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    Clinical Trial Results:
    A 6-month, Randomised, Double-blind, Placebo-controlled,Multi-centre, Parallel-group, Phase II Study with an Optional Safety Extension Treatment Period up to 6 months, to Evaluate the Efficacy, Safety, and Tolerability of 3 Different Doses of AZD5069 Twice Daily as Add-on Treatment to Medium to High Dose Inhaled Corticosteroids (ICS) and Long-acting β2 Agonists (LABA), in Patients with Uncontrolled Persistent Asthma

    Summary
    EudraCT number
    2012-001869-33
    Trial protocol
    GB   DE   CZ   HU   PL   SK   BG  
    Global end of trial date
    19 Dec 2014

    Results information
    Results version number
    v1(current)
    This version publication date
    21 Feb 2016
    First version publication date
    21 Feb 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D3551C00001
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    Pepparedsleden 1, Mölndal, Sweden, SE-431 83
    Public contact
    Bengt Larsson, AstraZeneca, SE-431 83 +46 31 7064277, bengt.larsson@astrazeneca.com
    Scientific contact
    Paul O’Byrne, St Joseph’s Healthcare, L8N 4A6 9055259140-33694, obyrnep@mcmaster.ca
    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
    19 Dec 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    19 Dec 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Dec 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the efficacy of 3 different doses of AZD5069 compared with placebo on the rate of severe asthma exacerbations over 6 months in adults with uncontrolled persistent asthma, despite treatment with medium to high dose ICS (≥fluticasone 500 μg or the equivalent daily) and LABA
    Protection of trial subjects
    This study was performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with the International Conference on Harmonisation (ICH)/Good Clinical Practice (GCP) and applicable regulatory requirements and the AstraZeneca policy on Bioethics and Human Biological Samples.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    27 Nov 2012
    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
    Slovakia: 36
    Country: Number of subjects enrolled
    South Africa: 11
    Country: Number of subjects enrolled
    Ukraine: 65
    Country: Number of subjects enrolled
    Bulgaria: 121
    Country: Number of subjects enrolled
    Canada: 5
    Country: Number of subjects enrolled
    Czech Republic: 29
    Country: Number of subjects enrolled
    Germany: 30
    Country: Number of subjects enrolled
    Hungary: 55
    Country: Number of subjects enrolled
    Mexico: 37
    Country: Number of subjects enrolled
    Poland: 114
    Country: Number of subjects enrolled
    Romania: 50
    Country: Number of subjects enrolled
    Russian Federation: 87
    Worldwide total number of subjects
    640
    EEA total number of subjects
    435
    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)
    0
    Adults (18-64 years)
    544
    From 65 to 84 years
    96
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    First patient enrolled: 27 November 2012 . Last patient last visit: 27 August 2014. Twelve centres across 12 countries participated in this study: Denmark (4), Germany (13), Poland (6),Russia (14), Sweden(13)and United Kingdom (5)

    Pre-assignment
    Screening details
    1146 patients enrolled in the study of which 640 were randomised, the remaining 506 patients were not randomised since they did not fulfilled all the inclusion conditions.

    Period 1
    Period 1 title
    Overrall study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    No

    Arm title
    AZD 5069 5mg
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    AZD 5069
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    5mg capsule BID

    Arm title
    AZD 5069 15 mg
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    AZD 5069
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    capsule 15mg, twice a day

    Arm title
    AZD5069 45mg
    Arm description
    -
    Arm type
    Experimental

    Investigational medicinal product name
    AZD 5069
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Capsules twice a day

    Arm title
    Placebo
    Arm description
    -
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    capsule to match AZD5069

    Number of subjects in period 1
    AZD 5069 5mg AZD 5069 15 mg AZD5069 45mg Placebo
    Started
    160
    156
    162
    162
    Completed
    145
    143
    145
    151
    Not completed
    15
    13
    17
    11
         Subject decision
    6
    5
    8
    4
         Protocol deviation
    1
    2
    -
    -
         Eligibility criteria not fulfilled
    6
    3
    2
    3
         Adverse event, serious fatal
    -
    -
    1
    -
         Adverse event, non-fatal
    -
    2
    5
    4
         unknown reason for study withdrawn
    1
    1
    -
    -
         Development of study specific withdrawal criteria
    1
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AZD 5069 5mg
    Reporting group description
    -

    Reporting group title
    AZD 5069 15 mg
    Reporting group description
    -

    Reporting group title
    AZD5069 45mg
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -

    Reporting group values
    AZD 5069 5mg AZD 5069 15 mg AZD5069 45mg Placebo Total
    Number of subjects
    160 156 162 162 640
    Age Categorical
    Units: Subjects
        ≥18 - <50
    64 57 68 48 237
        ≥50 - <65
    72 79 74 82 307
        ≥65
    24 20 20 32 96
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    53 ± 11.5 52 ± 12.7 51 ± 11.6 54 ± 11.1 -
    Gender Categorical
    Units: Subjects
        Female
    104 113 107 120 444
        Male
    56 43 55 42 196
    Subject analysis sets

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    All patients randomised to investigational product were included in the full analysis set (FAS), irrespective of their protocol adherence and continued participation in the study. Patients were analysed according to their randomised investigational product irrespective of whether or not they prematurely discontinued investigational product or administered the incorrect treatment. Patients who withdrew consent to participate in the study were included up to the date of their study termination.

    Subject analysis sets values
    Full analysis set
    Number of subjects
    640
    Age Categorical
    Units: Subjects
        ≥18 - <50
    237
        ≥50 - <65
    307
        ≥65
    96
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    52 ± 11.8
    Gender Categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    AZD 5069 5mg
    Reporting group description
    -

    Reporting group title
    AZD 5069 15 mg
    Reporting group description
    -

    Reporting group title
    AZD5069 45mg
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    Full analysis
    Subject analysis set description
    All patients randomised to investigational product were included in the full analysis set (FAS), irrespective of their protocol adherence and continued participation in the study. Patients were analysed according to their randomised investigational product irrespective of whether or not they prematurely discontinued investigational product or administered the incorrect treatment. Patients who withdrew consent to participate in the study were included up to the date of their study termination.

    Primary: number of severe exacerbations over 6 months

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    End point title
    number of severe exacerbations over 6 months
    End point description
    End point type
    Primary
    End point timeframe
    6 months
    End point values
    AZD 5069 5mg AZD 5069 15 mg AZD5069 45mg Placebo
    Number of subjects analysed
    156
    153
    161
    159
    Units: number
        number (not applicable)
    28
    33
    35
    25
    Statistical analysis title
    Analysis of the rate of severe exacerbations
    Statistical analysis description
    Primary Analysis Model: Rates, rate ratios and p-values are from a Poisson regression analysis with treatment, OCS use at baseline (yes or no),geographical region and FEV1 pre-bronchodilator at baseline included in the model.
    Comparison groups
    AZD5069 45mg v Placebo
    Number of subjects included in analysis
    320
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.119
    Method
    poission regression
    Parameter type
    Risk ratio (RR)
    Point estimate
    1.56
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.98
         upper limit
    2.49
    Statistical analysis title
    Analysis of the rate of severe exacerbations
    Statistical analysis description
    Primary Analysis Model: Rates, rate ratios and p-values are from a Poisson regression analysis with treatment, OCS use at baseline (yes or no),geographical region and FEV1 pre-bronchodilator at baseline included in the model.
    Comparison groups
    AZD 5069 15 mg v Placebo
    Number of subjects included in analysis
    312
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.141
    Method
    possion regression
    Parameter type
    Risk ratio (RR)
    Point estimate
    1.53
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.95
         upper limit
    2.46
    Statistical analysis title
    Analysis of the rate of severe exacerbations
    Statistical analysis description
    Primary Analysis Model: Rates, rate ratios and p-values are from a Poisson regression analysis with treatment, OCS use at baseline (yes or no),geographical region and FEV1 pre-bronchodilator at baseline included in the model.
    Comparison groups
    AZD 5069 5mg v Placebo
    Number of subjects included in analysis
    315
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.397
    Method
    possion resgrssion
    Parameter type
    Risk ratio (RR)
    Point estimate
    1.29
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.79
         upper limit
    2.11

    Primary: total number of days of severe exacerbation

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    End point title
    total number of days of severe exacerbation
    End point description
    End point type
    Primary
    End point timeframe
    over 6 months
    End point values
    AZD 5069 5mg AZD 5069 15 mg AZD5069 45mg Placebo
    Number of subjects analysed
    156
    153
    161
    159
    Units: days
        number (not applicable)
    255
    271
    291
    220
    Statistical analysis title
    total number of days of severe exacerbation
    Statistical analysis description
    Estimates, ratios and p-values are from a negative binomial regression analysis with treatment, OCS use at baseline (yes or no), geographical region and FEV1 pre-bronchodilator at baseline included in the model.
    Comparison groups
    AZD 5069 5mg v Placebo
    Number of subjects included in analysis
    315
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.111
    Method
    negative binomial regression
    Parameter type
    Risk ratio (RR)
    Point estimate
    1.64
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.98
         upper limit
    2.74
    Statistical analysis title
    total number of days of severe exacerbation
    Statistical analysis description
    Estimates, ratios and p-values are from a negative binomial regression analysis with treatment, OCS use at baseline (yes or no), geographical region and FEV1 pre-bronchodilator at baseline included in the model.
    Comparison groups
    AZD 5069 15 mg v Placebo
    Number of subjects included in analysis
    312
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.191
    Method
    negative binomial regression
    Parameter type
    Risk ratio (RR)
    Point estimate
    1.52
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.9
         upper limit
    2.58
    Statistical analysis title
    total number of days of severe exacerbation
    Statistical analysis description
    Estimates, ratios and p-values are from a negative binomial regression analysis with treatment, OCS use at baseline (yes or no), geographical region and FEV1 pre-bronchodilator at baseline included in the model.
    Comparison groups
    AZD5069 45mg v Placebo
    Number of subjects included in analysis
    320
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.123
    Method
    negative binomial regression
    Parameter type
    Risk ratio (RR)
    Point estimate
    1.62
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.97
         upper limit
    2.7

    Primary: Patients experiencing one or more severe exacerbations

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    End point title
    Patients experiencing one or more severe exacerbations
    End point description
    End point type
    Primary
    End point timeframe
    over 6 months
    End point values
    AZD 5069 5mg AZD 5069 15 mg AZD5069 45mg Placebo
    Number of subjects analysed
    156
    153
    161
    159
    Units: paticipents
        number (not applicable)
    23
    26
    28
    21
    Statistical analysis title
    experiencing one or more severe exacerbations
    Statistical analysis description
    logistic regression analysis with treatment, OCS use at baseline (yes or no) and geographical region included in the model.
    Comparison groups
    AZD 5069 5mg v Placebo
    Number of subjects included in analysis
    315
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.627
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.17
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.68
         upper limit
    2.02
    Statistical analysis title
    experiencing one or more severe exacerbations
    Statistical analysis description
    logistic regression analysis with treatment, OCS use at baseline (yes or no) and geographical region included in the model
    Comparison groups
    AZD 5069 15 mg v Placebo
    Number of subjects included in analysis
    312
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.296
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.4
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.82
         upper limit
    2.38
    Statistical analysis title
    experiencing one or more severe exacerbations
    Statistical analysis description
    logistic regression analysis with treatment, OCS use at baseline (yes or no) and geographical region included in the model
    Comparison groups
    AZD5069 45mg v Placebo
    Number of subjects included in analysis
    320
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.261
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.43
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.85
         upper limit
    2.41

    Secondary: event of asthma-specific hospital/intensive care unit (ICU)admissions

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    End point title
    event of asthma-specific hospital/intensive care unit (ICU)admissions
    End point description
    End point type
    Secondary
    End point timeframe
    over 6 months
    End point values
    AZD 5069 5mg AZD 5069 15 mg AZD5069 45mg Placebo
    Number of subjects analysed
    156
    153
    161
    159
    Units: events
        number (not applicable)
    2
    2
    4
    3
    Statistical analysis title
    rate of asthma-specific hospital(ICU) admissions
    Statistical analysis description
    Poisson regression analysis with treatment, OCS use at baseline (yes or no), geographical region and FEV1 pre-bronchodilator at baseline included in the model.
    Comparison groups
    AZD 5069 5mg v Placebo
    Number of subjects included in analysis
    315
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.806
    Method
    Poisson regression
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.8
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.17
         upper limit
    3.63
    Statistical analysis title
    rate of asthma-specific hospital(ICU) admissions
    Statistical analysis description
    Poisson regression analysis with treatment, OCS use at baseline (yes or no), geographical region and FEV1 pre-bronchodilator at baseline included in the model
    Comparison groups
    AZD 5069 15 mg v Placebo
    Number of subjects included in analysis
    312
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.844
    Method
    Poisson regression
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.83
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.18
         upper limit
    3.8
    Statistical analysis title
    rate of asthma-specific hospital (ICU) admissions
    Statistical analysis description
    Poisson regression analysis with treatment, OCS use at baseline (yes or no), geographical region and FEV1 pre-bronchodilator at baseline included in the model
    Comparison groups
    AZD5069 45mg v Placebo
    Number of subjects included in analysis
    320
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.563
    Method
    Poisson regression
    Parameter type
    Risk ratio (RR)
    Point estimate
    1.56
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.44
         upper limit
    5.59

    Secondary: total number of days of asthma-specific hospital /intensive care unit (ICU) admissions

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    End point title
    total number of days of asthma-specific hospital /intensive care unit (ICU) admissions
    End point description
    End point type
    Secondary
    End point timeframe
    over 6 months
    End point values
    AZD 5069 5mg AZD 5069 15 mg AZD5069 45mg Placebo
    Number of subjects analysed
    156
    153
    161
    159
    Units: days
        number (not applicable)
    9
    49
    53
    57
    Statistical analysis title
    days of asthma-specific hospital (ICU) admissions
    Statistical analysis description
    negative binomial regression analysis with treatment,OCS use at baseline (yes or no), geographical region and FEV1 pre-bronchodilator at baseline included in the model
    Comparison groups
    AZD 5069 5mg v Placebo
    Number of subjects included in analysis
    315
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0
    Method
    negative binomial regression
    Parameter type
    Risk ratio (RR)
    Point estimate
    0.02
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.01
         upper limit
    0.07
    Statistical analysis title
    days of asthma-specific hospital(ICU) admissions
    Statistical analysis description
    negative binomial regression analysis with treatment, OCS use at baseline (yes or no), geographical region and FEV1 pre-bronchodilator at baseline included in the model
    Comparison groups
    AZD 5069 15 mg v Placebo
    Number of subjects included in analysis
    312
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0
    Method
    negative binomial regression
    Parameter type
    Risk ratio (RR)
    Point estimate
    9.62
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    5.06
         upper limit
    18.28
    Statistical analysis title
    days of asthma-specific hospital(ICU) admissions
    Statistical analysis description
    negative binomial regression analysis with treatment,OCS use at baseline (yes or no), geographical region and FEV1 pre-bronchodilator at baseline included in the model.
    Comparison groups
    AZD5069 45mg v Placebo
    Number of subjects included in analysis
    320
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0
    Method
    negative binomial regression
    Parameter type
    Risk ratio (RR)
    Point estimate
    6.37
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    3.38
         upper limit
    11.97

    Secondary: total number of days of oral corticosteroids (OCS) use due to worsening in asthma symptoms

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    End point title
    total number of days of oral corticosteroids (OCS) use due to worsening in asthma symptoms
    End point description
    End point type
    Secondary
    End point timeframe
    over 6 months
    End point values
    AZD 5069 5mg AZD 5069 15 mg AZD5069 45mg Placebo
    Number of subjects analysed
    156
    153
    161
    159
    Units: days
        number (not applicable)
    247
    227
    266
    183
    Statistical analysis title
    days of OCS uses
    Statistical analysis description
    negative binomial regression analysis with treatment, OCS use at baseline (yes or no), geographical region and FEV1 pre-bronchodilator at baseline included in the model.
    Comparison groups
    AZD 5069 5mg v Placebo
    Number of subjects included in analysis
    315
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.067
    Method
    negative binomial regression
    Parameter type
    Risk ratio (RR)
    Point estimate
    1.77
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    1.06
         upper limit
    2.95
    Statistical analysis title
    days of OCS use
    Statistical analysis description
    negative binomial regression analysis with treatment, OCS use at baseline (yes or no), geographical region and FEV1 pre-bronchodilator at baseline included in the model.
    Comparison groups
    AZD 5069 15 mg v Placebo
    Number of subjects included in analysis
    312
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.164
    Method
    negative binomial regression
    Parameter type
    Risk ratio (RR)
    Point estimate
    1.57
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.92
         upper limit
    2.66
    Statistical analysis title
    days of OCS use
    Statistical analysis description
    negative binomial regression analysis with treatment, OCS use at baseline (yes or no), geographical region and FEV1 pre-bronchodilator at baseline included in the model.
    Comparison groups
    AZD5069 45mg v Placebo
    Number of subjects included in analysis
    320
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.172
    Method
    negative binomial regression
    Parameter type
    Risk ratio (RR)
    Point estimate
    1.54
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.92
         upper limit
    2.58

    Secondary: Pre-bronchodilator FEV1,measured before the morning administration of the investigational product

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    End point title
    Pre-bronchodilator FEV1,measured before the morning administration of the investigational product
    End point description
    Baseline is defined as the latest non-missing assessment prior to first dose (typically Visit 2, Randomisation). Treatment Period is defined as the average change from baseline across all available visits during the 6-month double-blindtreatment period regardless of whether or not a patient was actually taking IP at that visit.
    End point type
    Secondary
    End point timeframe
    Baseline and post treatment
    End point values
    AZD 5069 5mg AZD 5069 15 mg AZD5069 45mg Placebo
    Number of subjects analysed
    155
    151
    159
    158
    Units: liter
        least squares mean (standard error)
    0.07 ± 0.037
    0.08 ± 0.037
    0.11 ± 0.036
    0.09 ± 0.036
    Statistical analysis title
    FEV1 pre-bronchodilator
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD 5069 5mg v Placebo
    Number of subjects included in analysis
    313
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.601
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.02
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.08
         upper limit
    0.04
    Statistical analysis title
    FEV1 pre-bronchodilator
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD 5069 15 mg v Placebo
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.884
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.01
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.06
         upper limit
    0.05
    Statistical analysis title
    FEV1 pre-bronchodilator
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD5069 45mg v Placebo
    Number of subjects included in analysis
    317
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.47
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    0.03
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.03
         upper limit
    0.08

    Secondary: Post-bronchodilator FEV1,measured before the morning administration of the investigational product

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    End point title
    Post-bronchodilator FEV1,measured before the morning administration of the investigational product
    End point description
    Baseline is defined as the latest non-missing assessment prior to first dose (typically Visit 2, Randomisation).Treatment Period is defined as the average change from baseline across all available visits during the 6-month double-blindtreatment period regardless of whether or not a patient was actually taking IP at that visit.
    End point type
    Secondary
    End point timeframe
    Baseline and post treatment
    End point values
    AZD 5069 5mg AZD 5069 15 mg AZD5069 45mg Placebo
    Number of subjects analysed
    152
    147
    154
    153
    Units: liters
        least squares mean (standard error)
    0 ± 0.029
    0.03 ± 0.029
    0.04 ± 0.028
    0 ± 0.029
    Statistical analysis title
    FEV1 post-bronchodilator
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD 5069 5mg v Placebo
    Number of subjects included in analysis
    305
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.948
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    0
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.04
         upper limit
    0.05
    Statistical analysis title
    FEV1 post-bronchodilator
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD 5069 15 mg v Placebo
    Number of subjects included in analysis
    300
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.334
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    0.03
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.02
         upper limit
    0.07
    Statistical analysis title
    FEV1 post-bronchodilator
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD5069 45mg v Placebo
    Number of subjects included in analysis
    307
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.192
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    0.04
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.01
         upper limit
    0.08

    Secondary: Asthma control questionnaire [ACQ-5] score change from baseline to treatment period

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    End point title
    Asthma control questionnaire [ACQ-5] score change from baseline to treatment period
    End point description
    Treatment period is defined as the average of all available scores during the 6-month double-blind treatment period regardless of whether or not a patient was actually taking IP at that visit (excluding any unscheduled visits): the planned visits for completion were 1 month (visit 6), 2 months (visit 7), 3 months (visit 8), 4 months (visit 9) and 6 months (visit 11)
    End point type
    Secondary
    End point timeframe
    Baseline and post treatment
    End point values
    AZD 5069 5mg AZD 5069 15 mg AZD5069 45mg Placebo
    Number of subjects analysed
    149
    149
    154
    156
    Units: score
        least squares mean (standard error)
    -0.64 ± 0.097
    -0.66 ± 0.095
    -0.68 ± 0.094
    -0.7 ± 0.093
    Statistical analysis title
    Asthma control questionnaire
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and baseline score included in the model. Negative values for a difference show AZD5069 to have a favourable outcome compared to placebo.
    Comparison groups
    AZD 5069 5mg v Placebo
    Number of subjects included in analysis
    305
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.476
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    0.07
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.09
         upper limit
    0.22
    Statistical analysis title
    Asthma control questionnaire
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and baseline score included in the model. Negative values for a difference show AZD5069 to have a favourable outcome compared to placebo.
    Comparison groups
    AZD 5069 15 mg v Placebo
    Number of subjects included in analysis
    305
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.678
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    0.04
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.11
         upper limit
    0.19
    Statistical analysis title
    Asthma control questionnaire
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and baseline score included in the model. Negative values for a difference show AZD5069 to have a favourable outcome compared to placebo.
    Comparison groups
    AZD5069 45mg v Placebo
    Number of subjects included in analysis
    310
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.766
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    0.03
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -0.12
         upper limit
    0.18

    Secondary: Asthma quality of life questionnaire (AQLQ[s]) overall and domain scores change from baseline to treatment period

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    End point title
    Asthma quality of life questionnaire (AQLQ[s]) overall and domain scores change from baseline to treatment period
    End point description
    Treatment period is defined as the average of all available scores during the 6-month double-blind treatment period regardless of whether or not a patient was actually taking IP at that visit (excluding any unscheduled visits): the planned visits for completion were 1 month (visit 6), 3 months (visit 8) and 6 months (visit 11).
    End point type
    Secondary
    End point timeframe
    Baseline and post treatment
    End point values
    AZD 5069 5mg AZD 5069 15 mg AZD5069 45mg Placebo
    Number of subjects analysed
    145
    145
    152
    153
    Units: score
    least squares mean (standard error)
        overall score
    0.52 ± 0.091
    0.46 ± 0.089
    0.5 ± 0.088
    0.52 ± 0.089
        Symptoms
    0.63 ± 0.098
    0.61 ± 0.096
    0.65 ± 0.095
    0.62 ± 0.096
        Activity limitation
    0.47 ± 0.093
    0.39 ± 0.091
    0.46 ± 0.09
    0.49 ± 0.091
        Emotional function
    0.42 ± 0.106
    0.36 ± 0.104
    0.4 ± 0.103
    0.41 ± 0.104
    No statistical analyses for this end point

    Secondary: Percentage of symptom-free days (eDiary) change from baseline to post-randomisation periods

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    End point title
    Percentage of symptom-free days (eDiary) change from baseline to post-randomisation periods
    End point description
    Treatment Period is defined as the percentage of symptom-free days across the entire 6-month double-blind treatment period for a patient (out of the total number number of days where data was available within the treatment period regardless of whether or not a patient was actually taking IP on that day)
    End point type
    Secondary
    End point timeframe
    Baseline and Day1 to Day 28
    End point values
    AZD 5069 5mg AZD 5069 15 mg AZD5069 45mg Placebo
    Number of subjects analysed
    156
    153
    160
    159
    Units: percent
        least squares mean (standard error)
    1.2 ± 1.91
    1.6 ± 1.87
    -0.4 ± 1.85
    1.1 ± 1.84
    Statistical analysis title
    Percentage of symptom-free days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD 5069 5mg v Placebo
    Number of subjects included in analysis
    315
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.974
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    0.1
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -2.9
         upper limit
    3.1
    Statistical analysis title
    Percentage of symptom-free days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD 5069 15 mg v Placebo
    Number of subjects included in analysis
    312
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.797
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    0.5
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -2.5
         upper limit
    3.5
    Statistical analysis title
    Percentage of symptom-free days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD5069 45mg v Placebo
    Number of subjects included in analysis
    319
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.419
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -1.5
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -4.5
         upper limit
    1.5

    Secondary: Percentage of symptom-free days (eDiary) change from baseline to post-randomisation periods

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    End point title
    Percentage of symptom-free days (eDiary) change from baseline to post-randomisation periods
    End point description
    Treatment Period is defined as the percentage of symptom-free days across the entire 6-month double-blind treatment period for a patient (out of the total number number of days where data was available within the treatment period regardless of whether or not a patient was actually taking IP on that day)
    End point type
    Secondary
    End point timeframe
    Baselien and Day 29 to Day 56
    End point values
    AZD 5069 5mg AZD 5069 15 mg AZD5069 45mg Placebo
    Number of subjects analysed
    152
    148
    158
    155
    Units: percent
        least squares mean (standard error)
    3.4 ± 2.81
    2.6 ± 2.75
    0.2 ± 2.73
    3.1 ± 2.73
    Statistical analysis title
    Percentage of symptom-free days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derivedbaseline value included in the model.
    Comparison groups
    AZD 5069 5mg v Placebo
    Number of subjects included in analysis
    307
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.906
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    0.3
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -4.1
         upper limit
    4.7
    Statistical analysis title
    Percentage of symptom-free days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD 5069 15 mg v Placebo
    Number of subjects included in analysis
    303
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.83
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.6
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -5
         upper limit
    3.8
    Statistical analysis title
    Percentage of symptom-free days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derivedbaseline value included in the model.
    Comparison groups
    AZD5069 45mg v Placebo
    Number of subjects included in analysis
    313
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.266
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -2.9
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -7.3
         upper limit
    1.4

    Secondary: Percentage of symptom-free days (eDiary) change from baseline to post-randomisation periods

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    End point title
    Percentage of symptom-free days (eDiary) change from baseline to post-randomisation periods
    End point description
    Treatment Period is defined as the percentage of symptom-free days across the entire 6-month double-blind treatment period for a patient (out of the total number number of days where data was available within the treatment period regardless of whether or not a patient was actually taking IP on that day)
    End point type
    Secondary
    End point timeframe
    Baseline and Day 57 to Day 84
    End point values
    AZD 5069 5mg AZD 5069 15 mg AZD5069 45mg Placebo
    Number of subjects analysed
    149
    146
    155
    154
    Units: percent
        least squares mean (standard error)
    3 ± 3.05
    4.3 ± 2.99
    1.4 ± 2.96
    4 ± 2.96
    Statistical analysis title
    Percentage of symptom-free days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD 5069 5mg v Placebo
    Number of subjects included in analysis
    303
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.725
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -1
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -5.8
         upper limit
    3.8
    Statistical analysis title
    Percentage of symptom-free days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD 5069 15 mg v Placebo
    Number of subjects included in analysis
    300
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.904
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    0.4
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -4.4
         upper limit
    5.1
    Statistical analysis title
    Percentage of symptom-free days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD5069 45mg v Placebo
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.374
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -2.6
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -7.3
         upper limit
    2.2

    Secondary: Percentage of symptom-free days (eDiary) change from baseline to post-randomisation periods

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    End point title
    Percentage of symptom-free days (eDiary) change from baseline to post-randomisation periods
    End point description
    Treatment Period is defined as the percentage of symptom-free days across the entire 6-month double-blind treatment period for a patient (out of the total number number of days where data was available within the treatment period regardless of whether or not a patient was actually taking IP on that day)
    End point type
    Secondary
    End point timeframe
    Baseline and Day 85 to End of 6 Months
    End point values
    AZD 5069 5mg AZD 5069 15 mg AZD5069 45mg Placebo
    Number of subjects analysed
    148
    145
    152
    151
    Units: percent
        least squares mean (standard error)
    3.9 ± 3.17
    5.6 ± 3.11
    2.6 ± 3.11
    4.4 ± 3.09
    Statistical analysis title
    Percentage of symptom-free days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derivedbaseline value included in the model.
    Comparison groups
    AZD 5069 5mg v Placebo
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.884
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.4
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -5.4
         upper limit
    4.5
    Statistical analysis title
    Percentage of symptom-free days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derivedbaseline value included in the model.
    Comparison groups
    AZD 5069 15 mg v Placebo
    Number of subjects included in analysis
    296
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.688
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    1.2
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -3.8
         upper limit
    6.2
    Statistical analysis title
    Percentage of symptom-free days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derivedbaseline value included in the model.
    Comparison groups
    AZD5069 45mg v Placebo
    Number of subjects included in analysis
    303
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.557
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -1.8
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -6.7
         upper limit
    3.2

    Secondary: Percentage of symptom-free days (eDiary) change from baseline to post-randomisation periods

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    End point title
    Percentage of symptom-free days (eDiary) change from baseline to post-randomisation periods
    End point description
    Treatment Period is defined as the percentage of symptom-free days across the entire 6-month double-blind treatment period for a patient (out of the total number number of days where data was available within the treatment period regardless of whether or not a patient was actually taking IP on that day)
    End point type
    Secondary
    End point timeframe
    Baseline and treatment period
    End point values
    AZD 5069 5mg AZD 5069 15 mg AZD5069 45mg Placebo
    Number of subjects analysed
    156
    153
    160
    159
    Units: percent
        least squares mean (standard error)
    3.7 ± 2.61
    4.2 ± 2.56
    1.4 ± 2.53
    3.3 ± 2.53
    Statistical analysis title
    Percentage of symptom-free days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD 5069 5mg v Placebo
    Number of subjects included in analysis
    315
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.885
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    0.4
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -3.8
         upper limit
    4.5
    Statistical analysis title
    Percentage of symptom-free days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD 5069 15 mg v Placebo
    Number of subjects included in analysis
    312
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.721
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    0.9
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -3.2
         upper limit
    5
    Statistical analysis title
    Percentage of symptom-free days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD5069 45mg v Placebo
    Number of subjects included in analysis
    319
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.444
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -1.9
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -6
         upper limit
    2.2

    Secondary: Percentage of asthma-control days (eDiary) change from baseline to post-randomisation periods

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    End point title
    Percentage of asthma-control days (eDiary) change from baseline to post-randomisation periods
    End point description
    Treatment Period is defined as the percentage of symptom-free days across the entire 6-month double-blind treatment period for a patient (out of the total number number of days where data was available within the treatment period regardless of whether or not a patient was actually taking IP on that day).
    End point type
    Secondary
    End point timeframe
    Baseline and Day 1 to Day 28
    End point values
    AZD 5069 5mg AZD 5069 15 mg AZD5069 45mg Placebo
    Number of subjects analysed
    156
    153
    160
    159
    Units: percent
        least squares mean (standard error)
    1.2 ± 1.74
    1.7 ± 1.71
    -1.1 ± 1.68
    0.9 ± 1.68
    Statistical analysis title
    Percentage of asthma-control days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD 5069 5mg v Placebo
    Number of subjects included in analysis
    315
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.87
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    0.3
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -2.5
         upper limit
    3
    Statistical analysis title
    Percentage of asthma-control days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD 5069 15 mg v Placebo
    Number of subjects included in analysis
    312
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.625
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    0.8
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -1.9
         upper limit
    3.6
    Statistical analysis title
    Percentage of asthma-control days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD5069 45mg v Placebo
    Number of subjects included in analysis
    319
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.214
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -2.1
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -4.8
         upper limit
    0.7

    Secondary: Percentage of asthma-control days (eDiary) change from baseline to post-randomisation periods

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    End point title
    Percentage of asthma-control days (eDiary) change from baseline to post-randomisation periods
    End point description
    Treatment Period is defined as the percentage of symptom-free days across the entire 6-month double-blind treatment period for a patient (out of the total number number of days where data was available within the treatment period regardless of whether or not a patient was actually taking IP on that day).
    End point type
    Secondary
    End point timeframe
    Baseline and Day 29 to Day 56
    End point values
    AZD 5069 5mg AZD 5069 15 mg AZD5069 45mg Placebo
    Number of subjects analysed
    151
    148
    158
    155
    Units: percent
        least squares mean (standard error)
    2.7 ± 2.59
    3.5 ± 2.54
    -0.1 ± 2.51
    2.8 ± 2.52
    Statistical analysis title
    Percentage of asthma-control days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD 5069 5mg v Placebo
    Number of subjects included in analysis
    306
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.982
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.1
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -4.1
         upper limit
    4
    Statistical analysis title
    Percentage of asthma-control days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD 5069 15 mg v Placebo
    Number of subjects included in analysis
    303
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.764
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    0.7
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -3.3
         upper limit
    4.8
    Statistical analysis title
    Percentage of asthma-control days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD5069 45mg v Placebo
    Number of subjects included in analysis
    313
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.239
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -2.9
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -6.9
         upper limit
    1.1

    Secondary: Percentage of asthma-control days (eDiary) change from baseline to post-randomisation periods

    Close Top of page
    End point title
    Percentage of asthma-control days (eDiary) change from baseline to post-randomisation periods
    End point description
    Treatment Period is defined as the percentage of symptom-free days across the entire 6-month double-blind treatment period for a patient (out of the total number number of days where data was available within the treatment period regardless of whether or not a patient was actually taking IP on that day).
    End point type
    Secondary
    End point timeframe
    Baseline and Day 57 to Day 84
    End point values
    AZD 5069 5mg AZD 5069 15 mg AZD5069 45mg Placebo
    Number of subjects analysed
    149
    146
    155
    154
    Units: percent
        least squares mean (standard error)
    3.2 ± 2.92
    4.7 ± 2.87
    0.9 ± 2.84
    2.9 ± 2.84
    Statistical analysis title
    Percentage of asthma-control days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD 5069 5mg v Placebo
    Number of subjects included in analysis
    303
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.904
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    0.3
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -4.2
         upper limit
    4.9
    Statistical analysis title
    Percentage of asthma-control days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD 5069 15 mg v Placebo
    Number of subjects included in analysis
    300
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.519
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    1.8
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -2.8
         upper limit
    6.4
    Statistical analysis title
    Percentage of asthma-control days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD5069 45mg v Placebo
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.466
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -2
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -6.6
         upper limit
    2.5

    Secondary: Percentage of asthma-control days (eDiary) change from baseline to post-randomisation periods

    Close Top of page
    End point title
    Percentage of asthma-control days (eDiary) change from baseline to post-randomisation periods
    End point description
    Treatment Period is defined as the percentage of symptom-free days across the entire 6-month double-blind treatment period for a patient (out of the total number number of days where data was available within the treatment period regardless of whether or not a patient was actually taking IP on that day).
    End point type
    Secondary
    End point timeframe
    Bseline and Day 85 to End of 6 Months
    End point values
    AZD 5069 5mg AZD 5069 15 mg AZD5069 45mg Placebo
    Number of subjects analysed
    148
    145
    152
    151
    Units: percent
        least squares mean (standard error)
    3.9 ± 2.99
    5.7 ± 2.93
    1.4 ± 2.93
    2.4 ± 2.91
    Statistical analysis title
    Percentage of asthma-control days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD 5069 5mg v Placebo
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.604
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    1.5
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -3.2
         upper limit
    6.1
    Statistical analysis title
    Percentage of asthma-control days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derivedbaseline value included in the model.
    Comparison groups
    AZD 5069 15 mg v Placebo
    Number of subjects included in analysis
    296
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.256
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    3.2
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -1.5
         upper limit
    7.9
    Statistical analysis title
    Percentage of asthma-control days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derivedbaseline value included in the model.
    Comparison groups
    AZD5069 45mg v Placebo
    Number of subjects included in analysis
    303
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.71
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -1
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -5.7
         upper limit
    3.6

    Secondary: Percentage of asthma-control days (eDiary) change from baseline to post-randomisation periods

    Close Top of page
    End point title
    Percentage of asthma-control days (eDiary) change from baseline to post-randomisation periods
    End point description
    Treatment Period is defined as the percentage of symptom-free days across the entire 6-month double-blind treatment period for a patient (out of the total number number of days where data was available within the treatment period regardless of whether or not a patient was actually taking IP on that day).
    End point type
    Secondary
    End point timeframe
    Baseline and Treatment Period
    End point values
    AZD 5069 5mg AZD 5069 15 mg AZD5069 45mg Placebo
    Number of subjects analysed
    156
    153
    160
    159
    Units: percent
        least squares mean (standard error)
    3.5 ± 2.46
    4.4 ± 2.42
    0.6 ± 2.38
    2.3 ± 2.38
    Statistical analysis title
    Percentage of asthma-control days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD 5069 5mg v Placebo
    Number of subjects included in analysis
    315
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.605
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    1.2
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -2.7
         upper limit
    5.1
    Statistical analysis title
    Percentage of asthma-control days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD 5069 15 mg v Placebo
    Number of subjects included in analysis
    312
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.359
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    2.2
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -1.7
         upper limit
    6.1
    Statistical analysis title
    Percentage of asthma-control days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD5069 45mg v Placebo
    Number of subjects included in analysis
    319
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.475
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -1.7
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -5.5
         upper limit
    2.2

    Secondary: Percentage of rescue medication free days (eDiary) change from baseline to post-randomisation periods

    Close Top of page
    End point title
    Percentage of rescue medication free days (eDiary) change from baseline to post-randomisation periods
    End point description
    Treatment Period is defined as the percentage of rescue medication free days across the entire 6-month double-blind treatment period for a patient (out of the total number number of days where data was available within the treatment period regardless of whether or not a patient was actually taking IP on that day).
    End point type
    Secondary
    End point timeframe
    Baseline and Day 1 to Day 28
    End point values
    AZD 5069 5mg AZD 5069 15 mg AZD5069 45mg Placebo
    Number of subjects analysed
    156
    153
    160
    159
    Units: percent
        least squares mean (standard error)
    6.8 ± 2.89
    8.3 ± 2.84
    4 ± 2.79
    9.5 ± 2.8
    Statistical analysis title
    Percentage of rescue medication free days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD 5069 5mg v Placebo
    Number of subjects included in analysis
    315
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.324
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -2.7
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -7.3
         upper limit
    1.8
    Statistical analysis title
    Percentage of rescue medication free days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD 5069 15 mg v Placebo
    Number of subjects included in analysis
    312
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.664
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -1.2
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -5.8
         upper limit
    3.4
    Statistical analysis title
    Percentage of rescue medication free days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD5069 45mg v Placebo
    Number of subjects included in analysis
    319
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.047
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -5.5
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -10
         upper limit
    -1

    Secondary: Percentage of rescue medication free days (eDiary) change from baseline to post-randomisation periods

    Close Top of page
    End point title
    Percentage of rescue medication free days (eDiary) change from baseline to post-randomisation periods
    End point description
    Treatment Period is defined as the percentage of rescue medication free days across the entire 6-month double-blind treatment period for a patient (out of the total number number of days where data was available within the treatment period regardless of whether or not a patient was actually taking IP on that day).
    End point type
    Secondary
    End point timeframe
    Baseline and Day 29 to Day 56
    End point values
    AZD 5069 5mg AZD 5069 15 mg AZD5069 45mg Placebo
    Number of subjects analysed
    150
    148
    158
    155
    Units: percent
        least squares mean (standard error)
    15.4 ± 3.84
    17.6 ± 3.76
    10.7 ± 3.71
    9.5 ± 2.8
    Statistical analysis title
    Percentage of rescue medication free days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD 5069 5mg v Placebo
    Number of subjects included in analysis
    305
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.791
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -1
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -7
         upper limit
    5
    Statistical analysis title
    Percentage of rescue medication free days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD 5069 15 mg v Placebo
    Number of subjects included in analysis
    303
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.752
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    1.2
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -4.9
         upper limit
    7.2
    Statistical analysis title
    Percentage of rescue medication free days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD5069 45mg v Placebo
    Number of subjects included in analysis
    313
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.114
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -5.7
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -11.6
         upper limit
    0.2

    Secondary: Percentage of rescue medication free days (eDiary) change from baseline to post-randomisation periods

    Close Top of page
    End point title
    Percentage of rescue medication free days (eDiary) change from baseline to post-randomisation periods
    End point description
    Treatment Period is defined as the percentage of rescue medication free days across the entire 6-month double-blind treatment period for a patient (out of the total number number of days where data was available within the treatment period regardless of whether or not a patient was actually taking IP on that day).
    End point type
    Secondary
    End point timeframe
    Baseline and Day 57 to Day 84
    End point values
    AZD 5069 5mg AZD 5069 15 mg AZD5069 45mg Placebo
    Number of subjects analysed
    147
    146
    155
    153
    Units: percent
        least squares mean (standard error)
    19.8 ± 4.12
    19.2 ± 4.03
    12.3 ± 3.98
    18.7 ± 3.99
    Statistical analysis title
    Percentage of rescue medication free days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD 5069 5mg v Placebo
    Number of subjects included in analysis
    300
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.779
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    1.1
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -5.4
         upper limit
    7.6
    Statistical analysis title
    Percentage of rescue medication free days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD 5069 15 mg v Placebo
    Number of subjects included in analysis
    299
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.896
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    0.5
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -6
         upper limit
    7
    Statistical analysis title
    Percentage of rescue medication free days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD5069 45mg v Placebo
    Number of subjects included in analysis
    308
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.099
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -6.4
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -12.8
         upper limit
    0

    Secondary: Percentage of rescue medication free days (eDiary) change from baseline to post-randomisation periods

    Close Top of page
    End point title
    Percentage of rescue medication free days (eDiary) change from baseline to post-randomisation periods
    End point description
    Treatment Period is defined as the percentage of rescue medication free days across the entire 6-month double-blind treatment period for a patient (out of the total number number of days where data was available within the treatment period regardless of whether or not a patient was actually taking IP on that day).
    End point type
    Secondary
    End point timeframe
    Baseline and Day 85 to End of 6 Months
    End point values
    AZD 5069 5mg AZD 5069 15 mg AZD5069 45mg Placebo
    Number of subjects analysed
    147
    145
    152
    150
    Units: percent
        least squares mean (standard error)
    21.2 ± 4.25
    23.1 ± 4.16
    15.8 ± 4.16
    20 ± 4.14
    Statistical analysis title
    Percentage of rescue medication free days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD 5069 5mg v Placebo
    Number of subjects included in analysis
    297
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.767
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    1.2
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -5.5
         upper limit
    7.8
    Statistical analysis title
    Percentage of rescue medication free days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD 5069 15 mg v Placebo
    Number of subjects included in analysis
    295
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.445
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    3.1
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -3.6
         upper limit
    9.8
    Statistical analysis title
    Percentage of rescue medication free days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD5069 45mg v Placebo
    Number of subjects included in analysis
    302
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.298
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -4.2
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -10.8
         upper limit
    2.4

    Secondary: Percentage of rescue medication free days (eDiary) change from baseline to post-randomisation periods

    Close Top of page
    End point title
    Percentage of rescue medication free days (eDiary) change from baseline to post-randomisation periods
    End point description
    Treatment Period is defined as the percentage of rescue medication free days across the entire 6-month double-blind treatment period for a patient (out of the total number number of days where data was available within the treatment period regardless of whether or not a patient was actually taking IP on that day).
    End point type
    Secondary
    End point timeframe
    Baseline and Treatment Period
    End point values
    AZD 5069 5mg AZD 5069 15 mg AZD5069 45mg Placebo
    Number of subjects analysed
    156
    153
    160
    159
    Units: percent
        least squares mean (standard error)
    16.6 ± 3.58
    18.1 ± 3.51
    11.5 ± 3.46
    16.7 ± 3.46
    Statistical analysis title
    Percentage of rescue medication free days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD 5069 5mg v Placebo
    Number of subjects included in analysis
    315
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.969
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.1
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -5.8
         upper limit
    5.5
    Statistical analysis title
    Percentage of rescue medication free days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD 5069 15 mg v Placebo
    Number of subjects included in analysis
    312
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.7
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    1.3
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -4.3
         upper limit
    7
    Statistical analysis title
    Percentage of rescue medication free days
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD5069 45mg v Placebo
    Number of subjects included in analysis
    319
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.124
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -5.2
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -10.9
         upper limit
    0.4

    Secondary: Percentage of night-time awakenings due to asthma symptoms (eDiary) change from baseline to post-randomisation periods

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    End point title
    Percentage of night-time awakenings due to asthma symptoms (eDiary) change from baseline to post-randomisation periods
    End point description
    Treatment Period is defined as the percentage of night-time awakenings due to asthma symptoms across the entire 6-month double-blind treatment period for a patient (out of the total number of days where data was available within the treatment period, regardless of whether or not a patient was actually taking IP on that day).
    End point type
    Secondary
    End point timeframe
    Baseline and Day 1 to Day 28
    End point values
    AZD 5069 5mg AZD 5069 15 mg AZD5069 45mg Placebo
    Number of subjects analysed
    156
    153
    161
    159
    Units: percent
        least squares mean (standard error)
    -11.3 ± 2.85
    -11.1 ± 2.8
    -10.1 ± 2.75
    -8.9 ± 2.76
    Statistical analysis title
    Percentage of night-time awakenings
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD 5069 5mg v Placebo
    Number of subjects included in analysis
    315
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.375
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -2.4
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -6.9
         upper limit
    2.1
    Statistical analysis title
    Percentage of night-time awakenings
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD 5069 15 mg v Placebo
    Number of subjects included in analysis
    312
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.424
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -2.2
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -6.7
         upper limit
    2.3
    Statistical analysis title
    Percentage of night-time awakenings
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD5069 45mg v Placebo
    Number of subjects included in analysis
    320
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.663
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -1.2
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -5.6
         upper limit
    3.3

    Secondary: Percentage of night-time awakenings due to asthma symptoms (eDiary) change from baseline to post-randomisation periods

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    End point title
    Percentage of night-time awakenings due to asthma symptoms (eDiary) change from baseline to post-randomisation periods
    End point description
    Treatment Period is defined as the percentage of night-time awakenings due to asthma symptoms across the entire 6-month double-blind treatment period for a patient (out of the total number of days where data was available within the treatment period, regardless of whether or not a patient was actually taking IP on that day).
    End point type
    Secondary
    End point timeframe
    Baseline and Day 29 to Day 56
    End point values
    AZD 5069 5mg AZD 5069 15 mg AZD5069 45mg Placebo
    Number of subjects analysed
    152
    148
    158
    156
    Units: percent
        least squares mean (standard error)
    -18.2 ± 3.41
    -19 ± 3.35
    -15.2 ± 3.31
    -15.2 ± 3.32
    Statistical analysis title
    Percentage of night-time awakenings
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derivedbaseline value included in the model.
    Comparison groups
    AZD 5069 5mg v Placebo
    Number of subjects included in analysis
    308
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.359
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -3
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -8.3
         upper limit
    2.4
    Statistical analysis title
    Percentage of night-time awakenings
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD 5069 15 mg v Placebo
    Number of subjects included in analysis
    304
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.244
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -3.8
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -9.2
         upper limit
    1.6
    Statistical analysis title
    Percentage of night-time awakenings
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD5069 45mg v Placebo
    Number of subjects included in analysis
    314
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.995
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    0
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -5.3
         upper limit
    5.3

    Secondary: Percentage of night-time awakenings due to asthma symptoms (eDiary) change from baseline to post-randomisation periods

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    End point title
    Percentage of night-time awakenings due to asthma symptoms (eDiary) change from baseline to post-randomisation periods
    End point description
    Treatment Period is defined as the percentage of night-time awakenings due to asthma symptoms across the entire 6-month double-blind treatment period for a patient (out of the total number of days where data was available within the treatment period, regardless of whether or not a patient was actually taking IP on that day).
    End point type
    Secondary
    End point timeframe
    Baseline and Day 57 to Day 84
    End point values
    AZD 5069 5mg AZD 5069 15 mg AZD5069 45mg Placebo
    Number of subjects analysed
    149
    146
    155
    154
    Units: percent
        least squares mean (standard error)
    -22.1 ± 3.55
    -19.8 ± 3.48
    -17.6 ± 3.44
    -16.7 ± 3.45
    Statistical analysis title
    Percentage of night-time awakenings
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derivedbaseline value included in the model.
    Comparison groups
    AZD 5069 5mg v Placebo
    Number of subjects included in analysis
    303
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.111
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -5.4
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -10.9
         upper limit
    0.2
    Statistical analysis title
    Percentage of night-time awakenings
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD 5069 15 mg v Placebo
    Number of subjects included in analysis
    300
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.365
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -3.1
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -8.7
         upper limit
    2.5
    Statistical analysis title
    Percentage of night-time awakenings
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD5069 45mg v Placebo
    Number of subjects included in analysis
    309
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.793
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -0.9
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -6.4
         upper limit
    4.6

    Secondary: Percentage of night-time awakenings due to asthma symptoms (eDiary) change from baseline to post-randomisation periods

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    End point title
    Percentage of night-time awakenings due to asthma symptoms (eDiary) change from baseline to post-randomisation periods
    End point description
    Treatment Period is defined as the percentage of night-time awakenings due to asthma symptoms across the entire 6-month double-blind treatment period for a patient (out of the total number of days where data was available within the treatment period, regardless of whether or not a patient was actually taking IP on that day).
    End point type
    Secondary
    End point timeframe
    Baseline and Day 85 to End of 6 Months
    End point values
    AZD 5069 5mg AZD 5069 15 mg AZD5069 45mg Placebo
    Number of subjects analysed
    148
    145
    153
    152
    Units: percent
        least squares mean (standard error)
    -25.3 ± 3.64
    -25.5 ± 3.56
    -22.8 ± 3.09
    -21.8 ± 3.54
    Statistical analysis title
    Percentage of night-time awakenings
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD 5069 5mg v Placebo
    Number of subjects included in analysis
    300
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.318
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -3.4
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -9.1
         upper limit
    2.2
    Statistical analysis title
    Percentage of night-time awakenings
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD 5069 15 mg v Placebo
    Number of subjects included in analysis
    297
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.297
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -3.6
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -9.3
         upper limit
    2.1
    Statistical analysis title
    Percentage of night-time awakenings
    Statistical analysis description
    Statistical analysis is based on an ANCOVA model with treatment, OCS use at baseline (yes or no) and derived baseline value included in the model.
    Comparison groups
    AZD5069 45mg v Placebo
    Number of subjects included in analysis
    305
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.776
    Method
    ANCOVA
    Parameter type
    Mean difference (final values)
    Point estimate
    -1
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    -6.6
         upper limit
    4.6

    Secondary: Uncontrolled asthma weeks based on eDiary

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    End point title
    Uncontrolled asthma weeks based on eDiary
    End point description
    An uncontrolled asthma week is defined as the fulfilment of 1 of the following conditions: 1) two consecutive days with awakenings due to asthma on both nights and 2) a recorded use of rescue medication for symptom relief on at least 3 occasions per day, for 2 consecutive days (where one occasion is defined as one puff of rescue medication).Baseline is defined as the last 2 weeks (14 days) before randomisation for each patient.
    End point type
    Secondary
    End point timeframe
    Baseline and 6 months treatment period
    End point values
    AZD 5069 5mg AZD 5069 15 mg AZD5069 45mg Placebo
    Number of subjects analysed
    153
    151
    157
    157
    Units: weeks
        arithmetic mean (standard deviation)
    10.4 ± 9.84
    10.7 ± 10.02
    11 ± 10
    10.9 ± 9.89
    No statistical analyses for this end point

    Secondary: Well-controlled asthma weeks based on eDiary

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    End point title
    Well-controlled asthma weeks based on eDiary
    End point description
    A well-controlled asthma week is defined as the fulfilment of both conditions: 1) no night-time awakenings due to asthma symptoms and no severe or mild/moderate asthma exacerbations and 2) two or more of the following 3 criteria are fulfilled: a) asthma symptoms on no more than 2 days with a daytime symptom score of >1, b) no more than 2 days of rescue medication use, up to a maximum of 4 occasions per week (where one occasion is defined as one puff of rescue medication) and c) >=80% of predicted normal(PN) morning PEF every day (according to the ERS guidelines).
    End point type
    Secondary
    End point timeframe
    Baseline and 6 months treatment period
    End point values
    AZD 5069 5mg AZD 5069 15 mg AZD5069 45mg Placebo
    Number of subjects analysed
    154
    151
    157
    158
    Units: weeks
        arithmetic mean (standard deviation)
    2.4 ± 5.38
    1.9 ± 4.78
    1.7 ± 4.38
    2.3 ± 5.27
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Safety evaluations were performed for the 12 months of the study. 6-month results would be reported.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    AZD 5069 5mg
    Reporting group description
    -

    Reporting group title
    AZD 5069 15 mg
    Reporting group description
    -

    Reporting group title
    AZD5069 45mg
    Reporting group description
    -

    Reporting group title
    Placebo
    Reporting group description
    -

    Serious adverse events
    AZD 5069 5mg AZD 5069 15 mg AZD5069 45mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 156 (4.49%)
    8 / 153 (5.23%)
    14 / 161 (8.70%)
    13 / 159 (8.18%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Vascular disorders
    PERIPHERAL EMBOLISM
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 153 (0.00%)
    0 / 161 (0.00%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HYPERTENSION
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 153 (0.00%)
    0 / 161 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    RENAL CANCER
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 153 (0.00%)
    1 / 161 (0.62%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    LUNG NEOPLASM MALIGNANT
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 153 (0.00%)
    0 / 161 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    UTERINE LEIOMYOMA
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 153 (0.00%)
    0 / 161 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    OVARIAN CYST
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 153 (0.00%)
    1 / 161 (0.62%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    PATELLA FRACTURE
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 153 (0.00%)
    1 / 161 (0.62%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Investigations
    ALANINE AMINOTRANSFERASE INCREASED
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 153 (0.65%)
    0 / 161 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    ATRIAL FIBRILLATION
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 153 (0.00%)
    1 / 161 (0.62%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    CORONARY ARTERY DISEASE
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 153 (0.00%)
    0 / 161 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    PSEUDOHYPOPARATHYROIDISM
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 153 (0.00%)
    0 / 161 (0.00%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    NEUTROPENIA
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 153 (0.65%)
    0 / 161 (0.00%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    ASTHMA
         subjects affected / exposed
    4 / 156 (2.56%)
    3 / 153 (1.96%)
    4 / 161 (2.48%)
    3 / 159 (1.89%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 4
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ASTHMATIC CRISIS
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 153 (0.65%)
    0 / 161 (0.00%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    CRITICAL ILLNESS POLYNEUROPATHY
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 153 (0.65%)
    0 / 161 (0.00%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ISCHAEMIC STROKE
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 153 (0.00%)
    0 / 161 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    BARRETTS OESOPHAGUS
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 153 (0.65%)
    0 / 161 (0.00%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    GASTRITIS
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 153 (0.00%)
    1 / 161 (0.62%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HIATUS HERNIA
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 153 (0.65%)
    0 / 161 (0.00%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ABDOMINAL HERNIA
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 153 (0.00%)
    0 / 161 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    INGUINAL HERNIA
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 153 (0.00%)
    0 / 161 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    CHOLECYSTITIS CHRONIC
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 153 (0.00%)
    0 / 161 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    CHOLELITHIASIS
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 153 (0.65%)
    0 / 161 (0.00%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    CALCULUS URETERIC
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 153 (0.00%)
    0 / 161 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 153 (0.65%)
    0 / 161 (0.00%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    PNEUMONIA
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 153 (0.65%)
    3 / 161 (1.86%)
    2 / 159 (1.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ABDOMINAL ABSCESS
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 153 (0.00%)
    1 / 161 (0.62%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    HELICOBACTER GASTRITIS
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 153 (0.65%)
    0 / 161 (0.00%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    LOWER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 153 (0.00%)
    1 / 161 (0.62%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    LOWER RESPIRATORY TRACT INFECTION BACTERIAL
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 153 (0.00%)
    0 / 161 (0.00%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    SALMONELLOSIS
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 153 (0.65%)
    0 / 161 (0.00%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    STREPTOCOCCAL SEPSIS
         subjects affected / exposed
    0 / 156 (0.00%)
    1 / 153 (0.65%)
    0 / 161 (0.00%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    VIRAL UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 153 (0.00%)
    1 / 161 (0.62%)
    0 / 159 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    ACUTE TONSILLITIS
         subjects affected / exposed
    0 / 156 (0.00%)
    0 / 153 (0.00%)
    0 / 161 (0.00%)
    1 / 159 (0.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    AZD 5069 5mg AZD 5069 15 mg AZD5069 45mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    67 / 156 (42.95%)
    60 / 153 (39.22%)
    72 / 161 (44.72%)
    83 / 159 (52.20%)
    Respiratory, thoracic and mediastinal disorders
    ASTHMA
         subjects affected / exposed
    4 / 156 (2.56%)
    3 / 153 (1.96%)
    4 / 161 (2.48%)
    3 / 159 (1.89%)
         occurrences all number
    4
    3
    4
    3
    COUGH
         subjects affected / exposed
    3 / 156 (1.92%)
    2 / 153 (1.31%)
    1 / 161 (0.62%)
    0 / 159 (0.00%)
         occurrences all number
    3
    2
    1
    0
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    6 / 156 (3.85%)
    12 / 153 (7.84%)
    12 / 161 (7.45%)
    15 / 159 (9.43%)
         occurrences all number
    6
    12
    12
    15
    Gastrointestinal disorders
    ABDOMINAL PAIN UPPER
         subjects affected / exposed
    4 / 156 (2.56%)
    4 / 153 (2.61%)
    2 / 161 (1.24%)
    1 / 159 (0.63%)
         occurrences all number
    4
    4
    2
    1
    NAUSEA
         subjects affected / exposed
    2 / 156 (1.28%)
    3 / 153 (1.96%)
    3 / 161 (1.86%)
    3 / 159 (1.89%)
         occurrences all number
    2
    3
    3
    3
    DIARRHOEA
         subjects affected / exposed
    2 / 156 (1.28%)
    0 / 153 (0.00%)
    4 / 161 (2.48%)
    2 / 159 (1.26%)
         occurrences all number
    2
    0
    4
    2
    GASTROOESOPHAGEAL REFLUX DISEASE
         subjects affected / exposed
    1 / 156 (0.64%)
    0 / 153 (0.00%)
    4 / 161 (2.48%)
    1 / 159 (0.63%)
         occurrences all number
    1
    0
    4
    1
    Musculoskeletal and connective tissue disorders
    BACK PAIN
         subjects affected / exposed
    1 / 156 (0.64%)
    4 / 153 (2.61%)
    2 / 161 (1.24%)
    6 / 159 (3.77%)
         occurrences all number
    1
    4
    2
    6
    ARTHRALGIA
         subjects affected / exposed
    2 / 156 (1.28%)
    2 / 153 (1.31%)
    1 / 161 (0.62%)
    2 / 159 (1.26%)
         occurrences all number
    2
    2
    1
    2
    Infections and infestations
    NASOPHARYNGITIS
         subjects affected / exposed
    18 / 156 (11.54%)
    13 / 153 (8.50%)
    18 / 161 (11.18%)
    31 / 159 (19.50%)
         occurrences all number
    18
    13
    18
    31
    BRONCHITIS
         subjects affected / exposed
    1 / 156 (0.64%)
    6 / 153 (3.92%)
    7 / 161 (4.35%)
    10 / 159 (6.29%)
         occurrences all number
    1
    6
    7
    10
    PHARYNGITIS
         subjects affected / exposed
    5 / 156 (3.21%)
    4 / 153 (2.61%)
    3 / 161 (1.86%)
    5 / 159 (3.14%)
         occurrences all number
    5
    4
    3
    5
    VIRAL UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    3 / 156 (1.92%)
    3 / 153 (1.96%)
    6 / 161 (3.73%)
    2 / 159 (1.26%)
         occurrences all number
    3
    3
    6
    2
    INFLUENZA
         subjects affected / exposed
    4 / 156 (2.56%)
    3 / 153 (1.96%)
    3 / 161 (1.86%)
    3 / 159 (1.89%)
         occurrences all number
    4
    3
    3
    3
    PNEUMONIA
         subjects affected / exposed
    1 / 156 (0.64%)
    2 / 153 (1.31%)
    4 / 161 (2.48%)
    3 / 159 (1.89%)
         occurrences all number
    1
    2
    4
    3
    RHINITIS
         subjects affected / exposed
    1 / 156 (0.64%)
    4 / 153 (2.61%)
    2 / 161 (1.24%)
    0 / 159 (0.00%)
         occurrences all number
    1
    4
    2
    0
    SINUSITIS
         subjects affected / exposed
    3 / 156 (1.92%)
    1 / 153 (0.65%)
    3 / 161 (1.86%)
    5 / 159 (3.14%)
         occurrences all number
    3
    1
    3
    5
    LOWER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    1 / 156 (0.64%)
    1 / 153 (0.65%)
    4 / 161 (2.48%)
    3 / 159 (1.89%)
         occurrences all number
    1
    1
    4
    3
    URINARY TRACT INFECTION
         subjects affected / exposed
    0 / 156 (0.00%)
    3 / 153 (1.96%)
    3 / 161 (1.86%)
    2 / 159 (1.26%)
         occurrences all number
    0
    3
    3
    2
    GASTROENTERITIS
         subjects affected / exposed
    1 / 156 (0.64%)
    2 / 153 (1.31%)
    1 / 161 (0.62%)
    2 / 159 (1.26%)
         occurrences all number
    1
    2
    1
    2
    UPPER RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    6 / 156 (3.85%)
    2 / 153 (1.31%)
    3 / 161 (1.86%)
    3 / 159 (1.89%)
         occurrences all number
    6
    2
    3
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Oct 2012
    Clarification regarding the use of contraception during the study after new in vitro results became available. Clarification that patients were to contact the investigator regarding increased body temperatures and for worsening of asthma signs.

    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
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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