto Alegre, Rio Grande do Sul, 90035-074
BRA006
Santo André, São Paulo, 09090-790
BRA004
São Bernardo do Campo, 09715-090
BRA011
São Paulo, 05403-000
Chile7 sites
CHL005
Curicó, Maule Region, 3440000
CHL001
Providencia, Región-MetropolitanadeSantiago, 7500000
CHL002
Providencia, Región-MetropolitanadeSantiago, 7500000
CHL008
Providencia, Región-MetropolitanadeSantiago, 7500587
CHL004
Quillota, 2260000
CHL010
Talca, Maule Region, 3481349
CHL007
Valdivia, Los Ríos Region, 5110683
Taiwan7 sites
TWN003
Kaohsiung City, 80756
TWN002
Kaohsiung City, 82544
TWN001
Kaohsiung City, 833
TWN005
New Taipei City, 22060
TWN007
Taipei, 10002
TWN004
Taipei, 11217
TWN006
Taipei, 11490
Colombia6 sites
COL001
Bogotá, Bogota D.C., 111211
COL002
Bogota DC, 110131
COL003
Cali, Valle del Cauca Department, 760026
COL005
Floridablanca, Santander Department, 681004
COL004
Santiago de Cali, 076001
COL006
Zipaquirá, Cundinamarca, 250252
Peru5 sites
PER005
Chancay, 15131
PER001
Lima, 15001
PER003
Lima, 15036
PER002
Lima, 15084
PER006
Piura, 20001
Portugal5 sites
PRT005
Aveiro, 3814-501
PRT009
Braga, 4710-243
PRT006
Guarda, 6300-858
PRT002
Guimarães, 4835-044
PRT003
Lisbon, 1649-035
Serbia5 sites
SRB001
Belgrade, 11000
SRB003
Belgrade, 11000
SRB007
Niš, 18000
SRB014
Sombor, 25000
SRB010
Užice, 31000
Malaysia4 sites
MYS003
Kota Bharu, 16150
MYS001
Kuala Lumpur, WilayahPersekutuan KualaLumpur, 50603
MYS005
Kuala Lumpur, 50590
MYS004
Kuantan, Pahang, 25100
Netherlands4 sites
NLD001
Alkmaar, North Holland, 1815 JD
NLD002
Amsterdam, North Holland, 1105 AZ
NLD003
Arnhem, Gelderland, 6815 AD
NLD006
Rotterdam, 3015 GD
Greece3 sites
GRC003
Alexandroupoli, Evros, 681 00
GRC007
Heraklion, 71110
GRC006
Thessaloniki, 57010
Ireland3 sites
IRL003
Dublin, 15
IRL002
Dublin, Dublin 8
IRL001
Limerick, V94 F858
Thailand3 sites
THA003
Khon Kaen, 40002
THA002
Muang, Changwat Nonthaburi, 11000
THA004
Nakhonnayok, Changwat Nakhon Nayok, 26120
Latvia2 sites
LVA002
Daugavpils, Daugavpils Aprinkis, LV-5401
LVA005
Jūrmala, LV-2015
About this study
Official title: 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.
- Conditions
- Non-Cystic Fibrosis Bronchiectasis
- Being tested
- Brensocatib 10 mg, Brensocatib 25 mg, Placebo
- Keywords
- ASPEN, Brensocatib, INS1007
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brensocatib 10 mgDrug
Also called INS1007
Oral tablet.
Brensocatib 25 mgDrug
Also called INS1007
Oral tablet.
PlaceboDrug
Brensocatib-matching oral tablet.
| Study group | Role | What they receive |
|---|---|---|
| Brensocatib 10 milligrams (mg) | Experimental | Participants will receive brensocatib 10 mg, tablets orally, once daily, for 52 weeks. Receives: Drug: Brensocatib 10 mg |
| Brensocatib 25 mg | Experimental | Participants will receive brensocatib 25 mg, tablets orally, once daily, for 52 weeks. Receives: Drug: Brensocatib 25 mg |
| Placebo | Placebo comparator | Participants will receive a brensocatib-matching placebo, tablets orally, once daily, for 52 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized Rate of Pulmonary Exacerbations (PEs)
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.
Measured: Up to Week 52
Secondary outcomes (9)
Time to First PE
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.
Measured: Up to Week 52
Responder Status for Exacerbation-Free Over the 52-Week Treatment Period
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.
Measured: Up to Week 52
Change From Baseline at Week 52 in Postbronchodilator Forced Expiratory Volume in 1 Second (FEV1)
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.
Measured: Baseline, Week 52
Annualized Rate of Severe PEs
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.
Measured: 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
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.
Measured: Baseline, Week 52
Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Events (TEAEs)
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.
Measured: Up to Week 56
Plasma Concentration of Brensocatib in Adults (Main Study)
Measured: 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)
Measured: 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)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start1 Dec 2020
- Primary completion28 Oct 2024
- Study completion28 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Non-Cystic Fibrosis BronchiectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,767 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insmed Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04594369
- Sponsor's protocol ID
- INS1007-301
- Other IDs
- 2020-003688-25
- Acronym
- ASPEN
- Status last verified
- Nov 2025
- First submitted
- 14 Oct 2020
- Last updated
- 16 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
- Expanded access
- Available
Publications
Addrizzo-Harris D, Chalmers JD, Aliberti S, Burgel PR, Morrissey BM, Zhang X, Fan C, Lauterio M, Fucile S, Griffis D, Teper A. Efficacy and Safety of Brensocatib in Participants of Asian Race with Non-cystic Fibrosis Bronchiectasis: A Subgroup Analysis of the ASPEN Trial. Pulm Ther. 2026 Jul 16. doi: 10.1007/s41030-026-00375-w. Online ahead of print.
PubMed 42461571Morimoto K, Chalmers JD, Burgel PR, Daley CL, De Soyza A, Mauger D, Metersky ML, Zhang X, Li S, Goto Y, Teper A, Fernandez C, Hasegawa N. Efficacy and safety of brensocatib in Japanese patients with non-cystic fibrosis bronchiectasis: Analysis of the ASPEN trial. Respir Investig. 2026 Mar;64(2):101357. doi: 10.1016/j.resinv.2025.101357. Epub 2026 Jan 9.
PubMed 41519018Chalmers 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.
PubMed 40267423Chalmers 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.
PubMed 39040578Chalmers 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.
PubMed 35976570