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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04609878




Registration number
NCT04609878
Ethics application status
Date submitted
26/10/2020
Date registered
30/10/2020

Titles & IDs
Public title
Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (KALOS)
Scientific title
A Randomized, Double-Blind, Double Dummy, Parallel Group, Multicenter Variable Length Study to Assess the Efficacy and Safety of PT010 Relative to PT009 and Symbicort® in Adult and Adolescent Participants With Inadequately Controlled Asthma
Secondary ID [1] 0 0
2023-505787-11
Secondary ID [2] 0 0
D5982C00007
Universal Trial Number (UTN)
Trial acronym
KALOS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BGF MDI 320/28.8/9.6 µg
Treatment: Drugs - BGF MDI 320/14.4/9.6 µg
Treatment: Drugs - BFF MDI 320/9.6 µg
Treatment: Drugs - BFF pMDI 320/9 µg

Experimental: Budesonide, glycopyrronium, and formoterol fumarate (BGF) MDI 320/28.8/9.6 µg - BGF MDI 320/28.8/9.6 µg Budesonide, glycopyrronium, and formoterol fumarate (PT010) Metered Dose Inhaler (MDI)

Experimental: BGF MDI 320/14.4/9.6 µg - BGF MDI 320/14.4/9.6 µg Budesonide, glycopyrronium, and formoterol fumarate (PT010) Metered Dose Inhaler (MDI)

Active comparator: Budesonide and formoterol fumarate (BFF) MDI 320/9.6 µg - BFF MDI 320/9.6 µg (Experimental/Comparator) Budesonide and formoterol fumarate (PT009) Metered Dose Inhaler (MDI)

Active comparator: Symbicort® - Budesonide/ formoterol fumarate pressurized metered dose inhaler (pMDI) 320/9 µg


Treatment: Drugs: BGF MDI 320/28.8/9.6 µg
Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler

Treatment: Drugs: BGF MDI 320/14.4/9.6 µg
Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler

Treatment: Drugs: BFF MDI 320/9.6 µg
Budesonide and formoterol fumarate metered dose inhaler

Treatment: Drugs: BFF pMDI 320/9 µg
Budesonide/formoterol fumarate pressurized metered dose inhaler
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24
Timepoint [1] 0 0
24 Weeks
Primary outcome [2] 0 0
Rate of severe asthma exacerbations
Timepoint [2] 0 0
Up to 52 weeks
Secondary outcome [1] 0 0
Change from baseline in morning pre-dose trough FEV1 at Week 24
Timepoint [1] 0 0
24 Weeks
Secondary outcome [2] 0 0
Percentage of responders in Asthma Control Questionnaire (ACQ)-7 (=0.5 decrease equals response) at Week 24
Timepoint [2] 0 0
24 weeks
Secondary outcome [3] 0 0
Percentage of responders in ACQ-5 (=0.5 decrease equals response) at Week 24
Timepoint [3] 0 0
24 Weeks
Secondary outcome [4] 0 0
Percentage of responders in the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ +12) (=0.5 increase equals response) at Week 24
Timepoint [4] 0 0
24 weeks
Secondary outcome [5] 0 0
Percentage of responders in the St. George's Respiratory Questionnaire (SGRQ) (=4.0 unit decrease equals response) at Week 24
Timepoint [5] 0 0
24 Weeks
Secondary outcome [6] 0 0
Onset of action on Day 1: Absolute change in FEV1 at 5 minutes on Day 1
Timepoint [6] 0 0
Day 1
Secondary outcome [7] 0 0
Time to first severe asthma exacerbation
Timepoint [7] 0 0
Up to 52 Weeks
Secondary outcome [8] 0 0
Rate of moderate/severe asthma exacerbations
Timepoint [8] 0 0
Up to 52 Weeks
Secondary outcome [9] 0 0
Time to first moderate/severe asthma exacerbation
Timepoint [9] 0 0
Up to 52 Weeks
Secondary outcome [10] 0 0
Rate of severe asthma exacerbations for participants with percent predicted FEV1 = 55% at baseline.
Timepoint [10] 0 0
Up to 52 Weeks
Secondary outcome [11] 0 0
Rate of severe asthma exacerbations for participants with = 1 severe exacerbation in the 12 months prior to Visit 1.
Timepoint [11] 0 0
Up to 52 Weeks

Eligibility
Key inclusion criteria
1. 12 to 80 years of age, male and female, BMI <40 kg/m2; females must be not of childbearing potential or using a form of highly effective birth control.
2. Documented history of physician-diagnosed asthma > and/or = 1 year prior to V1.
3. Regularly using a stable daily ICS/LABA regimen (including a stable ICS dose) with medium-to-high ICS doses for at least 4 weeks prior to V1.
4. ACQ-7 total score =1.5 at Visits 1, 3, and 5 (pre-randomization).
5. FEV1 % (assessed as an average of the 60 and 30 minute pre-dose assessments) predicted normal at V1, 2, 3, 4, and 5 (pre-randomization)

* Participants = 18 years of age: < 80%
* Participants 12 to <18 years of age: < 90%
6. FEV1 post-albuterol at V2 or V3 (if repeat needed).

* Participants > and/or = 18 years of age: Increase > and/or = 12% and > and/or = 200 mL.
* Participants 12 to <18 years of age: Increase =12% either in the 12 months prior to Visit 1 or at Visit 2, or at Visit 3.
* Note: Even if there is documented history of reversibility, all participants must be assessed for reversibility at Visit 2 (and Visit 3, if reversibility is not demonstrated at Visit 2) to provide reversibility baseline data for characterization.
7. Willing and, in the opinion of the Investigator, able to adjust current asthma therapy, as required by the protocol.
8. Demonstrate acceptable MDI/pMDI administration technique.
9. Received no asthma medication other than run-in BFF MDI BID and albuterol as needed during screening (except for allowed medications as defined in Table 9 and systemic corticosteroid or ICS for the treatment of an asthma exacerbation).
10. eDiary 14-day compliance =70% during screening (defined as completing the daily eDiary for any 10 mornings and any 10 evenings and answering "Yes" to taking 2 puffs of run-in BFF MDI for any 10 mornings and 10 evenings in the last 14 days prior to randomization).
11. No respiratory infection in the 4 weeks prior to randomization, or asthma exacerbation treated with systemic corticosteroid and/or additional ICS treatment in the 4 weeks prior to randomization.
Minimum age
12 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Completed treatment for respiratory infection or asthma exacerbation with systemic corticosteroids within 4 weeks of V1.

2a. Participants where, in the opinion of the Investigator, treatment with biological therapy for asthma would be appropriate.

2b. Any marketed or investigational biologics within 3 months or 5 half-lives of V1, whichever is longer and must not be used during study duration.

3. Current smokers, former smokers with >10 pack-years history, or former smokers who stopped smoking <6 months prior to V1 (including all forms of tobacco, e-cigarettes or other vaping devices, and marijuana).

4. Current evidence of Chronic Obstructive Pulmonary Disease (COPD).

5a. Oral and IV corticosteroid use (any dose) within 4 weeks of V1.

5b. Use of systemic corticosteroids for any other reason except for the acute treatment of severe asthma exacerbation is prohibited for the duration of the study.

5c. Depot corticosteroid use for any reason within 3 months of V1.

6. Use of Long-Acting Muscarinic Antagonist (LAMA), either alone or as part of an inhaled combination therapy, in the 12 weeks prior to V1.

7. Use of oral beta2-agonist within 3 months of V1.

8. Use of any immunomodulators or immunosuppressive medication within 3 months or 5 half-lives, whichever is longer, and must not be used during the study duration.

9. Narrow angle glaucoma not adequately treated and/or change in vision that may be relevant, in the opinion of the Investigator, within 3 months of Visit 1.

10. Life-threatening asthma defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s).

11. Hospitalization for asthma within 2 months of Visit 1.

12. Known history of drug or alcohol abuse within 12 months of Visit 1.

13. Regular use of a nebulizer or a home nebulizer for receiving asthma medications.

14. Using any herbal products by inhalation or nebulizer within 4 weeks of Visit 1 and does not agree to stop during the study duration.

15. Participation in another clinical study with a study intervention administered in the last 30 days or 5 half-lives, whichever is longer. Any other study intervention that is not identified in the protocol is prohibited for use during study duration.

16. Participants with a known hypersensitivity to beta2-agonists, corticosteroids, anticholinergics, or any component of the MDI or pMDI.

17. Study Investigators, sub-Investigators, coordinators, and their employees or immediate family members.

18. For women only - currently pregnant (confirmed with positive highly sensitive pregnancy test), breast-feeding, or planned pregnancy during the study or not using acceptable contraception measures, as judged by the Investigator.

Please refer to the study protocol for the complete inclusion and exclusion criteria list.

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
15/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
21/03/2025
Actual
Sample size
Target
2200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Darlinghurst
Recruitment hospital [2] 0 0
Research Site - Melbourne
Recruitment hospital [3] 0 0
Research Site - South Brisbane
Recruitment hospital [4] 0 0
Research Site - Spearwood
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
6163 - Spearwood
Recruitment outside Australia
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United States of America
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Japan
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Japan
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Miyazaki-shi
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Japan
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Nagaoka-shi
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Nagoya-shi
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Obihiro
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Shimotsuga-gun
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Japan
State/province [172] 0 0
Tanabe-shi
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Japan
State/province [173] 0 0
Toon-shi
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Japan
State/province [174] 0 0
Toshima-ku
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Japan
State/province [175] 0 0
Toyama-shi
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Japan
State/province [176] 0 0
Tsuchiura-shi
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Japan
State/province [177] 0 0
Utsunomiya-shi
Country [178] 0 0
Japan
State/province [178] 0 0
Yanagawa-shi
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Japan
State/province [179] 0 0
Yokohama-shi
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Korea, Republic of
State/province [180] 0 0
Cheongju-si
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Korea, Republic of
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Gangwon-do
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Korea, Republic of
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Korea, Republic of
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Korea, Republic of
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Seoul
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Korea, Republic of
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Suwon-si
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Korea, Republic of
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Uijeongbu
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Korea, Republic of
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State/province [188] 0 0
Deventer
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Eindhoven
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Netherlands
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Heerlen
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Netherlands
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Auckland
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Nawton
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Nelson
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New Zealand
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Rotorua
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New Zealand
State/province [198] 0 0
Wellington
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Cusco
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Peru
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Lima
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Peru
State/province [201] 0 0
Piura
Country [202] 0 0
Philippines
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Baguio City
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Philippines
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Caloocan City
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Philippines
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Davao City
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Philippines
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Iloilo City
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Philippines
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Las Pinas
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Philippines
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Lipa City
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Philippines
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Philippines
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Manila
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Philippines
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Philippines
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Poland
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Poland
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Poland
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Poland
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Poland
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Krakow
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Poland
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Poland
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Poland
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Poland
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Poland
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Poland
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Poland
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Poland
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Tarnów
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Poland
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Wroclaw
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Puerto Rico
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Guaynabo
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Puerto Rico
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Ponce
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Puerto Rico
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Romania
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Bra?ov
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Romania
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Romania
State/province [238] 0 0
Ia?i
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Romania
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Spain
State/province [240] 0 0
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Spain
State/province [241] 0 0
Benalmádena
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Spain
State/province [242] 0 0
Coslada
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Spain
State/province [243] 0 0
Girona
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Spain
State/province [244] 0 0
L'Hospitalet de Llobregat
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Spain
State/province [245] 0 0
Madrid
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Spain
State/province [246] 0 0
Marbella (Málaga)
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Spain
State/province [247] 0 0
Málaga
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Spain
State/province [248] 0 0
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Spain
State/province [249] 0 0
Santander
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Spain
State/province [250] 0 0
Santiago De Compostela-Coruña
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Spain
State/province [251] 0 0
Valencia
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Spain
State/province [252] 0 0
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State/province [253] 0 0
Changhua
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Taiwan
State/province [254] 0 0
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Taiwan
State/province [255] 0 0
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Taiwan
State/province [256] 0 0
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Taiwan
State/province [257] 0 0
Taichung
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Taiwan
State/province [258] 0 0
Tainan
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Taiwan
State/province [259] 0 0
Taipei City
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Taiwan
State/province [260] 0 0
Taipei
Country [261] 0 0
Taiwan
State/province [261] 0 0
Tao-Yuan
Country [262] 0 0
Thailand
State/province [262] 0 0
Bang Kra So
Country [263] 0 0
Thailand
State/province [263] 0 0
Bangkok
Country [264] 0 0
Thailand
State/province [264] 0 0
Hat Yai
Country [265] 0 0
Thailand
State/province [265] 0 0
Hatyai
Country [266] 0 0
Thailand
State/province [266] 0 0
Khon Kaen
Country [267] 0 0
Thailand
State/province [267] 0 0
Mae Rim
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Thailand
State/province [268] 0 0
Muang
Country [269] 0 0
Thailand
State/province [269] 0 0
Mueang Chanthaburi
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Thailand
State/province [270] 0 0
Mueang
Country [271] 0 0
Vietnam
State/province [271] 0 0
Ha Noi
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Vietnam
State/province [272] 0 0
Hanoi
Country [273] 0 0
Vietnam
State/province [273] 0 0
Ho Chi Minh City
Country [274] 0 0
Vietnam
State/province [274] 0 0
Ho Chi Minh
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Vietnam
State/province [275] 0 0
Hochiminh

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
[email protected]
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

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 de-identified 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/NCT04609878