Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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/NCT04594369




Registration number
NCT04594369
Ethics application status
Date submitted
14/10/2020
Date registered
20/10/2020

Titles & IDs
Public title
A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis
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
Secondary ID [1] 0 0
2020-003688-25
Secondary ID [2] 0 0
INS1007-301
Universal Trial Number (UTN)
Trial acronym
ASPEN
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(has expanded access)
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Rate of Adjudicated Pulmonary Exacerbations (PEs)
Timepoint [1] 0 0
52 Weeks
Secondary outcome [1] 0 0
Time to First Adjudicated Pulmonary Exacerbation (PE)
Timepoint [1] 0 0
52 Weeks
Secondary outcome [2] 0 0
Percentage of Participants who are Pulmonary Exacerbation (PE) Free
Timepoint [2] 0 0
52 Weeks
Secondary outcome [3] 0 0
Change From Baseline in Postbronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Timepoint [3] 0 0
Baseline, at Week 52
Secondary outcome [4] 0 0
Rate of Severe Adjudicated Pulmonary Exacerbations (PEs)
Timepoint [4] 0 0
52 Weeks
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
Timepoint [5] 0 0
Baseline to Week 52
Secondary outcome [6] 0 0
Number of Participants who Experience at Least one Treatment-Emergent Adverse Events (TEAEs)
Timepoint [6] 0 0
56 Weeks
Secondary outcome [7] 0 0
Plasma Concentration of Brensocatib at Select Time Points
Timepoint [7] 0 0
Pre-dose and post-dose at multiple time points up to Week 52

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.
Minimum age
12 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
1/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/10/2024
Sample size
Target
Accrual to date
Final
1767
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
AUS013 - Kogarah
Recruitment hospital [2] 0 0
AUS008 - New Lambton Heights
Recruitment hospital [3] 0 0
AUS007 - Westmead
Recruitment hospital [4] 0 0
AUS012 - Cairns North
Recruitment hospital [5] 0 0
AUS001 - Chermside
Recruitment hospital [6] 0 0
AUS010 - Greenslopes
Recruitment hospital [7] 0 0
AUS006 - South Brisbane
Recruitment hospital [8] 0 0
AUS019 - South Brisbane
Recruitment hospital [9] 0 0
AUS011 - Adelaide
Recruitment hospital [10] 0 0
AUS017 - Bedford Park
Recruitment hospital [11] 0 0
AUS022 - North Adelaide
Recruitment hospital [12] 0 0
AUS009 - Woodville South
Recruitment hospital [13] 0 0
AUS002 - Box Hill
Recruitment hospital [14] 0 0
AUS014 - Clayton
Recruitment hospital [15] 0 0
AUS018 - Murdoch
Recruitment hospital [16] 0 0
AUS005 - Nedlands
Recruitment hospital [17] 0 0
AUS003 - Concord
Recruitment hospital [18] 0 0
AUS015 - Spearwood
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4870 - Cairns North
Recruitment postcode(s) [5] 0 0
4032 - Chermside
Recruitment postcode(s) [6] 0 0
4120 - Greenslopes
Recruitment postcode(s) [7] 0 0
4101 - South Brisbane
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
5042 - Bedford Park
Recruitment postcode(s) [10] 0 0
5006 - North Adelaide
Recruitment postcode(s) [11] 0 0
5011 - Woodville South
Recruitment postcode(s) [12] 0 0
3128 - Box Hill
Recruitment postcode(s) [13] 0 0
3168 - Clayton
Recruitment postcode(s) [14] 0 0
6150 - Murdoch
Recruitment postcode(s) [15] 0 0
6009 - Nedlands
Recruitment postcode(s) [16] 0 0
NSW 2139 - Concord
Recruitment postcode(s) [17] 0 0
6163 - Spearwood
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
Arkansas
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
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Iowa
Country [12] 0 0
United States of America
State/province [12] 0 0
Kansas
Country [13] 0 0
United States of America
State/province [13] 0 0
Louisiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Massachusetts
Country [16] 0 0
United States of America
State/province [16] 0 0
Minnesota
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
Country [18] 0 0
United States of America
State/province [18] 0 0
Nebraska
Country [19] 0 0
United States of America
State/province [19] 0 0
New Jersey
Country [20] 0 0
United States of America
State/province [20] 0 0
New York
Country [21] 0 0
United States of America
State/province [21] 0 0
North Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Ohio
Country [23] 0 0
United States of America
State/province [23] 0 0
Oregon
Country [24] 0 0
United States of America
State/province [24] 0 0
Pennsylvania
Country [25] 0 0
United States of America
State/province [25] 0 0
South Carolina
Country [26] 0 0
United States of America
State/province [26] 0 0
Tennessee
Country [27] 0 0
United States of America
State/province [27] 0 0
Texas
Country [28] 0 0
United States of America
State/province [28] 0 0
Virginia
Country [29] 0 0
United States of America
State/province [29] 0 0
Washington
Country [30] 0 0
Argentina
State/province [30] 0 0
Buenos Aires
Country [31] 0 0
Argentina
State/province [31] 0 0
Ciudad Autónoma De BuenosAires
Country [32] 0 0
Argentina
State/province [32] 0 0
Córdoba
Country [33] 0 0
Argentina
State/province [33] 0 0
Mendoza
Country [34] 0 0
Argentina
State/province [34] 0 0
Santa Fe
Country [35] 0 0
Argentina
State/province [35] 0 0
Tucumán
Country [36] 0 0
Argentina
State/province [36] 0 0
Rosario
Country [37] 0 0
Austria
State/province [37] 0 0
Linz
Country [38] 0 0
Belgium
State/province [38] 0 0
Oost-Vlaanderen
Country [39] 0 0
Belgium
State/province [39] 0 0
West-Vlaanderen
Country [40] 0 0
Belgium
State/province [40] 0 0
Leuven
Country [41] 0 0
Belgium
State/province [41] 0 0
Liège
Country [42] 0 0
Belgium
State/province [42] 0 0
Mechelen
Country [43] 0 0
Belgium
State/province [43] 0 0
Sint-Niklaas
Country [44] 0 0
Brazil
State/province [44] 0 0
Rio Grande Do Sul
Country [45] 0 0
Brazil
State/province [45] 0 0
Santa Catarina
Country [46] 0 0
Brazil
State/province [46] 0 0
São Paulo
Country [47] 0 0
Brazil
State/province [47] 0 0
Botucatu
Country [48] 0 0
Brazil
State/province [48] 0 0
São Bernardo do Campo
Country [49] 0 0
Bulgaria
State/province [49] 0 0
Sofia-Grad
Country [50] 0 0
Bulgaria
State/province [50] 0 0
Blagoevgrad
Country [51] 0 0
Bulgaria
State/province [51] 0 0
Gabrovo
Country [52] 0 0
Bulgaria
State/province [52] 0 0
Kozloduy
Country [53] 0 0
Bulgaria
State/province [53] 0 0
Lovech
Country [54] 0 0
Bulgaria
State/province [54] 0 0
Montana
Country [55] 0 0
Bulgaria
State/province [55] 0 0
Pazardzhik
Country [56] 0 0
Bulgaria
State/province [56] 0 0
Pleven
Country [57] 0 0
Bulgaria
State/province [57] 0 0
Plovdiv
Country [58] 0 0
Bulgaria
State/province [58] 0 0
Ruse
Country [59] 0 0
Bulgaria
State/province [59] 0 0
Sliven
Country [60] 0 0
Bulgaria
State/province [60] 0 0
Sofia
Country [61] 0 0
Bulgaria
State/province [61] 0 0
Veliko Tarnovo
Country [62] 0 0
Bulgaria
State/province [62] 0 0
Vidin
Country [63] 0 0
Bulgaria
State/province [63] 0 0
Vratsa
Country [64] 0 0
Canada
State/province [64] 0 0
Ontario
Country [65] 0 0
Canada
State/province [65] 0 0
Quebec
Country [66] 0 0
Chile
State/province [66] 0 0
Los Ríos
Country [67] 0 0
Chile
State/province [67] 0 0
Maule
Country [68] 0 0
Chile
State/province [68] 0 0
Región-MetropolitanadeSantiago
Country [69] 0 0
Chile
State/province [69] 0 0
Quillota
Country [70] 0 0
Colombia
State/province [70] 0 0
Cundinamarca
Country [71] 0 0
Colombia
State/province [71] 0 0
Distrito Capital De Bogotá
Country [72] 0 0
Colombia
State/province [72] 0 0
Santander
Country [73] 0 0
Colombia
State/province [73] 0 0
Valle Del Cauca
Country [74] 0 0
Colombia
State/province [74] 0 0
Bogota DC
Country [75] 0 0
Colombia
State/province [75] 0 0
Santiago de Cali
Country [76] 0 0
Denmark
State/province [76] 0 0
Capital
Country [77] 0 0
Denmark
State/province [77] 0 0
South Denmark
Country [78] 0 0
Denmark
State/province [78] 0 0
Aalborg
Country [79] 0 0
Denmark
State/province [79] 0 0
Aarhus
Country [80] 0 0
Denmark
State/province [80] 0 0
Hellerup
Country [81] 0 0
Denmark
State/province [81] 0 0
Roskilde
Country [82] 0 0
France
State/province [82] 0 0
Bas-Rhin
Country [83] 0 0
France
State/province [83] 0 0
Hérault
Country [84] 0 0
France
State/province [84] 0 0
Amiens cedex 1
Country [85] 0 0
France
State/province [85] 0 0
Creteil
Country [86] 0 0
France
State/province [86] 0 0
Nantes
Country [87] 0 0
France
State/province [87] 0 0
Nice
Country [88] 0 0
France
State/province [88] 0 0
Paris
Country [89] 0 0
France
State/province [89] 0 0
Toulouse
Country [90] 0 0
Germany
State/province [90] 0 0
Baden-Württemberg
Country [91] 0 0
Germany
State/province [91] 0 0
Bayern
Country [92] 0 0
Germany
State/province [92] 0 0
Brandenburg
Country [93] 0 0
Germany
State/province [93] 0 0
Hessen
Country [94] 0 0
Germany
State/province [94] 0 0
Niedersachsen
Country [95] 0 0
Germany
State/province [95] 0 0
Nordrhein-Westfalen
Country [96] 0 0
Germany
State/province [96] 0 0
Sachsen-Anhalt
Country [97] 0 0
Germany
State/province [97] 0 0
Sachsen
Country [98] 0 0
Germany
State/province [98] 0 0
Schleswig-Holstein
Country [99] 0 0
Germany
State/province [99] 0 0
Berlin
Country [100] 0 0
Germany
State/province [100] 0 0
Dresden
Country [101] 0 0
Germany
State/province [101] 0 0
Frankfurt
Country [102] 0 0
Germany
State/province [102] 0 0
Hannover
Country [103] 0 0
Germany
State/province [103] 0 0
Mainz
Country [104] 0 0
Germany
State/province [104] 0 0
Muenster
Country [105] 0 0
Greece
State/province [105] 0 0
Evros
Country [106] 0 0
Greece
State/province [106] 0 0
Herakleion
Country [107] 0 0
Greece
State/province [107] 0 0
Thessaloniki
Country [108] 0 0
Hungary
State/province [108] 0 0
Komárom-Esztergom
Country [109] 0 0
Ireland
State/province [109] 0 0
Dublin
Country [110] 0 0
Ireland
State/province [110] 0 0
Limerick
Country [111] 0 0
Israel
State/province [111] 0 0
Ashkelon
Country [112] 0 0
Israel
State/province [112] 0 0
Beer Sheva
Country [113] 0 0
Israel
State/province [113] 0 0
Haifa
Country [114] 0 0
Israel
State/province [114] 0 0
Jerusalem
Country [115] 0 0
Israel
State/province [115] 0 0
Kefar-Sava
Country [116] 0 0
Israel
State/province [116] 0 0
Petach Tikva
Country [117] 0 0
Israel
State/province [117] 0 0
Ramat Gan
Country [118] 0 0
Israel
State/province [118] 0 0
Rehovot
Country [119] 0 0
Israel
State/province [119] 0 0
Zerifin
Country [120] 0 0
Italy
State/province [120] 0 0
Emilia-Romagna
Country [121] 0 0
Italy
State/province [121] 0 0
Lombardia
Country [122] 0 0
Italy
State/province [122] 0 0
Toscana
Country [123] 0 0
Italy
State/province [123] 0 0
Milano
Country [124] 0 0
Italy
State/province [124] 0 0
Palermo
Country [125] 0 0
Italy
State/province [125] 0 0
Pavia
Country [126] 0 0
Italy
State/province [126] 0 0
Roma
Country [127] 0 0
Japan
State/province [127] 0 0
Aiti
Country [128] 0 0
Japan
State/province [128] 0 0
Ehime
Country [129] 0 0
Japan
State/province [129] 0 0
Hukuoka
Country [130] 0 0
Japan
State/province [130] 0 0
Hyôgo
Country [131] 0 0
Japan
State/province [131] 0 0
Ibaraki
Country [132] 0 0
Japan
State/province [132] 0 0
Kagawa
Country [133] 0 0
Japan
State/province [133] 0 0
Kanagawa
Country [134] 0 0
Japan
State/province [134] 0 0
Kumamoto
Country [135] 0 0
Japan
State/province [135] 0 0
Mie
Country [136] 0 0
Japan
State/province [136] 0 0
Miyagi
Country [137] 0 0
Japan
State/province [137] 0 0
Nagasaki
Country [138] 0 0
Japan
State/province [138] 0 0
Niigata
Country [139] 0 0
Japan
State/province [139] 0 0
Simane
Country [140] 0 0
Japan
State/province [140] 0 0
Tokyo
Country [141] 0 0
Japan
State/province [141] 0 0
Yamaguti
Country [142] 0 0
Japan
State/province [142] 0 0
Fukuoka-shi
Country [143] 0 0
Japan
State/province [143] 0 0
Hamamatsu-Shi
Country [144] 0 0
Japan
State/province [144] 0 0
Kita Kyushu-shi
Country [145] 0 0
Japan
State/province [145] 0 0
Matsue-shi
Country [146] 0 0
Japan
State/province [146] 0 0
Meguro-ku
Country [147] 0 0
Japan
State/province [147] 0 0
Toyonaka-shi
Country [148] 0 0
Korea, Republic of
State/province [148] 0 0
Gyeonggido
Country [149] 0 0
Korea, Republic of
State/province [149] 0 0
Seoul Teugbyeolsi
Country [150] 0 0
Korea, Republic of
State/province [150] 0 0
Incheon
Country [151] 0 0
Korea, Republic of
State/province [151] 0 0
Seoul
Country [152] 0 0
Latvia
State/province [152] 0 0
Daugavpils Aprinkis
Country [153] 0 0
Latvia
State/province [153] 0 0
Jurmala
Country [154] 0 0
Malaysia
State/province [154] 0 0
Pahang
Country [155] 0 0
Malaysia
State/province [155] 0 0
WilayahPersekutuan KualaLumpur
Country [156] 0 0
Malaysia
State/province [156] 0 0
Kota Bahru
Country [157] 0 0
Malaysia
State/province [157] 0 0
Kuala Lumpur
Country [158] 0 0
Mexico
State/province [158] 0 0
Jalisco
Country [159] 0 0
Mexico
State/province [159] 0 0
Nuevo León
Country [160] 0 0
Mexico
State/province [160] 0 0
Durango
Country [161] 0 0
Mexico
State/province [161] 0 0
Monterrey
Country [162] 0 0
Mexico
State/province [162] 0 0
Oaxaca
Country [163] 0 0
Netherlands
State/province [163] 0 0
Gelderland
Country [164] 0 0
Netherlands
State/province [164] 0 0
Noord-Holland
Country [165] 0 0
Netherlands
State/province [165] 0 0
Rotterdam
Country [166] 0 0
New Zealand
State/province [166] 0 0
Auckland
Country [167] 0 0
New Zealand
State/province [167] 0 0
Hawkes's Bay
Country [168] 0 0
New Zealand
State/province [168] 0 0
South Island
Country [169] 0 0
New Zealand
State/province [169] 0 0
Waikato
Country [170] 0 0
New Zealand
State/province [170] 0 0
Wellington
Country [171] 0 0
New Zealand
State/province [171] 0 0
Tauranga
Country [172] 0 0
Peru
State/province [172] 0 0
Chancay
Country [173] 0 0
Peru
State/province [173] 0 0
Lima
Country [174] 0 0
Peru
State/province [174] 0 0
Piura
Country [175] 0 0
Poland
State/province [175] 0 0
Swietokrzyskie
Country [176] 0 0
Poland
State/province [176] 0 0
Bialystok
Country [177] 0 0
Poland
State/province [177] 0 0
Bielsko Biala
Country [178] 0 0
Poland
State/province [178] 0 0
Katowice
Country [179] 0 0
Poland
State/province [179] 0 0
Kielce
Country [180] 0 0
Poland
State/province [180] 0 0
Krakow
Country [181] 0 0
Poland
State/province [181] 0 0
Ksawerow
Country [182] 0 0
Poland
State/province [182] 0 0
Rabka-Zdroj
Country [183] 0 0
Poland
State/province [183] 0 0
Rzeszów
Country [184] 0 0
Poland
State/province [184] 0 0
Siedlce
Country [185] 0 0
Poland
State/province [185] 0 0
Sosnowiec
Country [186] 0 0
Poland
State/province [186] 0 0
Sucha Beskidzka
Country [187] 0 0
Poland
State/province [187] 0 0
Szczecin
Country [188] 0 0
Poland
State/province [188] 0 0
Tarnow
Country [189] 0 0
Portugal
State/province [189] 0 0
Aveiro
Country [190] 0 0
Portugal
State/province [190] 0 0
Braga
Country [191] 0 0
Portugal
State/province [191] 0 0
Guarda
Country [192] 0 0
Portugal
State/province [192] 0 0
Guimaraes
Country [193] 0 0
Portugal
State/province [193] 0 0
Lisboa
Country [194] 0 0
Serbia
State/province [194] 0 0
Belgrade
Country [195] 0 0
Serbia
State/province [195] 0 0
Nis
Country [196] 0 0
Serbia
State/province [196] 0 0
Sombor
Country [197] 0 0
Serbia
State/province [197] 0 0
Uzice
Country [198] 0 0
Slovakia
State/province [198] 0 0
Bardejov
Country [199] 0 0
Slovakia
State/province [199] 0 0
Spisská Nová Ves
Country [200] 0 0
Spain
State/province [200] 0 0
A Coruña
Country [201] 0 0
Spain
State/province [201] 0 0
Asturias
Country [202] 0 0
Spain
State/province [202] 0 0
Barcelona
Country [203] 0 0
Spain
State/province [203] 0 0
Cantabria
Country [204] 0 0
Spain
State/province [204] 0 0
Madrid
Country [205] 0 0
Spain
State/province [205] 0 0
Navarra
Country [206] 0 0
Spain
State/province [206] 0 0
Girona
Country [207] 0 0
Spain
State/province [207] 0 0
L´Hospitalet de Llobregat
Country [208] 0 0
Taiwan
State/province [208] 0 0
Kaohsiung City
Country [209] 0 0
Taiwan
State/province [209] 0 0
Kaohsiung
Country [210] 0 0
Taiwan
State/province [210] 0 0
New Taipei City
Country [211] 0 0
Taiwan
State/province [211] 0 0
Taipei City
Country [212] 0 0
Taiwan
State/province [212] 0 0
Taipei
Country [213] 0 0
Thailand
State/province [213] 0 0
Nakhon Nayok
Country [214] 0 0
Thailand
State/province [214] 0 0
Nonthaburi
Country [215] 0 0
Thailand
State/province [215] 0 0
Khon Kaen
Country [216] 0 0
Turkey
State/province [216] 0 0
Samsun
Country [217] 0 0
Turkey
State/province [217] 0 0
Ankara
Country [218] 0 0
Turkey
State/province [218] 0 0
Canakkale
Country [219] 0 0
Turkey
State/province [219] 0 0
Izmir
Country [220] 0 0
Turkey
State/province [220] 0 0
Kocaeli
Country [221] 0 0
Turkey
State/province [221] 0 0
Konya
Country [222] 0 0
Turkey
State/province [222] 0 0
Mersin
Country [223] 0 0
Ukraine
State/province [223] 0 0
Kharkivs'ka Oblast
Country [224] 0 0
Ukraine
State/province [224] 0 0
Khersons'ka Oblast
Country [225] 0 0
Ukraine
State/province [225] 0 0
Poltavs'ka Oblast
Country [226] 0 0
Ukraine
State/province [226] 0 0
Dnipro
Country [227] 0 0
Ukraine
State/province [227] 0 0
Ivano-Frankivsk
Country [228] 0 0
Ukraine
State/province [228] 0 0
Kyiv
Country [229] 0 0
Ukraine
State/province [229] 0 0
Odesa
Country [230] 0 0
Ukraine
State/province [230] 0 0
Vinnytsia
Country [231] 0 0
United Kingdom
State/province [231] 0 0
Cambridgeshire
Country [232] 0 0
United Kingdom
State/province [232] 0 0
Devon
Country [233] 0 0
United Kingdom
State/province [233] 0 0
Norfolk
Country [234] 0 0
United Kingdom
State/province [234] 0 0
Vale Of Glamorgan, The
Country [235] 0 0
United Kingdom
State/province [235] 0 0
Yorkshire
Country [236] 0 0
United Kingdom
State/province [236] 0 0
Birmingham
Country [237] 0 0
United Kingdom
State/province [237] 0 0
Chertsey
Country [238] 0 0
United Kingdom
State/province [238] 0 0
Dundee
Country [239] 0 0
United Kingdom
State/province [239] 0 0
Liverpool
Country [240] 0 0
United Kingdom
State/province [240] 0 0
London
Country [241] 0 0
United Kingdom
State/province [241] 0 0
Manchester
Country [242] 0 0
United Kingdom
State/province [242] 0 0
Newcastle upon Tyne
Country [243] 0 0
United Kingdom
State/province [243] 0 0
Salford
Country [244] 0 0
United Kingdom
State/province [244] 0 0
Southampton
Country [245] 0 0
United Kingdom
State/province [245] 0 0
Swansea

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
Address 0 0
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?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04594369