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    Clinical Trial Results:
    A 6-week, phase III, double-blind, randomized, multi-centre, parallel-group study evaluating the efficacy and safety of 2 actuations Symbicort® (budesonide/formoterol) pMDI 40/2.25 μg twice daily compared with 1 inhalation Symbicort® Turbuhaler® 80/4.5 μg twice daily and 1 inhalation Pulmicort® (budesonide) Turbuhaler® 100 μg twice daily in adult and adolescent asthmatics

    Summary
    EudraCT number
    2007-002734-11
    Trial protocol
    HU   CZ   PL  
    Global end of trial date
    21 Jul 2008

    Results information
    Results version number
    v1(current)
    This version publication date
    01 Feb 2017
    First version publication date
    31 Jul 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D5897C00003
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    AstraZeneca R&D, SE-221 87 Lund, Sweden,
    Public contact
    Tomas Andersson, MD, AstraZeneca, aztrial_results_posting@astrazeneca.com
    Scientific contact
    Tomas Andersson, MD, AstraZeneca, aztrial_results_posting@astrazeneca.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    21 Jul 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Jul 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jul 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to show that Symbicort pMDI 40/2.25 μg 2 actuations bid is more efficacious than Pulmicort Turbuhaler 100 μg 1 inhalation bid over a 6-week treatment period in adolescents and adults with asthma by evaluation of change in morning peak expiratory flow (PEF) from baseline to the treatment period as the primary outcome variable. To compare the efficacy of Symbicort pMDI 40/2.25 μg 2 actuations bid with that of Symbicort Turbuhaler 80/4.5 μg 1 inhalation bid over a 6-week treatment period in adolescents and adults with asthma.
    Protection of trial subjects
    The study was approved in 4 countries by the independent ethics committees in the respective country. Informed consent was obtained from adult patients before any study specific procedure was conducted. For adolescent patients, informed consent was obtained from the patients’ parents/legal guardians, and subjects signed the paediatric study subject assent form before any study specific procedure.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    14 Sep 2007
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 264
    Country: Number of subjects enrolled
    Hungary: 227
    Country: Number of subjects enrolled
    Czech Republic: 132
    Country: Number of subjects enrolled
    Bulgaria: 119
    Worldwide total number of subjects
    742
    EEA total number of subjects
    742
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    104
    Adults (18-64 years)
    591
    From 65 to 84 years
    47
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    898 subjects enrolled; 156 not randomised: 94 incorrect enrolment, 9 adverse events, 18 voluntary discontinuations, 1 lost to follow-up, 1use of not allowed medication, 1 non-compliant

    Pre-assignment
    Screening details
    The study consisted of an enrolment visit, a 2-week run-in (standardization) period, randomization at Visit 3, and 2 further visits (Visits 4, 5) at 3 and 6 weeks. Subjects received 1 of 3 double-blinded treatments allocated in a random order

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Symbicort pMDI
    Arm description
    Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
    Arm type
    Experimental

    Investigational medicinal product name
    Symbicort pMDI 40/2.25 μg 2 actuations bid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Symbicort pMDI 40/2.25 μg 2 actuations bid

    Arm title
    Symbicort Turbuhaler
    Arm description
    Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
    Arm type
    Active comparator

    Investigational medicinal product name
    Symbicort Turbuhaler 80/4.5 μg 1 inhalation bid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Symbicort Turbuhaler 80/4.5 μg 1 inhalation bid

    Arm title
    Pulmicort Turbuhaler
    Arm description
    Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
    Arm type
    Active comparator

    Investigational medicinal product name
    Pulmicort Turbuhaler 100 μg 1 inhalation bid
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Pulmicort Turbuhaler 100 μg 1 inhalation bid

    Number of subjects in period 1
    Symbicort pMDI Symbicort Turbuhaler Pulmicort Turbuhaler
    Started
    253
    246
    243
    Completed
    249
    241
    238
    Not completed
    4
    5
    5
         Other
    1
    1
    -
         Intake of prohibitted conmed
    -
    -
    1
         Safety Reasons
    -
    -
    1
         Adverse event, non-fatal
    3
    2
    3
         Consent withdrawn by subject
    -
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Symbicort pMDI
    Reporting group description
    Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily

    Reporting group title
    Symbicort Turbuhaler
    Reporting group description
    Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily

    Reporting group title
    Pulmicort Turbuhaler
    Reporting group description
    Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily

    Reporting group values
    Symbicort pMDI Symbicort Turbuhaler Pulmicort Turbuhaler Total
    Number of subjects
    253 246 243 742
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0
        Newborns (0-27 days)
    0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0
        Children (2-11 years)
    0 0 0 0
        Adolescents (12-17 years)
    33 34 37 104
        Adults (18-64 years)
    207 192 192 591
        From 65-84 years
    13 20 14 47
        85 years and over
    0 0 0 0
    Age Continuous |
    Units: years
        arithmetic mean (full range (min-max))
    41.2 (12 to 75) 41.4 (12 to 76) 39.3 (12 to 78) -
    Gender, Male/Female
    Units: Participants
        Female
    152 142 131 425
        Male
    101 104 112 317
    Race
    Units: Subjects
        White
    253 246 243 742
    Time since diagnosis
    Units: years
        median (full range (min-max))
    7.1 (1 to 44) 6.5 (1 to 56) 7.8 (1 to 40) -

    End points

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    End points reporting groups
    Reporting group title
    Symbicort pMDI
    Reporting group description
    Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily

    Reporting group title
    Symbicort Turbuhaler
    Reporting group description
    Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily

    Reporting group title
    Pulmicort Turbuhaler
    Reporting group description
    Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily

    Primary: Morning Peak Expiratory Flow (PEF) (L/min)

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    End point title
    Morning Peak Expiratory Flow (PEF) (L/min)
    End point description
    Mean morning PEF on treatment (calculated as a mean using all available data after randomisation). No imputation of missing data was performed
    End point type
    Primary
    End point timeframe
    Baseline to 6 weeks
    End point values
    Symbicort pMDI Symbicort Turbuhaler Pulmicort Turbuhaler
    Number of subjects analysed
    253
    245
    243
    Units: Liters/min
        arithmetic mean (full range (min-max))
    360 (145 to 797)
    360 (190 to 673)
    356 (147 to 623)
    Statistical analysis title
    Change in mPEF (L/min)
    Comparison groups
    Symbicort pMDI v Pulmicort Turbuhaler
    Number of subjects included in analysis
    496
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.001
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    8.07
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    3.26
         upper limit
    12.9
    Statistical analysis title
    Change in mPEF (L/min)
    Comparison groups
    Symbicort pMDI v Symbicort Turbuhaler
    Number of subjects included in analysis
    498
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.707
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.921
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -5.73
         upper limit
    3.88

    Secondary: Evening Peak Expiratory Flow (PEF) (L/min)

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    End point title
    Evening Peak Expiratory Flow (PEF) (L/min)
    End point description
    Mean evening PEF on treatment (calculated as a mean using all available data after randomisation). No imputation of missing data was performed
    End point type
    Secondary
    End point timeframe
    Baseline to 6 weeks
    End point values
    Symbicort pMDI Symbicort Turbuhaler Pulmicort Turbuhaler
    Number of subjects analysed
    253
    245
    243
    Units: Liters/min
        arithmetic mean (full range (min-max))
    372 (151 to 814)
    370 (190 to 675)
    366 (146 to 635)
    Statistical analysis title
    change in ePEF (L/min)
    Comparison groups
    Symbicort pMDI v Pulmicort Turbuhaler
    Number of subjects included in analysis
    496
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    < 0.001
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    10.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    6.11
         upper limit
    15.4
    Statistical analysis title
    Change in ePEF (L/min)
    Comparison groups
    Symbicort pMDI v Symbicort Turbuhaler
    Number of subjects included in analysis
    498
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.51
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    1.55
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -3.08
         upper limit
    6.18

    Secondary: Asthma Symptom Score, Night

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    End point title
    Asthma Symptom Score, Night
    End point description
    Mean Asthma Symptom Score (Night) on treatment calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms.
    End point type
    Secondary
    End point timeframe
    Baseline to 6 weeks
    End point values
    Symbicort pMDI Symbicort Turbuhaler Pulmicort Turbuhaler
    Number of subjects analysed
    253
    245
    243
    Units: Units on a scale
        arithmetic mean (full range (min-max))
    0.878 (0 to 2.17)
    0.852 (0 to 2.59)
    0.98 (0 to 2.84)
    Statistical analysis title
    Change in Asthma Symptom Score, Night
    Comparison groups
    Symbicort pMDI v Symbicort Turbuhaler
    Number of subjects included in analysis
    498
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.013
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.088
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.157
         upper limit
    -0.019
    Statistical analysis title
    Change in Asthma Symptom Score, Night
    Comparison groups
    Symbicort pMDI v Symbicort Turbuhaler
    Number of subjects included in analysis
    498
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.403
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    0.029
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.039
         upper limit
    0.098

    Secondary: Asthma Symptom Score, Day

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    End point title
    Asthma Symptom Score, Day
    End point description
    Mean Asthma Symptom Score (Day) on treatment (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms
    End point type
    Secondary
    End point timeframe
    Baseline to 6 weeks
    End point values
    Symbicort pMDI Symbicort Turbuhaler Pulmicort Turbuhaler
    Number of subjects analysed
    253
    245
    243
    Units: Units on a scale
        arithmetic mean (full range (min-max))
    0.845 (0 to 2.74)
    0.798 (0 to 2.54)
    0.901 (0 to 2.87)
    Statistical analysis title
    Change in Asthma Symptom Score, Day
    Comparison groups
    Symbicort pMDI v Pulmicort Turbuhaler
    Number of subjects included in analysis
    496
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.075
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.06
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.127
         upper limit
    0.006
    Statistical analysis title
    Change in Asthma Symptom Score, day
    Comparison groups
    Symbicort pMDI v Symbicort Turbuhaler
    Number of subjects included in analysis
    498
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.347
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    0.032
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.035
         upper limit
    0.098

    Secondary: Asthma Symptom Score, Total

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    End point title
    Asthma Symptom Score, Total
    End point description
    Mean Asthma Symptom Score (Total) on treatment (calculated as a mean using all available data after randomization, with run-in values as covariate). No imputation of missing data was performed. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms
    End point type
    Secondary
    End point timeframe
    Baseline to 6 weeks
    End point values
    Symbicort pMDI Symbicort Turbuhaler Pulmicort Turbuhaler
    Number of subjects analysed
    253
    245
    243
    Units: Units on a scale
        arithmetic mean (full range (min-max))
    1.72 (0 to 4.91)
    1.65 (0 to 5.13)
    1.88 (0 to 5.72)
    Statistical analysis title
    Change in Asthma Symptom Score, Total
    Comparison groups
    Symbicort pMDI v Pulmicort Turbuhaler
    Number of subjects included in analysis
    496
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.023
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.148
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.275
         upper limit
    -0.02
    Statistical analysis title
    Change in Asthma Symptom Score, Total
    Comparison groups
    Symbicort pMDI v Symbicort Turbuhaler
    Number of subjects included in analysis
    498
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.356
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    0.06
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.067
         upper limit
    0.187

    Secondary: Percentage of Nights With Awakenings Due to Asthma

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    End point title
    Percentage of Nights With Awakenings Due to Asthma
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to 6 weeks
    End point values
    Symbicort pMDI Symbicort Turbuhaler Pulmicort Turbuhaler
    Number of subjects analysed
    253
    245
    243
    Units: Percentage of night
        arithmetic mean (full range (min-max))
    23.9 (0 to 100)
    25.9 (0 to 100)
    30.4 (0 to 100)
    Statistical analysis title
    Percentage of Nights With Awakenings Due to Asthma
    Comparison groups
    Symbicort pMDI v Pulmicort Turbuhaler
    Number of subjects included in analysis
    496
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.003
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -5.95
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -9.88
         upper limit
    -2.01
    Statistical analysis title
    Percentage of Nights With Awakenings Due to Asthma
    Comparison groups
    Symbicort pMDI v Symbicort Turbuhaler
    Number of subjects included in analysis
    498
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.743
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.655
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -4.58
         upper limit
    3.27

    Secondary: Use of Rescue Medication, Night

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    End point title
    Use of Rescue Medication, Night
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to 6 weeks
    End point values
    Symbicort pMDI Symbicort Turbuhaler Pulmicort Turbuhaler
    Number of subjects analysed
    253
    245
    243
    Units: Inhalations
        arithmetic mean (full range (min-max))
    0.65 (0 to 4.74)
    0.757 (0 to 8.17)
    0.844 (0 to 5.66)
    Statistical analysis title
    Use of Rescue Medication, Night
    Comparison groups
    Symbicort pMDI v Pulmicort Turbuhaler
    Number of subjects included in analysis
    496
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.215
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.33
         upper limit
    -0.1
    Statistical analysis title
    Use of Rescue Medication, Night
    Comparison groups
    Symbicort pMDI v Symbicort Turbuhaler
    Number of subjects included in analysis
    498
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.482
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.041
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.156
         upper limit
    0.074

    Secondary: Use of Rescue Medication, Day

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    End point title
    Use of Rescue Medication, Day
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to 6 weeks
    End point values
    Symbicort pMDI Symbicort Turbuhaler Pulmicort Turbuhaler
    Number of subjects analysed
    253
    245
    243
    Units: Inhalations
        arithmetic mean (full range (min-max))
    0.289 (0 to 3.81)
    0.329 (0 to 4.6)
    0.407 (0 to 5.15)
    Statistical analysis title
    Use of Rescue Medication, Day
    Comparison groups
    Symbicort pMDI v Pulmicort Turbuhaler
    Number of subjects included in analysis
    496
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.013
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.092
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.165
         upper limit
    -0.02
    Statistical analysis title
    Use of Rescue Medication, Day
    Comparison groups
    Symbicort pMDI v Symbicort Turbuhaler
    Number of subjects included in analysis
    498
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.572
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.021
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.145
         upper limit
    0.052

    Secondary: Use of Rescue Medication, Total

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    End point title
    Use of Rescue Medication, Total
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to 6 weeks
    End point values
    Symbicort pMDI Symbicort Turbuhaler Pulmicort Turbuhaler
    Number of subjects analysed
    253
    245
    243
    Units: Inhalations
        arithmetic mean (full range (min-max))
    0.939 (0 to 8.55)
    1.09 (0 to 10.8)
    1.25 (0 to 10.8)
    Statistical analysis title
    Use of Rescue Medication, Total
    Comparison groups
    Symbicort pMDI v Pulmicort Turbuhaler
    Number of subjects included in analysis
    496
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.303
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.473
         upper limit
    -0.132
    Statistical analysis title
    Use of Rescue Medication, Total
    Comparison groups
    Symbicort pMDI v Symbicort Turbuhaler
    Number of subjects included in analysis
    498
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.474
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.062
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.232
         upper limit
    0.108

    Secondary: Percentage of Symptom-free Days

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    End point title
    Percentage of Symptom-free Days
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to 6 weeks
    End point values
    Symbicort pMDI Symbicort Turbuhaler Pulmicort Turbuhaler
    Number of subjects analysed
    253
    245
    243
    Units: Percentage of days
        arithmetic mean (full range (min-max))
    18.9 (0 to 97.7)
    22.4 (0 to 96.4)
    15 (0 to 95.2)
    Statistical analysis title
    Percentage of Symptom-free Days
    Comparison groups
    Symbicort pMDI v Pulmicort Turbuhaler
    Number of subjects included in analysis
    496
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.126
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    3.16
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.891
         upper limit
    7.21
    Statistical analysis title
    Percentage of Symptom-free Days
    Comparison groups
    Symbicort pMDI v Symbicort Turbuhaler
    Number of subjects included in analysis
    498
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.186
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -2.73
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6.77
         upper limit
    1.32

    Secondary: Percentage of Asthma Control Days

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    End point title
    Percentage of Asthma Control Days
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to 6 weeks
    End point values
    Symbicort pMDI Symbicort Turbuhaler Pulmicort Turbuhaler
    Number of subjects analysed
    253
    245
    243
    Units: Percentage of days
        arithmetic mean (full range (min-max))
    18.8 (0 to 97.7)
    21.9 (0 to 96.4)
    14.7 (0 to 95.2)
    Statistical analysis title
    Percentage of Asthma Control Days
    Comparison groups
    Symbicort pMDI v Symbicort Turbuhaler
    Number of subjects included in analysis
    498
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.264
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -2.29
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6.32
         upper limit
    1.73
    Statistical analysis title
    Percentage of Asthma Control Days
    Comparison groups
    Symbicort pMDI v Pulmicort Turbuhaler
    Number of subjects included in analysis
    496
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.097
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    3.42
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.615
         upper limit
    7.45

    Secondary: Percentage of Rescue free Days

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    End point title
    Percentage of Rescue free Days
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to 6 weeks
    End point values
    Symbicort pMDI Symbicort Turbuhaler Pulmicort Turbuhaler
    Number of subjects analysed
    253
    245
    243
    Units: Percentage of days
        arithmetic mean (full range (min-max))
    59 (0 to 100)
    57.8 (0 to 100)
    50.9 (0 to 100)
    Statistical analysis title
    Percentage of Rescue free Days
    Comparison groups
    Symbicort pMDI v Pulmicort Turbuhaler
    Number of subjects included in analysis
    496
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.005
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    7.13
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    2.18
         upper limit
    12.1
    Statistical analysis title
    Percentage of Rescue free Days
    Comparison groups
    Symbicort pMDI v Symbicort Turbuhaler
    Number of subjects included in analysis
    498
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.632
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -1.21
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -6.15
         upper limit
    3.73

    Secondary: Forced Expiratory Volume in 1 Second (FEV1) (L)

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    End point title
    Forced Expiratory Volume in 1 Second (FEV1) (L)
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to 6 weeks
    End point values
    Symbicort pMDI Symbicort Turbuhaler Pulmicort Turbuhaler
    Number of subjects analysed
    253
    243
    242
    Units: Liters
        arithmetic mean (full range (min-max))
    2.59 (0.855 to 5.69)
    2.62 (1.18 to 4.86)
    2.65 (0.88 to 4.92)
    Statistical analysis title
    Change in FEV1 (L)
    Comparison groups
    Symbicort pMDI v Pulmicort Turbuhaler
    Number of subjects included in analysis
    495
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.51
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.02
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.0792
         upper limit
    0.0393
    Statistical analysis title
    Change in FEV1 (L)
    Comparison groups
    Symbicort pMDI v Symbicort Turbuhaler
    Number of subjects included in analysis
    496
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.096
    Method
    ANOVA
    Parameter type
    Mean difference (net)
    Point estimate
    -0.0502
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.109
         upper limit
    0.00889

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected from the enrolment visit (visit 1) until visit 5 (6 weeks after randomisation). Only AEs occuring on or after the first dose of study medication are presented in the summaries below,
    Adverse event reporting additional description
    A total of 99 patients reported non-serious adverse events; 38 on Symbicort pMDI, 30 on Symbicort Turbohaler, 31 on Pulmicort Turbohaler. Numbers for non-serious AEs in the reporting group table are based on the 2% threshold frequency.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    10.1
    Reporting groups
    Reporting group title
    Symbicort pMDI
    Reporting group description
    Symbicort pMDI

    Reporting group title
    Pulmicort Turbuhaler
    Reporting group description
    Pulmicort Turbuhaler

    Reporting group title
    Symbicort Turbuhaler
    Reporting group description
    Symbicort Turbuhaler

    Serious adverse events
    Symbicort pMDI Pulmicort Turbuhaler Symbicort Turbuhaler
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 253 (0.00%)
    1 / 243 (0.41%)
    1 / 246 (0.41%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
    alternative dictionary used: MedDRA 10.1
         subjects affected / exposed
    0 / 253 (0.00%)
    1 / 243 (0.41%)
    1 / 246 (0.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    Symbicort pMDI Pulmicort Turbuhaler Symbicort Turbuhaler
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 253 (8.30%)
    14 / 243 (5.76%)
    19 / 246 (7.72%)
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 253 (0.00%)
    4 / 243 (1.65%)
    2 / 246 (0.81%)
         occurrences all number
    0
    4
    2
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    6 / 253 (2.37%)
    4 / 243 (1.65%)
    5 / 246 (2.03%)
         occurrences all number
    6
    4
    5
    Pharyngitis
         subjects affected / exposed
    6 / 253 (2.37%)
    3 / 243 (1.23%)
    5 / 246 (2.03%)
         occurrences all number
    6
    3
    5
    Viral infection
         subjects affected / exposed
    5 / 253 (1.98%)
    3 / 243 (1.23%)
    1 / 246 (0.41%)
         occurrences all number
    5
    3
    1
    Nasopharyngitis
         subjects affected / exposed
    4 / 253 (1.58%)
    2 / 243 (0.82%)
    6 / 246 (2.44%)
         occurrences all number
    4
    2
    6

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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