Clinical trial NCT03218917: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Cystic Fibrosis Bronchiectasis
Keywords: P aeruginosa
bronchiectasis
active neutrophil elastase
Lead sponsor: Insmed Incorporated
Sponsor class: INDUSTRY
First posted: 2017-07-17
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Time to the First Pulmonary Exacerbation Over 24-Week Treatment Period
timeFrame: Baseline (Day 1) to Week 24
Secondary outcomes:
measure: Change From Baseline in Quality of Life Questionnaire - Bronchiectasis (QOL-B) Respiratory Symptoms Domain Score Over 24 Week Treatment Period
timeFrame: Baseline (Day 1) to Week 24
measure: Change From Screening in Post-Bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Over 24-Week Treatment Period
timeFrame: Screening (Days -42 to -1) to Week 24
measure: Change From Baseline in Concentration of Active Neutrophil Elastase (NE) in Sputum
timeFrame: Baseline (Day 1) to Week 24
measure: Number of Participants Who Experienced a Pulmonary Exacerbation
timeFrame: Baseline (Day 1) to Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Peoria
country: United States
facility: Phoenix Medical Group
state: Arizona
city: Newport Beach
country: United States
facility: NewportNativeMD
state: California
city: Palm Springs
country: United States
facility: Palmtree Clinical Research
state: California
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Denver
country: United States
facility: National Jewish Heath
state: Colorado
city: Farmington
country: United States
facility: UConn Health Center
state: Connecticut
city: Washington
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
city: Celebration
country: United States
facility: Clinical Research Specialists, LLC
state: Florida
city: Clearwater
country: United States
facility: St. Francis Medical Institute
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Miami Lakes
country: United States
facility: San Marcus Research Clinic, Inc.
state: Florida
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital Clinical Research Center
state: Florida
city: Atlanta
country: United States
facility: The Emory Clinic, Pulmonology
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: New Orleans
country: United States
facility: LSU Health Sciences Center
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University, Division of Pulmonary and Critical Care Medicine
state: Maryland
city: Towson
country: United States
facility: Pulmonary and Critical Care Associates of Baltimore
state: Maryland
city: Westminster
country: United States
facility: Mid Atlantic Pulmonary & Research Center
state: Maryland
city: Ann Arbor
country: United States
facility: Michigan Medicine
state: Michigan
city: New York
country: United States
facility: NYU Pulmonary & Critical Care Associates
state: New York
city: New York
country: United States
facility: Columbia University Medical Center/ New York Presbyterian Hospital
state: New York
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Novant Health Pulmonary Medicine South
state: North Carolina
city: Winston-Salem
country: United States
facility: Southeastern Research Center
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Mesquite
country: United States
facility: SMS Clinical Research, LLC
state: Texas
city: Tyler
country: United States
facility: The University of Texas Health Science at Tyler
state: Texas
city: Tacoma
country: United States
facility: MultiCare Institute for Research & Innovation
state: Washington
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: Mater Misericordia Medical Centre
state: Queensland
city: Brisbane
country: Australia
facility: Gallipoli Medical Research Foundation
state: Queensland
city: Chermside
country: Australia
facility: Metro North Hospital and Health Service (The Prince Charles Hospital)
state: Queensland
city: Adelaide
country: Australia
facility: Respiratory Clinical Trials Unit, Royal Adelaide Hospital
state: South Australia
city: Kent Town
country: Australia
facility: Respiratory Clinical Trials PTY LTD
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital, Eastern Clinical Research Unit
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Institute for Respiratory Health
state: Western Australia
city: Leuven
country: Belgium
facility: UZ Leuven
state: Vlaams Brabant
city: Razgrad
country: Bulgaria
facility: Medical Center ReSpiro Ltd (Kiselov)
state: Momina
city: Plovdiv
country: Bulgaria
facility: Medical Center UNIMED
city: Sliven
country: Bulgaria
facility: MHAT "Dr IvanSeliminski"-Sliven
city: Stara Zagora
country: Bulgaria
facility: Cardioart Medical Center
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
state: Capital Region
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Roskilde
country: Denmark
facility: Sjællands Universitetshospital, Roskilde
city: Donaustauf
country: Germany
facility: Krankenhaus Donaustauf
state: Bavaria
city: Munich
country: Germany
facility: Klinikum der Universität München Medizinische Klinik V Pneumologie / Mukoviszidose-Zentrum für Erwachsene
state: Bavaria
city: Nuernberg
country: Germany
facility: Klinikum Nuernberg
state: Bayern
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
state: Hessen
city: Frankfurt
country: Germany
facility: IKF Pneumologie Frankfurt
state: Hessen
city: Essen
country: Germany
facility: Ruhrlandklinik Essen, University Essen
state: NRW
city: Borstel
country: Germany
facility: Forschungszentrum Borstel
state: Schleswig-Holstein
city: Jena
country: Germany
facility: Universitätsklinikum Jena
state: Thuringen
city: Berlin
country: Germany
facility: Research Center for Medical Studies (RCMS)
city: München
country: Germany
facility: Städt. Klinikum München GmbH, Bogenhausen
city: Milan
country: Italy
facility: University of Milan, IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico
state: Lombardia
city: Monza
country: Italy
facility: Ospedale San Gerardo
state: Monza E Brianza
city: Pisa
country: Italy
facility: University Hospital of Pisa
state: Via Paradisa 2
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Telese Terme
country: Italy
facility: ICS Maugeri spa SB, IRCSS Telese
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
state: Jung-gu
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
state: Namdong-gu
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Incheon
country: Korea, Republic of
facility: The Catholic University of Korea Incheon St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, St. Paul's Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuis Group
city: Breda
country: Netherlands
facility: Amphia Longresearch Astma/COPD Uni 52/5e etage
city: Nijmegen
country: Netherlands
facility: RadboudUMC, location Dekkerswald
city: Sittard
country: Netherlands
facility: Zuyderland MC
city: Tauranga
country: New Zealand
facility: P3 Research
state: BOP
city: Hastings
country: New Zealand
facility: P3 Research (Hawke's Bay)
state: Hawkes Bay
city: Dunedin
country: New Zealand
facility: Southern District health Board/Dunedin Hospital
state: Otago
city: Hamilton
country: New Zealand
facility: Waikato District Health Board
state: Waikato
city: Auckland
country: New Zealand
facility: Auckland District Health Board, Greenlane clinical Centre
city: Wrocław
country: Poland
facility: Centrum Badan Klinicznych, Piotr Napora Lekarze i Spolka Partnerska, Osrodek Badan Wczesnej Fazy
state: Dolnośląskie
city: Kraków
country: Poland
facility: Grażyna Jasieniak Pinis Niepubliczny Zakład Opieki Zdrowotnej Atopia
city: Kraków
country: Poland
facility: NZOZ Krak-Medyk Sp. z o.o
city: Sucha Beskidzka
country: Poland
facility: Gabinet Lekarski Pediatryczno-Alergologiczny Zenon Bukowczan
city: Łódź
country: Poland
facility: Medical University of Lodz Poland
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: Changi General Hospital
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
city: Girona
country: Spain
facility: Hospital Universitari de Girona Dr. Josep Trueta
city: Valencia
country: Spain
facility: Hospital Universiatrio y politecnico La Fe
city: Dundee
country: United Kingdom
facility: NHS Tayside
state: Angus
city: Cambridge
country: United Kingdom
facility: Papworth Hospital NHS Foundation Trust
state: Cambridgeshire
city: Blackpool
country: United Kingdom
facility: Blackpool Teaching Hospitals NHS Foundation Trust
state: Lancashire
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital NHS Foundation Trust
state: Merseyside
city: Edinburgh
country: United Kingdom
facility: NHS Lothian
state: Scotland
city: Chertsey
country: United Kingdom
facility: Ashford and St Peter's Hospitals NHS Foundation Trust
state: Surrey
city: Wolverhampton
country: United Kingdom
facility: The Royal Wolverhampton NHS Trust
state: West Midlands
city: London
country: United Kingdom
facility: Royal Brompton & Harefield NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: Pennine Acute Hospitals NHS Trust
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
Study officials:
affiliation: Insmed Incorporated
name: Carlos Fernandez, MD
role: STUDY_DIRECTOR
References:
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.