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

NCT04594369 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: INS1007-3012020-003688-25
• Study Type: interventional
• Target: 1,767
• Locations: 35 countries
• Sites: 355

Brief 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.

Conditions

Non-Cystic Fibrosis Bronchiectasis

Keywords

ASPEN; Brensocatib; INS1007

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to Week 52

Secondary Outcomes (9)

• Time to First PE

  Up to Week 52

• Responder Status for Exacerbation-Free Over the 52-Week Treatment Period

  Up to Week 52

• Change From Baseline at Week 52 in Postbronchodilator Forced Expiratory Volume in 1 Second (FEV1)

  Baseline, Week 52

• Annualized Rate of Severe PEs

  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

  Baseline, Week 52

Study Arms (3)

Brensocatib 10 milligrams (mg)

EXPERIMENTAL

Participants will receive brensocatib 10 mg, tablets orally, once daily, for 52 weeks.

Drug: Brensocatib 10 mg

Brensocatib 25 mg

EXPERIMENTAL

Participants will receive brensocatib 25 mg, tablets orally, once daily, for 52 weeks.

Drug: Brensocatib 25 mg

Placebo

PLACEBO COMPARATOR

Participants will receive a brensocatib-matching placebo, tablets orally, once daily, for 52 weeks.

Drug: Placebo

Interventions

Brensocatib 10 mg DRUG

Oral tablet.

Also known as: INS1007

Brensocatib 10 milligrams (mg)

Brensocatib 25 mg DRUG

Oral tablet.

Also known as: INS1007

Brensocatib 25 mg

Placebo DRUG

Brensocatib-matching oral tablet.

Placebo

Eligibility Criteria

• Age: 12 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• a. 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Insmed Incorporated: lead

Study Sites (373)

USA013

Birmingham, Alabama, 35233, United States

Location

USA080

Conway, Arkansas, 72032, United States

Location

USA044

Little Rock, Arkansas, 72205, United States

Location

USA104

Fresno, California, 93702, United States

Location

USA055

Los Angeles, California, 90048, United States

Location

USA029

Newport Beach, California, 92663, United States

Location

USA102

Northridge, California, 91324, United States

Location

USA022

Palm Springs, California, 92262, United States

Location

USA024

Sacramento, California, 95817, United States

Location

USA035

San Diego, California, 92120, United States

Location

USA078

Santa Barbara, California, 93105, United States

Location

USA027

Ventura, California, 93003, United States

Location

USA075

Denver, Colorado, 80206, United States

Location

USA017

Farmington, Connecticut, 06030, United States

Location

USA001

Washington D.C., District of Columbia, 20007, United States

Location

USA015

Clearwater, Florida, 33765, United States

Location

USA076

Gainesville, Florida, 32610, United States

Location

USA082

Jacksonville, Florida, 32224, United States

Location

USA039

Kissimmee, Florida, 34746, United States

Location

USA072

Leesburg, Florida, 34748, United States

Location

USA037

Miami, Florida, 33126, United States

Location

USA019

Miami Lakes, Florida, 33014, United States

Location

USA049

Naples, Florida, 34102, United States

Location

USA052

Orlando, Florida, 32825, United States

Location

USA103

Plantation, Florida, 33324, United States

Location

USA084

Sarasota, Florida, 34239, United States

Location

USA089

St. Petersburg, Florida, 33704, United States

Location

USA074

St. Petersburg, Florida, 33707, United States

Location

USA120

Tampa, Florida, 33606, United States

Location

USA012

Atlanta, Georgia, 30342, United States

Location

USA053

Augusta, Georgia, 30912, United States

Location

USA073

Chicago, Illinois, 60611, United States

Location

USA061

Maywood, Illinois, 60153, United States

Location

USA115

Hammond, Indiana, 46324, United States

Location

USA063

Iowa City, Iowa, 52242, United States

Location

USA031

Kansas City, Kansas, 66160, United States

Location

USA020

New Orleans, Louisiana, 70112, United States

Location

USA051

New Orleans, Louisiana, 70112, United States

Location

USA003

Baltimore, Maryland, 21224, United States

Location

USA079

Boston, Massachusetts, 02114, United States

Location

USA064

Springfield, Massachusetts, 01199, United States

Location

USA010

Rochester, Minnesota, 55905, United States

Location

USA006

Chesterfield, Missouri, 63017, United States

Location

USA059

St Louis, Missouri, 63110, United States

Location

USA110

Lincoln, Nebraska, 68510, United States

Location

USA065

Toms River, New Jersey, 08755, United States

Location

USA066

New Hyde Park, New York, 11042, United States

Location

USA021

New York, New York, 10017, United States

Location

USA085

New York, New York, 10032, United States

Location

USA033

Gastonia, North Carolina, 28054, United States

Location

USA096

Huntersville, North Carolina, 28078, United States

Location

USA026

Winston-Salem, North Carolina, 27103, United States

Location

USA067

Cincinnati, Ohio, 45267, United States

Location

USA093

Cleveland, Ohio, 44195, United States

Location

USA023

Portland, Oregon, 97239, United States

Location

USA038

DuBois, Pennsylvania, 15801, United States

Location

USA046

Philadelphia, Pennsylvania, 19104, United States

Location

USA005

Charleston, South Carolina, 29425, United States

Location

USA036

Rock Hill, South Carolina, 29732, United States

Location

USA041

Franklin, Tennessee, 37067, United States

Location

USA109

Nashville, Tennessee, 37232, United States

Location

USA097

Dallas, Texas, 75246, United States

Location

USA050

McKinney, Texas, 75069, United States

Location

USA011

San Antonio, Texas, 78258, United States

Location

USA002

Tyler, Texas, 75708, United States

Location

USA034

Williamsburg, Virginia, 23188, United States

Location

USA088

Vancouver, Washington, 98664, United States

Location

ARG027

Bahía Blanca, Buenos Aires, 8000, Argentina

Location

ARG021

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1121ABE, Argentina

Location

ARG022

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1122AAK, Argentina

Location

ARG002

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1414AIF, Argentina

Location

ARG001

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1425AZB, Argentina

Location

ARG003

Ciudad Autónoma de BuenosAires, Buenos Aires, C1425BEN, Argentina

Location

ARG004

Ciudad Autónoma de BuenosAires, Buenos Aires, C1426ABP, Argentina

Location

ARG006

La Plata, Buenos Aires, B1902COS, Argentina

Location

ARG013

Mar del Plata, Buenos Aires, B7600FYK, Argentina

Location

ARG017

Mar del Plata, Buenos Aires, CP 7600, Argentina

Location

ARG009

Villa Vatteone, Buenos Aires, B1853AIK, Argentina

Location

ARG012

Buenos Aires, Ciudad Autónoma de BuenosAires, C10227AAP, Argentina

Location

ARG018

Buenos Aires, Ciudad Autónoma de BuenosAires, C1060, Argentina

Location

ARG026

Recoleta, Ciudad Autónoma de BuenosAires, C1425EFD, Argentina

Location

ARG023

Río Cuarto, Córdoba Province, 5800, Argentina

Location

ARG014

Vistalba, Mendoza Province, M5544, Argentina

Location

ARG010

Rosario, Santa Fe Province, S2000DTC, Argentina

Location

ARG015

San Miguel de Tucumán, Tucumán Province, T4000IFL, Argentina

Location

ARG025

San Miguel de Tucumán, Tucumán Province, T4000IHE, Argentina

Location

ARG005

Córdoba, X5003DCE, Argentina

Location

ARG007

Mendoza, M5500CCG, Argentina

Location

ARG011

Rosario, S2000JKR, Argentina

Location

ARG019

Santa Fe, 3000, Argentina

Location

AUS013

Kogarah, New South Wales, 2217, Australia

Location

AUS008

New Lambton Heights, New South Wales, 2305, Australia

Location

AUS007

Westmead, New South Wales, 2145, Australia

Location

AUS012

Cairns North, Queensland, 4870, Australia

Location

AUS001

Chermside, Queensland, 4032, Australia

Location

AUS010

Greenslopes, Queensland, 4120, Australia

Location

AUS006

South Brisbane, Queensland, 4101, Australia

Location

AUS019

South Brisbane, Queensland, 4101, Australia

Location

AUS011

Adelaide, South Australia, 5000, Australia

Location

AUS017

Bedford Park, South Australia, 5042, Australia

Location

AUS022

North Adelaide, South Australia, 5006, Australia

Location

AUS009

Woodville South, South Australia, 5011, Australia

Location

AUS002

Box Hill, Victoria, 3128, Australia

Location

AUS014

Clayton, Victoria, 3168, Australia

Location

AUS018

Murdoch, Western Australia, 6150, Australia

Location

AUS005

Nedlands, Western Australia, 6009, Australia

Location

AUS003

Concord, NSW 2139, Australia

Location

AUS015

Spearwood, 6163, Australia

Location

AUT002

Linz, 4021, Austria

Location

BEL002

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

BEL009

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

BEL004

Roeselare, West-Vlaanderen, 8800, Belgium

Location

BEL001

Leuven, 3000, Belgium

Location

BEL007

Liège, 4000, Belgium

Location

BEL003

Mechelen, 2800, Belgium

Location

BEL008

Sint-Niklaas, 9100, Belgium

Location

BRA009

Passo Fundo, Rio Grande do Sul, 99010-120, Brazil

Location

BRA005

Porto Alegre, Rio Grande do Sul, 90035-074, Brazil

Location

BRA001

Blumenau, Santa Catarina, 89030-240, Brazil

Location

BRA006

Santo André, São Paulo, 09090-790, Brazil

Location

BRA003

Botucatu, 18618-686, Brazil

Location

BRA004

São Bernardo do Campo, 09715-090, Brazil

Location

BRA011

São Paulo, 05403-000, Brazil

Location

BGR011

Sofia, Sofia-Grad, 1336, Bulgaria

Location

BGR009

Sofia, Sofia-Grad, 1510, Bulgaria

Location

BGR002

Sofia, Sofia-Grad, 1680, Bulgaria

Location

BGR005

Blagoevgrad, 2700, Bulgaria

Location

BGR006

Gabrovo, 5300, Bulgaria

Location

BGR014

Kozloduy, 3320, Bulgaria

Location

BGR015

Lovech, 5500, Bulgaria

Location

BGR007

Montana, 3400, Bulgaria

Location

BGR018

Pazardzhik, 4400, Bulgaria

Location

BGR019

Pleven, 5800, Bulgaria

Location

BGR004

Plovdiv, 4023, Bulgaria

Location

BGR008

Rousse, 7002, Bulgaria

Location

BGR017

Sliven, 8800, Bulgaria

Location

BGR010

Sofia, 1233, Bulgaria

Location

BGR012

Veliko Tarnovo, 5000, Bulgaria

Location

BGR013

Vidin, 3700, Bulgaria

Location

BGR016

Vratsa, 3000, Bulgaria

Location

CAN004

Toronto, Ontario, M5T 3A9, Canada

Location

CAN002

Montreal, Quebec, H2X 0A9, Canada

Location

CHL007

Valdivia, Los Ríos Region, 5110683, Chile

Location

CHL005

Curicó, Maule Region, 3440000, Chile

Location

CHL010

Talca, Maule Region, 3481349, Chile

Location

CHL001

Providencia, Región-MetropolitanadeSantiago, 7500000, Chile

Location

CHL002

Providencia, Región-MetropolitanadeSantiago, 7500000, Chile

Location

CHL008

Providencia, Región-MetropolitanadeSantiago, 7500587, Chile

Location

CHL004

Quillota, 2260000, Chile

Location

COL001

Bogotá, Bogota D.C., 111211, Colombia

Location

COL006

Zipaquirá, Cundinamarca, 250252, Colombia

Location

COL005

Floridablanca, Santander Department, 681004, Colombia

Location

COL003

Cali, Valle del Cauca Department, 760026, Colombia

Location

COL002

Bogota DC, 110131, Colombia

Location

COL004

Santiago de Cali, 076001, Colombia

Location

DNK008

Copenhagen O, Capital, 2100, Denmark

Location

DNK001

Hvidovre, Capital, DK-2650, Denmark

Location

DNK005

Odense C, Region Syddanmark, 5000, Denmark

Location

DNK006

Vejle, Region Syddanmark, 7100, Denmark

Location

DNK003

Aalborg, 9000, Denmark

Location

DNK007

Aarhus, DK-8200, Denmark

Location

DNK004

Hellerup, 2900, Denmark

Location

DNK002

Roskilde, 4000, Denmark

Location

FRA002

Strasbourg, Bas-Rhin, 67091, France

Location

FRA005

Montpellier, Hérault, 34295, France

Location

FRA004

Amiens, 80054, France

Location

FRA011

Créteil, 94010, France

Location

FRA003

Nantes, 44093, France

Location

FRA009

Nice, 6002, France

Location

FRA010

Paris, 75014, France

Location

FRA006

Toulouse, 31400, France

Location

DEU009

Heidelberg, Baden-Wurttemberg, 69126, Germany

Location

DEU025

München, Bavaria, 80336, Germany

Location

DEU027

Potsdam, Brandenburg, 14467, Germany

Location

DEU008

Frankfurt am Main, Hesse, 60590, Germany

Location

DEU005

Marburg, Hesse, 35037, Germany

Location

DEU031

Hanover, Lower Saxony, 30625, Germany

Location

DEU013

Essen, North Rhine-Westphalia, 45239, Germany

Location

DEU003

Leipzig, Saxony, 04347, Germany

Location

DEU016

Halle, Saxony-Anhalt, 06120, Germany

Location

DEU020

Geesthacht, Schleswig-Holstein, 21502, Germany

Location

DEU002

Berlin, 10717, Germany

Location

DEU019

Berlin, 10961, Germany

Location

DEU006

Berlin, 13125, Germany

Location

DEU011

Berlin, 13353, Germany

Location

DEU014

Dresden, 01307, Germany

Location

DEU021

Frankfurt, 60389, Germany

Location

DEU015

Hanover, 30625, Germany

Location

DEU023

Mainz, 55128, Germany

Location

DEU029

Münster, 48149, Germany

Location

GRC003

Alexandroupoli, Evros, 681 00, Greece

Location

GRC007

Heraklion, 71110, Greece

Location

GRC006

Thessaloniki, 57010, Greece

Location

HUN005

Tatabánya, Komárom-Esztergom, 2800, Hungary

Location

IRL003

Dublin, 15, Ireland

Location

IRL002

Dublin, Dublin 8, Ireland

Location

IRL001

Limerick, V94 F858, Ireland

Location

ISR001

Ashkelon, 78278, Israel

Location

ISR010

Beersheba, 84101, Israel

Location

ISR008

Haifa, 34362, Israel

Location

ISR006

Jerusalem, 91031, Israel

Location

ISR002

Jerusalem, 91120, Israel

Location

ISR009

Kefar Sava, 44281, Israel

Location

ISR011

Petah Tikva, 49100, Israel

Location

ISR007

Ramat Gan, 52621, Israel

Location

ISR003

Rehovot, 76100, Israel

Location

ISR004

Ẕerifin, 70300, Israel

Location

ITA010

Bologna, Emilia-Romagna, 40138, Italy

Location

ITA008

Ferrara, Emilia-Romagna, 44124, Italy

Location

ITA002

Reggio Emilia, Emilia-Romagna, 42100, Italy

Location

ITA006

Milan, Lombardy, 20122, Italy

Location

ITA012

Milan, Lombardy, 20122, Italy

Location

ITA011

Rozzano, Lombardy, 20089, Italy

Location

ITA004

Siena, Tuscany, 53100, Italy

Location

ITA003

Milan, 20157, Italy

Location

ITA001

Palermo, 90127, Italy

Location

ITA007

Pavia, 27100, Italy

Location

ITA009

Roma, 00168, Italy

Location

JPN029

Toyoake, Aiti, 470-1192, Japan

Location

JPN031

Toon-Shi, Ehime, 791-0203, Japan

Location

JPN027

Fukuoka, Hukuoka, 815-0032, Japan

Location

JPN023

Iizuka-Shi, Hukuoka, 820-0018, Japan

Location

JPN009

Kobe, Hyôgo, 650-0047, Japan

Location

JPN020

Kasama-Shi, Ibaraki, 309-1703, Japan

Location

JPN001

Naka-gun, Ibaraki, 319-1113, Japan

Location

JPN022

Takamatsu, Kagawa-ken, 761-8073, Japan

Location

JPN028

Yokohama-Shi Konan-Ku, Kanagawa, 234-0054, Japan

Location

JPN005

Koshi Shi, Kumamoto, 861-1196, Japan

Location

JPN008

Matsusaka-shi, Mie-ken, 515-8544, Japan

Location

JPN011

Tsu, Mie-ken, 514-1101, Japan

Location

JPN034

Sendai, Miyagi, 981-0914, Japan

Location

JPN013

Nagasaki, Nagasaki, 852-8501, Japan

Location

JPN012

Chuo-ku, Niigata, 951-8510, Japan

Location

JPN015

Matsue, Shimane, 690-8556, Japan

Location

JPN007

Kiyose, Tokyo, 204-8522, Japan

Location

JPN014

Ōta-ku, Tokyo, 143-8541, Japan

Location

JPN006

Shinagawa-ku, Tokyo, 140-8522, Japan

Location

JPN017

Shinagawa-ku, Tokyo, 141-8625, Japan

Location

JPN002

Shinjuku-ku, Tokyo, 160-8582, Japan

Location

JPN032

Shinjuku-ku, Tokyo, 1628655, Japan

Location

JPN019

Shimonoseki-Shi, Yamaguchi, 750-0041, Japan

Location

JPN030

Fukuoka, 8408571, Japan

Location

JPN003

Hamamatsu, 434-8511, Japan

Location

JPN004

Kita Kyushu-shi, 807-8556, Japan

Location

JPN016

Matsue, 690-8504, Japan

Location

JPN010

Meguro-ku, 152-0021, Japan

Location

JPN018

Toyonaka-shi, 560-8552, Japan

Location

LVA002

Daugavpils, Daugavpils Aprinkis, LV-5401, Latvia

Location

LVA005

Jūrmala, LV-2015, Latvia

Location

MYS004

Kuantan, Pahang, 25100, Malaysia

Location

MYS001

Kuala Lumpur, WilayahPersekutuan KualaLumpur, 50603, Malaysia

Location

MYS003

Kota Bharu, 16150, Malaysia

Location

MYS005

Kuala Lumpur, 50590, Malaysia

Location

MEX007

Guadalajara, Jalisco, 44160, Mexico

Location

MEX008

Guadalajara, Jalisco, 44160, Mexico

Location

MEX005

Guadalajara, Jalisco, 44220, Mexico

Location

MEX004

Guadalajara, Jalisco, 44700, Mexico

Location

MEX003

Monterrey, Nuevo León, 64460, Mexico

Location

MEX006

Durango, 34080, Mexico

Location

MEX001

Monterrey, 64718, Mexico

Location

MEX002

Oaxaca City, 68000, Mexico

Location

NLD003

Arnhem, Gelderland, 6815 AD, Netherlands

Location

NLD001

Alkmaar, North Holland, 1815 JD, Netherlands

Location

NLD002

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

NLD006

Rotterdam, 3015 GD, Netherlands

Location

NZL006

Otahuhu, Auckland, 1640, New Zealand

Location

NZL009

Hastings, Hawkes's Bay, 4122, New Zealand

Location

NZL005

Christchurch, South Island, 8011, New Zealand

Location

NZL001

Dunedin, South Island, 9001, New Zealand

Location

NZL002

Hamilton, Waikato Region, 3204, New Zealand

Location

NZL011

Paraparaumu, Wellington Region, 5032, New Zealand

Location

NZL003

Auckland, 1051, New Zealand

Location

NZL008

Auckland, 1051, New Zealand

Location

NZL007

Tauranga, 3110, New Zealand

Location

NZL010

Wellington, 6021, New Zealand

Location

PER005

Chancay, 15131, Peru

Location

PER001

Lima, 15001, Peru

Location

PER003

Lima, 15036, Peru

Location

PER002

Lima, 15084, Peru

Location

PER006

Piura, 20001, Peru

Location

POL005

Bialystok, 15-044, Poland

Location

POL006

Bielsko-Biala, 43-300, Poland

Location

POL016

Katowice, 40-081, Poland

Location

POL015

Kielce, 25-751, Poland

Location

POL017

Krakow, 30-510, Poland

Location

POL018

Ksawerów, 95-054, Poland

Location

POL008

Rabka-Zdrój, 34-700, Poland

Location

POL011

Rzeszów, 35-051, Poland

Location

POL010

Siedlce, 08-110, Poland

Location

POL007

Sosnowiec, 41-208, Poland

Location

POL001

Sucha Beskidzka, 34-200, Poland

Location

POL014

Szczecin, 70-111, Poland

Location

POL009

Tarnów, 33-100, Poland

Location

POL012

Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, 27-400, Poland

Location

PRT005

Aveiro, 3814-501, Portugal

Location

PRT009

Braga, 4710-243, Portugal

Location

PRT006

Guarda, 6300-858, Portugal

Location

PRT002

Guimarães, 4835-044, Portugal

Location

PRT003

Lisbon, 1649-035, Portugal

Location

SRB001

Belgrade, 11000, Serbia

Location

SRB003

Belgrade, 11000, Serbia

Location

SRB007

Niš, 18000, Serbia

Location

SRB014

Sombor, 25000, Serbia

Location

SRB010

Užice, 31000, Serbia

Location

SVK002

Bardejov, 085 01, Slovakia

Location

SVK003

Spisská Nová Ves, 052 01, Slovakia

Location

KOR015

Ansan-si, Gyeonggido, 15355, South Korea

Location

KOR008

Bucheon-si, Gyeonggido, 14584, South Korea

Location

KOR007

Seongnam-si, Gyeonggido, 13620, South Korea

Location

KOR003

Seoul, Seoul Teugbyeolsi, 05030, South Korea

Location

KOR004

Incheon, 21431, South Korea

Location

KOR012

Seoul, 02447, South Korea

Location

KOR011

Seoul, 02841, South Korea

Location

KOR009

Seoul, 03312, South Korea

Location

KOR013

Seoul, 03722, South Korea

Location

KOR010

Seoul, 06273, South Korea

Location

KOR005

Seoul, 06591, South Korea

Location

ESP009

Santiago de Compostela, A Coruña, 15706, Spain

Location

ESP013

Badalona, Barcelona, 08036, Spain

Location

ESP012

Santander, Cantabria, 39008, Spain

Location

ESP015

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

ESP011

Pamplona, Navarre, 31008, Spain

Location

ESP008

Oviedo, Principality of Asturias, 33011, Spain

Location

ESP003

Barcelona, 08035, Spain

Location

ESP016

Barcelona, 8036, Spain

Location

ESP001

Girona, 17007, Spain

Location

ESP006

L'Hospitalet de Llobregat, 08907, Spain

Location

ESP007

Madrid, 28007, Spain

Location

ESP002

Madrid, Spain

Location

TWN003

Kaohsiung City, 80756, Taiwan

Location

TWN002

Kaohsiung City, 82544, Taiwan

Location

TWN001

Kaohsiung City, 833, Taiwan

Location

TWN005

New Taipei City, 22060, Taiwan

Location

TWN007

Taipei, 10002, Taiwan

Location

TWN004

Taipei, 11217, Taiwan

Location

TWN006

Taipei, 11490, Taiwan

Location

THA004

Nakhonnayok, Changwat Nakhon Nayok, 26120, Thailand

Location

THA002

Muang, Changwat Nonthaburi, 11000, Thailand

Location

THA003

Khon Kaen, 40002, Thailand

Location

TUR006

Atakum, Samsun, 55270, Turkey (Türkiye)

Location

TUR010

Ankara, 6010, Turkey (Türkiye)

Location

TUR011

Ankara, 6340, Turkey (Türkiye)

Location

TUR003

Çanakkale, 17110, Turkey (Türkiye)

Location

TUR008

Izmir, 35100, Turkey (Türkiye)

Location

TUR004

Izmir, 35110, Turkey (Türkiye)

Location

TUR009

Kocaeli, 41380, Turkey (Türkiye)

Location

TUR005

Konya, 42075, Turkey (Türkiye)

Location

TUR001

Mersin, 33079, Turkey (Türkiye)

Location

UKR001

Kharkiv, Kharkivs’ka Oblast’, 61124, Ukraine

Location

UKR007

Kherson, Kherson Oblast, 73003, Ukraine

Location

UKR005

Poltava, Poltava Oblast, 36010, Ukraine

Location

UKR012

Dnipro, 49102, Ukraine

Location

UKR009

Ivano-Frankivsk, 76018, Ukraine

Location

UKR008

Kyiv, 01033, Ukraine

Location

UKR004

Kyiv, 03038, Ukraine

Location

UKR003

Odesa, 65025, Ukraine

Location

UKR010

Vinnytsia, 21018, Ukraine

Location

GBR001

Cambridge, Cambridgeshire, CB23 3RE, United Kingdom

Location

GBR015

Exeter, Devon, EX2 5DW, United Kingdom

Location

GBR017

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

GBR013

Llandough, Vale of Glamorgan, the, CF64 2XX, United Kingdom

Location

GBR016

Bradford, Yorkshire, BD9 6RJ, United Kingdom

Location

GBR006

Birmingham, B9 5SS, United Kingdom

Location

GBR002

Chertsey, KT16 0PZ, United Kingdom

Location

GBR007

Dundee, DDI 9SY, United Kingdom

Location

GBR004

Liverpool, L14 3PE, United Kingdom

Location

GBR009

London, SW3 6NP, United Kingdom

Location

GBR008

Manchester, M23 9LT, United Kingdom

Location

GBR011

Manchester, M8 5RB, United Kingdom

Location

GBR003

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

GBR012

Salford, M6 8HD, United Kingdom

Location

GBR018

Southampton, SO16 6YD, United Kingdom

Location

GBR010

Swansea, SA6 6NL, United Kingdom

Location

Related Publications (4)

• Morimoto 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.

  PMID: 41519018 DERIVED

• Chalmers JD, Burgel PR, Daley CL, De Soyza A, Haworth CS, Mauger D, Loebinger MR, McShane PJ, Ringshausen FC, Blasi F, Shteinberg M, Mange K, Teper A, Fernandez C, Zambrano M, Fan C, Zhang X, Metersky ML; ASPEN Investigators. Phase 3 Trial of the DPP-1 Inhibitor Brensocatib in Bronchiectasis. N Engl J Med. 2025 Apr 24;392(16):1569-1581. doi: 10.1056/NEJMoa2411664.

  PMID: 40267423 DERIVED

• Chalmers JD, Burgel PR, Daley CL, De Soyza A, Haworth CS, Mauger D, Mange K, Teper A, Fernandez C, Conroy D, Metersky M. Brensocatib in non-cystic fibrosis bronchiectasis: ASPEN protocol and baseline characteristics. ERJ Open Res. 2024 Jul 22;10(4):00151-2024. doi: 10.1183/23120541.00151-2024. eCollection 2024 Jul.

  PMID: 39040578 DERIVED

• 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.

  PMID: 35976570 DERIVED

MeSH Terms

Interventions

brensocatib

Results Point of Contact

• Title: Insmed Medical Information
• Organization: Insmed Incorporated

medicalinformation@Insmed.com

1-844-446-7633

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 20, 2020
• Study Start: December 1, 2020
• Primary Completion: October 28, 2024
• Study Completion: October 28, 2024
• Last Updated: December 16, 2025
• Results First Posted: December 16, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (14); AU (1); KR (11); MY (4); JP (29); DK (8); IE (3); CO (6); IT (11); AR (23); BR (7); ME (8); CA (2); BE (7); SE (5); GR (3); ES (12); CL (7); TW (7); LA (2); US (67); FR (8); UA (9); SL (2); TU (9); NL (4); TH (3); NZ (10); PE (5); GB (16); BU (17); DE (19); PT (5); HU (1); IL (10)