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Non-Cystic Fibrosis BronchiectasisPhase 2NCT03218917

Assessment of INS1007 in Participants With Non-Cystic Fibrosis Bronchiectasis

A Phase 2 study testing Brensocatib 10 mg and Brensocatib 25 mg in people with Non-Cystic Fibrosis Bronchiectasis, run by Insmed Incorporated at 108 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of the study is to evaluate if INS1007 can reduce pulmonary exacerbations over a 24-week treatment period in participants with non-cystic fibrosis bronchiectasis. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Non-Cystic Fibrosis Bronchiectasis
What is being tested?
Brensocatib 10 mg and Brensocatib 25 mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
256 participants
Where
108 sitesin 14 countries
Study dates
31 Oct 2017to 12 Dec 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical history consistent with NCFBE (cough, chronic sputum production and/or recurrent respiratory infections)
  • Are current sputum producers with a history of chronic expectoration and able to provide a sputum sample during Screening
  • Have at least 2 documented pulmonary exacerbations in the past 12 months before Screening

Who cannot join

  • Have a primary diagnosis of chronic obstructive pulmonary disease (COPD) or asthma
  • Have bronchiectasis due to cystic fibrosis (CF), hypogammaglobulinemia, common variable immunodeficiency, or alpha1-antitrypsin deficiency
  • Are current smokers
  • Are currently being treated for a nontuberculous mycobacterial lung infection, allergic bronchopulmonary aspergillosis, or tuberculosis
  • Have any acute infections, (including respiratory infections)

Trial locations and contacts

108 sites in 14 countries.

108 sites in 14 countries

United States36 sites

  • Michigan Medicine

    Ann Arbor, Michigan, 48109

  • The Emory Clinic, Pulmonology

    Atlanta, Georgia, 30342-2147

  • Johns Hopkins University, Division of Pulmonary and Critical Care Medicine

    Baltimore, Maryland, 21205

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • Clinical Research Specialists, LLC

    Celebration, Florida, 34747

  • The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Novant Health Pulmonary Medicine South

    Charlotte, North Carolina, 28215

  • University of Chicago

    Chicago, Illinois, 60637

  • St. Francis Medical Institute

    Clearwater, Florida, 33765

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • National Jewish Heath

    Denver, Colorado, 80206

  • UConn Health Center

    Farmington, Connecticut, 06030-1321

  • University of Florida

    Gainesville, Florida, 32610

  • University of Iowa

    Iowa City, Iowa, 52242

  • SMS Clinical Research, LLC

    Mesquite, Texas, 75149

  • University of Miami Miller School of Medicine

    Miami, Florida, 33136

  • San Marcus Research Clinic, Inc.

    Miami Lakes, Florida, 33014

  • LSU Health Sciences Center

    New Orleans, Louisiana, 70112

  • NYU Pulmonary & Critical Care Associates

    New York, New York, 10016

  • Columbia University Medical Center/ New York Presbyterian Hospital

    New York, New York, 10032

  • NewportNativeMD

    Newport Beach, California, 92663

  • Palmtree Clinical Research

    Palm Springs, California, 92262-4871

  • Phoenix Medical Group

    Peoria, Arizona, 85381

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • UC Davis Medical Center

    Sacramento, California, 95817

  • Sarasota Memorial Hospital Clinical Research Center

    Sarasota, Florida, 34239

  • Stanford University Medical Center

    Stanford, California, 94305-5236

  • MultiCare Institute for Research & Innovation

    Tacoma, Washington, 98405

  • Pulmonary and Critical Care Associates of Baltimore

    Towson, Maryland, 21286

  • The University of Texas Health Science at Tyler

    Tyler, Texas, 75708

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • Mid Atlantic Pulmonary & Research Center

    Westminster, Maryland, 21157

  • Southeastern Research Center

    Winston-Salem, North Carolina, 27103

Other trials in United States

Germany10 sites

  • Research Center for Medical Studies (RCMS)

    Berlin, 10717

  • Forschungszentrum Borstel

    Borstel, Schleswig-Holstein, 23845

  • Krankenhaus Donaustauf

    Donaustauf, Bavaria, 93093

  • Ruhrlandklinik Essen, University Essen

    Essen, North Rhine-Westphalia, 45239

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, Hesse, 60590

  • IKF Pneumologie Frankfurt

    Frankfurt am Main, Hesse, 60596

  • Universitätsklinikum Jena

    Jena, Thuringia, 7747

  • Städt. Klinikum München GmbH, Bogenhausen

    München, 81925

  • Klinikum der Universität München Medizinische Klinik V Pneumologie / Mukoviszidose-Zentrum für Erwachsene

    Munich, Bavaria, 80336

  • Klinikum Nuernberg

    Nuremberg, Bavaria, 90419

Other trials in Germany

United Kingdom10 sites

  • Blackpool Teaching Hospitals NHS Foundation Trust

    Blackpool, Lancashire, FY38NR

  • Papworth Hospital NHS Foundation Trust

    Cambridge, Cambridgeshire, CB23 3RE

  • Ashford and St Peter's Hospitals NHS Foundation Trust

    Chertsey, Surrey, KT16 0PZ

  • NHS Tayside

    Dundee, Angus, DD1 9SY

  • NHS Lothian

    Edinburgh, Scotland, EH16 4SA

  • Liverpool Heart and Chest Hospital NHS Foundation Trust

    Liverpool, Merseyside, L14 3PE

  • Royal Brompton & Harefield NHS Foundation Trust

    London, SW3 6HP

  • Pennine Acute Hospitals NHS Trust

    Manchester, M8 5RB

  • University Hospital Southampton NHS Foundation Trust

    Southampton, SO16 6YD

  • The Royal Wolverhampton NHS Trust

    Wolverhampton, West Midlands, WV10 0QP

Other trials in United Kingdom

Australia9 sites

  • Respiratory Clinical Trials Unit, Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Box Hill Hospital, Eastern Clinical Research Unit

    Box Hill, Victoria, 3128

  • Mater Misericordia Medical Centre

    Brisbane, Queensland, 4101

  • Gallipoli Medical Research Foundation

    Brisbane, Queensland, 4120

  • Metro North Hospital and Health Service (The Prince Charles Hospital)

    Chermside, Queensland, 4032

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • Respiratory Clinical Trials PTY LTD

    Kent Town, South Australia, 5067

  • Alfred Hospital

    Melbourne, Victoria, 3004

  • Institute for Respiratory Health

    Nedlands, Western Australia, 6009

Other trials in Australia

South Korea9 sites

  • Chonnam National University Hospital

    Gwangju, 61469

  • Inha University Hospital

    Incheon, Jung-gu, 22332

  • Gachon University Gil Medical Center

    Incheon, Namdong-gu, 21565

  • The Catholic University of Korea Incheon St. Mary's Hospital

    Incheon, 21431

  • The Catholic University of Korea, St. Paul's Hospital

    Seoul, 02559

  • Seoul National University Hospital

    Seoul, 03080

  • Konkuk University Medical Center

    Seoul, 05030

  • Asan Medical Center

    Seoul, 05505

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 06591

Other trials in South Korea

Italy5 sites

  • University of Milan, IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico

    Milan, Lombardy, 20122

  • Ospedale San Gerardo

    Monza, Monza E Brianza, 20900

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

  • University Hospital of Pisa

    Pisa, Via Paradisa 2, 56124

  • ICS Maugeri spa SB, IRCSS Telese

    Telese Terme, 82037

Other trials in Italy

New Zealand5 sites

  • Auckland District Health Board, Greenlane clinical Centre

    Auckland, 1051

  • Southern District health Board/Dunedin Hospital

    Dunedin, Otago, 9016

  • Waikato District Health Board

    Hamilton, Waikato Region, 3204

  • P3 Research (Hawke's Bay)

    Hastings, Hawkes Bay, 4130

  • P3 Research

    Tauranga, BOP, 3110

Other trials in New Zealand

Poland5 sites

  • Grażyna Jasieniak Pinis Niepubliczny Zakład Opieki Zdrowotnej Atopia

    Krakow, 31-159

  • NZOZ Krak-Medyk Sp. z o.o

    Krakow, 31-455

  • Medical University of Lodz Poland

    Lodz, 90-153

  • Gabinet Lekarski Pediatryczno-Alergologiczny Zenon Bukowczan

    Sucha Beskidzka, 34-200

  • Centrum Badan Klinicznych, Piotr Napora Lekarze i Spolka Partnerska, Osrodek Badan Wczesnej Fazy

    Wroclaw, Lower Silesian Voivodeship, 51-162

Other trials in Poland

Spain5 sites

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital Universitari de Bellvitge

    Barcelona, 08907

  • Hospital Universitari de Girona Dr. Josep Trueta

    Girona, 17007

  • Hospital Universiatrio y politecnico La Fe

    Valencia, 46026

Other trials in Spain

Bulgaria4 sites

  • Medical Center UNIMED

    Plovdiv, 4000

  • Medical Center ReSpiro Ltd (Kiselov)

    Razgrad, Momina, 7200

  • MHAT "Dr IvanSeliminski"-Sliven

    Sliven, 8800

  • Cardioart Medical Center

    Stara Zagora, 6000

Other trials in Bulgaria

Netherlands4 sites

  • Noordwest Ziekenhuis Group

    Alkmaar, 1815JD

  • Amphia Longresearch Astma/COPD Uni 52/5e etage

    Breda, 4818CK

  • RadboudUMC, location Dekkerswald

    Nijmegen, 6525GA

  • Zuyderland MC

    Sittard, 6162BG

Other trials in Netherlands

Denmark3 sites

  • Aarhus University Hospital

    Aarhus, 8000

  • Hvidovre Hospital

    Hvidovre, Capital Region, 2650

  • Sjællands Universitetshospital, Roskilde

    Roskilde, 4000

Other trials in Denmark

Singapore2 sites

  • Singapore General Hospital

    Singapore, 169856

  • Changi General Hospital

    Singapore, 529889

Other trials in Singapore

Belgium1 site

  • UZ Leuven

    Leuven, Vlaams Brabant, 3000

Other trials in Belgium

About this study

Official title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety & Tolerability, and PK of INS1007 Administered Once Daily for 24 Weeks in Subjects With Non-CF Bronchiectasis - The Willow Study

The purpose of the study is to evaluate if INS1007 can reduce pulmonary exacerbations over a 24-week treatment period in participants with non-cystic fibrosis bronchiectasis.

Read the detailed description

Phase 2 randomized, double-blind, placebo-controlled, parallel-group, multicenter, multi-national study to assess the efficacy, safety and tolerability, and pharmacokinetics (PK) of INS1007 administered once daily for 24 weeks in participants with non-cystic fibrosis bronchiectasis (NCFBE).

Being tested
Brensocatib 10 mg, Brensocatib 25 mg, Placebo
Keywords
P aeruginosa, bronchiectasis, active neutrophil elastase
Medical subject headings
Bronchiectasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brensocatib 10 mgDrug

    Administered once per day for 24 weeks

  • Brensocatib 25 mgDrug

    Administered once per day for 24 weeks

  • PlaceboDrug

    Administered once per day for 24 weeks

Study groups in NCT03218917
Study groupRoleWhat they receive
Brensocatib 10 mgExperimentalParticipants received brensocatib 10 mg once daily (QD) before breakfast, for 24 weeks.
Receives: Drug: Brensocatib 10 mg
Brensocatib 25 mgExperimentalParticipants received brensocatib 25 mg QD before breakfast, for 24 weeks.
Receives: Drug: Brensocatib 25 mg
PlaceboPlacebo comparatorParticipants received the matching placebo QD before breakfast, for 24 weeks.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to the First Pulmonary Exacerbation Over 24-Week Treatment Period

    Time to first pulmonary exacerbation was calculated as the number of days from the date of randomization to the date of first documentation of an exacerbation. 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 4 weeks must have occurred between one exacerbation onset and the next. Any exacerbation that occurred less than 4 weeks from the prior exacerbation was not considered a new exacerbation. The analysis was performed using the stratified log rank test and using Kaplan Meier (KM) curves.

    Measured: Baseline (Day 1) to Week 24

Secondary outcomes (4)

  1. Change From Baseline in Quality of Life Questionnaire - Bronchiectasis (QOL-B) Respiratory Symptoms Domain Score Over 24 Week Treatment Period

    The QOL-B is a validated, self-administered patient reported outcome (PRO) that assesses symptoms, functioning, and health-related (HR) QOL for participants with non-cystic fibrosis bronchiectasis (NCFBE). The QOL-B 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 and HR QoL. A positive change from Baseline indicates improvement in symptoms. For this outcome measure, change in the respiratory symptoms domain score from Baseline was reported. The analysis was based on mixed model for repeated measures (MMRM) approach.

    Measured: Baseline (Day 1) to Week 24

  2. Change From Screening in Post-Bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Over 24-Week Treatment Period

    FEV1 was used to assess lung function and is the maximum amount of air that can be forced out in one second after taking a deep breath. The percent predicted FEV1 was calculated by converting the spirometer reading to a percentage of what would be predicted as normal FEV1 based on a several personal factors (e.g. sex, age, etc.). Change from screening in percent predicted FEV1 to Week 24 was calculated as: percent predicted FEV1 value at Week 24 and percent predicted FEV1 value at screening. A positive percent change from screening indicates an improvement in lung function. The analysis was done using analysis of covariance (ANCOVA) with Pa colonization status and maintenance macrolide antibiotic use at Baseline as covariates.

    Measured: Screening (Days -42 to -1) to Week 24

  3. Change From Baseline in Concentration of Active Neutrophil Elastase (NE) in Sputum

    The concentration of active NE in sputum, was measured by the difference between the pre-treatment concentration and on-treatment concentration. In bronchiectasis, activation of neutrophils in the airway leads to release of NE which leads to damaged airway walls, mucus hypersecretion, exacerbated inflammation, which in turn affects neutrophil and macrophage functions, increasing the risk of infection. Negative change from Baseline indicates improvement.

    Measured: Baseline (Day 1) to Week 24

  4. Number of Participants Who Experienced a Pulmonary Exacerbation

    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 4 weeks must have occurred between one exacerbation onset and the next. Any exacerbation that occurred less than 4 weeks from the prior exacerbation was not considered a new exacerbation.

    Measured: Baseline (Day 1) to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2017
  2. Study start31 Oct 2017
  3. Primary completion12 Dec 2019
  4. Study completion12 Dec 2019

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
256 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03218917
Sponsor's protocol ID
INS1007-201
Other IDs
2017-002533-32, 2017
Status last verified
Mar 2023
First submitted
11 Jul 2017
Last updated
27 Mar 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Johnson ED, Long MB, Perea L, Shih VH, Fernandez C, Teper A, Cipolla D, McIntosh E, Galloway R, Eke Z, Shuttleworth M, Hull R, Spinou A, De Soyza A, Ringshausen FC, Goeminne P, Lorent N, Haworth C, Loebinger MR, Blasi F, Shteinberg M, Aliberti S, Polverino E, Sibila O, Shoemark A, Mange K, Huang JTJ, Stobo J, Chalmers JD. Broad Immunomodulatory Effects of the Dipeptidyl Peptidase-1 Inhibitor Brensocatib in Bronchiectasis: Data from the Phase 2, Double-Blind, Placebo-controlled WILLOW Trial. Am J Respir Crit Care Med. 2025 May;211(5):770-778. doi: 10.1164/rccm.202408-1545OC.

    PubMed 39938076

  • Basso J, Chen KJ, Zhou Y, Mark L, LaSala D, Dorfman A, Atalla M, Chun D, Viramontes V, Chang C, Leifer F, McDonald PP, Cipolla DC. The pharmacokinetic profile of brensocatib and its effect on pharmacodynamic biomarkers including NE, PR3, and CatG in various rodent species. Front Pharmacol. 2023 Jul 19;14:1208780. doi: 10.3389/fphar.2023.1208780. eCollection 2023.

    PubMed 37538173

  • Cipolla D, Zhang J, Korkmaz B, Chalmers JD, Basso J, Lasala D, Fernandez C, Teper A, Mange KC, Perkins WR, Sullivan EJ. Dipeptidyl peptidase-1 inhibition with brensocatib reduces the activity of all major neutrophil serine proteases in patients with bronchiectasis: results from the WILLOW trial. Respir Res. 2023 May 17;24(1):133. doi: 10.1186/s12931-023-02444-z.

    PubMed 37198686

  • Chalmers JD, Haworth CS, Metersky ML, Loebinger MR, Blasi F, Sibila O, O'Donnell AE, Sullivan EJ, Mange KC, Fernandez C, Zou J, Daley CL; WILLOW Investigators. Phase 2 Trial of the DPP-1 Inhibitor Brensocatib in Bronchiectasis. N Engl J Med. 2020 Nov 26;383(22):2127-2137. doi: 10.1056/NEJMoa2021713. Epub 2020 Sep 7.

    PubMed 32897034

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Brensocatib 10 mg and Brensocatib 25 mg in people with Non-Cystic Fibrosis Bronchiectasis, run by Insmed Incorporated at 108 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 108 sites in United States, Germany, United Kingdom, Australia, South Korea and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to the First Pulmonary Exacerbation Over 24-Week Treatment Period (time frame: Baseline (Day 1) to Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03218917, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023.

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