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    Clinical Trial Results:
    A 4-week, open-label, randomized, multi-centre, parallel-group study evaluating the safety and efficacy of 4 actuations Symbicort® (budesonide/formoterol) HFA pMDI 40/2.25 μg twice daily, with and without spacer, in children (6-11 years) with asthma

    Summary
    EudraCT number
    		 2007-002722-29
    Trial protocol
    		 HU  
    Global end of trial date
    17 Jun 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
    D5897C00004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    AstraZeneca R&D Lund, 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
    17 Jun 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Jun 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Jun 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 (delivered dose) 4 actuations twice daily (bid) with spacer has a similar systemic steroid potency as Symbicort pMDI 40/2.25 μg, 4 actuations bid in children with asthma.
    Protection of trial subjects
    The study was approved in Poland, Hungary and Russia by the Independent Ethics Committees (IECs) in each respective country. Informed consent was obtained from the patient’s parent/legal guardian and assent from the patient before any study-specific procedure was conducted.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 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: 66
    Country: Number of subjects enrolled
    Hungary: 30
    Country: Number of subjects enrolled
    Russian Federation: 11
    Worldwide total number of subjects
    107
    EEA total number of subjects
    96
    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)
    107
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 137 subjects enrolled; 30 non randomised: 26 failed inclusion criteria, 2 voluntary discontinuations, 1 incorrect enrolment, 1 adverse event. 107 subjects were randomised

    Pre-assignment
    Screening details
    		 The study consisted of an enrolment visit, a 2 week run-in period, a randomization at Visit 3, and 2 further visits (Visits 4,5) at 2 and 4 weeks. Subjects received 1 of 2 open label 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
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 With Spacer
    Arm description
    		 Budesonide/formoterol pMDI 40/2.25ug + spacer
    Arm type
    		 Experimental

    Investigational medicinal product name
    Symbicort pMDI 40/2.25 μg 4 actuations bid with spacer
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    2 actuations bid (every morning and every evening).

    Arm title
    		 Without Spacer
    Arm description
    		 Budesonide/formoterol pMDI 40/2.25 ug
    Arm type
    		 Experimental

    Investigational medicinal product name
    Symbicort pMDI 40/2.25 μg 4 actuations bid without spacer
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    2 actuations bid (every morning and every evening).

    Number of subjects in period 1
    		With Spacer Without Spacer
    Started
    55
    52
    Completed
    55
    52

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    With Spacer
    Reporting group description
    		 Budesonide/formoterol pMDI 40/2.25ug + spacer

    Reporting group title
    Without Spacer
    Reporting group description
    		 Budesonide/formoterol pMDI 40/2.25 ug

    Reporting group values
    		 With Spacer Without Spacer Total
    Number of subjects
    		 55 52 107
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 55 52 107
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous |
    Units: years
        arithmetic mean (full range (min-max))
    		 8.6 (6 to 11) 8.9 (6 to 11) -
    Gender, Male/Female
    Units: Participants
        Female
    		 21 22 43
        Male
    		 34 30 64
    Race
    Units: Subjects
        White
    		 55 52 107
    Median time since diagnosis
    Units: years
        median (full range (min-max))
    		 3 (0.4 to 9) 3.55 (0.6 to 8.7) -

    End points

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    End points reporting groups
    Reporting group title
    With Spacer
    Reporting group description
    		 Budesonide/formoterol pMDI 40/2.25ug + spacer

    Reporting group title
    Without Spacer
    Reporting group description
    		 Budesonide/formoterol pMDI 40/2.25 ug

    Primary: Urinary Free Cortisol (UFC)

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    End point title
    		 Urinary Free Cortisol (UFC)
    End point description
    Ratio between the value at the end of treatment and the value at start of treatment, including only patients with values at both baseline and end of treatment
    End point type
    Primary
    End point timeframe
    At baseline and 4 weeks
    End point values
    		 With Spacer Without Spacer
    Number of subjects analysed
    54
    51
    Units: Ratio
        geometric mean (full range (min-max))
    0.86 (0.2 to 2.4)
    1.03 (0.12 to 5.4)
    Statistical analysis title
    		 24-hour UFC
    Comparison groups
    With Spacer v Without Spacer
    Number of subjects included in analysis
    105
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1666
    Method
    		 ANOVA
    Parameter type
    		 Ratio
    Point estimate
    0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.713
         upper limit
    		 1.061

    Secondary: Forced Expiratory Volume in 1 Second (FEV1)

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    End point title
    		 Forced Expiratory Volume in 1 Second (FEV1)
    End point description
    Changes in FEV1 from baseline to the mean value at 2 weeks to 4 weeks with the baseline value as a covariate.
    End point type
    Secondary
    End point timeframe
    At baseline, at 2 weeks and 4 weeks
    End point values
    		 With Spacer Without Spacer
    Number of subjects analysed
    55
    52
    Units: Liters
        arithmetic mean (full range (min-max))
    0.17 (-0.38 to 0.76)
    0.14 (-0.34 to 0.82)
    Statistical analysis title
    		 Comparison of FEV1
    Comparison groups
    With Spacer v Without Spacer
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.61
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.0235
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.0663
         upper limit
    		 0.113

    Secondary: Morning Peak Expiratory Flow (mPEF)

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    End point title
    		 Morning Peak Expiratory Flow (mPEF)
    End point description
    Change in average value from the run-in to the treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry were estimated using linear interpolation.
    End point type
    Secondary
    End point timeframe
    Daily during run-in and daily during treatment period of 4 weeks
    End point values
    		 With Spacer Without Spacer
    Number of subjects analysed
    55
    52
    Units: Liters/min
        arithmetic mean (full range (min-max))
    243 (116 to 413)
    256 (153 to 418)
    Statistical analysis title
    		 Change in mPEF
    Statistical analysis description
    change from baseline in mean values during the treatment period
    Comparison groups
    With Spacer v Without Spacer
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.087
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    8.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.2
         upper limit
    		 17.4

    Secondary: Evening Peak Expiratory Flow (ePEF)

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    End point title
    		 Evening Peak Expiratory Flow (ePEF)
    End point description
    Change in average value from the run-in to the treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation. Missing data between the first and last entry were estimated using linear interpolation.
    End point type
    Secondary
    End point timeframe
    Daily during run-in and daily during treatment period of 4 weeks
    End point values
    		 With Spacer Without Spacer
    Number of subjects analysed
    55
    52
    Units: Liters/min
        arithmetic mean (full range (min-max))
    250 (138 to 429)
    262 (166 to 420)
    Statistical analysis title
    		 Change in ePEF
    Statistical analysis description
    change from baseline in mean values during the treatment period
    Comparison groups
    With Spacer v Without Spacer
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.038
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    9.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.56
         upper limit
    		 18.6

    Secondary: Asthma Symptoms at Night

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    End point title
    		 Asthma Symptoms at Night
    End point description
    Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms.
    End point type
    Secondary
    End point timeframe
    Daily during run-in and daily during treatment period of 4 weeks
    End point values
    		 With Spacer Without Spacer
    Number of subjects analysed
    55
    52
    Units: Units on a scale
        arithmetic mean (full range (min-max))
    0.643 (0 to 1.88)
    0.705 (0 to 1.93)
    Statistical analysis title
    		 Change in Asthma Symptom Scores (night)
    Statistical analysis description
    change from baseline in mean score during the treatment period
    Comparison groups
    With Spacer v Without Spacer
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.945
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.005
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.153
         upper limit
    		 0.143

    Secondary: Asthma Symptoms at Day

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    End point title
    		 Asthma Symptoms at Day
    End point description
    Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation. Daily scale:0 = No symptoms; 1 = Mild symptoms; 2 = Moderate symptoms; 3 = Severe symptoms.
    End point type
    Secondary
    End point timeframe
    Daily during run-in and daily during treatment period of 4 weeks
    End point values
    		 With Spacer Without Spacer
    Number of subjects analysed
    55
    52
    Units: Units on a scale
        arithmetic mean (full range (min-max))
    0.708 (0 to 1.96)
    0.806 (0 to 2)
    Statistical analysis title
    		 Change in Asthma Symptom Scores (day)
    Statistical analysis description
    change from baseline in mean score during the treatment period
    Comparison groups
    With Spacer v Without Spacer
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.987
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.001
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.104
         upper limit
    		 0.148

    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
    Change in Percentage of nights with awakenings, average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation.
    End point type
    Secondary
    End point timeframe
    Daily during run-in and daily during treatment period of 4 weeks
    End point values
    		 With Spacer Without Spacer
    Number of subjects analysed
    55
    52
    Units: Percentage of nights
        arithmetic mean (full range (min-max))
    16.1 (0 to 100)
    15.5 (0 to 100)
    Statistical analysis title
    		 Change in %Nights with Awakenings
    Statistical analysis description
    change from baseline in mean % during the treatment period
    Comparison groups
    With Spacer v Without Spacer
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.724
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -1.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9.34
         upper limit
    		 6.51

    Secondary: Use of Rescue Medication at Night

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    End point title
    		 Use of Rescue Medication at Night
    End point description
    Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation.
    End point type
    Secondary
    End point timeframe
    Daily during run-in and daily during treatment period of 4 weeks
    End point values
    		 With Spacer Without Spacer
    Number of subjects analysed
    55
    52
    Units: Inhalations
        arithmetic mean (full range (min-max))
    0.214 (0 to 2.86)
    0.136 (0 to 1.69)
    Statistical analysis title
    		 Change in Use of Rescue Medication (night)
    Statistical analysis description
    change from baseline in mean use during the treatment period
    Comparison groups
    With Spacer v Without Spacer
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.692
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.026
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.104
         upper limit
    		 0.157

    Secondary: Use of Rescue Medication at Day

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    End point title
    		 Use of Rescue Medication at Day
    End point description
    Change in average value from the run-in to treatment period, calculated using all available data for the 10 last days of run-in, and all available data after randomisation.Missing data between the first and last entry estimated using linear interpolation.
    End point type
    Secondary
    End point timeframe
    Daily during run-in and daily during treatment period of 4 weeks
    End point values
    		 With Spacer Without Spacer
    Number of subjects analysed
    55
    52
    Units: Inhalations
        arithmetic mean (full range (min-max))
    0.277 (0 to 3.14)
    0.227 (0 to 1.96)
    Statistical analysis title
    		 Change in Use of Rescue Medication (day)
    Statistical analysis description
    change from baseline in mean use during the treatment period
    Comparison groups
    With Spacer v Without Spacer
    Number of subjects included in analysis
    107
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.694
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.028
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.166
         upper limit
    		 0.111

    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 (4 weeks after randomisation).
    Adverse event reporting additional description
    Adverse events were recorded by period (run-in, treatment, post-treatment). Only adverse events occuring during the treatment period are included in the summary below.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.1
    Reporting groups
    Reporting group title
    Without Spacer
    Reporting group description
    		 Budesonide/formoterol pMDI 40/2.25 ug

    Reporting group title
    With Spacer
    Reporting group description
    		 Budesonide/formoterol pMDI 40/2.25ug + spacer

    Serious adverse events
    		 Without Spacer With Spacer
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 52 (0.00%)
    0 / 55 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Without Spacer With Spacer
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 52 (15.38%)
    5 / 55 (9.09%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 52 (1.92%)
    1 / 55 (1.82%)
         occurrences all number
    1
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 55 (0.00%)
         occurrences all number
    2
    0
    Respiratory, thoracic and mediastinal disorders
    Nasopharyngitis
         subjects affected / exposed
    2 / 52 (3.85%)
    0 / 55 (0.00%)
         occurrences all number
    2
    0
    Cough
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Dysphonia
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Nocturia
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Infections and infestations
    Viral upper respiratory tract infection
         subjects affected / exposed
    2 / 52 (3.85%)
    0 / 55 (0.00%)
         occurrences all number
    2
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Rhinitis
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 55 (1.82%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0
    Bronchitis
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 55 (0.00%)
         occurrences all number
    1
    0

    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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    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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