Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03218917




Registration number
NCT03218917
Ethics application status
Date submitted
11/07/2017
Date registered
17/07/2017
Date last updated
27/03/2023

Titles & IDs
Public title
Assessment of INS1007 in Participants With Non-Cystic Fibrosis Bronchiectasis
Scientific 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
Secondary ID [1] 0 0
2017-002533-32
Secondary ID [2] 0 0
INS1007-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Cystic Fibrosis Bronchiectasis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Brensocatib 10 mg
Treatment: Drugs - Brensocatib 25 mg
Treatment: Drugs - Placebo

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

Experimental: Brensocatib 25 mg - Participants received brensocatib 25 mg QD before breakfast, for 24 weeks.

Placebo comparator: Placebo - Participants received the matching placebo QD before breakfast, for 24 weeks.


Treatment: Drugs: Brensocatib 10 mg
Administered once per day for 24 weeks

Treatment: Drugs: Brensocatib 25 mg
Administered once per day for 24 weeks

Treatment: Drugs: Placebo
Administered once per day for 24 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to the First Pulmonary Exacerbation Over 24-Week Treatment Period
Timepoint [1] 0 0
Baseline (Day 1) to Week 24
Secondary outcome [1] 0 0
Change From Baseline in Quality of Life Questionnaire - Bronchiectasis (QOL-B) Respiratory Symptoms Domain Score Over 24 Week Treatment Period
Timepoint [1] 0 0
Baseline (Day 1) to Week 24
Secondary outcome [2] 0 0
Change From Screening in Post-Bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Over 24-Week Treatment Period
Timepoint [2] 0 0
Screening (Days -42 to -1) to Week 24
Secondary outcome [3] 0 0
Change From Baseline in Concentration of Active Neutrophil Elastase (NE) in Sputum
Timepoint [3] 0 0
Baseline (Day 1) to Week 24
Secondary outcome [4] 0 0
Number of Participants Who Experienced a Pulmonary Exacerbation
Timepoint [4] 0 0
Baseline (Day 1) to Week 24

Eligibility
Key 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
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/10/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/12/2019
Sample size
Target
Accrual to date
Final
256
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Mater Misericordia Medical Centre - Brisbane
Recruitment hospital [3] 0 0
Gallipoli Medical Research Foundation - Brisbane
Recruitment hospital [4] 0 0
Metro North Hospital and Health Service (The Prince Charles Hospital) - Chermside
Recruitment hospital [5] 0 0
Respiratory Clinical Trials Unit, Royal Adelaide Hospital - Adelaide
Recruitment hospital [6] 0 0
Respiratory Clinical Trials PTY LTD - Kent Town
Recruitment hospital [7] 0 0
Box Hill Hospital, Eastern Clinical Research Unit - Box Hill
Recruitment hospital [8] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [9] 0 0
Institute for Respiratory Health - Nedlands
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
4101 - Brisbane
Recruitment postcode(s) [3] 0 0
4120 - Brisbane
Recruitment postcode(s) [4] 0 0
4032 - Chermside
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment postcode(s) [6] 0 0
5067 - Kent Town
Recruitment postcode(s) [7] 0 0
3128 - Box Hill
Recruitment postcode(s) [8] 0 0
3004 - Melbourne
Recruitment postcode(s) [9] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Iowa
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
North Carolina
Country [16] 0 0
United States of America
State/province [16] 0 0
Ohio
Country [17] 0 0
United States of America
State/province [17] 0 0
Oregon
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Washington
Country [21] 0 0
Belgium
State/province [21] 0 0
Vlaams Brabant
Country [22] 0 0
Bulgaria
State/province [22] 0 0
Momina
Country [23] 0 0
Bulgaria
State/province [23] 0 0
Plovdiv
Country [24] 0 0
Bulgaria
State/province [24] 0 0
Sliven
Country [25] 0 0
Bulgaria
State/province [25] 0 0
Stara Zagora
Country [26] 0 0
Denmark
State/province [26] 0 0
Capital Region
Country [27] 0 0
Denmark
State/province [27] 0 0
Aarhus
Country [28] 0 0
Denmark
State/province [28] 0 0
Roskilde
Country [29] 0 0
Germany
State/province [29] 0 0
Bavaria
Country [30] 0 0
Germany
State/province [30] 0 0
Bayern
Country [31] 0 0
Germany
State/province [31] 0 0
Hessen
Country [32] 0 0
Germany
State/province [32] 0 0
NRW
Country [33] 0 0
Germany
State/province [33] 0 0
Schleswig-Holstein
Country [34] 0 0
Germany
State/province [34] 0 0
Thuringen
Country [35] 0 0
Germany
State/province [35] 0 0
Berlin
Country [36] 0 0
Germany
State/province [36] 0 0
München
Country [37] 0 0
Italy
State/province [37] 0 0
Lombardia
Country [38] 0 0
Italy
State/province [38] 0 0
Monza E Brianza
Country [39] 0 0
Italy
State/province [39] 0 0
Via Paradisa 2
Country [40] 0 0
Italy
State/province [40] 0 0
Pavia
Country [41] 0 0
Italy
State/province [41] 0 0
Telese Terme
Country [42] 0 0
Korea, Republic of
State/province [42] 0 0
Jung-gu
Country [43] 0 0
Korea, Republic of
State/province [43] 0 0
Namdong-gu
Country [44] 0 0
Korea, Republic of
State/province [44] 0 0
Gwangju
Country [45] 0 0
Korea, Republic of
State/province [45] 0 0
Incheon
Country [46] 0 0
Korea, Republic of
State/province [46] 0 0
Seoul
Country [47] 0 0
Netherlands
State/province [47] 0 0
Alkmaar
Country [48] 0 0
Netherlands
State/province [48] 0 0
Breda
Country [49] 0 0
Netherlands
State/province [49] 0 0
Nijmegen
Country [50] 0 0
Netherlands
State/province [50] 0 0
Sittard
Country [51] 0 0
New Zealand
State/province [51] 0 0
BOP
Country [52] 0 0
New Zealand
State/province [52] 0 0
Hawkes Bay
Country [53] 0 0
New Zealand
State/province [53] 0 0
Otago
Country [54] 0 0
New Zealand
State/province [54] 0 0
Waikato
Country [55] 0 0
New Zealand
State/province [55] 0 0
Auckland
Country [56] 0 0
Poland
State/province [56] 0 0
Dolnoslaskie
Country [57] 0 0
Poland
State/province [57] 0 0
Kraków
Country [58] 0 0
Poland
State/province [58] 0 0
Sucha Beskidzka
Country [59] 0 0
Poland
State/province [59] 0 0
Lódz
Country [60] 0 0
Singapore
State/province [60] 0 0
Singapore
Country [61] 0 0
Spain
State/province [61] 0 0
Barcelona
Country [62] 0 0
Spain
State/province [62] 0 0
Girona
Country [63] 0 0
Spain
State/province [63] 0 0
Valencia
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Angus
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Cambridgeshire
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Lancashire
Country [67] 0 0
United Kingdom
State/province [67] 0 0
Merseyside
Country [68] 0 0
United Kingdom
State/province [68] 0 0
Scotland
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Surrey
Country [70] 0 0
United Kingdom
State/province [70] 0 0
West Midlands
Country [71] 0 0
United Kingdom
State/province [71] 0 0
London
Country [72] 0 0
United Kingdom
State/province [72] 0 0
Manchester
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Insmed Incorporated
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03218917
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Carlos Fernandez, MD
Address 0 0
Insmed Incorporated
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03218917