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    Clinical Trial Results:
    Efficacy and safety of Symbicort® Turbuhaler® 160/4.5 μg/inhalation, two inhalations twice daily plus as-needed, compared with Seretide™ Diskus™ 50/500 μg/inhalation, one inhalation twice daily plus terbutaline Turbuhaler 0.4 mg/inhalation as-needed - a 6-month, randomised, double-blind, parallel-group, active-controlled, multi-national phase IIIB study in adult and adolescent patients with persistent asthma (AHEAD)

    Summary
    EudraCT number
    		 2004-004905-11
    Trial protocol
    		 DE   ES  
    Global end of trial date
    27 Oct 2006

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Apr 2016
    First version publication date
    28 Apr 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D5890C00002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    R&D Lund, SE-221 87 Lund, Sweden,
    Public contact
    Bjorn Rubin, AstraZeneca, ClinicalTrialTransparency@astrazeneca.com
    Scientific contact
    Bjorn Rubin, AstraZeneca, ClinicalTrialTransparency@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
    27 Oct 2006
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Oct 2006
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Oct 2006
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to compare the efficacy of 2 inhalations of Symbicort Turbuhaler 160/4.5 μg/inhalation twice daily plus Symbicort Turbuhaler 160/4.5 μg/inhalation as-needed with 1 inhalation of Seretide Diskus 50/500 μg/inhalation twice daily plus terbutaline Turbuhaler 0.4 mg/inhalation as-needed in patients with persistent asthma by evaluation of time to first severe asthma exacerbation as the primary outcome variable.
    Protection of trial subjects
    The final clinical study protocol (CSP), including the final version of the Informed Consent Form, was approved or given a favourable opinion in writing by an Institutional Review Board (IRB) or Independent Ethics Committee (IEC). The investigator was to submit written approval to AstraZeneca before enrolling any patient into the study. In addition, before any participation in the genetic research part of the study took place, this part of the study (in CSP Appendix D) had to be approved by the appropriate IRB or IEC as well as the principal investigator(s). The principal investigator at each centre was to ensure that the patients were given full and adequate oral and written information about the nature, purpose, possible risk, and possible benefit of the study. Patients were also to be notified that they were free to discontinue from the study at any time. The patients were to be given the opportunity to ask questions and allowed time to consider the information provided. For patients under age, this also applied to parent/legal guardian. The patient’s/parent’s/legal guardian’s signed and dated informed consent was to be obtained before conducting any procedure specifically for the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 May 2005
    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
    Argentina: 383
    Country: Number of subjects enrolled
    Australia: 107
    Country: Number of subjects enrolled
    Brazil: 128
    Country: Number of subjects enrolled
    Canada: 135
    Country: Number of subjects enrolled
    China: 222
    Country: Number of subjects enrolled
    France: 139
    Country: Number of subjects enrolled
    Germany: 151
    Country: Number of subjects enrolled
    India: 40
    Country: Number of subjects enrolled
    Indonesia: 89
    Country: Number of subjects enrolled
    Malaysia: 57
    Country: Number of subjects enrolled
    Mexico: 224
    Country: Number of subjects enrolled
    Philippines: 62
    Country: Number of subjects enrolled
    Singapore: 15
    Country: Number of subjects enrolled
    South Africa: 392
    Country: Number of subjects enrolled
    Spain: 74
    Country: Number of subjects enrolled
    Thailand: 60
    Country: Number of subjects enrolled
    Vietnam: 31
    Worldwide total number of subjects
    2309
    EEA total number of subjects
    364
    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)
    324
    Adults (18-64 years)
    1822
    From 65 to 84 years
    163
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This multicenter study was conducted in 17 countries between 2 May 2005 and 29 May 2006.

    Pre-assignment
    Screening details
    		 The study consisted of an enrolment visit, a 2-week run-in (standardization) period, randomization at Visit 2, and 3 further visits (Visits 3-5) at 4, 13 and 26 weeks. Subjects received 1 of 2 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 SMART
    Arm description
    		 Symbicort® Turbuhaler® 160/4.5 μg/inhalation,two inhalations twice daily plus as-needed
    Arm type
    		 Experimental

    Investigational medicinal product name
    Symbicort® Turbuhaler® 160/4.5 μg/inhalation
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    2 inhalations twice daily

    Arm title
    		 Seretide
    Arm description
    		 Seretide™ Diskus™ 50/500 μg/inhalation, one inhalation twice daily plus terbutaline Turbuhaler 0.4 mg/inhalation as-needed
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Seretide™ Diskus 50/500 μg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    1 inhalation twice daily

    Number of subjects in period 1
    		Symbicort SMART Seretide
    Started
    1154
    1155
    Completed
    1056
    1040
    Not completed
    98
    115
         Adverse event, non-fatal
    11
    20
         Due to other reasons
    38
    46
         Lost to follow-up
    9
    9
         Protocol deviation
    40
    40

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Symbicort SMART
    Reporting group description
    		 Symbicort® Turbuhaler® 160/4.5 μg/inhalation,two inhalations twice daily plus as-needed

    Reporting group title
    Seretide
    Reporting group description
    		 Seretide™ Diskus™ 50/500 μg/inhalation, one inhalation twice daily plus terbutaline Turbuhaler 0.4 mg/inhalation as-needed

    Reporting group values
    		 Symbicort SMART Seretide Total
    Number of subjects
    		 1154 1155 2309
    Age categorical
    Age
    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)
    		 0 0 0
        Adolescents (12-17 years)
    		 163 161 324
        Adults (18-64 years)
    		 910 912 1822
        From 65-84 years
    		 81 82 163
        85 years and over
    		 0 0 0
    Age continuous
    Age
    Units: years
        arithmetic mean (full range (min-max))
    		 39.6 (12 to 80) 39.2 (12 to 80) -
    Gender categorical
    Units: Subjects
        Female
    		 711 711 1422
        Male
    		 443 444 887

    End points

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    End points reporting groups
    Reporting group title
    Symbicort SMART
    Reporting group description
    		 Symbicort® Turbuhaler® 160/4.5 μg/inhalation,two inhalations twice daily plus as-needed

    Reporting group title
    Seretide
    Reporting group description
    		 Seretide™ Diskus™ 50/500 μg/inhalation, one inhalation twice daily plus terbutaline Turbuhaler 0.4 mg/inhalation as-needed

    Primary: Number of severe asthma exacerbations

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    End point title
    		 Number of severe asthma exacerbations
    End point description
    severe asthma exacerbations during the treatment period
    End point type
    Primary
    End point timeframe
    26 weeks
    End point values
    		 Symbicort SMART Seretide
    Number of subjects analysed
    1151
    1153
    Units: no. of patients with at least 1 event
        No of patients with at least one event
    108
    130
    Statistical analysis title
    		 Time to first severe exacerbation
    Statistical analysis description
    Cox-proportional hazards model for time to first event
    Comparison groups
    Symbicort SMART v Seretide
    Number of subjects included in analysis
    2304
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.12
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 1.05
    Statistical analysis title
    		 Number of severe asthma exacerbations
    Statistical analysis description
    Analysis of number of severe exacerbations reported per subject.
    Comparison groups
    Symbicort SMART v Seretide
    Number of subjects included in analysis
    2304
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.039
    Method
    		 Poisson Regression
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 0.99

    Secondary: Total daily no. of inhalations

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    End point title
    		 Total daily no. of inhalations
    End point description
    use of as-needed medication
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Symbicort SMART Seretide
    Number of subjects analysed
    1143
    1145
    Units: average daily no. of inhalations
        arithmetic mean (full range (min-max))
    0.95 (0 to 7.6)
    1.01 (0 to 8)
    Statistical analysis title
    		 Total daily no. of inhalations
    Statistical analysis description
    Use of as-needed medication
    Comparison groups
    Symbicort SMART v Seretide
    Number of subjects included in analysis
    2288
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.36
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.12
         upper limit
    		 0.04

    Secondary: Morning PEF(L/min)

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    End point title
    		 Morning PEF(L/min)
    End point description
    End point type
    Secondary
    End point timeframe
    Morning
    End point values
    		 Symbicort SMART Seretide
    Number of subjects analysed
    1143
    1145
    Units: L/min
        arithmetic mean (full range (min-max))
    359.5 (134 to 702)
    359.4 (119 to 735)
    Statistical analysis title
    		 PEF (L/min)
    Comparison groups
    Symbicort SMART v Seretide
    Number of subjects included in analysis
    2288
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.67
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.4
         upper limit
    		 2.8

    Secondary: Evening PEF (L/min)

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    End point title
    		 Evening PEF (L/min)
    End point description
    End point type
    Secondary
    End point timeframe
    evening
    End point values
    		 Symbicort SMART Seretide
    Number of subjects analysed
    1143
    1145
    Units: L/min
        arithmetic mean (full range (min-max))
    362.3 (120 to 707)
    361.7 (131 to 739)
    Statistical analysis title
    		 Evening PEF
    Comparison groups
    Symbicort SMART v Seretide
    Number of subjects included in analysis
    2288
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.42
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.1
         upper limit
    		 4.9

    Secondary: Asthma symptoms - total score

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    End point title
    		 Asthma symptoms - total score
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Symbicort SMART Seretide
    Number of subjects analysed
    1140
    1143
    Units: total score
        arithmetic mean (full range (min-max))
    0.98 (0 to 5.2)
    0.98 (0 to 5.2)
    Statistical analysis title
    		 Asthma symptoms - total score
    Comparison groups
    Symbicort SMART v Seretide
    Number of subjects included in analysis
    2283
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.92
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.06
         upper limit
    		 0.07

    Secondary: Nights with awakenings due to asthma symptoms (%)

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    End point title
    		 Nights with awakenings due to asthma symptoms (%)
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Symbicort SMART Seretide
    Number of subjects analysed
    1140
    1143
    Units: Percentage
        arithmetic mean (full range (min-max))
    12 (0 to 100)
    13.3 (0 to 100)
    Statistical analysis title
    		 Nights with awakenings (%)
    Comparison groups
    Symbicort SMART v Seretide
    Number of subjects included in analysis
    2283
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.11
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.8
         upper limit
    		 0.3

    Secondary: Symptom free days (%)

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    End point title
    		 Symptom free days (%)
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Symbicort SMART Seretide
    Number of subjects analysed
    1144
    1145
    Units: Percentage
        arithmetic mean (full range (min-max))
    47.2 (0 to 100)
    48.1 (0 to 100)
    Statistical analysis title
    		 Symptom free days (%)
    Comparison groups
    Symbicort SMART v Seretide
    Number of subjects included in analysis
    2289
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.73
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.3
         upper limit
    		 2.3

    Secondary: Asthma control days (%)

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    End point title
    		 Asthma control days (%)
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Symbicort SMART Seretide
    Number of subjects analysed
    1144
    1145
    Units: Percentage
        arithmetic mean (full range (min-max))
    44 (0 to 100)
    44.9 (0 to 100)
    Statistical analysis title
    		 Asthma control days (%)
    Comparison groups
    Symbicort SMART v Seretide
    Number of subjects included in analysis
    2289
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.37
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.1
         upper limit
    		 1.5

    Secondary: Mild asthma exacerbations

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    End point title
    		 Mild asthma exacerbations
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Symbicort SMART Seretide
    Number of subjects analysed
    1144
    1145
    Units: No. of patients with at least 1 event
        No of patients with at least one event
    683
    679
    Statistical analysis title
    		 Time to first mild exacerbation
    Comparison groups
    Symbicort SMART v Seretide
    Number of subjects included in analysis
    2289
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.75
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.017
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.914
         upper limit
    		 1.131
    Statistical analysis title
    		 Number of mild exacerbations
    Comparison groups
    Symbicort SMART v Seretide
    Number of subjects included in analysis
    2289
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.12
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.919
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.824
         upper limit
    		 1.024

    Secondary: Mean FEV1 during the treatment period

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    End point title
    		 Mean FEV1 during the treatment period
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Symbicort SMART Seretide
    Number of subjects analysed
    1135
    1138
    Units: Litres
        arithmetic mean (full range (min-max))
    2.522 (0.8 to 5.4)
    2.494 (0.74 to 5.04)
    Statistical analysis title
    		 Mean FEV1 during the treatment period
    Comparison groups
    Symbicort SMART v Seretide
    Number of subjects included in analysis
    2273
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.26
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.014
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.011
         upper limit
    		 0.039

    Secondary: Asthma Control Questionnaire

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    End point title
    		 Asthma Control Questionnaire
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Symbicort SMART Seretide
    Number of subjects analysed
    1105
    1112
    Units: mean score
        arithmetic mean (full range (min-max))
    1.08 (0 to 5)
    1.12 (0 to 5.27)
    Statistical analysis title
    		 ACQ
    Comparison groups
    Symbicort SMART v Seretide
    Number of subjects included in analysis
    2217
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.59
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.015
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.071
         upper limit
    		 0.04

    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 (26 weeks after randomisation). Only adverse events occuring after the start of randomised study medication are included in the summaries below.
    Adverse event reporting additional description
    A total of 911 patients reported non-serious adverse events; 451 on Symbicort SMART, 460 on Seretide. Numbers for non-serious AEs in the reporting group table are based on the 5% threshold frequency.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9.0
    Reporting groups
    Reporting group title
    Symbicort SMART
    Reporting group description
    		 Symbicort® Turbuhaler® 160/4.5 μg/inhalation,two inhalations twice daily plus as-needed

    Reporting group title
    Seretide
    Reporting group description
    		 Seretide™ Diskus™ 50/500 μg/inhalation, one inhalation twice daily plus terbutaline Turbuhaler 0.4 mg/inhalation as-needed

    Serious adverse events
    		 Symbicort SMART Seretide
    Total subjects affected by serious adverse events
         subjects affected / exposed
    30 / 1151 (2.61%)
    31 / 1153 (2.69%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Benign ovarian tumour
         subjects affected / exposed
    0 / 1151 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    1 / 1151 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenoma benign
         subjects affected / exposed
    1 / 1151 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine leiomyoma
         subjects affected / exposed
    0 / 1151 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 1151 (0.09%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 1151 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    0 / 1151 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    0 / 1151 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    5 / 1151 (0.43%)
    5 / 1153 (0.43%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 1151 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Major depression
         subjects affected / exposed
    1 / 1151 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Wrist fracture
         subjects affected / exposed
    1 / 1151 (0.09%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road traffic accident
         subjects affected / exposed
    0 / 1151 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 1151 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    0 / 1151 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin laceration
         subjects affected / exposed
    1 / 1151 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Limb injury
         subjects affected / exposed
    0 / 1151 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tooth fracture
         subjects affected / exposed
    1 / 1151 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Forearm fracture
         subjects affected / exposed
    0 / 1151 (0.00%)
    2 / 1153 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Coronary artery disease
         subjects affected / exposed
    1 / 1151 (0.09%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    0 / 1151 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 1151 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronary artery stenosis
         subjects affected / exposed
    1 / 1151 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute coronary syndrome
         subjects affected / exposed
    1 / 1151 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina pectoris
         subjects affected / exposed
    1 / 1151 (0.09%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 1151 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral infarction
         subjects affected / exposed
    1 / 1151 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 1151 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parkinson’s disease
         subjects affected / exposed
    1 / 1151 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastric polyps
         subjects affected / exposed
    1 / 1151 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food poisoning
         subjects affected / exposed
    0 / 1151 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspepsia
         subjects affected / exposed
    0 / 1151 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    1 / 1151 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    1 / 1151 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal colic
         subjects affected / exposed
    0 / 1151 (0.00%)
    2 / 1153 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Spinal osteoarthritis
         subjects affected / exposed
    0 / 1151 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rheumatoid arthritis
         subjects affected / exposed
    0 / 1151 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    1 / 1151 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bunion
         subjects affected / exposed
    1 / 1151 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral disc protusion
         subjects affected / exposed
    0 / 1151 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 1151 (0.00%)
    2 / 1153 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dengue fever
         subjects affected / exposed
    2 / 1151 (0.17%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Typhoid fever
         subjects affected / exposed
    1 / 1151 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 1151 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    1 / 1151 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    0 / 1151 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perianal abscess
         subjects affected / exposed
    1 / 1151 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised infection
         subjects affected / exposed
    1 / 1151 (0.09%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster ophthalmic
         subjects affected / exposed
    0 / 1151 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis acute
         subjects affected / exposed
    0 / 1151 (0.00%)
    1 / 1153 (0.09%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 1151 (0.17%)
    2 / 1153 (0.17%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 1151 (0.17%)
    0 / 1153 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Symbicort SMART Seretide
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    111 / 1151 (9.64%)
    111 / 1153 (9.63%)
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    64 / 1151 (5.56%)
    61 / 1153 (5.29%)
         occurrences all number
    83
    76
    Nasopharyngitis
         subjects affected / exposed
    54 / 1151 (4.69%)
    57 / 1153 (4.94%)
         occurrences all number
    67
    63

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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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