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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02149199




Registration number
NCT02149199
Ethics application status
Date submitted
16/05/2014
Date registered
29/05/2014
Date last updated
15/11/2019

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 Terbutaline 'as Needed' and With Pulmicort® Twice Daily Plus Terbutaline 'as Needed' in Adult and Adolescent Patients With Asthma.
Secondary ID [1] 0 0
2013-004474-96
Secondary ID [2] 0 0
D589SC00001
Universal Trial Number (UTN)
Trial acronym
SYGMA1
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 - terbutaline 'as needed' + placebo budesonide bid
Treatment: Drugs - budesonide 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: terbutaline "as needed"+placebo Pulmicort bid - terbutaline Turbuhaler 0.4 mg 'as needed' + placebo Pulmicort 200 µg Turbuhaler 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: terbutaline 'as needed' + placebo budesonide bid
Terbutaline 0.4 mg powder for inhalation 'as needed' plus placebo Pulmicort (budesonide) 200 µg powder for inhalation, 1 inhalation twice daily (morning and evening), 52-week treatment

Treatment: Drugs: budesonide 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
'Well-controlled Asthma Week' - a Derived Binary Variable (Yes/No) - A well-controlled asthma week is defined as the fulfilment of both conditions A) and B) below: A) Two or more of the following criteria are fulfilled: - No more than 2 days with a daily asthma symptom score >1 - No more than 2 days of 'as needed' medication use, up to a maximum of 4 occasions per week (multiple occasions per day should be regarded as separate occasions) - Morning PEF =80% of Predicted Normal every day B) Both of the following criteria are fulfilled: - No nighttime awakenings due to asthma - No additional inhaled and/or systemic glucocorticosteroid treatment due to asthma. The binary variable well-controlled asthma week was derived for each patient and study week. In addition, for each week, the percent of patients with well-controlled asthma week was derived. It is required that the eDiary had to be completed on at least 5 days in a week to be a well-controlled asthma week.
Timepoint [1] 0 0
Weekly, up to 52 weeks
Secondary outcome [1] 0 0
Number of Participants Experiencing at Least One Severe Asthma Exacerbation - A severe exacerbation is defined as a deterioration of asthma requiring any of the following: use of systemic glucocorticosteroids (GCS) for at least 3 days, inpatient hospitalization, or emergency room visit due to asthma that required systemic steroids
Timepoint [1] 0 0
Day 1 up to 52 weeks
Secondary outcome [2] 0 0
Number of Participants Experiencing at Least One Moderate or Severe Asthma Exacerbation - A moderate exacerbation is defined as a deterioration of asthma requiring a change in treatment, i.e. initiation of prescribed additional ICS treatment to avoid progression of the worsening of asthma to a severe exacerbation.
A severe exacerbation is defined as a deterioration of asthma requiring any of the following: use of systemic glucocorticosteroids (GCS) for at least 3 days, inpatient hospitalization, or emergency room visit due to asthma that required systemic steroids
Timepoint [2] 0 0
Day 1 up to 52 weeks
Secondary outcome [3] 0 0
Average Change From Baseline in Pre-dose Forced Expiratory Volume in 1 Second (FEV1) - Overall estimate of FEV1 (mL) pre-bronchodilator change from baseline. Baseline is the measurement at Visit 3 (prior to first dose of Investigational Product) from MMRM (mixed model repeated measures analysis).
Timepoint [3] 0 0
Study weeks 0,4,16,28,40,52
Secondary outcome [4] 0 0
Average Change From Baseline in Morning Peak Expiratory Flow (PEF) - Morning peak expiratory flow (eDiary) change from baseline over the randomised treatment period. Baseline is defined as the mean of all non-missing morning measurements during the last 10 days of the run-in period.
Timepoint [4] 0 0
up to 52 weeks
Secondary outcome [5] 0 0
Average Change From Baseline in Evening PEF - Evening peak expiratory flow (eDiary) change from baseline during the randomised treatment period. Baseline is defined as the mean of all non-missing evening measurements during the last 10 days of the run-in period.
Timepoint [5] 0 0
up to 52 weeks
Secondary outcome [6] 0 0
Average Change From Baseline in Number of Inhalations of 'as Needed' Medication. - 'As needed' inhalations change from baseline over the randomised treatment period. Baseline is defined as the last 10 days of the run-in period. 'As needed' use was calculated as the cumulative doses of 'as needed' medication over the randomised treatment period divided by the follow-up time (number of days - 1). ie, average number of inhalations per day.
Timepoint [6] 0 0
up to 52 weeks
Secondary outcome [7] 0 0
Average Change From Baseline in Asthma Symptom Score - Asthma symptom score (eDiary) change from baseline during the randomised treatment period. Symptom score is entered morning and evening by the patient on a 4-point scale from 0 to 3 with higher values indicating more severe symptoms. Asthma symptom score is then the sum of the day and night scores, which implies a range of scores from 0 - 6, with higher values indicating more severe symptoms. Baseline is defined as the mean of all non-missing measurements during the last 10 days of the run-in period.
Timepoint [7] 0 0
up to 52 weeks
Secondary outcome [8] 0 0
Change From Baseline in the Percentage of Nighttime Awakenings Due to Asthma - Night-time awakenings (%) due to asthma change from baseline. Variable analysed is the proportion (%) of nights during the relevant period with night-time awakenings. Baseline refers to the last 10 nights of the run-in period.
Timepoint [8] 0 0
up to 52 weeks
Secondary outcome [9] 0 0
Change From Baseline in Percentage of Symptom-free Days - Symptom-free days (%) change from baseline during the randomised treatment period.Variable analysed is the proportion (%) of symptom-free days during the relevant period. Baseline refers to the last 10 days of the run-in period.
Timepoint [9] 0 0
up to 52 weeks
Secondary outcome [10] 0 0
Change From Baseline in Percentage of 'As Needed' Free Days - 'As needed' free days (%) change from baseline during the randomised treatment period. An 'as needed' free day is defined as a day and night with no use of 'as needed' medication. Variable analysed is the proportion (%) of 'as needed' free days during the relevant period. Baseline refers to the last 10 days of the run-in period.
Timepoint [10] 0 0
up to 52 weeks
Secondary outcome [11] 0 0
Change From Baseline in Percentage of Asthma Control Days - Asthma control days (%) change from baseline. An asthma control day is defined as the fulfilment of all of the following criteria; a day and night with no asthma symptoms, a night with no awakenings due to asthma symptoms and a day and night with no use of 'as needed' medication. Variable analysed is the proportion (%) of asthma control days during the randomised treatment period. Baseline refers to the last 10 days of the run-in period.
Timepoint [11] 0 0
up to 52 weeks
Secondary outcome [12] 0 0
Number of Patients With Study Specific Asthma Related Discontinuation - Study specific asthma related discontinuation
Timepoint [12] 0 0
up to 52 weeks
Secondary outcome [13] 0 0
Poorly Controlled Asthma Weeks - A poorly-controlled asthma week is defined as a week meeting any one of the following conditions: Two or more consecutive days with awakenings due to asthma on both nights; A recorded use of 'as needed' medication for symptom relief of at least 3 occasions per day, for at least 2 consecutive days; Additional systemic GCS treatment required for severe exacerbation. If there were sufficient data within a week available to confirm the week was not poorly-controlled, the week is labelled as 'does not meet criteria for poorly-controlled'.
Timepoint [13] 0 0
Weekly for up to 52 weeks
Secondary outcome [14] 0 0
Number of Participants Experiencing at Least One Occasion With Additional Steroids for Asthma - Additional steroids for asthma includes any additional inhaled and/or systemic glucocorticosteroids treatment due to asthma while in the randomised treatment period.
Timepoint [14] 0 0
Day 1 up to 52 weeks
Secondary outcome [15] 0 0
Average Change From Baseline in Asthma Control Questionnaire (ACQ-5) - Asthma Control Questionnaire 5-item version score change from baseline. ACQ questionnaire contains five questions on patients' symptoms, which are assessed on a 7-point scale from 0 (representing good control) to 6 (representing poor control). The score is the mean score of all questions for which responses are provided.
Timepoint [15] 0 0
Study weeks 0,4,16,28,40,52
Secondary outcome [16] 0 0
Average Change From Baseline in Asthma Quality of Life Questionnaire; Standard Version (AQLQ(S)) - Asthma Quality of Life Questionnaire Standardised Version (AQLQ (S) overall score change from baseline. AQLQ(S) consists of 32 questions in 4 domains. Each question is assessed on a 7-point scale from 1 to 7, with higher values indicating better health-related quality of life. The overall score is calculated as the mean score of all 32 items.
Timepoint [16] 0 0
Study weeks 0,16,28,40,52
Secondary outcome [17] 0 0
Percentage of Controller Use Days - ICS controller use days (%) during the randomised treatment period is calculated as the cumulative number of days when any controller medication (containing ICS) was taken including maintenance (Pulmicort bid group) and 'as needed' medication (Symbicort 'as needed' group) and additional prescribed ICS for asthma exacerbations and/or long term poor asthma control (all treatment groups), divided by the number of days in the randomised treatment period.
Timepoint [17] 0 0
up to 52 weeks
Secondary outcome [18] 0 0
Annual Severe Asthma Exacerbation Rate - Severe asthma exacerbations over the randomised treatment period.
Timepoint [18] 0 0
up to 52 weeks
Secondary outcome [19] 0 0
Annual Moderate or Severe Asthma Exacerbation Rate - Moderate or severe asthma exacerbations during the randomised treatment period.
Timepoint [19] 0 0
up to 52 weeks

Eligibility
Key inclusion criteria
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
Step 2 treatment according to Global Initiative for Asthma guidelines 5. Patients treated
with 'as needed' inhaled short-acting bronchodilator(s) only should have pre-bronchodilator
Forced Expiratory Volume in one second (FEV1) = 60 % of Predicted Normal (PN) and
post-bronchodilator FEV1 = 80 % PN 6. Patients treated with low stable dose of inhaled
corticosteroid or leukotriene antagonist in addition to 'as needed' use of inhaled
short-acting 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. 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 inhaled short-acting bronchodilator(s) within 30
days prior to Visit 1 or between Visits 1 and 2; or a treatment other than Bricanyl
Turbuhaler from Visit 2 until randomization 3. Patient has required treatment with oral,
rectal or parenteral glucocorticosteroids (GCS) within 30 days and/or depot parenteral GCS
within 12 weeks prior to Visit 1 4. Smoker (current or previous) with a smoking history of
= 10 pack years 5. Pregnancy, breast-feeding or planned pregnancy during the study.
Minimum age
12 Years
Maximum age
130 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Bedford Park
Recruitment hospital [2] 0 0
Research Site - Concord
Recruitment hospital [3] 0 0
Research Site - Maroubra
Recruitment hospital [4] 0 0
Research Site - Murdoch
Recruitment hospital [5] 0 0
Research Site - Wollongong
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2035 - Maroubra
Recruitment postcode(s) [4] 0 0
6150 - Murdoch
Recruitment postcode(s) [5] 0 0
2522 - Wollongong
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Alphaville
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Brazil
State/province [2] 0 0
Botucatu
Country [3] 0 0
Brazil
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Porto Alegre
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Brazil
State/province [4] 0 0
Salvador
Country [5] 0 0
Brazil
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Santo Andre
Country [6] 0 0
Brazil
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Sao Paulo
Country [7] 0 0
Brazil
State/province [7] 0 0
Sorocaba
Country [8] 0 0
Bulgaria
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Dupnitsa
Country [9] 0 0
Bulgaria
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Gotse Delchev
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Bulgaria
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Kozloduy
Country [11] 0 0
Bulgaria
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Pazardzhik
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Bulgaria
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Plovdiv
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Bulgaria
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Razgrad
Country [14] 0 0
Bulgaria
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Roman
Country [15] 0 0
Bulgaria
State/province [15] 0 0
Ruse
Country [16] 0 0
Bulgaria
State/province [16] 0 0
Sandanski
Country [17] 0 0
Bulgaria
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Sofia
Country [18] 0 0
Bulgaria
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Varna
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Bulgaria
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Velingrad
Country [20] 0 0
Bulgaria
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Vratsa
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Newfoundland and Labrador
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Canada
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Ontario
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Canada
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Quebec
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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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Talcahuano
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Beijing
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China
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Changsha
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China
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Chengdu
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Guangzhou
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Haikou
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Hohhot
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Shenyang
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Xuzhou
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Edelény
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Hajdúnánás
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Pécs
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Szeged
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Korea, Republic of
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Cheongju-si
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Incheon
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Seoul
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Surco
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Bialystok
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Kielce
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Poznan
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Slupca
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Tarnów
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Trzebnica
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Turek
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Zabrze
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Lódz
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Romania
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Brasov
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Cluj-Napoca
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Romania
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Constanta
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Romania
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Pitesti
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Romania
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Timisoara
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Russian Federation
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Chelyabinsk
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Ekaterinburg
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Gatchina
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Ivanovo
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Kazan
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Kemerovo
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Krasnoyarsk
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Moscow
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Nizhny Novgorod
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Novosibirsk
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Penza
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Perm
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Russian Federation
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Petrozavodsk
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Russian Federation
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Pyatigorsk
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Russian Federation
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Ryazan
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Russian Federation
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Saint - Petersburg
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Russian Federation
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Saint Petersburg
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Saratov
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Russian Federation
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St. Petersburg
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Russian Federation
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St.Petersburg
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Russian Federation
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Ulyanovsk
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Russian Federation
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Vladikavkaz
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Russian Federation
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Volgograd
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Russian Federation
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Voronezh
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Russian Federation
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Yaroslavl
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South Africa
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Boksburg North
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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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Middelburg
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South Africa
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Queenswood
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South Africa
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Stanger
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South Africa
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Verulam
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Ukraine
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Cherkasy
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Ukraine
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Dnipropetrovsk
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Ukraine
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Ivano-Frankivsk
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Ukraine
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Kharkiv
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Ukraine
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Kyiv
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Ukraine
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Lutsk
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Ukraine
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Lviv
Country [137] 0 0
Ukraine
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Odesa
Country [138] 0 0
Ukraine
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Vinnytsia
Country [139] 0 0
Ukraine
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Zaporizhzhya
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United Kingdom
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Bath
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United Kingdom
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Coventry
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United Kingdom
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Leamington Spa
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United Kingdom
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Mortimer Reading
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United Kingdom
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Trowbridge
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Vietnam
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Dong Nai
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Vietnam
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Hai Phong
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Vietnam
State/province [147] 0 0
Hanoi
Country [148] 0 0
Vietnam
State/province [148] 0 0
Ho Chi Minh
Country [149] 0 0
Vietnam
State/province [149] 0 0
Hochiminh

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: 1) terbutaline Turbuhaler® 'as
needed' and with 2) Pulmicort (budesonide) Turbuhaler® twice daily plus terbutaline
Turbuhaler® 'as needed'.
Trial website
https://clinicaltrials.gov/show/NCT02149199
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul M O'Byrne, MB, FRCP(C), FRSC
Address 0 0
McMaster University, Hamilton, Canada
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
Other publications