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    Clinical Trial Results:
    A 12-Week, Double-Blind, Randomised, Multi-Centre, Parallel-Group Study Evaluating the Efficacy, Safety, and Patient Use (User Study) of Symbicort®1 (Budesonide/Formoterol) Breath-Actuated Metered Dose Inhaler (BA MDI) 2x160/4.5 μg Twice Daily Compared with Symbicort® (Budesonide/Formoterol) AC (Actuation Counter) pMDI 2x160/4.5 μg Twice Daily and Budesonide AC pMDI 2x160 μg Twice Daily in Adult and Adolescent Asthmatics

    Summary
    EudraCT number
    		 2011-002523-17
    Trial protocol
    		 HU   BG  
    Global end of trial date
    02 Mar 2013

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

    Trial information

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    Trial identification
    Sponsor protocol code
    D589OC00003
    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-431 83 Mölndal, Sweden,
    Public contact
    Dr Ulf Nihlen, MD, AstraZeneca, aztrial_results_posting@astrazeneca.com
    Scientific contact
    Dr Ulf Nihlen, 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
    02 Mar 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Mar 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Mar 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare the efficacy of Symbicort BA MDI 2x160/4.5 μg bid with that of Symbicort AC pMDI 2x160/4.5 μg bid by evaluation of: forced expiratory volume during first second (FEV1), 60 minutes post-dose and FEV1 pre-dose.
    Protection of trial subjects
    The Institutional review board (IRB)/independent ethics committee (IEC) for each study site approved the final clinical study protocol (CSP), including the final version of the informed consent form (ICF) and any other written information and/or materials that were provided to the patients. The PI at each centre ensured that each patient was given full and adequate oral and written information about the nature, purpose, possible risk, and benefit of the study. Each patient was notified that they were free to discontinue from the study at any time. Patients were given the opportunity to ask questions and were allowed time to consider the information provided. The PI at each centre ensured that each patient provided signed and dated informed consent before conducting any procedure specifically for the study. In patients below the age of consent, informed consent was obtained from both the patient and the patient’s parent/legal guardian
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Nov 2011
    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
    Hungary: 38
    Country: Number of subjects enrolled
    United States: 150
    Country: Number of subjects enrolled
    Bulgaria: 26
    Worldwide total number of subjects
    214
    EEA total number of subjects
    64
    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)
    21
    Adults (18-64 years)
    178
    From 65 to 84 years
    15
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This was a multicentre trial conducted in 3 countries between November 2011 and August 2012.

    Pre-assignment
    Screening details
    		 The study consisted from an enrolment visit, a 2- week run in (standardization) period, randomization at visit 4, and 3 further visits (visits 5- 7) at 3, 7 and 12 weeks. During the 2-week-run-in period patients were treated with budesonide AC pMDI 2x160μg bid. After this period subjects were randomized to receive 1 of 3 doouble blinded treatments.

    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, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Symbicort BA MDI
    Arm description
    		 Symbicort BA MDI 2x160/4.5 μg twice daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    Symbicort BA MDI
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Symbicort BA MDI 2x160/4.5 μg twice daily

    Arm title
    		 Symbicort pMDI
    Arm description
    		 Symbicort AC pDMI 2x160/4.5 μg twice daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    Symbicort pMDI
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Symbicort pMDI 2x160/4.5 μg twice daily

    Arm title
    		 Budesonide
    Arm description
    		 Budesonide AC pMDI 2x160 μg twice daily
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Budesonide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Budesonide pMDI 2x160 μg twice daily

    Number of subjects in period 1
    		Symbicort BA MDI Symbicort pMDI Budesonide
    Started
    71
    71
    72
    Completed
    63
    67
    65
    Not completed
    8
    4
    7
         Consent withdrawn by subject
    4
    -
    2
         Adverse event, non-fatal
    2
    3
    3
         Eligibility criteria + other
    2
    1
    1
         Protocol deviation
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Symbicort BA MDI
    Reporting group description
    		 Symbicort BA MDI 2x160/4.5 μg twice daily

    Reporting group title
    Symbicort pMDI
    Reporting group description
    		 Symbicort AC pDMI 2x160/4.5 μg twice daily

    Reporting group title
    Budesonide
    Reporting group description
    		 Budesonide AC pMDI 2x160 μg twice daily

    Reporting group values
    		 Symbicort BA MDI Symbicort pMDI Budesonide Total
    Number of subjects
    		 71 71 72 214
    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)
    		 6 8 7 21
        Adults (18-64 years)
    		 60 56 62 178
        From 65-84 years
    		 5 7 3 15
        85 years and over
    		 0 0 0 0
    Age Continuous |
    Units: Years
        arithmetic mean (standard deviation)
    		 42.83 ± 16.156 42.62 ± 16.873 42.72 ± 14.424 -
    Gender, Male/Female
    Units: Participants
        Female
    		 37 47 35 119
        Male
    		 34 24 37 95
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0 0
        Asian
    		 4 1 1 6
        Native Hawaiian or Other Pacific Islander
    		 0 0 1 1
        Black or African American
    		 9 7 11 27
        White
    		 57 63 57 177
        More than one race
    		 0 0 0 0
        Unknown or Not Reported
    		 1 0 2 3
    Years since asthma diagnosis
    Units: years
        arithmetic mean (standard deviation)
    		 24.26 ± 14.891 24.12 ± 15.128 24.38 ± 15.183 -

    End points

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    End points reporting groups
    Reporting group title
    Symbicort BA MDI
    Reporting group description
    		 Symbicort BA MDI 2x160/4.5 μg twice daily

    Reporting group title
    Symbicort pMDI
    Reporting group description
    		 Symbicort AC pDMI 2x160/4.5 μg twice daily

    Reporting group title
    Budesonide
    Reporting group description
    		 Budesonide AC pMDI 2x160 μg twice daily

    Primary: Forced expiratory volume in 1 second (FEV1) - Post dose

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    End point title
    		 Forced expiratory volume in 1 second (FEV1) - Post dose
    End point description
    Descriptive statistics for post-dose FEV1 (L) by visit; Baseline defined as the last pre-dose value prior to 1st dose of randomized therapy. Trt Avg = Mean of all available valid values after randomization.
    End point type
    Primary
    End point timeframe
    60 minutes post-dose in clinic visits at baseline, and week 3, 7, 12
    End point values
    		 Symbicort BA MDI Symbicort pMDI Budesonide
    Number of subjects analysed
    71
    71
    71
    Units: Liter
    geometric mean (geometric coefficient of variation)
        Baseline (Week 0 )
    2.09 ± 31.46
    1.97 ± 27.16
    2.12 ± 26.34
        Week 0
    2.49 ± 32.14
    2.35 ± 25.97
    2.28 ± 27.18
        Week 3
    2.52 ± 31.98
    2.34 ± 26.31
    2.3 ± 30.22
        Week 7
    2.59 ± 32.17
    2.35 ± 27.22
    2.33 ± 29.29
        Week 12
    2.52 ± 30.71
    2.39 ± 27.31
    2.3 ± 28.27
        Treatment Average
    2.53 ± 30.57
    2.37 ± 26.33
    2.3 ± 28.36
    Statistical analysis title
    		 FEV1 - Symbicort pMDI vs Budesonide
    Statistical analysis description
    The comparison of Symbicort AC pMDI 2x160/4.5 µg bid with budesonide AC pMDI 2x160 µg bid for post dose FEV1
    Comparison groups
    Symbicort pMDI v Budesonide
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Estimated Geometic Mean Ratio
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.06
         upper limit
    		 1.14
    Statistical analysis title
    		 FEV1 - Symbicort BA MDI vs Symbicort pMDI
    Statistical analysis description
    The comparisons of Symbicort BA MDI 2x160/4.5 µg bid with Symbicort AC pMDI 2x160/4.5 µg bid for post dose FEV1.
    Comparison groups
    Symbicort BA MDI v Symbicort pMDI
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.547
    Method
    		 ANCOVA
    Parameter type
    		 Estimated Geometric Mean Ratio
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.97
         upper limit
    		 1.05
    Notes
    [1] - Assuming a standard deviation of 0.2 (for pre dose FEV1) on the log-scale and 60 patients/arm, the width of the confidence interval will extend 0.072 from the point estimate on the log-scale. The lower and upper limits of the CI for the ratio of effects will thus be obtained by multiplying the estimated ratio by 0.931 and 1.075, respectively.

    Primary: Forced expiratory volume in 1 second (FEV1) - Pre dose

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    End point title
    		 Forced expiratory volume in 1 second (FEV1) - Pre dose
    End point description
    Descriptive statistics for predose FEV1(L) by visit; Baseline defined as the last pre-dose value prior to 1st dose of randomized therapy. Trt Avg = Mean of all available valid values after randomization.
    End point type
    Primary
    End point timeframe
    Pre AM dose in clinic visits at baseline, and week 3, 7, 12
    End point values
    		 Symbicort BA MDI Symbicort pMDI Budesonide
    Number of subjects analysed
    71
    71
    71
    Units: Liters
    geometric mean (geometric coefficient of variation)
        Baseline (Week 0)
    2.09 ± 31.46
    1.97 ± 27.16
    2.12 ± 26.34
        Week 3
    2.32 ± 32.79
    2.12 ± 28.29
    2.22 ± 31.21
        Week 7
    2.4 ± 32.86
    2.11 ± 29.96
    2.25 ± 29.01
        Week 12
    2.34 ± 30.84
    2.17 ± 31.29
    2.23 ± 30.15
        Average of treatment period
    2.34 ± 30.15
    2.15 ± 29.15
    2.23 ± 29.36
    Statistical analysis title
    		 FEV1 pre-dose - Symbicort BA MDI vs Symbicort pMDI
    Statistical analysis description
    The comparisons of Symbicort BA MDI 2x160/4.5 µg bid with Symbicort AC pMDI 2x160/4.5 µg bid, for pre-dose FEV1.
    Comparison groups
    Symbicort BA MDI v Symbicort pMDI
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 = 0.131
    Method
    		 ANCOVA
    Parameter type
    		 Estimated Geometric Mean Ratio
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.99
         upper limit
    		 1.08
    Notes
    [2] - Assuming a standard deviation of 0.2 (for pre dose FEV1) on the log-scale and 60 patients/arm, the width of the confidence interval will extend 0.072 from the point estimate on the log-scale. The lower and upper limits of the CI for the ratio of effects will thus be obtained by multiplying the estimated ratio by 0.931 and 1.075, respectively.

    Secondary: Peak expiratory flow

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    End point title
    		 Peak expiratory flow
    End point description
    End point type
    Secondary
    End point timeframe
    Recorded morning upon rising and evening before sleep for 14 weeks
    End point values
    		 Symbicort BA MDI Symbicort pMDI Budesonide
    Number of subjects analysed
    71
    71
    71
    Units: L/Min
    arithmetic mean (standard deviation)
        Morning Peak expiratory flow (Baseline)
    357.95 ± 100.59
    335.7 ± 102.99
    360.46 ± 103.09
        Evening Peak expiratory flow (Baseline)
    364.61 ± 103.62
    347.86 ± 110.8
    367.64 ± 102.73
        Evening Peak expiratory flow (Treatment Average)
    379.96 ± 104.72
    362.99 ± 112.63
    348.94 ± 97.94
        Morning Peak expiratory flow (Treatment Average)
    376.28 ± 106.76
    353.69 ± 108.72
    343.59 ± 98.12
    Statistical analysis title
    		 mPEF - Symbicort BA MDI vs Symbicort pMDI
    Statistical analysis description
    Morning peak expiratory flow (mPEF): Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort BA MDI 2x160/4.5 μg bid and Symbicort AC pMDI 2x160/4.5 µg bid
    Comparison groups
    Symbicort BA MDI v Symbicort pMDI
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 = 0.825
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    1.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.81
         upper limit
    		 14.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.75
    Notes
    [3] - No adjustment were be made for multiplicity for these supportive variables and nominal p-values were reported.
    Statistical analysis title
    		 mPEF - Symbicort pMDI vs Budesonide
    Statistical analysis description
    Morning peak expiratory flow (mPEF): Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort AC pMDI 2x160/4.5 µg bid minus Budesonide AC pMDI 2x160 µg bid
    Comparison groups
    Symbicort pMDI v Budesonide
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    33.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 20.11
         upper limit
    		 46.93
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.8
    Statistical analysis title
    		 ePEF - Symbicort BA MDI vs Symbicort pMDI
    Statistical analysis description
    Evening peak expiratory flow (ePEF): Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort BA MDI 2x160/4.5 μg bid and Symbicort AC pMDI 2x160/4.5 µg bid.
    Comparison groups
    Symbicort BA MDI v Symbicort pMDI
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    P-value
    		 = 0.81
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    1.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.66
         upper limit
    		 13.61
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.15
    Notes
    [4] - No adjustment were made for multiplicity for these supportive variables and nominal p-values were reported.
    Statistical analysis title
    		 ePEF - Symbicort pMDi vs Budesonide
    Statistical analysis description
    Evening peak expiratory flow (ePEF): Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort AC pMDI 2x160/4.5 µg bid and Budesonide AC pMDI 2x160 µg bid.
    Comparison groups
    Symbicort pMDI v Budesonide
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    32.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 20.01
         upper limit
    		 44.49
    Variability estimate
    Standard error of the mean
    Dispersion value
    6.21

    Secondary: Asthma symptoms Score (Total)

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    End point title
    		 Asthma symptoms Score (Total)
    End point description
    The total score is calculated as sum of the morning and evening scores of each day and the treatment period mean score is defined as the mean of all total score recorded during the 12-week treatment period. Trt Avg=Mean total score of double-blind period values.(day/night score ranges from 0 to 3; 0=no asthma symptoms; 3= unable to do normal activities (or to sleep) due to asthma). Higher score represents worse outcome.
    End point type
    Secondary
    End point timeframe
    Recorded between 6:00 – 11:00 AM from previous 12 hours and 6:00 -11:00 PM from previous 12 hours for 14 weeks
    End point values
    		 Symbicort BA MDI Symbicort pMDI Budesonide
    Number of subjects analysed
    71
    71
    71
    Units: Asthma score on a scale of 0 to 3
    arithmetic mean (standard deviation)
        Baseline
    2.04 ± 0.98
    1.92 ± 0.72
    2.12 ± 0.88
        Treatment Average (Trt Avg)
    1.68 ± 1.1
    1.45 ± 0.91
    2.02 ± 0.96
    Statistical analysis title
    		 Total Symptom score - Symb. BA MDI vs Symb. pMDI
    Statistical analysis description
    Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort BA MDI 2x160/4.5 μg bid and Symbicort AC pMDI 2x160/4.5 µg bid.
    Comparison groups
    Symbicort BA MDI v Symbicort pMDI
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 = 0.272
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 0.35
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.11
    Notes
    [5] - No adjustment were made for multiplicity for these supportive variables and nominal p-values were reported.

    Secondary: Night-time awakenings due to asthma symptoms(% Awakening-free nights)

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    End point title
    		 Night-time awakenings due to asthma symptoms(% Awakening-free nights)
    End point description
    The percentage of days with no awakenings due to asthma. Baseline= Mean % awakening-free nights during run-in period ; Trt Avg=Mean % awakening-free nights during double-blind period.
    End point type
    Secondary
    End point timeframe
    Recorded 6:00 – 11:00 AM for 14 weeks
    End point values
    		 Symbicort BA MDI Symbicort pMDI Budesonide
    Number of subjects analysed
    71
    71
    71
    Units: Percentage of days with no awakenings
    arithmetic mean (standard deviation)
        Baseline
    78.54 ± 28.97
    78.76 ± 29.76
    81.59 ± 25.32
        Treatment Average (Trt Avg)
    83.73 ± 30.9
    89.93 ± 21.4
    84.62 ± 26.31
    Statistical analysis title
    		 Nightime Awakenings - Symb. BA MDI vs Symb. pMDI
    Statistical analysis description
    Comparing mean changes from baseline to the average of the double-blind treatment period between Symbicort BA MDI 2x160/4.5 μg bid and Symbicort AC pMDI 2x160/4.5 µg bid.
    Comparison groups
    Symbicort BA MDI v Symbicort pMDI
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 other [6]
    P-value
    		 = 0.025
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -6.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -11.41
         upper limit
    		 -0.79
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.69
    Notes
    [6] - No adjustment were made for multiplicity for these supportive variables and nominal p-values were reported.

    Secondary: Use of rescue medication day and night (Total daily rescue medication use)

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    End point title
    		 Use of rescue medication day and night (Total daily rescue medication use)
    End point description
    Total daily rescue medication use is calculated as the sum of morning and evening use each day and averaged over the 12 weeks treatment periods to calculate the treatment period mean. Baseline= Mean rescue medication used during run-in period ; Trt Avg=Mean rescue medication used during double-blind period.
    End point type
    Secondary
    End point timeframe
    Recorded between 6:00 – 11:00 AM from previous 12 hours and 6:00 -11:00 PM from previous 12 hours for 14 weeks
    End point values
    		 Symbicort BA MDI Symbicort pMDI Budesonide
    Number of subjects analysed
    71
    71
    71
    Units: Inhalations/24 hrs
    arithmetic mean (standard deviation)
        Baseline
    2.55 ± 2.48
    2.19 ± 1.75
    2.65 ± 2.36
        Treatment Average (Trt Avg)
    1.81 ± 2.67
    1.26 ± 1.6
    2.34 ± 2.38
    Statistical analysis title
    		 Total Daily Rescue Med-Symb. BA MDI vs Symb. pMDI
    Statistical analysis description
    Comparing mean changes from baseline to the average of the double-blind treatment period between BAI Symbicort BA MDI 2x160/4.5 μg bid and pMDI Symbicort AC pMDI 2x160/4.5 µg bid.
    Comparison groups
    Symbicort BA MDI v Symbicort pMDI
    Number of subjects included in analysis
    142
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    P-value
    		 = 0.258
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.19
         upper limit
    		 0.71
    Variability estimate
    Standard error of the mean
    Dispersion value
    0.23
    Notes
    [7] - No adjustment were made for multiplicity for these supportive variables and nominal p-values were reported.

    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 follow-up (14 weeks after randomisation). Events occurring on or after first dose of study medication are included in the summaries.
    Adverse event reporting additional description
    1 patient from the Budesonide group has not taken any dose of the IP, so not included in the Safety population'. A total of 19 patients reported non-serious adverse events; 19 on Budesonide, 21 on Symbicort BA MDI, 24 on Symbicort pMDI.. 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
    15.0
    Reporting groups
    Reporting group title
    Budesonide
    Reporting group description
    		 Budesonide AC pMDI 2x160 μg twice daily

    Reporting group title
    Symbicort BA MDI
    Reporting group description
    		 Symbicort BA MDI 2x160/4.5 μg twice daily

    Reporting group title
    Symbicort pMDI
    Reporting group description
    		 Symbicort AC pDMI 2x160/4.5 μg twice daily

    Serious adverse events
    		 Budesonide Symbicort BA MDI Symbicort pMDI
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 71 (0.00%)
    1 / 71 (1.41%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Infections and infestations
    APPENDICITIS
         subjects affected / exposed
    0 / 71 (0.00%)
    0 / 71 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    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
    		 Budesonide Symbicort BA MDI Symbicort pMDI
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 71 (8.45%)
    6 / 71 (8.45%)
    9 / 71 (12.68%)
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    3 / 71 (4.23%)
    1 / 71 (1.41%)
    2 / 71 (2.82%)
         occurrences all number
    3
    1
    2
    Infections and infestations
    VIRAL UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    3 / 71 (4.23%)
    2 / 71 (2.82%)
    5 / 71 (7.04%)
         occurrences all number
    3
    2
    5
    UPPER RESPIRATORY TRACT INFECTION BACTERIAL
         subjects affected / exposed
    1 / 71 (1.41%)
    2 / 71 (2.82%)
    0 / 71 (0.00%)
         occurrences all number
    1
    2
    0
    Bronchitis
         subjects affected / exposed
    0 / 71 (0.00%)
    1 / 71 (1.41%)
    3 / 71 (4.23%)
         occurrences all number
    0
    1
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Oct 2011
    Clarify the timing of spirometry measurements in the morning. To allow the patients to undergo rescreen, so that at rescreening the patients would meet the time requirements for various elements by Visit 2 in the inclusion criteria without changing the patient characterisation in the study or jeopardizing patient safety.

    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.
    No. of participants in the safety analysis set is (71 for all the group) as 1 patients from the Budesonide group has not taken any dose of the IP, so not included in the Safety population.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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