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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

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
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United States of America
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Alabama
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Arizona
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District of Columbia
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Southampton

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03218917