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Assessment of INS1007 in Participants With Non-Cystic Fibrosis Bronchiectasis

Primary Purpose

Non-Cystic Fibrosis Bronchiectasis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Brensocatib 10 mg
Brensocatib 25 mg
Placebo
Sponsored by
Insmed Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Cystic Fibrosis Bronchiectasis focused on measuring P aeruginosa, bronchiectasis, active neutrophil elastase

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • University of Alabama at Birmingham
  • Phoenix Medical Group
  • NewportNativeMD
  • Palmtree Clinical Research
  • UC Davis Medical Center
  • Stanford University Medical Center
  • National Jewish Heath
  • UConn Health Center
  • MedStar Georgetown University Hospital
  • Clinical Research Specialists, LLC
  • St. Francis Medical Institute
  • University of Florida
  • San Marcus Research Clinic, Inc.
  • University of Miami Miller School of Medicine
  • Sarasota Memorial Hospital Clinical Research Center
  • The Emory Clinic, Pulmonology
  • University of Chicago
  • University of Iowa
  • LSU Health Sciences Center
  • Johns Hopkins University, Division of Pulmonary and Critical Care Medicine
  • Pulmonary and Critical Care Associates of Baltimore
  • Mid Atlantic Pulmonary & Research Center
  • Michigan Medicine
  • NYU Pulmonary & Critical Care Associates
  • Columbia University Medical Center/ New York Presbyterian Hospital
  • The University of North Carolina at Chapel Hill
  • Novant Health Pulmonary Medicine South
  • Southeastern Research Center
  • University Hospitals Cleveland Medical Center
  • Cleveland Clinic
  • Oregon Health & Science University
  • University of Pennsylvania
  • Temple University Hospital
  • SMS Clinical Research, LLC
  • The University of Texas Health Science at Tyler
  • MultiCare Institute for Research & Innovation
  • Concord Repatriation General Hospital
  • Mater Misericordia Medical Centre
  • Gallipoli Medical Research Foundation
  • Metro North Hospital and Health Service (The Prince Charles Hospital)
  • Respiratory Clinical Trials Unit, Royal Adelaide Hospital
  • Respiratory Clinical Trials PTY LTD
  • Box Hill Hospital, Eastern Clinical Research Unit
  • Alfred Hospital
  • Institute for Respiratory Health
  • UZ Leuven
  • Medical Center ReSpiro Ltd (Kiselov)
  • Medical Center UNIMED
  • MHAT "Dr IvanSeliminski"-Sliven
  • Cardioart Medical Center
  • Hvidovre Hospital
  • Aarhus University Hospital
  • Sjællands Universitetshospital, Roskilde
  • Krankenhaus Donaustauf
  • Klinikum der Universität München Medizinische Klinik V Pneumologie / Mukoviszidose-Zentrum für Erwachsene
  • Klinikum Nuernberg
  • Universitätsklinikum Frankfurt
  • IKF Pneumologie Frankfurt
  • Ruhrlandklinik Essen, University Essen
  • Forschungszentrum Borstel
  • Universitätsklinikum Jena
  • Research Center for Medical Studies (RCMS)
  • Städt. Klinikum München GmbH, Bogenhausen
  • University of Milan, IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico
  • Ospedale San Gerardo
  • University Hospital of Pisa
  • Fondazione IRCCS Policlinico San Matteo
  • ICS Maugeri spa SB, IRCSS Telese
  • Inha University Hospital
  • Gachon University Gil Medical Center
  • Chonnam National University Hospital
  • The Catholic University of Korea Incheon St. Mary's Hospital
  • The Catholic University of Korea, St. Paul's Hospital
  • Seoul National University Hospital
  • Konkuk University Medical Center
  • Asan Medical Center
  • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Noordwest Ziekenhuis Group
  • Amphia Longresearch Astma/COPD Uni 52/5e etage
  • RadboudUMC, location Dekkerswald
  • Zuyderland MC
  • P3 Research
  • P3 Research (Hawke's Bay)
  • Southern District health Board/Dunedin Hospital
  • Waikato District Health Board
  • Auckland District Health Board, Greenlane clinical Centre
  • Centrum Badan Klinicznych, Piotr Napora Lekarze i Spolka Partnerska, Osrodek Badan Wczesnej Fazy
  • Grażyna Jasieniak Pinis Niepubliczny Zakład Opieki Zdrowotnej Atopia
  • NZOZ Krak-Medyk Sp. z o.o
  • Gabinet Lekarski Pediatryczno-Alergologiczny Zenon Bukowczan
  • Medical University of Lodz Poland
  • Singapore General Hospital
  • Changi General Hospital
  • Hospital Clinic de Barcelona
  • Hospital de la Santa Creu i Sant Pau
  • Hospital Universitari de Bellvitge
  • Hospital Universitari de Girona Dr. Josep Trueta
  • Hospital Universiatrio y politecnico La Fe
  • NHS Tayside
  • Papworth Hospital NHS Foundation Trust
  • Blackpool Teaching Hospitals NHS Foundation Trust
  • Liverpool Heart and Chest Hospital NHS Foundation Trust
  • NHS Lothian
  • Ashford and St Peter's Hospitals NHS Foundation Trust
  • The Royal Wolverhampton NHS Trust
  • Royal Brompton & Harefield NHS Foundation Trust
  • Pennine Acute Hospitals NHS Trust
  • University Hospital Southampton NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Brensocatib 10 mg

Brensocatib 25 mg

Placebo

Arm Description

Participants received brensocatib 10 mg once daily (QD) before breakfast, for 24 weeks.

Participants received brensocatib 25 mg QD before breakfast, for 24 weeks.

Participants received the matching placebo QD before breakfast, for 24 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
July 11, 2017
Last Updated
March 23, 2023
Sponsor
Insmed Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT03218917
Brief Title
Assessment of INS1007 in Participants With Non-Cystic Fibrosis Bronchiectasis
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 31, 2017 (Actual)
Primary Completion Date
December 12, 2019 (Actual)
Study Completion Date
December 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insmed Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Cystic Fibrosis Bronchiectasis
Keywords
P aeruginosa, bronchiectasis, active neutrophil elastase

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
256 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brensocatib 10 mg
Arm Type
Experimental
Arm Description
Participants received brensocatib 10 mg once daily (QD) before breakfast, for 24 weeks.
Arm Title
Brensocatib 25 mg
Arm Type
Experimental
Arm Description
Participants received brensocatib 25 mg QD before breakfast, for 24 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received the matching placebo QD before breakfast, for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Brensocatib 10 mg
Intervention Description
Administered once per day for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Brensocatib 25 mg
Intervention Description
Administered once per day for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered once per day for 24 weeks
Primary Outcome Measure Information:
Title
Time to the First Pulmonary Exacerbation Over 24-Week Treatment Period
Description
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.
Time Frame
Baseline (Day 1) to Week 24
Secondary Outcome Measure Information:
Title
Change From Baseline in Quality of Life Questionnaire - Bronchiectasis (QOL-B) Respiratory Symptoms Domain Score Over 24 Week Treatment Period
Description
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.
Time Frame
Baseline (Day 1) to Week 24
Title
Change From Screening in Post-Bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Over 24-Week Treatment Period
Description
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.
Time Frame
Screening (Days -42 to -1) to Week 24
Title
Change From Baseline in Concentration of Active Neutrophil Elastase (NE) in Sputum
Description
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.
Time Frame
Baseline (Day 1) to Week 24
Title
Number of Participants Who Experienced a Pulmonary Exacerbation
Description
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.
Time Frame
Baseline (Day 1) to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Fernandez, MD
Organizational Affiliation
Insmed Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Phoenix Medical Group
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
NewportNativeMD
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Palmtree Clinical Research
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262-4871
Country
United States
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5236
Country
United States
Facility Name
National Jewish Heath
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
UConn Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030-1321
Country
United States
Facility Name
MedStar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Clinical Research Specialists, LLC
City
Celebration
State/Province
Florida
ZIP/Postal Code
34747
Country
United States
Facility Name
St. Francis Medical Institute
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
San Marcus Research Clinic, Inc.
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Sarasota Memorial Hospital Clinical Research Center
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
The Emory Clinic, Pulmonology
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342-2147
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
LSU Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Johns Hopkins University, Division of Pulmonary and Critical Care Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Pulmonary and Critical Care Associates of Baltimore
City
Towson
State/Province
Maryland
ZIP/Postal Code
21286
Country
United States
Facility Name
Mid Atlantic Pulmonary & Research Center
City
Westminster
State/Province
Maryland
ZIP/Postal Code
21157
Country
United States
Facility Name
Michigan Medicine
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
NYU Pulmonary & Critical Care Associates
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia University Medical Center/ New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
The University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Novant Health Pulmonary Medicine South
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28215
Country
United States
Facility Name
Southeastern Research Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
SMS Clinical Research, LLC
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75149
Country
United States
Facility Name
The University of Texas Health Science at Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75708
Country
United States
Facility Name
MultiCare Institute for Research & Innovation
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Mater Misericordia Medical Centre
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Gallipoli Medical Research Foundation
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
Facility Name
Metro North Hospital and Health Service (The Prince Charles Hospital)
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Respiratory Clinical Trials Unit, Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Respiratory Clinical Trials PTY LTD
City
Kent Town
State/Province
South Australia
ZIP/Postal Code
5067
Country
Australia
Facility Name
Box Hill Hospital, Eastern Clinical Research Unit
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Institute for Respiratory Health
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
UZ Leuven
City
Leuven
State/Province
Vlaams Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Medical Center ReSpiro Ltd (Kiselov)
City
Razgrad
State/Province
Momina
ZIP/Postal Code
7200
Country
Bulgaria
Facility Name
Medical Center UNIMED
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
MHAT "Dr IvanSeliminski"-Sliven
City
Sliven
ZIP/Postal Code
8800
Country
Bulgaria
Facility Name
Cardioart Medical Center
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
Hvidovre Hospital
City
Hvidovre
State/Province
Capital Region
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Sjællands Universitetshospital, Roskilde
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Krankenhaus Donaustauf
City
Donaustauf
State/Province
Bavaria
ZIP/Postal Code
93093
Country
Germany
Facility Name
Klinikum der Universität München Medizinische Klinik V Pneumologie / Mukoviszidose-Zentrum für Erwachsene
City
Munich
State/Province
Bavaria
ZIP/Postal Code
80336
Country
Germany
Facility Name
Klinikum Nuernberg
City
Nuernberg
State/Province
Bayern
ZIP/Postal Code
90419
Country
Germany
Facility Name
Universitätsklinikum Frankfurt
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
IKF Pneumologie Frankfurt
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60596
Country
Germany
Facility Name
Ruhrlandklinik Essen, University Essen
City
Essen
State/Province
NRW
ZIP/Postal Code
45239
Country
Germany
Facility Name
Forschungszentrum Borstel
City
Borstel
State/Province
Schleswig-Holstein
ZIP/Postal Code
23845
Country
Germany
Facility Name
Universitätsklinikum Jena
City
Jena
State/Province
Thuringen
ZIP/Postal Code
7747
Country
Germany
Facility Name
Research Center for Medical Studies (RCMS)
City
Berlin
ZIP/Postal Code
10717
Country
Germany
Facility Name
Städt. Klinikum München GmbH, Bogenhausen
City
München
ZIP/Postal Code
81925
Country
Germany
Facility Name
University of Milan, IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico
City
Milan
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Facility Name
Ospedale San Gerardo
City
Monza
State/Province
Monza E Brianza
ZIP/Postal Code
20900
Country
Italy
Facility Name
University Hospital of Pisa
City
Pisa
State/Province
Via Paradisa 2
ZIP/Postal Code
56124
Country
Italy
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
ICS Maugeri spa SB, IRCSS Telese
City
Telese Terme
ZIP/Postal Code
82037
Country
Italy
Facility Name
Inha University Hospital
City
Incheon
State/Province
Jung-gu
ZIP/Postal Code
22332
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
State/Province
Namdong-gu
ZIP/Postal Code
21565
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
ZIP/Postal Code
61469
Country
Korea, Republic of
Facility Name
The Catholic University of Korea Incheon St. Mary's Hospital
City
Incheon
ZIP/Postal Code
21431
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, St. Paul's Hospital
City
Seoul
ZIP/Postal Code
02559
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
05030
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Noordwest Ziekenhuis Group
City
Alkmaar
ZIP/Postal Code
1815JD
Country
Netherlands
Facility Name
Amphia Longresearch Astma/COPD Uni 52/5e etage
City
Breda
ZIP/Postal Code
4818CK
Country
Netherlands
Facility Name
RadboudUMC, location Dekkerswald
City
Nijmegen
ZIP/Postal Code
6525GA
Country
Netherlands
Facility Name
Zuyderland MC
City
Sittard
ZIP/Postal Code
6162BG
Country
Netherlands
Facility Name
P3 Research
City
Tauranga
State/Province
BOP
ZIP/Postal Code
3110
Country
New Zealand
Facility Name
P3 Research (Hawke's Bay)
City
Hastings
State/Province
Hawkes Bay
ZIP/Postal Code
4130
Country
New Zealand
Facility Name
Southern District health Board/Dunedin Hospital
City
Dunedin
State/Province
Otago
ZIP/Postal Code
9016
Country
New Zealand
Facility Name
Waikato District Health Board
City
Hamilton
State/Province
Waikato
ZIP/Postal Code
3204
Country
New Zealand
Facility Name
Auckland District Health Board, Greenlane clinical Centre
City
Auckland
ZIP/Postal Code
1051
Country
New Zealand
Facility Name
Centrum Badan Klinicznych, Piotr Napora Lekarze i Spolka Partnerska, Osrodek Badan Wczesnej Fazy
City
Wrocław
State/Province
Dolnośląskie
ZIP/Postal Code
51-162
Country
Poland
Facility Name
Grażyna Jasieniak Pinis Niepubliczny Zakład Opieki Zdrowotnej Atopia
City
Kraków
ZIP/Postal Code
31-159
Country
Poland
Facility Name
NZOZ Krak-Medyk Sp. z o.o
City
Kraków
ZIP/Postal Code
31-455
Country
Poland
Facility Name
Gabinet Lekarski Pediatryczno-Alergologiczny Zenon Bukowczan
City
Sucha Beskidzka
ZIP/Postal Code
34-200
Country
Poland
Facility Name
Medical University of Lodz Poland
City
Łódź
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169856
Country
Singapore
Facility Name
Changi General Hospital
City
Singapore
ZIP/Postal Code
529889
Country
Singapore
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Universitari de Bellvitge
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitari de Girona Dr. Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
Facility Name
Hospital Universiatrio y politecnico La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
NHS Tayside
City
Dundee
State/Province
Angus
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Papworth Hospital NHS Foundation Trust
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB23 3RE
Country
United Kingdom
Facility Name
Blackpool Teaching Hospitals NHS Foundation Trust
City
Blackpool
State/Province
Lancashire
ZIP/Postal Code
FY38NR
Country
United Kingdom
Facility Name
Liverpool Heart and Chest Hospital NHS Foundation Trust
City
Liverpool
State/Province
Merseyside
ZIP/Postal Code
L14 3PE
Country
United Kingdom
Facility Name
NHS Lothian
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Facility Name
Ashford and St Peter's Hospitals NHS Foundation Trust
City
Chertsey
State/Province
Surrey
ZIP/Postal Code
KT16 0PZ
Country
United Kingdom
Facility Name
The Royal Wolverhampton NHS Trust
City
Wolverhampton
State/Province
West Midlands
ZIP/Postal Code
WV10 0QP
Country
United Kingdom
Facility Name
Royal Brompton & Harefield NHS Foundation Trust
City
London
ZIP/Postal Code
SW3 6HP
Country
United Kingdom
Facility Name
Pennine Acute Hospitals NHS Trust
City
Manchester
ZIP/Postal Code
M8 5RB
Country
United Kingdom
Facility Name
University Hospital Southampton NHS Foundation Trust
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32897034
Citation
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.
Results Reference
derived

Learn more about this trial

Assessment of INS1007 in Participants With Non-Cystic Fibrosis Bronchiectasis

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