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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02224157




Registration number
NCT02224157
Ethics application status
Date submitted
19/08/2014
Date registered
25/08/2014
Date last updated
25/11/2019

Titles & IDs
Public title
A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma
Scientific title
A Clinical Study Comparing Symbicort 'as Needed' With Pulmicort Twice Daily Plus Terbutaline 'as Needed' in Adult and Adolescent Patients With Asthma
Secondary ID [1] 0 0
2013-004473-28
Secondary ID [2] 0 0
D589SC00003
Universal Trial Number (UTN)
Trial acronym
SYGMA2
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 - budesonide/formoterol 'as needed' + budesonide placebo bid
Treatment: Drugs - budesonode bid + terbutaline 'as needed'

Experimental: Symbicort "as needed"+placebo Pulmicort bid - Symbicort (budesonide/formoterol) Turbuhaler 160/4.5 µg 'as needed' + Placebo Pulmicort Turbuhaler 200 µg bid

Active Comparator: Pulmicort bid + terbutaline "as needed" - Pulmicort 200 µg Turbuhaler bid + terbutaline 0.4 mg Turbuhaler 'as needed'


Treatment: Drugs: budesonide/formoterol 'as needed' + budesonide placebo bid
Symbicort (budesonide/ formoterol) 160/4.5 µg powder for inhalation 'as needed' plus Pulmicort placebo 200 µg powder for inhalation, 1 inhalation twice daily (morning and evening), 52-week treatment

Treatment: Drugs: budesonode bid + terbutaline 'as needed'
Pulmicort (budesonide) 200 µg powder for inhalation, 1 inhalation twice daily (morning and evening) plus terbutaline 0.4 mg powder for inhalation 'as needed', 52-week treatment
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Annual Severe Asthma Exacerbation Rate - Non-inferiority Analysis
Timepoint [1] 0 0
up to 52 weeks
Primary outcome [2] 0 0
Annual Severe Asthma Exacerbation Rate - Superiority Analysis
Timepoint [2] 0 0
up to 52 weeks
Secondary outcome [1] 0 0
Number of Participants Experiencing at Least One Severe Asthma Exacerbation
Timepoint [1] 0 0
Day 1 up to 52 weeks
Secondary outcome [2] 0 0
Average Change From Baseline in Pre-bronchodilator FEV1
Timepoint [2] 0 0
Study weeks 0,17, 34, 52
Secondary outcome [3] 0 0
Number of Participants With Study Specific Asthma Related Discontinuation
Timepoint [3] 0 0
Day 1 up to 52 weeks
Secondary outcome [4] 0 0
Average Change From Baseline in 'as Needed' Use
Timepoint [4] 0 0
Week 0 up to 52 weeks
Secondary outcome [5] 0 0
Change From Baseline in Percent of 'as Needed' Free Days
Timepoint [5] 0 0
Week 0 up to 52 weeks
Secondary outcome [6] 0 0
Percentage of Controller Use Days
Timepoint [6] 0 0
Week 0 up to 52 weeks
Secondary outcome [7] 0 0
Average Change From Baseline in Asthma Control Questionnaire (5-item Version) - ACQ-5 Score
Timepoint [7] 0 0
Study weeks 0, 17, 34, 52
Secondary outcome [8] 0 0
Average Change From Baseline in Asthma Quality of Life Questionnaire Standardised Version - AQLQ(S) Score
Timepoint [8] 0 0
Study weeks 0,17, 34, 52

Eligibility
Key inclusion criteria
1. Provision of informed consent prior to any study specific procedures. For patients
under-age, signed informed consent from both the patient and the patient's
parent/legal guardian is required

2. Male or Female, =12 years of age

3. Documented diagnosis of asthma for at least 6 months prior to Visit 1

4. Patients who are in need of GINA step 2 treatment

5. Patients treated with a short acting inhaled bronchodilator(s) only should have
pre-bronchodilator FEV1 = 60 % of predicted normal (PN) and post-bronchodilator FEV1 =
80 % PN

6. Patients treated with low stable dose of ICS or leukotriene antagonists in addition to
short acting inhaled bronchodilator(s) should have pre-bronchodilator FEV1 =80 % PN

7. Patients should have reversible airway obstruction

8. To be randomized patients must have used Bricanyl Turbuhaler as needed on at least 3
separate days during the last week of the run in period
Minimum age
12 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient has a history of life-threatening asthma including intubation and intensive
care unit admission

2. Patient has had an asthma worsening requiring change in treatment other than short
acting inhaled bronchodilator(s) within 30 days prior to Visit 1 and from Visit 1
until randomization

3. Patient has required treatment with oral, rectal or parenteral GCS within 30 days
and/or depot parenteral GCS within 12 weeks prior to Visit 1

4. Current or previous smoker with a smoking history of = 10 pack years

5. Pregnancy, breast-feeding or planned pregnancy during the study

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 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
28/11/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/08/2017
Sample size
Target
Accrual to date
Final
4215
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Botucatu
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Brazil
State/province [2] 0 0
Florianopolis
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Brazil
State/province [3] 0 0
Goiania
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Brazil
State/province [4] 0 0
Porto Alegre
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Brazil
State/province [5] 0 0
Salvador
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Brazil
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Santo Andre
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Brazil
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Sao Paulo
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Brazil
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Sorocaba
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Brazil
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São Paulo
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Bulgaria
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Blagoevgrad
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Bulgaria
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Pernik
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Bulgaria
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Petrich
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Bulgaria
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Pleven
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Bulgaria
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Razlog
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Bulgaria
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Sliven
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Bulgaria
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Smolyan
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Bulgaria
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Sofia
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Bulgaria
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Stara Zagora
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Bulgaria
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Varna
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Bulgaria
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Veliko Tarnovo
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Bulgaria
State/province [21] 0 0
Vidin
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Bulgaria
State/province [22] 0 0
Yambol
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Chile
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Curico
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Chile
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Quillota
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Chile
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Santiago
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Chile
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Talca
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Chile
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Viña del Mar
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Colombia
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Barranquilla
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Colombia
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Bogota
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Colombia
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Bogotá
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Colombia
State/province [31] 0 0
Medellin
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Czechia
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Ceska Lipa
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Czechia
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Kladno
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Czechia
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Kralupy nad Vltavou
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Czechia
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Kutna Hora
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Czechia
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Czechia
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Czechia
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Praha 5
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Czechia
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Praha
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Czechia
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Rokycany
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Czechia
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Rudna U Prahy
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Czechia
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Tabor
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Czechia
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Teplice
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Czechia
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Zatec
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France
State/province [49] 0 0
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Country [50] 0 0
France
State/province [50] 0 0
Colmar
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France
State/province [51] 0 0
Joue-les-Tours
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France
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Nantes Cedex 2
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France
State/province [53] 0 0
Nimes
Country [54] 0 0
France
State/province [54] 0 0
Reze
Country [55] 0 0
Germany
State/province [55] 0 0
Bad Lippspringe
Country [56] 0 0
Germany
State/province [56] 0 0
Berlin
Country [57] 0 0
Germany
State/province [57] 0 0
Cottbus
Country [58] 0 0
Germany
State/province [58] 0 0
Frankfurt/Main
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Germany
State/province [59] 0 0
Geesthacht
Country [60] 0 0
Germany
State/province [60] 0 0
Großhansdorf
Country [61] 0 0
Germany
State/province [61] 0 0
Hamburg
Country [62] 0 0
Germany
State/province [62] 0 0
Hannover
Country [63] 0 0
Germany
State/province [63] 0 0
Leipzig
Country [64] 0 0
Germany
State/province [64] 0 0
Lübeck
Country [65] 0 0
Germany
State/province [65] 0 0
Neu-Isenburg
Country [66] 0 0
Germany
State/province [66] 0 0
Oldenburg
Country [67] 0 0
Germany
State/province [67] 0 0
Reinfeld
Country [68] 0 0
Germany
State/province [68] 0 0
Rüdersdorf
Country [69] 0 0
Germany
State/province [69] 0 0
Schleswig
Country [70] 0 0
Germany
State/province [70] 0 0
Warendorf
Country [71] 0 0
Hungary
State/province [71] 0 0
Aszód
Country [72] 0 0
Hungary
State/province [72] 0 0
Balassagyarmat
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Hungary
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Berettyóújfalu
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Hungary
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Budapest
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Hungary
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Cegléd
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Hungary
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Gyula
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State/province [77] 0 0
Gödöllo
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Hungary
State/province [78] 0 0
Hajdúnánás
Country [79] 0 0
Hungary
State/province [79] 0 0
Létavértes
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Hungary
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Makó
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Hungary
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Miskolc
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Hungary
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Mórahalom
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Hungary
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Pécs
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Hungary
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Siófok
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Hungary
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Szeged
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Hungary
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Szombathely
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Hungary
State/province [87] 0 0
Vásárosnamény
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Hungary
State/province [88] 0 0
Érd
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Korea, Republic of
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Busan
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Korea, Republic of
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Cheongju-si
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Korea, Republic of
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Daegu
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seongnam-si
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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-si
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Korea, Republic of
State/province [97] 0 0
Wonju-si
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Chihuahua
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Tlanepantla
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Zapopan
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Maroubra
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Rotorua
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Tauranga
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Cercado De Lima
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Chancay
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Lima
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Peru
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Miraflores
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Peru
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Santa Beatriz
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Lipa City
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Philippines
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Manila
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Philippines
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Pasig City
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Philippines
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Quezon City
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Bialystok
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Poland
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Gizycko
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Poland
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Koscian
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Poland
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Kraków
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Lublin
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Mragowo
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Ostrów Wielkopolski
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Pabianice
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Pila
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Poland
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Poznan
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Poland
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Poland
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Rzeszów
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Poland
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Bragadiru
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Brasov
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Bucharest
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Constanta
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Russian Federation
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Kemerovo
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Russian Federation
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Moscow
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Russian Federation
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Tomsk
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Russian Federation
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Ufa
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Russian Federation
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Russian Federation
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Russian Federation
State/province [175] 0 0
Vsevolozhsk
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Dhahran
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Levice
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Zilina
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Zvolen
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South Africa
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Bellville
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South Africa
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Boksburg North
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South Africa
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Cape Town
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South Africa
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Durban
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South Africa
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Johannesburg
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South Africa
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Lenasia
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South Africa
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Mowbray
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South Africa
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Panorama
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South Africa
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Phoenix
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South Africa
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Verulam
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Alicante
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Badalona
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Barcelona
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Spain
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Bilbao (Vizcaya)
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Marbella (Málaga)
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Spain
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Oviedo
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Spain
State/province [215] 0 0
Sevilla
Country [216] 0 0
Spain
State/province [216] 0 0
Terrassa (Barcelona)
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Spain
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Valencia
Country [218] 0 0
Sweden
State/province [218] 0 0
Borås
Country [219] 0 0
Sweden
State/province [219] 0 0
Lund
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Sweden
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Malmo
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Sweden
State/province [221] 0 0
Stockholm
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State/province [222] 0 0
Värnamo
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Sweden
State/province [223] 0 0
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State/province [224] 0 0
Bangkok
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Thailand
State/province [225] 0 0
Chonburi
Country [226] 0 0
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State/province [226] 0 0
Hat Yai
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State/province [227] 0 0
Khon Kaen
Country [228] 0 0
Thailand
State/province [228] 0 0
Muang,
Country [229] 0 0
Thailand
State/province [229] 0 0
Nonthaburi
Country [230] 0 0
Thailand
State/province [230] 0 0
Pathumthani
Country [231] 0 0
Ukraine
State/province [231] 0 0
Cherkasy
Country [232] 0 0
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State/province [232] 0 0
Chernihiv
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Chernivtsi
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Dnipro
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Kherson
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Kyiv
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Lviv
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Odessa
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Ternopil
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Uzhgorod
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State/province [246] 0 0
Zaporizhzhya
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State/province [247] 0 0
Can Tho
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State/province [248] 0 0
Ha Noi
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Vietnam
State/province [249] 0 0
Hanoi
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State/province [250] 0 0
Ho Chi Minh
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Hochiminh
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Vietnam
State/province [252] 0 0
Hue

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to test if Symbicort (budesonide/formoterol) Turbuhaler is
effective in treating asthma when used 'as needed' in patients with milder asthma. The
efficacy of Symbicort 'as needed' will be compared with Pulmicort (budesonide) Turbuhaler
twice daily plus terbutaline Turbuhaler 'as needed'
Trial website
https://clinicaltrials.gov/ct2/show/NCT02224157
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Carin Jorup, MD
Address 0 0
AstraZeneca Research & Development
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02224157