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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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
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Secondary ID [1]
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2017-002533-32
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Secondary ID [2]
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INS1007-201
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-Cystic Fibrosis Bronchiectasis
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Inflammatory and Immune System
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Connective tissue diseases
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to the First Pulmonary Exacerbation Over 24-Week Treatment Period
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline (Day 1) to Week 24
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Secondary outcome [1]
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Change From Baseline in Quality of Life Questionnaire - Bronchiectasis (QOL-B) Respiratory Symptoms Domain Score Over 24 Week Treatment Period
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline (Day 1) to Week 24
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Secondary outcome [2]
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Change From Screening in Post-Bronchodilator Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Over 24-Week Treatment Period
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Assessment method [2]
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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.
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Timepoint [2]
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Screening (Days -42 to -1) to Week 24
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Secondary outcome [3]
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Change From Baseline in Concentration of Active Neutrophil Elastase (NE) in Sputum
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline (Day 1) to Week 24
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Secondary outcome [4]
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Number of Participants Who Experienced a Pulmonary Exacerbation
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline (Day 1) to Week 24
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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
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Minimum age
18
Years
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Maximum age
85
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
31/10/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
12/12/2019
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Sample size
Target
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Accrual to date
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Final
256
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Concord Repatriation General Hospital - Concord
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Mater Misericordia Medical Centre - Brisbane
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Gallipoli Medical Research Foundation - Brisbane
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Metro North Hospital and Health Service (The Prince Charles Hospital) - Chermside
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Respiratory Clinical Trials Unit, Royal Adelaide Hospital - Adelaide
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Respiratory Clinical Trials PTY LTD - Kent Town
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Box Hill Hospital, Eastern Clinical Research Unit - Box Hill
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Alfred Hospital - Melbourne
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Institute for Respiratory Health - Nedlands
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2139 - Concord
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4101 - Brisbane
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4120 - Brisbane
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4032 - Chermside
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5000 - Adelaide
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5067 - Kent Town
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Recruitment postcode(s) [7]
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3128 - Box Hill
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3004 - Melbourne
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Recruitment postcode(s) [9]
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6009 - Nedlands
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Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
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Name
Insmed Incorporated
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03218917
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Carlos Fernandez, MD
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Address
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Insmed Incorporated
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03218917
Download to PDF