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/NCT06283966




Registration number
NCT06283966
Ethics application status
Date submitted
21/02/2024
Date registered
28/02/2024

Titles & IDs
Public title
A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease
Scientific title
A Randomized, Double-blind, Parallel Group, Multi-center, Phase III Study to Assess the Efficacy of Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhaler Relative to Glycopyrronium and Formoterol Fumarate MDI on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease (THARROS)
Secondary ID [1] 0 0
D5989C00001
Universal Trial Number (UTN)
Trial acronym
THARROS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COPD (Chronic Obstructive Pulmonary Disease) 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BGF MDI 320/14.4/9.6 µg
Treatment: Drugs - GFF MDI 14.4/9.6 µg

Experimental: BGF arm - BGF MDI 320/14.4/9.6 µg BID

Experimental: GFF arm - GFF MDI 14.4/9.6 µg BID


Treatment: Drugs: BGF MDI 320/14.4/9.6 µg
Budesonide, glycopyrronium, and formoterol fumarate pressurized inhalation suspension

Treatment: Drugs: GFF MDI 14.4/9.6 µg
Glycopyrronium and formoterol fumarate pressurized inhalation suspension
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to first severe cardiac or COPD event
Timepoint [1] 0 0
Up to 3 years
Secondary outcome [1] 0 0
Time to first severe COPD exacerbation event
Timepoint [1] 0 0
Up to 3 years
Secondary outcome [2] 0 0
Time to first severe cardiac event
Timepoint [2] 0 0
Up to 3 years
Secondary outcome [3] 0 0
Time to cardiopulmonary death
Timepoint [3] 0 0
Up to 3 years
Secondary outcome [4] 0 0
Moderate/severe COPD exacerbation rate
Timepoint [4] 0 0
Over time, up 3 years
Secondary outcome [5] 0 0
Time to Myocardial Infarction (MI) hospitalization or cardiac death
Timepoint [5] 0 0
Up to 3 years
Secondary outcome [6] 0 0
Time to Heart Failure (HF) acute healthcare visit/hospitalization or cardiac death
Timepoint [6] 0 0
Up to 3 years

Eligibility
Key inclusion criteria
1. Male or female participants must be 40 to 80 years of age inclusive, at the time of signing

the ICF.
2. Demonstrate acceptable MDI administration technique at Visit 1 (V1) and Visit 2 (V2)
3. A diagnosis of COPD confirmed by a post-bronchodilator FEV1/FVC ratio < 70%

at V1.
4. Current or former smokers with a history of at least 10 pack-years of cigarette smoking;

defined as (number of cigarettes per day/20) x number of years smoked. Previous smokers are defined as those who have stopped smoking for at least 6

months prior to V1.
5. A baseline peripheral blood eosinophil count of = 100 cells/mm3 assessed at Visit 1 by

the central laboratory
6. A CAT score of = 10 at Visit 1.
7. Participant must fulfill at least 1 of the 4 CV disease/risk factor criteria below [(a), (b),

(c), or (d)]:
1. : Established CV Disease
2. : Combination of CV risk factors:

* Hypertension
* Diabetes Mellitus
* Chronic Kidney Disease
* Dyslipidemia
* Obesity
3. : High risk of CV disease determined using an established CV risk assessment

tool.
4. : CT coronary Artery Calcification
8. Willing and, in the opinion of the investigator, able to adjust current COPD therapy, as

required by the protocol.
9. Willing to visit at the study site or participate in virtual visits as required per the protocol

to complete all study assessments.
10. A female is eligible to enter and participate in the study if the female is of:

* Non-childbearing potential: either permanently sterilized or who are post-menopausal.
* Childbearing potential: has a negative serum pregnancy test at V1 and must use one

highly effective form of birth control.
11. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Active diagnosis of asthma within the past 5 years (previous diagnosis as a child or adolescent are eligible), asthma-COPD overlap, or any other chronic respiratory disease other than COPD such as alpha-1 antitrypsin deficiency, active tuberculosis, lung fibrosis, sarcoidosis, interstitial lung disease, and pulmonary hypertension.
2. End-stage renal disease requiring renal replacement therapy
3. History of heart or lung transplant or actively listed for heart or lung transplant.
4. Implanted left ventricular assist device or implant anticipated in < 3 months.
5. History of lung cancer and/or treatment for lung cancer within the 5 years prior to Visit 1.
6. Unstable or life-threatening cardiac disease - participants with any of the following at Visit 1 would be excluded:

1. An MI or unstable angina in the last 8 weeks
2. Unstable or life-threatening cardiac arrhythmia requiring intervention in the last 8 weeks.

NOTE: Any participant who experiences unstable or life-threatening cardiac disease during the run-in period will be excluded but can be rescreened 8 weeks after the resolution of the event.
7. Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 8 weeks prior to Visit 1
8. Any life-threatening condition, including malignancy, with a life expectancy < 5 years, other than CV disease or COPD, that might prevent the participant from completing the study.
9. Use of maintenance ICS treatment within the past 12 months.
10. Unable to abstain from protocol-defined prohibited medications
11. Participation in another clinical study with a study intervention administered in the last 30 days or 5 half-lives, whichever is longer prior to Visit 1 (any other investigational product that is not identified in protocol is prohibited for use during the duration of the study).
12. Participants with a known hypersensitivity to LAMA, LABA or ICS or any component of the MDI.
13. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
14. Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
15. Previous randomization in the present study.
16. For females only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding

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 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/02/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
3/03/2028
Actual
Sample size
Target
5000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Cairns
Recruitment hospital [2] 0 0
Research Site - Chermside
Recruitment hospital [3] 0 0
Research Site - Coffs Harbour
Recruitment hospital [4] 0 0
Research Site - Spearwood
Recruitment hospital [5] 0 0
Research Site - St Albans
Recruitment hospital [6] 0 0
Research Site - Taringa
Recruitment postcode(s) [1] 0 0
4870 - Cairns
Recruitment postcode(s) [2] 0 0
4032 - Chermside
Recruitment postcode(s) [3] 0 0
02450 - Coffs Harbour
Recruitment postcode(s) [4] 0 0
6163 - Spearwood
Recruitment postcode(s) [5] 0 0
3021 - St Albans
Recruitment postcode(s) [6] 0 0
4068 - Taringa
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
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Idaho
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
Kansas
Country [12] 0 0
United States of America
State/province [12] 0 0
Kentucky
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
Michigan
Country [17] 0 0
United States of America
State/province [17] 0 0
Mississippi
Country [18] 0 0
United States of America
State/province [18] 0 0
Missouri
Country [19] 0 0
United States of America
State/province [19] 0 0
Montana
Country [20] 0 0
United States of America
State/province [20] 0 0
Nebraska
Country [21] 0 0
United States of America
State/province [21] 0 0
Nevada
Country [22] 0 0
United States of America
State/province [22] 0 0
New Jersey
Country [23] 0 0
United States of America
State/province [23] 0 0
New Mexico
Country [24] 0 0
United States of America
State/province [24] 0 0
New York
Country [25] 0 0
United States of America
State/province [25] 0 0
North Carolina
Country [26] 0 0
United States of America
State/province [26] 0 0
Ohio
Country [27] 0 0
United States of America
State/province [27] 0 0
Oklahoma
Country [28] 0 0
United States of America
State/province [28] 0 0
Oregon
Country [29] 0 0
United States of America
State/province [29] 0 0
Pennsylvania
Country [30] 0 0
United States of America
State/province [30] 0 0
South Carolina
Country [31] 0 0
United States of America
State/province [31] 0 0
South Dakota
Country [32] 0 0
United States of America
State/province [32] 0 0
Tennessee
Country [33] 0 0
United States of America
State/province [33] 0 0
Texas
Country [34] 0 0
United States of America
State/province [34] 0 0
Utah
Country [35] 0 0
United States of America
State/province [35] 0 0
Virginia
Country [36] 0 0
United States of America
State/province [36] 0 0
Washington
Country [37] 0 0
United States of America
State/province [37] 0 0
West Virginia
Country [38] 0 0
United States of America
State/province [38] 0 0
Wisconsin
Country [39] 0 0
Argentina
State/province [39] 0 0
Buenos Aires
Country [40] 0 0
Argentina
State/province [40] 0 0
Caba
Country [41] 0 0
Argentina
State/province [41] 0 0
Capital Federal
Country [42] 0 0
Argentina
State/province [42] 0 0
Ciudad Autónomas De Buenos Aires
Country [43] 0 0
Argentina
State/province [43] 0 0
Florencio Varela
Country [44] 0 0
Argentina
State/province [44] 0 0
Florida
Country [45] 0 0
Argentina
State/province [45] 0 0
Mar del Plata
Country [46] 0 0
Argentina
State/province [46] 0 0
Mendoza
Country [47] 0 0
Argentina
State/province [47] 0 0
Ranelagh
Country [48] 0 0
Argentina
State/province [48] 0 0
Rosario
Country [49] 0 0
Argentina
State/province [49] 0 0
San Fernando
Country [50] 0 0
Argentina
State/province [50] 0 0
San Miguel de Tucumán
Country [51] 0 0
Austria
State/province [51] 0 0
Bad Ischl
Country [52] 0 0
Austria
State/province [52] 0 0
Braunau
Country [53] 0 0
Austria
State/province [53] 0 0
Feldbach
Country [54] 0 0
Austria
State/province [54] 0 0
Wien
Country [55] 0 0
Brazil
State/province [55] 0 0
Belo Horizonte
Country [56] 0 0
Brazil
State/province [56] 0 0
Blumenau
Country [57] 0 0
Brazil
State/province [57] 0 0
Brasilia
Country [58] 0 0
Brazil
State/province [58] 0 0
Campina Grande do Sul
Country [59] 0 0
Brazil
State/province [59] 0 0
Campinas
Country [60] 0 0
Brazil
State/province [60] 0 0
Caxias do Sul
Country [61] 0 0
Brazil
State/province [61] 0 0
Curitiba
Country [62] 0 0
Brazil
State/province [62] 0 0
Ijui
Country [63] 0 0
Brazil
State/province [63] 0 0
Juiz de Fora
Country [64] 0 0
Brazil
State/province [64] 0 0
Natal
Country [65] 0 0
Brazil
State/province [65] 0 0
Niterói
Country [66] 0 0
Brazil
State/province [66] 0 0
Porto Alegre
Country [67] 0 0
Brazil
State/province [67] 0 0
Recife
Country [68] 0 0
Brazil
State/province [68] 0 0
Rio de Janeiro
Country [69] 0 0
Brazil
State/province [69] 0 0
Salvador
Country [70] 0 0
Brazil
State/province [70] 0 0
Santo Andre
Country [71] 0 0
Brazil
State/province [71] 0 0
Sao Bernardo do Campo
Country [72] 0 0
Brazil
State/province [72] 0 0
Sao Jose Do Rio Preto
Country [73] 0 0
Brazil
State/province [73] 0 0
Serra
Country [74] 0 0
Brazil
State/province [74] 0 0
Sorocaba
Country [75] 0 0
Brazil
State/province [75] 0 0
São Paulo
Country [76] 0 0
Brazil
State/province [76] 0 0
Volta Redonda
Country [77] 0 0
Brazil
State/province [77] 0 0
Votuporanga
Country [78] 0 0
Bulgaria
State/province [78] 0 0
Burgas
Country [79] 0 0
Bulgaria
State/province [79] 0 0
Dupnitsa
Country [80] 0 0
Bulgaria
State/province [80] 0 0
Haskovo
Country [81] 0 0
Bulgaria
State/province [81] 0 0
Kozloduy
Country [82] 0 0
Bulgaria
State/province [82] 0 0
Montana
Country [83] 0 0
Bulgaria
State/province [83] 0 0
Panagyurishte
Country [84] 0 0
Bulgaria
State/province [84] 0 0
Pazardzhik
Country [85] 0 0
Bulgaria
State/province [85] 0 0
Pleven
Country [86] 0 0
Bulgaria
State/province [86] 0 0
Plovdiv
Country [87] 0 0
Bulgaria
State/province [87] 0 0
Ruse
Country [88] 0 0
Bulgaria
State/province [88] 0 0
Sandanski
Country [89] 0 0
Bulgaria
State/province [89] 0 0
Sliven
Country [90] 0 0
Bulgaria
State/province [90] 0 0
Sofia
Country [91] 0 0
Bulgaria
State/province [91] 0 0
Vratsa
Country [92] 0 0
Bulgaria
State/province [92] 0 0
Yambol
Country [93] 0 0
Canada
State/province [93] 0 0
Alberta
Country [94] 0 0
Canada
State/province [94] 0 0
British Columbia
Country [95] 0 0
Canada
State/province [95] 0 0
Nova Scotia
Country [96] 0 0
Canada
State/province [96] 0 0
Ontario
Country [97] 0 0
Canada
State/province [97] 0 0
Quebec
Country [98] 0 0
Canada
State/province [98] 0 0
Saskatchewan
Country [99] 0 0
Chile
State/province [99] 0 0
Curico
Country [100] 0 0
Chile
State/province [100] 0 0
Quillota
Country [101] 0 0
Chile
State/province [101] 0 0
Santiago
Country [102] 0 0
Chile
State/province [102] 0 0
Talca
Country [103] 0 0
Chile
State/province [103] 0 0
Temuco
Country [104] 0 0
Chile
State/province [104] 0 0
Victoria
Country [105] 0 0
Chile
State/province [105] 0 0
Vitacura
Country [106] 0 0
Chile
State/province [106] 0 0
Viña del Mar
Country [107] 0 0
China
State/province [107] 0 0
Anhui
Country [108] 0 0
China
State/province [108] 0 0
Anyang
Country [109] 0 0
China
State/province [109] 0 0
Baotou
Country [110] 0 0
China
State/province [110] 0 0
Changsha
Country [111] 0 0
China
State/province [111] 0 0
Changzhi
Country [112] 0 0
China
State/province [112] 0 0
Chengdu
Country [113] 0 0
China
State/province [113] 0 0
Chifeng
Country [114] 0 0
China
State/province [114] 0 0
Chizhou
Country [115] 0 0
China
State/province [115] 0 0
Chongqing
Country [116] 0 0
China
State/province [116] 0 0
Guangzhou
Country [117] 0 0
China
State/province [117] 0 0
Hangzhou
Country [118] 0 0
China
State/province [118] 0 0
Heze
Country [119] 0 0
China
State/province [119] 0 0
Hohhot
Country [120] 0 0
China
State/province [120] 0 0
Huizhou
Country [121] 0 0
China
State/province [121] 0 0
Jiaozuo
Country [122] 0 0
China
State/province [122] 0 0
Jinhua
Country [123] 0 0
China
State/province [123] 0 0
Jining
Country [124] 0 0
China
State/province [124] 0 0
Kaifeng
Country [125] 0 0
China
State/province [125] 0 0
Lanzhou
Country [126] 0 0
China
State/province [126] 0 0
Nanchang
Country [127] 0 0
China
State/province [127] 0 0
Nanjing
Country [128] 0 0
China
State/province [128] 0 0
Pingxiang
Country [129] 0 0
China
State/province [129] 0 0
Qingdao
Country [130] 0 0
China
State/province [130] 0 0
Shanghai
Country [131] 0 0
China
State/province [131] 0 0
Shenyang
Country [132] 0 0
China
State/province [132] 0 0
Shijiazhuang
Country [133] 0 0
China
State/province [133] 0 0
Siping
Country [134] 0 0
China
State/province [134] 0 0
Taicang
Country [135] 0 0
China
State/province [135] 0 0
Taiyuan
Country [136] 0 0
China
State/province [136] 0 0
Taizhou
Country [137] 0 0
China
State/province [137] 0 0
Urumqi
Country [138] 0 0
China
State/province [138] 0 0
Wenzhou
Country [139] 0 0
China
State/province [139] 0 0
Xi'an
Country [140] 0 0
China
State/province [140] 0 0
Xinxiang
Country [141] 0 0
China
State/province [141] 0 0
Xuzhou
Country [142] 0 0
China
State/province [142] 0 0
Yangzhou
Country [143] 0 0
China
State/province [143] 0 0
Yinchuan
Country [144] 0 0
China
State/province [144] 0 0
Zhengzhou
Country [145] 0 0
Colombia
State/province [145] 0 0
Armenia
Country [146] 0 0
Colombia
State/province [146] 0 0
Barranquilla
Country [147] 0 0
Colombia
State/province [147] 0 0
Bogota
Country [148] 0 0
Colombia
State/province [148] 0 0
Manizales
Country [149] 0 0
Colombia
State/province [149] 0 0
Medellin
Country [150] 0 0
Colombia
State/province [150] 0 0
Piedecuesta
Country [151] 0 0
Colombia
State/province [151] 0 0
Rionegro
Country [152] 0 0
Czechia
State/province [152] 0 0
Brandys nad Labem
Country [153] 0 0
Czechia
State/province [153] 0 0
Olomouc
Country [154] 0 0
Czechia
State/province [154] 0 0
Ostrava
Country [155] 0 0
Czechia
State/province [155] 0 0
Praha 1
Country [156] 0 0
Czechia
State/province [156] 0 0
Rokycany
Country [157] 0 0
Denmark
State/province [157] 0 0
Aalborg
Country [158] 0 0
Denmark
State/province [158] 0 0
Esbjerg
Country [159] 0 0
Denmark
State/province [159] 0 0
Hvidovre
Country [160] 0 0
Denmark
State/province [160] 0 0
København NV
Country [161] 0 0
Denmark
State/province [161] 0 0
Næstved
Country [162] 0 0
Denmark
State/province [162] 0 0
Vejle
Country [163] 0 0
Finland
State/province [163] 0 0
Helsinki
Country [164] 0 0
Finland
State/province [164] 0 0
Kuopio
Country [165] 0 0
Finland
State/province [165] 0 0
Turku
Country [166] 0 0
France
State/province [166] 0 0
Aix en Provence
Country [167] 0 0
France
State/province [167] 0 0
Aurillac Cedex
Country [168] 0 0
France
State/province [168] 0 0
Bayonne
Country [169] 0 0
France
State/province [169] 0 0
Biarritz
Country [170] 0 0
France
State/province [170] 0 0
Brest Cedex
Country [171] 0 0
France
State/province [171] 0 0
Brest
Country [172] 0 0
France
State/province [172] 0 0
Cannes
Country [173] 0 0
France
State/province [173] 0 0
La Tronche
Country [174] 0 0
France
State/province [174] 0 0
Le Coudray Cedex
Country [175] 0 0
France
State/province [175] 0 0
Lyon Cedex 04
Country [176] 0 0
France
State/province [176] 0 0
Marseille
Country [177] 0 0
France
State/province [177] 0 0
Mulhouse
Country [178] 0 0
France
State/province [178] 0 0
Paris Cedex 13
Country [179] 0 0
France
State/province [179] 0 0
Paris
Country [180] 0 0
France
State/province [180] 0 0
Pessac
Country [181] 0 0
France
State/province [181] 0 0
Pringy Cedex
Country [182] 0 0
France
State/province [182] 0 0
Quint-Fonsegrives
Country [183] 0 0
France
State/province [183] 0 0
Reims
Country [184] 0 0
France
State/province [184] 0 0
Roscoff
Country [185] 0 0
France
State/province [185] 0 0
Vandoeuvre-Les-Nancy Cedex
Country [186] 0 0
France
State/province [186] 0 0
VANNES cedex
Country [187] 0 0
Germany
State/province [187] 0 0
Augsburg
Country [188] 0 0
Germany
State/province [188] 0 0
Berlin
Country [189] 0 0
Germany
State/province [189] 0 0
Bremen
Country [190] 0 0
Germany
State/province [190] 0 0
Cottbus
Country [191] 0 0
Germany
State/province [191] 0 0
Dachau
Country [192] 0 0
Germany
State/province [192] 0 0
Darmstadt
Country [193] 0 0
Germany
State/province [193] 0 0
Deggingen
Country [194] 0 0
Germany
State/province [194] 0 0
Dresden
Country [195] 0 0
Germany
State/province [195] 0 0
Essen
Country [196] 0 0
Germany
State/province [196] 0 0
Frankfurt/Main
Country [197] 0 0
Germany
State/province [197] 0 0
Frankfurt
Country [198] 0 0
Germany
State/province [198] 0 0
Großhansdorf
Country [199] 0 0
Germany
State/province [199] 0 0
Hamburg
Country [200] 0 0
Germany
State/province [200] 0 0
Hannover
Country [201] 0 0
Germany
State/province [201] 0 0
Heidelberg
Country [202] 0 0
Germany
State/province [202] 0 0
Ibbenbüren
Country [203] 0 0
Germany
State/province [203] 0 0
Karlsruhe
Country [204] 0 0
Germany
State/province [204] 0 0
Leipzig
Country [205] 0 0
Germany
State/province [205] 0 0
Lübeck
Country [206] 0 0
Germany
State/province [206] 0 0
Mainz
Country [207] 0 0
Germany
State/province [207] 0 0
Moers
Country [208] 0 0
Germany
State/province [208] 0 0
München
Country [209] 0 0
Germany
State/province [209] 0 0
Offenbach am Main
Country [210] 0 0
Germany
State/province [210] 0 0
Rheine
Country [211] 0 0
Germany
State/province [211] 0 0
Riesa
Country [212] 0 0
Germany
State/province [212] 0 0
Solingen
Country [213] 0 0
Germany
State/province [213] 0 0
Wallerfing
Country [214] 0 0
Germany
State/province [214] 0 0
Weißenburg
Country [215] 0 0
Germany
State/province [215] 0 0
Wermsdorf
Country [216] 0 0
Germany
State/province [216] 0 0
Wiesbaden
Country [217] 0 0
Germany
State/province [217] 0 0
Witten
Country [218] 0 0
Greece
State/province [218] 0 0
Athens
Country [219] 0 0
Greece
State/province [219] 0 0
Exohi Thessaloniki
Country [220] 0 0
Greece
State/province [220] 0 0
Ioannina
Country [221] 0 0
Greece
State/province [221] 0 0
Patras
Country [222] 0 0
Greece
State/province [222] 0 0
Thessaloniki
Country [223] 0 0
Hungary
State/province [223] 0 0
Budapest
Country [224] 0 0
Hungary
State/province [224] 0 0
Edelény
Country [225] 0 0
Hungary
State/province [225] 0 0
Gyöngyös - Mátraháza
Country [226] 0 0
Hungary
State/province [226] 0 0
Gödöllo
Country [227] 0 0
Hungary
State/province [227] 0 0
Hajdúnánás
Country [228] 0 0
Hungary
State/province [228] 0 0
Kalocsa
Country [229] 0 0
Hungary
State/province [229] 0 0
Komádi
Country [230] 0 0
Hungary
State/province [230] 0 0
Monor
Country [231] 0 0
Hungary
State/province [231] 0 0
Pécs
Country [232] 0 0
Hungary
State/province [232] 0 0
Püspökladány
Country [233] 0 0
Hungary
State/province [233] 0 0
Szolnok
Country [234] 0 0
Hungary
State/province [234] 0 0
Százhalombatta
Country [235] 0 0
Hungary
State/province [235] 0 0
Székesfehérvár
Country [236] 0 0
Hungary
State/province [236] 0 0
Tapolca
Country [237] 0 0
India
State/province [237] 0 0
Ahmedabad
Country [238] 0 0
India
State/province [238] 0 0
Aligarh
Country [239] 0 0
India
State/province [239] 0 0
Belagavi
Country [240] 0 0
India
State/province [240] 0 0
Calicut
Country [241] 0 0
India
State/province [241] 0 0
Chandigarh
Country [242] 0 0
India
State/province [242] 0 0
Dehradun
Country [243] 0 0
India
State/province [243] 0 0
Delhi
Country [244] 0 0
India
State/province [244] 0 0
Hyderabad
Country [245] 0 0
India
State/province [245] 0 0
Jaipur
Country [246] 0 0
India
State/province [246] 0 0
Kolkata
Country [247] 0 0
India
State/province [247] 0 0
London
Country [248] 0 0
India
State/province [248] 0 0
Mangalore
Country [249] 0 0
India
State/province [249] 0 0
Mumbai
Country [250] 0 0
India
State/province [250] 0 0
Nagpur
Country [251] 0 0
Italy
State/province [251] 0 0
Ancona
Country [252] 0 0
Italy
State/province [252] 0 0
Firenze
Country [253] 0 0
Italy
State/province [253] 0 0
Genoa
Country [254] 0 0
Italy
State/province [254] 0 0
Mestre
Country [255] 0 0
Italy
State/province [255] 0 0
Milano
Country [256] 0 0
Italy
State/province [256] 0 0
Modena
Country [257] 0 0
Italy
State/province [257] 0 0
Napoli
Country [258] 0 0
Italy
State/province [258] 0 0
Pavia
Country [259] 0 0
Italy
State/province [259] 0 0
Perugia
Country [260] 0 0
Italy
State/province [260] 0 0
Roma
Country [261] 0 0
Italy
State/province [261] 0 0
Rome
Country [262] 0 0
Italy
State/province [262] 0 0
Siena
Country [263] 0 0
Italy
State/province [263] 0 0
Varese
Country [264] 0 0
Japan
State/province [264] 0 0
Fujieda-shi
Country [265] 0 0
Japan
State/province [265] 0 0
Fukuoka-shi
Country [266] 0 0
Japan
State/province [266] 0 0
Kitakyusyu
Country [267] 0 0
Japan
State/province [267] 0 0
Kobe-shi
Country [268] 0 0
Japan
State/province [268] 0 0
Kure-shi
Country [269] 0 0
Japan
State/province [269] 0 0
Kyoto-shi
Country [270] 0 0
Japan
State/province [270] 0 0
Mizunami-shi
Country [271] 0 0
Japan
State/province [271] 0 0
Osaka-shi
Country [272] 0 0
Japan
State/province [272] 0 0
Shinjuku-ku
Country [273] 0 0
Japan
State/province [273] 0 0
Takamatsu-shi
Country [274] 0 0
Japan
State/province [274] 0 0
Yamagata-shi
Country [275] 0 0
Japan
State/province [275] 0 0
Yanagawa-shi
Country [276] 0 0
Japan
State/province [276] 0 0
Yokohama-shi
Country [277] 0 0
Korea, Republic of
State/province [277] 0 0
Daegu
Country [278] 0 0
Korea, Republic of
State/province [278] 0 0
Guri-si
Country [279] 0 0
Korea, Republic of
State/province [279] 0 0
Gwangju
Country [280] 0 0
Korea, Republic of
State/province [280] 0 0
Jeonju
Country [281] 0 0
Korea, Republic of
State/province [281] 0 0
Seoul
Country [282] 0 0
Korea, Republic of
State/province [282] 0 0
Uijeongbu
Country [283] 0 0
Korea, Republic of
State/province [283] 0 0
Ulsan
Country [284] 0 0
Malaysia
State/province [284] 0 0
Alor Setar
Country [285] 0 0
Malaysia
State/province [285] 0 0
Kajang
Country [286] 0 0
Malaysia
State/province [286] 0 0
Kuala Lumpur
Country [287] 0 0
Malaysia
State/province [287] 0 0
Kuala Pilah
Country [288] 0 0
Malaysia
State/province [288] 0 0
Sandakan
Country [289] 0 0
Malaysia
State/province [289] 0 0
Sarawak Miri
Country [290] 0 0
Malaysia
State/province [290] 0 0
Seremban
Country [291] 0 0
Malaysia
State/province [291] 0 0
Sibu
Country [292] 0 0
Mexico
State/province [292] 0 0
Benito Juarez
Country [293] 0 0
Mexico
State/province [293] 0 0
Chihuahua
Country [294] 0 0
Mexico
State/province [294] 0 0
Cuernavaca
Country [295] 0 0
Mexico
State/province [295] 0 0
Culiacan
Country [296] 0 0
Mexico
State/province [296] 0 0
Guadalajara
Country [297] 0 0
Mexico
State/province [297] 0 0
Juriquilla
Country [298] 0 0
Mexico
State/province [298] 0 0
Merida
Country [299] 0 0
Mexico
State/province [299] 0 0
Metepec
Country [300] 0 0
Mexico
State/province [300] 0 0
Mexico City
Country [301] 0 0
Mexico
State/province [301] 0 0
Monterrey
Country [302] 0 0
Mexico
State/province [302] 0 0
Oaxaca
Country [303] 0 0
Mexico
State/province [303] 0 0
Tijuana
Country [304] 0 0
Mexico
State/province [304] 0 0
Veracruz
Country [305] 0 0
Mexico
State/province [305] 0 0
Xalapa
Country [306] 0 0
Mexico
State/province [306] 0 0
Zapopan
Country [307] 0 0
Norway
State/province [307] 0 0
Kongsberg
Country [308] 0 0
Norway
State/province [308] 0 0
Lørenskog
Country [309] 0 0
Norway
State/province [309] 0 0
Trondheim
Country [310] 0 0
Peru
State/province [310] 0 0
Concepción Del Uruguay
Country [311] 0 0
Peru
State/province [311] 0 0
el Agustino
Country [312] 0 0
Peru
State/province [312] 0 0
Lima
Country [313] 0 0
Peru
State/province [313] 0 0
Piura
Country [314] 0 0
Philippines
State/province [314] 0 0
Dagupan City
Country [315] 0 0
Philippines
State/province [315] 0 0
Iloilo City
Country [316] 0 0
Philippines
State/province [316] 0 0
Las Pinas
Country [317] 0 0
Philippines
State/province [317] 0 0
Mabalacat
Country [318] 0 0
Philippines
State/province [318] 0 0
Manila
Country [319] 0 0
Philippines
State/province [319] 0 0
Marilao
Country [320] 0 0
Philippines
State/province [320] 0 0
Puerto Princesa City
Country [321] 0 0
Philippines
State/province [321] 0 0
Quezon City
Country [322] 0 0
Philippines
State/province [322] 0 0
Roxas City
Country [323] 0 0
Philippines
State/province [323] 0 0
Tondo
Country [324] 0 0
Poland
State/province [324] 0 0
Bialystok
Country [325] 0 0
Poland
State/province [325] 0 0
Bydgoszcz
Country [326] 0 0
Poland
State/province [326] 0 0
Chojnice
Country [327] 0 0
Poland
State/province [327] 0 0
Godziesze Male
Country [328] 0 0
Poland
State/province [328] 0 0
Inowroclaw
Country [329] 0 0
Poland
State/province [329] 0 0
Karczew
Country [330] 0 0
Poland
State/province [330] 0 0
Katowice
Country [331] 0 0
Poland
State/province [331] 0 0
Kielce
Country [332] 0 0
Poland
State/province [332] 0 0
Krakow
Country [333] 0 0
Poland
State/province [333] 0 0
Kraków
Country [334] 0 0
Poland
State/province [334] 0 0
Libiaz
Country [335] 0 0
Poland
State/province [335] 0 0
Lubin
Country [336] 0 0
Poland
State/province [336] 0 0
Lublin
Country [337] 0 0
Poland
State/province [337] 0 0
Ostrowiec Swietokrzyski
Country [338] 0 0
Poland
State/province [338] 0 0
Piaseczno
Country [339] 0 0
Poland
State/province [339] 0 0
Poznan
Country [340] 0 0
Poland
State/province [340] 0 0
Plock
Country [341] 0 0
Poland
State/province [341] 0 0
Rzeszów
Country [342] 0 0
Poland
State/province [342] 0 0
Skórzewo
Country [343] 0 0
Poland
State/province [343] 0 0
Sochaczew
Country [344] 0 0
Poland
State/province [344] 0 0
Sosnowiec
Country [345] 0 0
Poland
State/province [345] 0 0
Szczecin
Country [346] 0 0
Poland
State/province [346] 0 0
Slupsk
Country [347] 0 0
Poland
State/province [347] 0 0
Torun
Country [348] 0 0
Poland
State/province [348] 0 0
Ustron
Country [349] 0 0
Poland
State/province [349] 0 0
Warszawa
Country [350] 0 0
Poland
State/province [350] 0 0
Wroclaw
Country [351] 0 0
Poland
State/province [351] 0 0
Lódz
Country [352] 0 0
Romania
State/province [352] 0 0
Bucharest
Country [353] 0 0
Romania
State/province [353] 0 0
Cluj-Napoca
Country [354] 0 0
Romania
State/province [354] 0 0
Leamna de Sus
Country [355] 0 0
Romania
State/province [355] 0 0
Targu Mures
Country [356] 0 0
Romania
State/province [356] 0 0
Timisoara
Country [357] 0 0
Serbia
State/province [357] 0 0
Belgrade
Country [358] 0 0
Slovakia
State/province [358] 0 0
Brezno
Country [359] 0 0
Slovakia
State/province [359] 0 0
Humenne
Country [360] 0 0
Slovakia
State/province [360] 0 0
Kosice
Country [361] 0 0
Slovakia
State/province [361] 0 0
Královský Chlmec
Country [362] 0 0
Slovakia
State/province [362] 0 0
Levice
Country [363] 0 0
Slovakia
State/province [363] 0 0
Presov
Country [364] 0 0
Slovakia
State/province [364] 0 0
Topolcany
Country [365] 0 0
Spain
State/province [365] 0 0
Badia Del Vallès
Country [366] 0 0
Spain
State/province [366] 0 0
Barakaldo
Country [367] 0 0
Spain
State/province [367] 0 0
Barcelona
Country [368] 0 0
Spain
State/province [368] 0 0
Cabra
Country [369] 0 0
Spain
State/province [369] 0 0
Castro Urdiales
Country [370] 0 0
Spain
State/province [370] 0 0
Granada
Country [371] 0 0
Spain
State/province [371] 0 0
Madrid
Country [372] 0 0
Spain
State/province [372] 0 0
Marbella (Málaga)
Country [373] 0 0
Spain
State/province [373] 0 0
Mataró
Country [374] 0 0
Spain
State/province [374] 0 0
Málaga
Country [375] 0 0
Spain
State/province [375] 0 0
Palma
Country [376] 0 0
Spain
State/province [376] 0 0
Santiago De Compostela-Coruña
Country [377] 0 0
Spain
State/province [377] 0 0
Tenerife
Country [378] 0 0
Spain
State/province [378] 0 0
Viladecans
Country [379] 0 0
Sweden
State/province [379] 0 0
Göteborg
Country [380] 0 0
Sweden
State/province [380] 0 0
Höllviken
Country [381] 0 0
Sweden
State/province [381] 0 0
Kungsbacka
Country [382] 0 0
Sweden
State/province [382] 0 0
Lund
Country [383] 0 0
Sweden
State/province [383] 0 0
Stockholm
Country [384] 0 0
Sweden
State/province [384] 0 0
Umeå
Country [385] 0 0
Sweden
State/province [385] 0 0
Örebro
Country [386] 0 0
Taiwan
State/province [386] 0 0
Changhua County
Country [387] 0 0
Taiwan
State/province [387] 0 0
Kao Hsiung
Country [388] 0 0
Taiwan
State/province [388] 0 0
Kaohsiung
Country [389] 0 0
Taiwan
State/province [389] 0 0
Taichung
Country [390] 0 0
Taiwan
State/province [390] 0 0
Tainan City
Country [391] 0 0
Taiwan
State/province [391] 0 0
Taipei
Country [392] 0 0
Taiwan
State/province [392] 0 0
Taoyuan City
Country [393] 0 0
Taiwan
State/province [393] 0 0
Taoyuan
Country [394] 0 0
Taiwan
State/province [394] 0 0
Yunlin
Country [395] 0 0
Thailand
State/province [395] 0 0
Bang Kra So
Country [396] 0 0
Thailand
State/province [396] 0 0
Bangkok
Country [397] 0 0
Thailand
State/province [397] 0 0
Hat Yai
Country [398] 0 0
Thailand
State/province [398] 0 0
Khlong Luang
Country [399] 0 0
Thailand
State/province [399] 0 0
Muang
Country [400] 0 0
Thailand
State/province [400] 0 0
Ongkharak
Country [401] 0 0
Thailand
State/province [401] 0 0
Phitsanulok
Country [402] 0 0
Thailand
State/province [402] 0 0
Ratchathewi
Country [403] 0 0
Turkey
State/province [403] 0 0
Adana
Country [404] 0 0
Turkey
State/province [404] 0 0
Afyonkarahisar
Country [405] 0 0
Turkey
State/province [405] 0 0
Antalya
Country [406] 0 0
Turkey
State/province [406] 0 0
Bursa
Country [407] 0 0
Turkey
State/province [407] 0 0
Canakkale
Country [408] 0 0
Turkey
State/province [408] 0 0
Isparta
Country [409] 0 0
Turkey
State/province [409] 0 0
Istanbul
Country [410] 0 0
Turkey
State/province [410] 0 0
Izmir
Country [411] 0 0
Turkey
State/province [411] 0 0
Kocaeli
Country [412] 0 0
Turkey
State/province [412] 0 0
Mersin
Country [413] 0 0
Turkey
State/province [413] 0 0
Tekirdag
Country [414] 0 0
Turkey
State/province [414] 0 0
Zeytinburnu
Country [415] 0 0
Turkey
State/province [415] 0 0
Çankaya
Country [416] 0 0
Ukraine
State/province [416] 0 0
Chernivtsi
Country [417] 0 0
Ukraine
State/province [417] 0 0
Chernivts?
Country [418] 0 0
Ukraine
State/province [418] 0 0
Ivano-Frankivsk
Country [419] 0 0
Ukraine
State/province [419] 0 0
Kyiv
Country [420] 0 0
Ukraine
State/province [420] 0 0
Ternopil
Country [421] 0 0
Ukraine
State/province [421] 0 0
Uzhhorod
Country [422] 0 0
Ukraine
State/province [422] 0 0
Vinnytsia
Country [423] 0 0
United Kingdom
State/province [423] 0 0
Bicester
Country [424] 0 0
United Kingdom
State/province [424] 0 0
Bollington
Country [425] 0 0
United Kingdom
State/province [425] 0 0
Chesterfield
Country [426] 0 0
United Kingdom
State/province [426] 0 0
Corby
Country [427] 0 0
United Kingdom
State/province [427] 0 0
Fowey
Country [428] 0 0
United Kingdom
State/province [428] 0 0
Glasgow
Country [429] 0 0
United Kingdom
State/province [429] 0 0
Hownslow
Country [430] 0 0
United Kingdom
State/province [430] 0 0
Liverpool
Country [431] 0 0
United Kingdom
State/province [431] 0 0
London
Country [432] 0 0
United Kingdom
State/province [432] 0 0
Newquay
Country [433] 0 0
United Kingdom
State/province [433] 0 0
North Somerset
Country [434] 0 0
United Kingdom
State/province [434] 0 0
Northallerton
Country [435] 0 0
United Kingdom
State/province [435] 0 0
Norwich
Country [436] 0 0
United Kingdom
State/province [436] 0 0
Nottingham
Country [437] 0 0
United Kingdom
State/province [437] 0 0
Perth
Country [438] 0 0
United Kingdom
State/province [438] 0 0
Poole
Country [439] 0 0
United Kingdom
State/province [439] 0 0
Sheffield
Country [440] 0 0
United Kingdom
State/province [440] 0 0
Torbay
Country [441] 0 0
United Kingdom
State/province [441] 0 0
Whitney
Country [442] 0 0
United Kingdom
State/province [442] 0 0
Witney

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
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
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
information.center@astrazeneca.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available to whom?
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


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/NCT06283966