Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04594369
Registration number
NCT04594369
Ethics application status
Date submitted
14/10/2020
Date registered
20/10/2020
Date last updated
25/03/2024
Titles & IDs
Public title
A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis
Query!
Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects With Non-Cystic Fibrosis Bronchiectasis - The ASPEN Study
Query!
Secondary ID [1]
0
0
2020-003688-25
Query!
Secondary ID [2]
0
0
INS1007-301
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
ASPEN
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Non-Cystic Fibrosis Bronchiectasis
0
0
Query!
Condition category
Condition code
Respiratory
0
0
0
0
Query!
Other respiratory disorders / diseases
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Connective tissue diseases
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Intervention/exposure
Study type
Interventional(has expanded access)
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Brensocatib 10 mg
Treatment: Drugs - Brensocatib 25 mg
Treatment: Drugs - Placebo
Experimental: Brensocatib 10 mg - Participants will receive brensocatib 10 mg, tablets orally, once daily, for 52 weeks.
Experimental: Brensocatib 25 mg - Participants will receive brensocatib 25 mg, tablets orally, once daily, for 52 weeks.
Placebo Comparator: Placebo - Participants will receive a brensocatib-matching placebo, tablets orally, once daily, for 52 weeks.
Treatment: Drugs: Brensocatib 10 mg
Oral tablet.
Treatment: Drugs: Brensocatib 25 mg
Oral tablet.
Treatment: Drugs: Placebo
Brensocatib-matching oral tablet.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Rate of Adjudicated Pulmonary Exacerbations (PEs)
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
52 Weeks
Query!
Secondary outcome [1]
0
0
Time to First Adjudicated Pulmonary Exacerbation (PE)
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
52 Weeks
Query!
Secondary outcome [2]
0
0
Percentage of Participants who are Pulmonary Exacerbation (PE) Free
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
52 Weeks
Query!
Secondary outcome [3]
0
0
Change From Baseline in Postbronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
Baseline, at Week 52
Query!
Secondary outcome [4]
0
0
Rate of Severe Adjudicated Pulmonary Exacerbations (PEs)
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
52 Weeks
Query!
Secondary outcome [5]
0
0
Change from Baseline to Week 52 in Quality of Life Questionnaire - Bronchiectasis (QOL-B) Respiratory Symptoms Domain Score in Adult Participants
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
Baseline to Week 52
Query!
Secondary outcome [6]
0
0
Number of Participants who Experience at Least one Treatment-Emergent Adverse Events (TEAEs)
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
56 Weeks
Query!
Secondary outcome [7]
0
0
Plasma Concentration of Brensocatib at Select Time Points
Query!
Assessment method [7]
0
0
Query!
Timepoint [7]
0
0
Pre-dose and post-dose at multiple time points up to Week 52
Query!
Eligibility
Key inclusion criteria
1. Provide their signed study informed consent to participate.
a. Adolescent participants must have signed study assent form to participate, and the
adolescent's parent or legal guardian must have provided signed informed consent for
the adolescent to participate.
2. Clinical history consistent with non-cystic fibrosis bronchiectasis (NCFBE) (cough,
chronic sputum production and/or recurrent respiratory infections) that is confirmed
by chest computerized tomography (CT) scan.
3. At least 2 PEs defined by need for antibiotic prescription by a physician for the
signs and symptoms of respiratory infections in the past 12 months before the
Screening Visit.
a. Adolescent participants are required to have at least 1 pulmonary exacerbation in
the prior 12 months.
4. Women must be postmenopausal (defined as no menses for 12 months without an
alternative medical cause), surgically sterile, or using highly effective
contraception (ie, methods that can achieve a failure rate <1% per year when used
consistently and correctly) from Day 1 to at least 90 days after the last dose.
5. Male participants with female partners of childbearing potential must be using
effective contraception from Day 1 to at least 90 days after the last dose.
6. Male participants with pregnant or non-pregnant women of child-bearing potential
partners must use condoms to avoid potential exposure to the embryo/fetus.
Query!
Minimum age
12
Years
Query!
Query!
Maximum age
85
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. A primary diagnosis of chronic obstructive pulmonary disease (COPD) or asthma as
judged by the Investigator.
2. Bronchiectasis due to cystic fibrosis.
3. Current smokers as defined per Centers for Disease Control (CDC).
4. Known or suspected immunodeficiency disorder, including history of invasive
opportunistic infections.
5. Known history of human immunodeficiency virus (HIV) infection.
6. Currently being treated for nontuberculous mycobacteria (NTM) lung infection, allergic
bronchopulmonary aspergillosis, or tuberculosis (TB).
7. Active and current symptomatic infection by 2019 corona virus disease (COVID-19).
8. Inability to follow the procedures of the study (eg, due to language problems or
psychological disorders).
9. Receiving medications or therapy that are prohibited as concomitant medications.
10. Previously participated in a clinical trial for brensocatib.
11. Received any live attenuated vaccine within 4 weeks prior to the first administration
of brensocatib.
12. Suffering an exacerbation 4 weeks before Screening or during the Screening period.
13. Adult participants only: Have compliance issues with completion of electronic diary
entries during the Screening Period and in the opinion of the Investigator, compliance
is unlikely to improve during the study.
14. Participated in any other interventional clinical studies within 3 months before
Screening Visit.
15. History of alcohol or drug abuse within 6 months prior to the Screening Visit.
16. Is the Investigator or any Sub-Investigator, research assistant, pharmacist, study
coordinator, other staff or relative thereof directly involved in the conduct of the
study.
17. Known history of hypersensitivity to brensocatib or any of its excipients.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/12/2020
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
22/03/2024
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1767
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
AUS013 - Kogarah
Query!
Recruitment hospital [2]
0
0
AUS008 - New Lambton Heights
Query!
Recruitment hospital [3]
0
0
AUS007 - Westmead
Query!
Recruitment hospital [4]
0
0
AUS012 - Cairns North
Query!
Recruitment hospital [5]
0
0
AUS001 - Chermside
Query!
Recruitment hospital [6]
0
0
AUS010 - Greenslopes
Query!
Recruitment hospital [7]
0
0
AUS006 - South Brisbane
Query!
Recruitment hospital [8]
0
0
AUS019 - South Brisbane
Query!
Recruitment hospital [9]
0
0
AUS011 - Adelaide
Query!
Recruitment hospital [10]
0
0
AUS017 - Bedford Park
Query!
Recruitment hospital [11]
0
0
AUS022 - North Adelaide
Query!
Recruitment hospital [12]
0
0
AUS009 - Woodville South
Query!
Recruitment hospital [13]
0
0
AUS002 - Box Hill
Query!
Recruitment hospital [14]
0
0
AUS014 - Clayton
Query!
Recruitment hospital [15]
0
0
AUS018 - Murdoch
Query!
Recruitment hospital [16]
0
0
AUS005 - Nedlands
Query!
Recruitment hospital [17]
0
0
AUS003 - Concord
Query!
Recruitment hospital [18]
0
0
AUS015 - Spearwood
Query!
Recruitment postcode(s) [1]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [2]
0
0
2305 - New Lambton Heights
Query!
Recruitment postcode(s) [3]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [4]
0
0
4870 - Cairns North
Query!
Recruitment postcode(s) [5]
0
0
4032 - Chermside
Query!
Recruitment postcode(s) [6]
0
0
4120 - Greenslopes
Query!
Recruitment postcode(s) [7]
0
0
4101 - South Brisbane
Query!
Recruitment postcode(s) [8]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [9]
0
0
5042 - Bedford Park
Query!
Recruitment postcode(s) [10]
0
0
5006 - North Adelaide
Query!
Recruitment postcode(s) [11]
0
0
5011 - Woodville South
Query!
Recruitment postcode(s) [12]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [13]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [14]
0
0
6150 - Murdoch
Query!
Recruitment postcode(s) [15]
0
0
6009 - Nedlands
Query!
Recruitment postcode(s) [16]
0
0
NSW 2139 - Concord
Query!
Recruitment postcode(s) [17]
0
0
6163 - Spearwood
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arkansas
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Connecticut
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
District of Columbia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Florida
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Georgia
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Illinois
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Indiana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Iowa
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Kansas
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Louisiana
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Maryland
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Massachusetts
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Minnesota
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Missouri
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Nebraska
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
New Jersey
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
New York
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
North Carolina
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Ohio
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Oregon
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Pennsylvania
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
South Carolina
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Tennessee
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Texas
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Virginia
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Washington
Query!
Country [30]
0
0
Argentina
Query!
State/province [30]
0
0
Buenos Aires
Query!
Country [31]
0
0
Argentina
Query!
State/province [31]
0
0
Ciudad Autónoma De BuenosAires
Query!
Country [32]
0
0
Argentina
Query!
State/province [32]
0
0
Córdoba
Query!
Country [33]
0
0
Argentina
Query!
State/province [33]
0
0
Mendoza
Query!
Country [34]
0
0
Argentina
Query!
State/province [34]
0
0
Santa Fe
Query!
Country [35]
0
0
Argentina
Query!
State/province [35]
0
0
Tucumán
Query!
Country [36]
0
0
Argentina
Query!
State/province [36]
0
0
Rosario
Query!
Country [37]
0
0
Austria
Query!
State/province [37]
0
0
Linz
Query!
Country [38]
0
0
Belgium
Query!
State/province [38]
0
0
Oost-Vlaanderen
Query!
Country [39]
0
0
Belgium
Query!
State/province [39]
0
0
West-Vlaanderen
Query!
Country [40]
0
0
Belgium
Query!
State/province [40]
0
0
Leuven
Query!
Country [41]
0
0
Belgium
Query!
State/province [41]
0
0
Liège
Query!
Country [42]
0
0
Belgium
Query!
State/province [42]
0
0
Mechelen
Query!
Country [43]
0
0
Belgium
Query!
State/province [43]
0
0
Sint-Niklaas
Query!
Country [44]
0
0
Brazil
Query!
State/province [44]
0
0
Rio Grande Do Sul
Query!
Country [45]
0
0
Brazil
Query!
State/province [45]
0
0
Santa Catarina
Query!
Country [46]
0
0
Brazil
Query!
State/province [46]
0
0
São Paulo
Query!
Country [47]
0
0
Brazil
Query!
State/province [47]
0
0
Botucatu
Query!
Country [48]
0
0
Brazil
Query!
State/province [48]
0
0
São Bernardo do Campo
Query!
Country [49]
0
0
Bulgaria
Query!
State/province [49]
0
0
Sofia-Grad
Query!
Country [50]
0
0
Bulgaria
Query!
State/province [50]
0
0
Blagoevgrad
Query!
Country [51]
0
0
Bulgaria
Query!
State/province [51]
0
0
Gabrovo
Query!
Country [52]
0
0
Bulgaria
Query!
State/province [52]
0
0
Kozloduy
Query!
Country [53]
0
0
Bulgaria
Query!
State/province [53]
0
0
Lovech
Query!
Country [54]
0
0
Bulgaria
Query!
State/province [54]
0
0
Montana
Query!
Country [55]
0
0
Bulgaria
Query!
State/province [55]
0
0
Pazardzhik
Query!
Country [56]
0
0
Bulgaria
Query!
State/province [56]
0
0
Pleven
Query!
Country [57]
0
0
Bulgaria
Query!
State/province [57]
0
0
Plovdiv
Query!
Country [58]
0
0
Bulgaria
Query!
State/province [58]
0
0
Ruse
Query!
Country [59]
0
0
Bulgaria
Query!
State/province [59]
0
0
Sliven
Query!
Country [60]
0
0
Bulgaria
Query!
State/province [60]
0
0
Sofia
Query!
Country [61]
0
0
Bulgaria
Query!
State/province [61]
0
0
Veliko Tarnovo
Query!
Country [62]
0
0
Bulgaria
Query!
State/province [62]
0
0
Vidin
Query!
Country [63]
0
0
Bulgaria
Query!
State/province [63]
0
0
Vratsa
Query!
Country [64]
0
0
Canada
Query!
State/province [64]
0
0
Ontario
Query!
Country [65]
0
0
Canada
Query!
State/province [65]
0
0
Quebec
Query!
Country [66]
0
0
Chile
Query!
State/province [66]
0
0
Los Ríos
Query!
Country [67]
0
0
Chile
Query!
State/province [67]
0
0
Maule
Query!
Country [68]
0
0
Chile
Query!
State/province [68]
0
0
Región-MetropolitanadeSantiago
Query!
Country [69]
0
0
Chile
Query!
State/province [69]
0
0
Quillota
Query!
Country [70]
0
0
Colombia
Query!
State/province [70]
0
0
Cundinamarca
Query!
Country [71]
0
0
Colombia
Query!
State/province [71]
0
0
Distrito Capital De Bogotá
Query!
Country [72]
0
0
Colombia
Query!
State/province [72]
0
0
Santander
Query!
Country [73]
0
0
Colombia
Query!
State/province [73]
0
0
Valle Del Cauca
Query!
Country [74]
0
0
Colombia
Query!
State/province [74]
0
0
Bogota DC
Query!
Country [75]
0
0
Colombia
Query!
State/province [75]
0
0
Santiago de Cali
Query!
Country [76]
0
0
Denmark
Query!
State/province [76]
0
0
Capital
Query!
Country [77]
0
0
Denmark
Query!
State/province [77]
0
0
South Denmark
Query!
Country [78]
0
0
Denmark
Query!
State/province [78]
0
0
Aalborg
Query!
Country [79]
0
0
Denmark
Query!
State/province [79]
0
0
Aarhus
Query!
Country [80]
0
0
Denmark
Query!
State/province [80]
0
0
Hellerup
Query!
Country [81]
0
0
Denmark
Query!
State/province [81]
0
0
Roskilde
Query!
Country [82]
0
0
France
Query!
State/province [82]
0
0
Bas-Rhin
Query!
Country [83]
0
0
France
Query!
State/province [83]
0
0
Hérault
Query!
Country [84]
0
0
France
Query!
State/province [84]
0
0
Amiens cedex 1
Query!
Country [85]
0
0
France
Query!
State/province [85]
0
0
Creteil
Query!
Country [86]
0
0
France
Query!
State/province [86]
0
0
Nantes
Query!
Country [87]
0
0
France
Query!
State/province [87]
0
0
Nice
Query!
Country [88]
0
0
France
Query!
State/province [88]
0
0
Paris
Query!
Country [89]
0
0
France
Query!
State/province [89]
0
0
Toulouse
Query!
Country [90]
0
0
Germany
Query!
State/province [90]
0
0
Baden-Württemberg
Query!
Country [91]
0
0
Germany
Query!
State/province [91]
0
0
Bayern
Query!
Country [92]
0
0
Germany
Query!
State/province [92]
0
0
Brandenburg
Query!
Country [93]
0
0
Germany
Query!
State/province [93]
0
0
Hessen
Query!
Country [94]
0
0
Germany
Query!
State/province [94]
0
0
Niedersachsen
Query!
Country [95]
0
0
Germany
Query!
State/province [95]
0
0
Nordrhein-Westfalen
Query!
Country [96]
0
0
Germany
Query!
State/province [96]
0
0
Sachsen-Anhalt
Query!
Country [97]
0
0
Germany
Query!
State/province [97]
0
0
Sachsen
Query!
Country [98]
0
0
Germany
Query!
State/province [98]
0
0
Schleswig-Holstein
Query!
Country [99]
0
0
Germany
Query!
State/province [99]
0
0
Berlin
Query!
Country [100]
0
0
Germany
Query!
State/province [100]
0
0
Dresden
Query!
Country [101]
0
0
Germany
Query!
State/province [101]
0
0
Frankfurt
Query!
Country [102]
0
0
Germany
Query!
State/province [102]
0
0
Hannover
Query!
Country [103]
0
0
Germany
Query!
State/province [103]
0
0
Mainz
Query!
Country [104]
0
0
Germany
Query!
State/province [104]
0
0
Muenster
Query!
Country [105]
0
0
Greece
Query!
State/province [105]
0
0
Evros
Query!
Country [106]
0
0
Greece
Query!
State/province [106]
0
0
Herakleion
Query!
Country [107]
0
0
Greece
Query!
State/province [107]
0
0
Thessaloniki
Query!
Country [108]
0
0
Hungary
Query!
State/province [108]
0
0
Komárom-Esztergom
Query!
Country [109]
0
0
Ireland
Query!
State/province [109]
0
0
Dublin
Query!
Country [110]
0
0
Ireland
Query!
State/province [110]
0
0
Limerick
Query!
Country [111]
0
0
Israel
Query!
State/province [111]
0
0
Ashkelon
Query!
Country [112]
0
0
Israel
Query!
State/province [112]
0
0
Beer Sheva
Query!
Country [113]
0
0
Israel
Query!
State/province [113]
0
0
Haifa
Query!
Country [114]
0
0
Israel
Query!
State/province [114]
0
0
Jerusalem
Query!
Country [115]
0
0
Israel
Query!
State/province [115]
0
0
Kefar-Sava
Query!
Country [116]
0
0
Israel
Query!
State/province [116]
0
0
Petach Tikva
Query!
Country [117]
0
0
Israel
Query!
State/province [117]
0
0
Ramat Gan
Query!
Country [118]
0
0
Israel
Query!
State/province [118]
0
0
Rehovot
Query!
Country [119]
0
0
Israel
Query!
State/province [119]
0
0
Zerifin
Query!
Country [120]
0
0
Italy
Query!
State/province [120]
0
0
Emilia-Romagna
Query!
Country [121]
0
0
Italy
Query!
State/province [121]
0
0
Lombardia
Query!
Country [122]
0
0
Italy
Query!
State/province [122]
0
0
Toscana
Query!
Country [123]
0
0
Italy
Query!
State/province [123]
0
0
Milano
Query!
Country [124]
0
0
Italy
Query!
State/province [124]
0
0
Palermo
Query!
Country [125]
0
0
Italy
Query!
State/province [125]
0
0
Pavia
Query!
Country [126]
0
0
Italy
Query!
State/province [126]
0
0
Roma
Query!
Country [127]
0
0
Japan
Query!
State/province [127]
0
0
Aiti
Query!
Country [128]
0
0
Japan
Query!
State/province [128]
0
0
Ehime
Query!
Country [129]
0
0
Japan
Query!
State/province [129]
0
0
Hukuoka
Query!
Country [130]
0
0
Japan
Query!
State/province [130]
0
0
Hyôgo
Query!
Country [131]
0
0
Japan
Query!
State/province [131]
0
0
Ibaraki
Query!
Country [132]
0
0
Japan
Query!
State/province [132]
0
0
Kagawa
Query!
Country [133]
0
0
Japan
Query!
State/province [133]
0
0
Kanagawa
Query!
Country [134]
0
0
Japan
Query!
State/province [134]
0
0
Kumamoto
Query!
Country [135]
0
0
Japan
Query!
State/province [135]
0
0
Mie
Query!
Country [136]
0
0
Japan
Query!
State/province [136]
0
0
Miyagi
Query!
Country [137]
0
0
Japan
Query!
State/province [137]
0
0
Nagasaki
Query!
Country [138]
0
0
Japan
Query!
State/province [138]
0
0
Niigata
Query!
Country [139]
0
0
Japan
Query!
State/province [139]
0
0
Simane
Query!
Country [140]
0
0
Japan
Query!
State/province [140]
0
0
Tokyo
Query!
Country [141]
0
0
Japan
Query!
State/province [141]
0
0
Yamaguti
Query!
Country [142]
0
0
Japan
Query!
State/province [142]
0
0
Fukuoka-shi
Query!
Country [143]
0
0
Japan
Query!
State/province [143]
0
0
Hamamatsu-Shi
Query!
Country [144]
0
0
Japan
Query!
State/province [144]
0
0
Kita Kyushu-shi
Query!
Country [145]
0
0
Japan
Query!
State/province [145]
0
0
Matsue-shi
Query!
Country [146]
0
0
Japan
Query!
State/province [146]
0
0
Meguro-ku
Query!
Country [147]
0
0
Japan
Query!
State/province [147]
0
0
Toyonaka-shi
Query!
Country [148]
0
0
Korea, Republic of
Query!
State/province [148]
0
0
Gyeonggido
Query!
Country [149]
0
0
Korea, Republic of
Query!
State/province [149]
0
0
Seoul Teugbyeolsi
Query!
Country [150]
0
0
Korea, Republic of
Query!
State/province [150]
0
0
Incheon
Query!
Country [151]
0
0
Korea, Republic of
Query!
State/province [151]
0
0
Seoul
Query!
Country [152]
0
0
Latvia
Query!
State/province [152]
0
0
Daugavpils Aprinkis
Query!
Country [153]
0
0
Latvia
Query!
State/province [153]
0
0
Jurmala
Query!
Country [154]
0
0
Malaysia
Query!
State/province [154]
0
0
Pahang
Query!
Country [155]
0
0
Malaysia
Query!
State/province [155]
0
0
WilayahPersekutuan KualaLumpur
Query!
Country [156]
0
0
Malaysia
Query!
State/province [156]
0
0
Kota Bahru
Query!
Country [157]
0
0
Malaysia
Query!
State/province [157]
0
0
Kuala Lumpur
Query!
Country [158]
0
0
Mexico
Query!
State/province [158]
0
0
Jalisco
Query!
Country [159]
0
0
Mexico
Query!
State/province [159]
0
0
Nuevo León
Query!
Country [160]
0
0
Mexico
Query!
State/province [160]
0
0
Durango
Query!
Country [161]
0
0
Mexico
Query!
State/province [161]
0
0
Monterrey
Query!
Country [162]
0
0
Mexico
Query!
State/province [162]
0
0
Oaxaca
Query!
Country [163]
0
0
Netherlands
Query!
State/province [163]
0
0
Gelderland
Query!
Country [164]
0
0
Netherlands
Query!
State/province [164]
0
0
Noord-Holland
Query!
Country [165]
0
0
Netherlands
Query!
State/province [165]
0
0
Rotterdam
Query!
Country [166]
0
0
New Zealand
Query!
State/province [166]
0
0
Auckland
Query!
Country [167]
0
0
New Zealand
Query!
State/province [167]
0
0
Hawkes's Bay
Query!
Country [168]
0
0
New Zealand
Query!
State/province [168]
0
0
South Island
Query!
Country [169]
0
0
New Zealand
Query!
State/province [169]
0
0
Waikato
Query!
Country [170]
0
0
New Zealand
Query!
State/province [170]
0
0
Wellington
Query!
Country [171]
0
0
New Zealand
Query!
State/province [171]
0
0
Tauranga
Query!
Country [172]
0
0
Peru
Query!
State/province [172]
0
0
Chancay
Query!
Country [173]
0
0
Peru
Query!
State/province [173]
0
0
Lima
Query!
Country [174]
0
0
Peru
Query!
State/province [174]
0
0
Piura
Query!
Country [175]
0
0
Poland
Query!
State/province [175]
0
0
Swietokrzyskie
Query!
Country [176]
0
0
Poland
Query!
State/province [176]
0
0
Bialystok
Query!
Country [177]
0
0
Poland
Query!
State/province [177]
0
0
Bielsko Biala
Query!
Country [178]
0
0
Poland
Query!
State/province [178]
0
0
Katowice
Query!
Country [179]
0
0
Poland
Query!
State/province [179]
0
0
Kielce
Query!
Country [180]
0
0
Poland
Query!
State/province [180]
0
0
Krakow
Query!
Country [181]
0
0
Poland
Query!
State/province [181]
0
0
Ksawerow
Query!
Country [182]
0
0
Poland
Query!
State/province [182]
0
0
Rabka-Zdroj
Query!
Country [183]
0
0
Poland
Query!
State/province [183]
0
0
Rzeszów
Query!
Country [184]
0
0
Poland
Query!
State/province [184]
0
0
Siedlce
Query!
Country [185]
0
0
Poland
Query!
State/province [185]
0
0
Sosnowiec
Query!
Country [186]
0
0
Poland
Query!
State/province [186]
0
0
Sucha Beskidzka
Query!
Country [187]
0
0
Poland
Query!
State/province [187]
0
0
Szczecin
Query!
Country [188]
0
0
Poland
Query!
State/province [188]
0
0
Tarnow
Query!
Country [189]
0
0
Portugal
Query!
State/province [189]
0
0
Aveiro
Query!
Country [190]
0
0
Portugal
Query!
State/province [190]
0
0
Braga
Query!
Country [191]
0
0
Portugal
Query!
State/province [191]
0
0
Guarda
Query!
Country [192]
0
0
Portugal
Query!
State/province [192]
0
0
Guimaraes
Query!
Country [193]
0
0
Portugal
Query!
State/province [193]
0
0
Lisboa
Query!
Country [194]
0
0
Serbia
Query!
State/province [194]
0
0
Belgrade
Query!
Country [195]
0
0
Serbia
Query!
State/province [195]
0
0
Nis
Query!
Country [196]
0
0
Serbia
Query!
State/province [196]
0
0
Sombor
Query!
Country [197]
0
0
Serbia
Query!
State/province [197]
0
0
Uzice
Query!
Country [198]
0
0
Slovakia
Query!
State/province [198]
0
0
Bardejov
Query!
Country [199]
0
0
Slovakia
Query!
State/province [199]
0
0
Spisská Nová Ves
Query!
Country [200]
0
0
Spain
Query!
State/province [200]
0
0
A Coruña
Query!
Country [201]
0
0
Spain
Query!
State/province [201]
0
0
Asturias
Query!
Country [202]
0
0
Spain
Query!
State/province [202]
0
0
Barcelona
Query!
Country [203]
0
0
Spain
Query!
State/province [203]
0
0
Cantabria
Query!
Country [204]
0
0
Spain
Query!
State/province [204]
0
0
Madrid
Query!
Country [205]
0
0
Spain
Query!
State/province [205]
0
0
Navarra
Query!
Country [206]
0
0
Spain
Query!
State/province [206]
0
0
Girona
Query!
Country [207]
0
0
Spain
Query!
State/province [207]
0
0
L´Hospitalet de Llobregat
Query!
Country [208]
0
0
Taiwan
Query!
State/province [208]
0
0
Kaohsiung City
Query!
Country [209]
0
0
Taiwan
Query!
State/province [209]
0
0
Kaohsiung
Query!
Country [210]
0
0
Taiwan
Query!
State/province [210]
0
0
New Taipei City
Query!
Country [211]
0
0
Taiwan
Query!
State/province [211]
0
0
Taipei City
Query!
Country [212]
0
0
Taiwan
Query!
State/province [212]
0
0
Taipei
Query!
Country [213]
0
0
Thailand
Query!
State/province [213]
0
0
Nakhon Nayok
Query!
Country [214]
0
0
Thailand
Query!
State/province [214]
0
0
Nonthaburi
Query!
Country [215]
0
0
Thailand
Query!
State/province [215]
0
0
Khon Kaen
Query!
Country [216]
0
0
Turkey
Query!
State/province [216]
0
0
Samsun
Query!
Country [217]
0
0
Turkey
Query!
State/province [217]
0
0
Ankara
Query!
Country [218]
0
0
Turkey
Query!
State/province [218]
0
0
Canakkale
Query!
Country [219]
0
0
Turkey
Query!
State/province [219]
0
0
Izmir
Query!
Country [220]
0
0
Turkey
Query!
State/province [220]
0
0
Kocaeli
Query!
Country [221]
0
0
Turkey
Query!
State/province [221]
0
0
Konya
Query!
Country [222]
0
0
Turkey
Query!
State/province [222]
0
0
Mersin
Query!
Country [223]
0
0
Ukraine
Query!
State/province [223]
0
0
Kharkivs'ka Oblast
Query!
Country [224]
0
0
Ukraine
Query!
State/province [224]
0
0
Khersons'ka Oblast
Query!
Country [225]
0
0
Ukraine
Query!
State/province [225]
0
0
Poltavs'ka Oblast
Query!
Country [226]
0
0
Ukraine
Query!
State/province [226]
0
0
Dnipro
Query!
Country [227]
0
0
Ukraine
Query!
State/province [227]
0
0
Ivano-Frankivsk
Query!
Country [228]
0
0
Ukraine
Query!
State/province [228]
0
0
Kyiv
Query!
Country [229]
0
0
Ukraine
Query!
State/province [229]
0
0
Odesa
Query!
Country [230]
0
0
Ukraine
Query!
State/province [230]
0
0
Vinnytsia
Query!
Country [231]
0
0
United Kingdom
Query!
State/province [231]
0
0
Cambridgeshire
Query!
Country [232]
0
0
United Kingdom
Query!
State/province [232]
0
0
Devon
Query!
Country [233]
0
0
United Kingdom
Query!
State/province [233]
0
0
Norfolk
Query!
Country [234]
0
0
United Kingdom
Query!
State/province [234]
0
0
Vale Of Glamorgan, The
Query!
Country [235]
0
0
United Kingdom
Query!
State/province [235]
0
0
Yorkshire
Query!
Country [236]
0
0
United Kingdom
Query!
State/province [236]
0
0
Birmingham
Query!
Country [237]
0
0
United Kingdom
Query!
State/province [237]
0
0
Chertsey
Query!
Country [238]
0
0
United Kingdom
Query!
State/province [238]
0
0
Dundee
Query!
Country [239]
0
0
United Kingdom
Query!
State/province [239]
0
0
Liverpool
Query!
Country [240]
0
0
United Kingdom
Query!
State/province [240]
0
0
London
Query!
Country [241]
0
0
United Kingdom
Query!
State/province [241]
0
0
Manchester
Query!
Country [242]
0
0
United Kingdom
Query!
State/province [242]
0
0
Newcastle upon Tyne
Query!
Country [243]
0
0
United Kingdom
Query!
State/province [243]
0
0
Salford
Query!
Country [244]
0
0
United Kingdom
Query!
State/province [244]
0
0
Southampton
Query!
Country [245]
0
0
United Kingdom
Query!
State/province [245]
0
0
Swansea
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Insmed Incorporated
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The primary objective of this study is to evaluate the effect of brensocatib at 10 mg and 25
mg compared with placebo on the rate of pulmonary exacerbations (PEs) over the 52-week
treatment period.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT04594369
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04594369
Download to PDF