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    Clinical Trial Results:
    Effect of Low Dose Continuous Treatment with Ciclesonide over One Year on the Time to First Exacerbation in Children with Mild Asthma Versus Intermittent Treatment for Exacerbations

    Summary
    EudraCT number
    		 2007-003736-34
    Trial protocol
    		 HU  
    Global end of trial date
    25 Jun 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 May 2017
    First version publication date
    28 May 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    BY9010/CA-101
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00163293
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    One MedImmune Way, Gaithersburg, United States, 20878
    Public contact
    AstraZeneca Clinical Study Information Center, AstraZeneca, +1 877-240-9479, information.center@astrazeneca.com
    Scientific contact
    AstraZeneca Clinical Study Information Center, AstraZeneca, +1 877-240-9479, information.center@astrazeneca.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    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
    25 Jun 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Jun 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Jun 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of this study is to compare the efficacy of ciclesonide with respect to reduction of the number of asthma exacerbations in children with mild persistent asthma. Treatment medication will be administered as follows: ciclesonide will be inhaled once daily, using one of the two dose levels versus placebo together with other corticosteroids used as intermittent treatment. The study duration consists of a baseline period (3 to 4 weeks) and a treatment period (12 months). The study will provide further data on safety and tolerability of ciclesonide.
    Protection of trial subjects
    All study participants or their representative were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    24 Jan 2005
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Canada: 142
    Country: Number of subjects enrolled
    Hungary: 39
    Country: Number of subjects enrolled
    South Africa: 59
    Worldwide total number of subjects
    240
    EEA total number of subjects
    39
    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)
    240
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants took part in the study at 30 investigative sites in Canada, Hungary and South Africa from 24 January 2005 to 25 June 2009.

    Pre-assignment
    Screening details
    		 Children who experienced symptoms consistent with mild asthma for at least 12 months were enrolled in 1 of 3 treatment groups: once a day placebo, 100 µg or 200 µg ciclesonide.

    Pre-assignment period milestones
    Number of subjects started
    		 240
    Number of subjects completed
    		 239

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Did not receive study drug.: 1
    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ciclesonide 100 µg
    Arm description
    		 Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ciclesonide 100 µg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour, solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    50 µg two puffs once daily, in the evening via a metered-dose inhaler (50 µg ex-valve corresponds to 40 µg ex-actuator)

    Arm title
    		 Ciclesonide 200 µg
    Arm description
    		 Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ciclesonide 200 µg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour, solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    100 µg two puffs once daily, in the evening via a metered-dose inhaler (100 µg ex-valve corresponds to 80 µg ex-actuator)

    Arm title
    		 Placebo
    Arm description
    		 Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo-matching ciclesonide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour, solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    two puffs once daily, in the evening, via a metered-dose inhaler

    Number of subjects in period 1 [1]
    		Ciclesonide 100 µg Ciclesonide 200 µg Placebo
    Started
    79
    76
    84
    Completed
    66
    69
    66
    Not completed
    13
    7
    18
         Reasons Not Specified
    13
    7
    18
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 240 patients were randomized but only 239 were treated.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ciclesonide 100 µg
    Reporting group description
    		 Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.

    Reporting group title
    Ciclesonide 200 µg
    Reporting group description
    		 Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.

    Reporting group title
    Placebo
    Reporting group description
    		 Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.

    Reporting group values
    		 Ciclesonide 100 µg Ciclesonide 200 µg Placebo Total
    Number of subjects
    		 79 76 84 239
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 79 76 84 239
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 7.9 ( 2.06 ) 7.7 ( 1.84 ) 8.1 ( 2.19 ) -
    Gender, Male/Female
    Units: participants
        Female
    		 33 31 34 98
        Male
    		 46 45 50 141
    Race/Ethnicity, Customized
    Units: Subjects
        Asian
    		 6 6 6 18
        Black
    		 4 2 5 11
        Caucasian
    		 55 53 59 167
        Other
    		 14 15 14 43
    Smoking Classification
    Units: Subjects
        Non-Smokers
    		 79 76 84 239
    Study Specific Characteristic | Weight
    Weight data was only available for n=77, 76, 84 participants, respectively.
    Units: kg
        arithmetic mean (standard deviation)
    		 29.9 ( 9.701 ) 30.01 ( 9.247 ) 33.13 ( 11.64 ) -
    Study Specific Characteristic | Body Mass Index (BMI)
    BMI data was only available for n=77, 76, 84 participants, respectively.
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 17.3 ( 3.107 ) 17.69 ( 2.977 ) 18.68 ( 4.069 ) -

    End points

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    End points reporting groups
    Reporting group title
    Ciclesonide 100 µg
    Reporting group description
    		 Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.

    Reporting group title
    Ciclesonide 200 µg
    Reporting group description
    		 Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.

    Reporting group title
    Placebo
    Reporting group description
    		 Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.

    Primary: Time to First Asthma Exacerbation

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    End point title
    		 Time to First Asthma Exacerbation
    End point description
    Time to first asthma exacerbation is defined as the time in days until the first asthma exacerbation, or to the end of treatment visit. In the absence of an exacerbation, an early treatment discontinuation is treated as a censored observation on the day following the last use of study drug. Intention to Treat (ITT) analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.
    End point type
    Primary
    End point timeframe
    Up to 12 months
    End point values
    		 Ciclesonide 100 µg Ciclesonide 200 µg Placebo
    Number of subjects analysed
    79
    76
    84
    Units: days
        arithmetic mean (standard error)
    225.1 ( 14.73 )
    249.5 ( 14.79 )
    227.2 ( 15.2 )
    Statistical analysis title
    		 Analysis 1
    Comparison groups
    Ciclesonide 100 µg v Placebo
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6625
    Method
    		 Logrank
    Confidence interval
    Statistical analysis title
    		 Analysis 2
    Comparison groups
    Ciclesonide 200 µg v Placebo
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7303
    Method
    		 Logrank
    Confidence interval

    Primary: Exacerbations (Post-hoc Analysis of Annual Rates)

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    End point title
    		 Exacerbations (Post-hoc Analysis of Annual Rates)
    End point description
    A model-based analysis of asthma exacerbation was performed to adjust to important covariables. The distribution of the data suggested a Poisson regression modeling (zero inflated) strategy. After a variable selection process considering also variable-by-treatment interactions, the variables centre, age [years] and race were identified to be important beside treatment. The parameters centre and age [years] were allocated to zero-model part and the variables treatment and race to the Poisson model part. The estimates of the per-treatment rates are based on a negative-binomial distribution. ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.
    End point type
    Primary
    End point timeframe
    Up to 12 months
    End point values
    		 Ciclesonide 100 µg Ciclesonide 200 µg Placebo
    Number of subjects analysed
    79
    76
    84
    Units: number of events per year
        least squares mean (standard error)
    0.9343 ( 0.2909 )
    0.8794 ( 0.2747 )
    1.2621 ( 0.2768 )
    Statistical analysis title
    		 Analysis 1
    Comparison groups
    Ciclesonide 100 µg v Placebo
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1291 [1]
    Method
    		 Wald Chi-square
    Confidence interval
    Notes
    [1] - zero inflated Poisson model: adjustment for centre and age [yrs] (zero model), treatment and race (Poisson model)
    Statistical analysis title
    		 Analysis 2
    Comparison groups
    Ciclesonide 200 µg v Placebo
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0145 [2]
    Method
    		 Wald Chi-square
    Confidence interval
    Notes
    [2] - zero inflated Poisson model: adjustment for centre and age [yrs] (zero model), treatment and race (Poisson model)

    Secondary: Growth Velocity as Assessed by Stadiometric Height Measurement

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    End point title
    		 Growth Velocity as Assessed by Stadiometric Height Measurement
    End point description
    Standing height measured in millimeters (mm) with a wall-mounted stadiometer. Safety analysis set included all randomized participants who received at least 1 dose of trial medication.
    End point type
    Secondary
    End point timeframe
    Up to 12 months
    End point values
    		 Ciclesonide 100 µg Ciclesonide 200 µg Placebo
    Number of subjects analysed
    79
    76
    84
    Units: mm/year
        arithmetic mean (standard deviation)
    55.32 ( 25.81 )
    64.6 ( 27.31 )
    54.91 ( 21.78 )
    No statistical analyses for this end point

    Secondary: Mean Rate of Asthma Exacerbations per Year

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    End point title
    		 Mean Rate of Asthma Exacerbations per Year
    End point description
    Rate of asthma exacerbations per year is equal to total number of asthma exacerbations during treatment/time on treatment (year). ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.
    End point type
    Secondary
    End point timeframe
    Up to 12 months
    End point values
    		 Ciclesonide 100 µg Ciclesonide 200 µg Placebo
    Number of subjects analysed
    79
    76
    84
    Units: number of exacerbations per year
        arithmetic mean (standard deviation)
    0.88 ( 1.366 )
    0.85 ( 1.31 )
    3.28 ( 19.874 )
    Statistical analysis title
    		 Analysis 2
    Comparison groups
    Ciclesonide 200 µg v Placebo
    Number of subjects included in analysis
    160
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6844
    Method
    		 Kruskal-wallis
    Confidence interval
    Statistical analysis title
    		 Analysis 1
    Comparison groups
    Ciclesonide 100 µg v Placebo
    Number of subjects included in analysis
    163
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.4754
    Method
    		 Kruskal-wallis
    Confidence interval

    Secondary: Duration of Exacerbations

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    End point title
    		 Duration of Exacerbations
    End point description
    Duration of exacerbation was defined as the time in days when the criteria for an exacerbation were met to the time when peak flow measurements returned to baseline. ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.
    End point type
    Secondary
    End point timeframe
    Up to 12 months
    End point values
    		 Ciclesonide 100 µg Ciclesonide 200 µg Placebo
    Number of subjects analysed
    79
    76
    84
    Units: days
        arithmetic mean (standard deviation)
    9.17 ( 6.198 )
    9.31 ( 7.65 )
    7.92 ( 4.061 )
    No statistical analyses for this end point

    Secondary: Number of Exacerbations per Participant

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    End point title
    		 Number of Exacerbations per Participant
    End point description
    The mean number of asthma exacerbations per participant is reported. ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.
    End point type
    Secondary
    End point timeframe
    Up to 12 months
    End point values
    		 Ciclesonide 100 µg Ciclesonide 200 µg Placebo
    Number of subjects analysed
    79
    76
    84
    Units: exacerbations
        arithmetic mean (standard deviation)
    0.72 ( 1.025 )
    0.78 ( 1.028 )
    0.95 ( 1.316 )
    No statistical analyses for this end point

    Secondary: Percentage of Participants who Dropped-out due to Asthma Exacerbation

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    End point title
    		 Percentage of Participants who Dropped-out due to Asthma Exacerbation
    End point description
    ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome.
    End point type
    Secondary
    End point timeframe
    Up to 12 months
    End point values
    		 Ciclesonide 100 µg Ciclesonide 200 µg Placebo
    Number of subjects analysed
    79
    76
    84
    Units: percentage of participants
        number (not applicable)
    1.3
    1.3
    4.8
    No statistical analyses for this end point

    Secondary: Change From Baseline in Forced Expiratory Volume in one Second (FEV1) (Absolute Value)

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    End point title
    		 Change From Baseline in Forced Expiratory Volume in one Second (FEV1) (Absolute Value)
    End point description
    FEV1 is the maximal amount of air forcefully exhaled from the lungs in one second. Spirometry was used for assessment of FEV1. A positive change from Baseline indicates improvement. ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. "n" in the category is the number of participants with data available at the given time-point.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 1, 2, 4, 6, 8, 10 and 12
    End point values
    		 Ciclesonide 100 µg Ciclesonide 200 µg Placebo
    Number of subjects analysed
    79
    76
    84
    Units: liters
    arithmetic mean (standard deviation)
        Change at Month 1 (n=78, 76, 81)
    0.019 ( 0.1715 )
    0.018 ( 0.1639 )
    0.012 ( 0.1627 )
        Change at Month 2 (n=76, 73, 77)
    0.024 ( 0.1416 )
    0.06 ( 0.1582 )
    0.005 ( 0.1416 )
        Change at Month 4 (n=68, 72, 75)
    0.065 ( 0.1483 )
    0.083 ( 0.1486 )
    0.076 ( 0.1725 )
        Change at Month 6 (n=67, 72, 72)
    0.091 ( 0.1714 )
    0.125 ( 0.1975 )
    0.078 ( 0.1855 )
        Change at Month 8 (n=66, 71, 68)
    0.075 ( 0.2144 )
    0.126 ( 0.2089 )
    0.12 ( 0.1855 )
        Change at Month 10 (n=66, 69, 67)
    0.143 ( 0.1458 )
    0.168 ( 0.191 )
    0.146 ( 0.1609 )
        Change at Month 12 (n=65, 69, 65)
    0.161 ( 0.2022 )
    0.185 ( 0.2024 )
    0.178 ( 0.1593 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Forced Expiratory Volume in one Second (FEV1) (Percent Predicted)

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    End point title
    		 Change From Baseline in Forced Expiratory Volume in one Second (FEV1) (Percent Predicted)
    End point description
    FEV1 is the maximal amount of air forcefully exhaled from the lungs in one second. Spirometry was used for assessment of FEV1. A positive change from Baseline indicates improvement. ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. "n" in the category is the number of participants with data available at the given time-point.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 1, 2, 4, 6, 8, 10 and 12
    End point values
    		 Ciclesonide 100 µg Ciclesonide 200 µg Placebo
    Number of subjects analysed
    79
    76
    84
    Units: percent predicted FEV1
    arithmetic mean (standard deviation)
        Change at Month 1 (n=78, 76, 81)
    1 ( 10.96 )
    0.6 ( 9.67 )
    1 ( 9.06 )
        Change at Month 2 (n=76, 73, 77)
    1.4 ( 8.5 )
    3.4 ( 9.6 )
    0.3 ( 8.05 )
        Change at Month 4 (n=68, 72, 75)
    4 ( 8.69 )
    4.6 ( 9.31 )
    5.1 ( 9.83 )
        Change at Month 6 (n=67, 72, 72)
    5.5 ( 10 )
    7.2 ( 11.35 )
    4.9 ( 10.93 )
        Change at Month 8 (n=66, 71, 68)
    4.4 ( 12.44 )
    6.5 ( 12.25 )
    7.1 ( 10.24 )
        Change at Month 10 (n=66, 69, 67)
    8.6 ( 9.41 )
    9.1 ( 10.48 )
    8.7 ( 9.22 )
        Change at Month 12 (n=65, 69, 65)
    9.5 ( 10.96 )
    10.1 ( 11.29 )
    10.4 ( 9.89 )
    No statistical analyses for this end point

    Secondary: Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries

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    End point title
    		 Morning and Evening Peak Expiratory Flow (PEF) Measurements by Diary Entries
    End point description
    PEF is the maximum speed of expiration. Spirometry was used for assessment of PEF. ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. "n" in the category is the number of participants with data available at the given time-point.
    End point type
    Secondary
    End point timeframe
    Months 1, 2, 4, 6, 8, 10 and 12
    End point values
    		 Ciclesonide 100 µg Ciclesonide 200 µg Placebo
    Number of subjects analysed
    79
    76
    84
    Units: liters/second
    arithmetic mean (standard deviation)
        Month 1, Evening PEF (n=78, 76, 80)
    235.72 ( 63.882 )
    238.16 ( 52.565 )
    241.89 ( 70.619 )
        Month 1, Morning PEF (n=78, 76, 81)
    232.09 ( 64.933 )
    234.41 ( 52.908 )
    233.81 ( 66.039 )
        Month 2, Evening PEF (n=76, 71, 77)
    241.07 ( 58.604 )
    241.16 ( 50.422 )
    244.67 ( 67.846 )
        Month 2, Morning PEF (n=76, 72, 77)
    236.92 ( 61.243 )
    236.42 ( 52.323 )
    239.07 ( 70.132 )
        Month 4, Evening PEF (n=68, 72, 75)
    249.75 ( 58.528 )
    243.52 ( 49.076 )
    245.91 ( 65.802 )
        Month 4, Morning PEF (n=68, 71, 76)
    242.93 ( 56.658 )
    241.91 ( 48.498 )
    240.16 ( 65.211 )
        Month 6, Evening PEF (n=67, 72, 73)
    251.88 ( 60.255 )
    249.36 ( 59.294 )
    246.44 ( 63.946 )
        Month 6, Morning PEF (n=67, 72, 73)
    246.44 ( 59.781 )
    246.75 ( 60.02 )
    238.81 ( 63.419 )
        Month 8, Evening PEF (n=66, 70, 69)
    253.49 ( 59.666 )
    250.92 ( 51.376 )
    245.72 ( 61.399 )
        Month 8, Morning PEF (n=66, 71, 69)
    247.24 ( 59.806 )
    246.97 ( 51.592 )
    239.73 ( 61.733 )
        Month 10, Evening PEF (n=65, 70, 68)
    254.21 ( 56.815 )
    256.44 ( 56.469 )
    251.69 ( 60.704 )
        Month 10, Morning PEF (n=66, 70, 68)
    247.94 ( 60.418 )
    254.04 ( 56.719 )
    246.23 ( 62.805 )
        Month 12, Evening PEF (n=68, 71, 70)
    255.97 ( 57.291 )
    263.87 ( 58.469 )
    261.88 ( 61.383 )
        Month 12, Morning PEF (n=75, 73, 78)
    245.84 ( 59.834 )
    258.62 ( 57.009 )
    250.55 ( 63.204 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in PEF by Diary Entries

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    End point title
    		 Change From Baseline in PEF by Diary Entries
    End point description
    PEF is the maximum speed of expiration. Spirometry was used for assessment of PEF. A positive change from Baseline indicates improvement. ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. "n" in the category is the number of participants with data available at the given time-point.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 1, 2, 4, 6, 8, 10 and 12
    End point values
    		 Ciclesonide 100 µg Ciclesonide 200 µg Placebo
    Number of subjects analysed
    79
    76
    84
    Units: liters/second
    arithmetic mean (standard deviation)
        Change at Month 1, Evening PEF (n=78, 76, 80)
    8.46 ( 17.952 )
    8.54 ( 19.474 )
    6.06 ( 39.183 )
        Change at Month 1, Morning PEF (n=78, 76, 81)
    11.69 ( 21.268 )
    10.82 ( 20.372 )
    7.54 ( 25.697 )
        Change at Month 2, Evening PEF (n=76, 71, 77)
    13.66 ( 28.491 )
    13.04 ( 20.89 )
    10.83 ( 40.563 )
        Change at Month 2, Morning PEF (n=76, 72, 77)
    17.12 ( 32.068 )
    14.3 ( 22.649 )
    14.29 ( 37.228 )
        Change at Month 4, Evening PEF (n=68, 72, 75)
    20.41 ( 22.058 )
    16.01 ( 21.547 )
    13.62 ( 37.99 )
        Change at Month 4, Morning PEF (n=68, 71, 76)
    21.33 ( 26.603 )
    18.24 ( 22.808 )
    16.28 ( 34.841 )
        Change at Month 6, Evening PEF (n=67, 72, 73)
    22.44 ( 28.236 )
    21.86 ( 38.28 )
    13.14 ( 33.321 )
        Change at Month 6, Morning PEF (n=67, 72, 73)
    24.82 ( 30.613 )
    24.68 ( 40.981 )
    14.44 ( 29.95 )
        Change at Month 8, Evening PEF (n=66, 70, 69)
    25.47 ( 27.43 )
    21.38 ( 28.648 )
    13.3 ( 37.061 )
        Change at Month 8, Morning PEF (n=66, 71, 69)
    27.16 ( 32.53 )
    23.76 ( 29.089 )
    16.03 ( 34.017 )
        Change at Month 10, Evening PEF (n=65, 70, 68)
    25.68 ( 30.945 )
    26.78 ( 34.255 )
    18.04 ( 38.209 )
        Change at Month 10, Morning PEF (n=66, 70, 68)
    27.86 ( 38.406 )
    29.84 ( 36.39 )
    21.25 ( 34.94 )
        Change at Month 12, Evening PEF (n=68, 71, 70)
    28.24 ( 28.811 )
    33.35 ( 38.772 )
    25.38 ( 43.284 )
        Change at Month 12, Morning PEF (n=75, 73, 78)
    26.84 ( 32.932 )
    34.31 ( 41.166 )
    24.37 ( 39.312 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Diurnal PEF Fluctuation

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    End point title
    		 Change From Baseline in Diurnal PEF Fluctuation
    End point description
    Diurnal PEF Fluctuation is equal to [(Higher PEF – Lower PEF)/0.5*(Higher PEF + Lower PEF)] * 100%. A positive change from Baseline indicates improvement. ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. "n" in the category is the number of participants with data available at the given time-point.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 1, 2, 4, 6, 8, 10 and 12
    End point values
    		 Ciclesonide 100 µg Ciclesonide 200 µg Placebo
    Number of subjects analysed
    79
    76
    84
    Units: percent fluctuation
    arithmetic mean (standard deviation)
        Change at Month 1 (n=78, 76, 80)
    -0.59 ( 3.97 )
    0.06 ( 3.772 )
    0 ( 3.867 )
        Change at Month 2 (n=76, 71, 77)
    -0.13 ( 5.009 )
    -0.16 ( 4.131 )
    0.15 ( 5.084 )
        Change at Month 4 (n=68, 71, 75)
    -0.65 ( 5.251 )
    -1.01 ( 3.784 )
    -0.55 ( 4.421 )
        Change at Month 6 (n=67, 72, 73)
    -1.01 ( 4.351 )
    -0.22 ( 5.86 )
    -0.47 ( 4.28 )
        Change at Month 8 (n=66, 70, 69)
    -1.12 ( 4.83 )
    -1.21 ( 3.757 )
    -1.11 ( 4.048 )
        Change at Month 10 (n=64, 70, 68)
    -1.46 ( 5.221 )
    -0.7 ( 4.319 )
    -1.14 ( 4.059 )
        Change at Month 12 (n=68, 70, 70)
    -1.81 ( 4.913 )
    -0.62 ( 4.44 )
    -1.26 ( 4.187 )
    No statistical analyses for this end point

    Secondary: Total Asthma Symptom Score by Diary Entries

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    End point title
    		 Total Asthma Symptom Score by Diary Entries
    End point description
    Total Asthma Score=daytime asthma score + night-time asthma score, where higher score indicates worsening of disease. Night-time asthma score is assessed on a 5 point scale where 0=No symptoms, slept through the night, 1=Slept well but some complaints in the morning, 2=Woke up once because of asthma (including early wakening), 3=Woke up several times because of asthma (including early wakening) and 4=Bad night, awake most of the night because of asthma. Day-time asthma score is assessed on a 5 point scale where 0=Very well, no symptoms, 1=one episode of wheezing, cough or breathlessness, 2=More than 1 episode of wheezing, cough or breathlessness without interfering with normal activities, 3=Wheezing, cough or shortness of breath most of the day which interfered to some extent with normal activities and 4=Asthma very bad. Unable to carry out daily activities as usual. ITT analysis. "n" in the category is the number of participants with data available at the given time-point.
    End point type
    Secondary
    End point timeframe
    Months 1, 2, 4, 6, 8, 10 and 12
    End point values
    		 Ciclesonide 100 µg Ciclesonide 200 µg Placebo
    Number of subjects analysed
    79
    76
    84
    Units: score on a scale
    arithmetic mean (standard deviation)
        Month 1 (n=77, 75, 79)
    0.37 ( 0.489 )
    0.22 ( 0.329 )
    0.32 ( 0.535 )
        Month 2 (n=76, 70, 77)
    0.26 ( 0.424 )
    0.14 ( 0.246 )
    0.28 ( 0.484 )
        Month 4 (n=68, 72, 75)
    0.18 ( 0.342 )
    0.12 ( 0.178 )
    0.24 ( 0.359 )
        Month 6 (n=67, 72, 73)
    0.16 ( 0.289 )
    0.17 ( 0.294 )
    0.18 ( 0.289 )
        Month 8 (n=66, 69, 69)
    0.17 ( 0.283 )
    0.13 ( 0.243 )
    0.23 ( 0.414 )
        Month 10 (n=64, 70, 68)
    0.12 ( 0.253 )
    0.11 ( 0.227 )
    0.24 ( 0.49 )
        Month 12 (n=68, 69, 70)
    0.11 ( 0.24 )
    0.08 ( 0.129 )
    0.15 ( 0.338 )
    No statistical analyses for this end point

    Secondary: Percentage of Nights with Nocturnal Awakenings due to Asthma Symptoms

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    End point title
    		 Percentage of Nights with Nocturnal Awakenings due to Asthma Symptoms
    End point description
    Nocturnal awakenings due to asthma symptoms were recorded in the participant's diary. ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. "n" in the category is the number of participants with data available at the given time-point.
    End point type
    Secondary
    End point timeframe
    Months 1, 2, 4, 6, 8, 10 and 12
    End point values
    		 Ciclesonide 100 µg Ciclesonide 200 µg Placebo
    Number of subjects analysed
    79
    76
    84
    Units: percentage of nights
    arithmetic mean (standard deviation)
        Month 1 (n=78, 75, 80)
    2.4 ( 6.159 )
    1.64 ( 4.256 )
    1.85 ( 4.223 )
        Month 2 (n=76, 73, 77)
    1.96 ( 5.877 )
    0.62 ( 2.364 )
    1.73 ( 4.662 )
        Month 4 (n=68, 72, 75)
    1.33 ( 4.017 )
    0.86 ( 2.139 )
    1.54 ( 4.106 )
        Month 6 (n=67, 72, 73)
    0.87 ( 2.527 )
    1.51 ( 3.288 )
    1.26 ( 3.235 )
        Month 8 (n=66, 70, 69)
    1.62 ( 4.129 )
    1.05 ( 2.823 )
    1.82 ( 5.024 )
        Month 10 (n=66, 70, 68)
    1.93 ( 7.106 )
    0.59 ( 2.22 )
    1.88 ( 5.468 )
        Month 12 (n=74, 73, 78)
    0.41 ( 1.554 )
    1.84 ( 11.769 )
    0.53 ( 1.853 )
    No statistical analyses for this end point

    Secondary: Rescue Medication Use per Day

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    End point title
    		 Rescue Medication Use per Day
    End point description
    Salbutamol (100 μg/puff) was used as rescue medication according to the individual needs of the participant. Each use was documented in the participant’s diary. ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. "n" in the category is the number of participants with data available at the given time-point.
    End point type
    Secondary
    End point timeframe
    Months 1, 2, 4, 6, 8, 10 and 12
    End point values
    		 Ciclesonide 100 µg Ciclesonide 200 µg Placebo
    Number of subjects analysed
    79
    76
    84
    Units: puffs/day
    arithmetic mean (standard deviation)
        Month 1 (n=57, 51, 54)
    1 ( 1.345 )
    0.83 ( 1.148 )
    0.87 ( 0.91 )
        Month 2 (n=53, 40, 46)
    0.99 ( 1.296 )
    0.53 ( 0.728 )
    0.97 ( 1.298 )
        Month 4 (n=48, 47, 51)
    0.88 ( 1.3 )
    1.18 ( 1.595 )
    1.27 ( 1.984 )
        Month 6 (n=45, 43, 44)
    0.79 ( 1.084 )
    1.07 ( 1.329 )
    0.92 ( 1.583 )
        Month 8 (n=38, 42, 45)
    1.01 ( 1.53 )
    1.13 ( 1.95 )
    0.97 ( 1.219 )
        Month 10 (n=38, 41, 39)
    0.93 ( 1.423 )
    0.95 ( 1.243 )
    0.83 ( 1.113 )
        Month 12 (n=36, 40, 40)
    0.71 ( 0.897 )
    1.01 ( 1.36 )
    0.75 ( 1.152 )
    No statistical analyses for this end point

    Secondary: Percentage of Rescue Medication Free Days

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    End point title
    		 Percentage of Rescue Medication Free Days
    End point description
    Days without use of rescue medication documented in the participant’s diary were reported. ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. "n" in the category is the number of participants with data available at the given time-point.
    End point type
    Secondary
    End point timeframe
    Months 1, 2, 4, 6, 8, 10 and 12
    End point values
    		 Ciclesonide 100 µg Ciclesonide 200 µg Placebo
    Number of subjects analysed
    79
    76
    84
    Units: percentage of days
    arithmetic mean (standard deviation)
        Month 1 (n=55, 53, 54)
    47.94 ( 44.405 )
    47.34 ( 44.984 )
    44.37 ( 45.367 )
        Month 2 (n=52, 41, 48)
    48.78 ( 46.442 )
    54.46 ( 46.668 )
    45.31 ( 47.761 )
        Month 4 (n=49, 48, 52)
    49.91 ( 48.274 )
    46.51 ( 45.209 )
    45.91 ( 46.328 )
        Month 6 (n=47, 44, 45)
    49.63 ( 48.084 )
    48.14 ( 45.321 )
    49.42 ( 47.515 )
        Month 8 (n=39, 42, 44)
    47.93 ( 45.17 )
    50.5 ( 46.1 )
    45.22 ( 45.002 )
        Month 10 (n=40, 40, 37)
    46.22 ( 47.901 )
    49.78 ( 48.521 )
    52.7 ( 46.015 )
        Month 12 (n=35, 41, 40)
    53.58 ( 47.785 )
    53.63 ( 48.358 )
    58.03 ( 46.264 )
    No statistical analyses for this end point

    Secondary: Percentage of Asthma Symptom Free Days

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    End point title
    		 Percentage of Asthma Symptom Free Days
    End point description
    Days without Asthma Symptom documented in the participant's diary were reported. ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. "n" in the category is the number of participants with data available at the given time-point.
    End point type
    Secondary
    End point timeframe
    Months 1, 2, 4, 6, 8, 10 and 12
    End point values
    		 Ciclesonide 100 µg Ciclesonide 200 µg Placebo
    Number of subjects analysed
    79
    76
    84
    Units: percentage of days
    arithmetic mean (standard deviation)
        Month 1 (n=62, 60, 60)
    37.32 ( 40.983 )
    36.95 ( 42.207 )
    35 ( 43.032 )
        Month 2 (n=61, 50, 56)
    38.47 ( 44.743 )
    41.16 ( 44.738 )
    33.56 ( 44.161 )
        Month 4 (n=54,55, 59)
    42.57 ( 46.573 )
    38.83 ( 44.042 )
    35.78 ( 43.538 )
        Month 6 (n=53, 50, 51)
    41.75 ( 46.474 )
    39.87 ( 43.744 )
    40.09 ( 45.274 )
        Month 8 (n=46, 46, 46)
    38.86 ( 43.312 )
    43.9 ( 45.377 )
    40.03 ( 43.369 )
        Month 10 (n=43, 47, 44)
    41 ( 46.575 )
    41.65 ( 47.435 )
    39.83 ( 44.332 )
        Month 12 (n=42, 44, 45)
    43.2 ( 46.787 )
    42.03 ( 47.093 )
    44.61 ( 46.12 )
    No statistical analyses for this end point

    Secondary: Quality of Life Assessments as per Paediatric Asthma Quality of Life Questionnaire, Standardized (PAQLQ[S])

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    End point title
    		 Quality of Life Assessments as per Paediatric Asthma Quality of Life Questionnaire, Standardized (PAQLQ[S])
    End point description
    The PAQLQ(S) consists of 23 items divided into three domains: Activity limitations (items 1-3, 19, 22); Symptoms (items 4, 6, 8, 10, 12, 14, 16, 18, 20, 23) and Emotional function (items 5, 7, 9, 11, 13, 15, 17, 21). Participants were asked to answer each question using a seven-point scale (where “1” indicated maximum impairment and “7” indicated no impairment) and recall their experience during the previous week. Overall PAQLQ score is equal to the mean of all 23 items for a total possible score 1 (worst) to 7 (best). ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. "n" in the category is the number of participants with data available at the given time-point.
    End point type
    Secondary
    End point timeframe
    Months 2, 6 and 12
    End point values
    		 Ciclesonide 100 µg Ciclesonide 200 µg Placebo
    Number of subjects analysed
    79
    76
    84
    Units: score on a scale
    arithmetic mean (standard deviation)
        Month 2 (n=70, 73, 75)
    6.21 ( 0.979 )
    6.27 ( 0.878 )
    6.08 ( 1.031 )
        Month 6 (n=65, 72, 72)
    6.33 ( 0.874 )
    6.26 ( 0.982 )
    6.3 ( 0.933 )
        Month 12 (n=64, 69, 65)
    6.42 ( 0.786 )
    6.34 ( 0.946 )
    6.36 ( 0.824 )
    No statistical analyses for this end point

    Secondary: Quality of Life Assessments as per Paediatric Asthma Caregiver’s Quality of Life Questionnaire (PACQLQ)

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    End point title
    		 Quality of Life Assessments as per Paediatric Asthma Caregiver’s Quality of Life Questionnaire (PACQLQ)
    End point description
    The PACQLQ consists of 13 items divided into two domains: Activity limitations (items 2, 4, 6, 8) and Emotional function (items 1, 3, 5, 7, 9, 10, 11, 12, 13). Caregivers answered each question using a seven-point scale (whereby “1” indicated maximum impairment and “7” indicated no impairment) and recalled their experiences during the previous week. Overall PACQLQ score is equal to the mean of all 13 items for a total possible score of 1 (worst) to 7 (best). ITT analysis set included all participants of the full analysis set who received at least one dose of study medication and had at least one post-baseline measurement of the primary efficacy outcome. "n" in the category is the number of participants with data available at the given time-point.
    End point type
    Secondary
    End point timeframe
    Months 2, 6 and 12
    End point values
    		 Ciclesonide 100 µg Ciclesonide 200 µg Placebo
    Number of subjects analysed
    79
    76
    84
    Units: score on a scale
    arithmetic mean (standard deviation)
        Month 2 (n=73, 73, 76)
    5.87 ( 1.196 )
    6.16 ( 1.033 )
    6.08 ( 1.078 )
        Month 6 (n=67, 72, 73)
    6.15 ( 1.005 )
    6.16 ( 1.115 )
    6.31 ( 0.927 )
        Month 12 (n=66, 69, 66)
    6.32 ( 0.849 )
    6.25 ( 0.712 )
    6.31 ( 0.899 )
    No statistical analyses for this end point

    Secondary: Number of Participants with Clinically Significant Vital Signs Findings

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    End point title
    		 Number of Participants with Clinically Significant Vital Signs Findings
    End point description
    Vital signs included body temperature, systolic and diastolic blood pressure and heart rate in beats per minute (bpm). The investigator determined if the result was clinically significant based on the following criteria: Systolic Blood Pressure >130 mmHg or <80 mmHg or a >20 mmHg difference from Baseline; Diastolic Blood Pressure > 85 mmHg; and Resting Heart Rate >140 bpm or <60 bpm or a >30 bpm difference from Baseline. Safety analysis set included all randomized participants who received at least 1 dose of trial medication.
    End point type
    Secondary
    End point timeframe
    Up to 12 months
    End point values
    		 Ciclesonide 100 µg Ciclesonide 200 µg Placebo
    Number of subjects analysed
    79
    76
    84
    Units: participants
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants with Clinically Significant Physical Examination Findings

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    End point title
    		 Number of Participants with Clinically Significant Physical Examination Findings
    End point description
    A thorough physical examination was performed consisting of examinations of the following body systems: (1) eyes; (2) ears, nose, throat; (3) lungs/thorax; (4) heart/cardiovascular system; (5) abdomen; (6) skin and mucosae; (7) nervous system; (8) lymph nodes; (9) musculo-skeletal system; (10) physical examinations other than body systems described in (1) to (9). The investigator determined if any of the findings were clinically significant. Safety analysis set included all randomized participants who received at least 1 dose of trial medication.
    End point type
    Secondary
    End point timeframe
    Up to 12 months
    End point values
    		 Ciclesonide 100 µg Ciclesonide 200 µg Placebo
    Number of subjects analysed
    79
    76
    84
    Units: participants
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants with Clinically Significant Laboratory Values

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    End point title
    		 Number of Participants with Clinically Significant Laboratory Values
    End point description
    Clinically significant laboratory values were hematology and chemistry tests determined by the investigator to be clinically significant based on the following criteria: Hemoglobin <9.5 g/dL; Erythrocytes <3.0 x 10^6/μL or >6.5 x 10^6/μL; White Blood Count <3000/mm^3 or >20000/mm^3; serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT), gamma-glutamyl transpeptidase (GGT), Total Bilirubin and Glucose >2 times Upper limit of Normal Range (ULNR); Alkaline Phosphatase and Creatine Kinase >3 times ULNR; Creatinine >1.5 times ULN; Potassium >5.0 mmol/L or <3.0 mmol/L; and Sodium >150 mmol/L or 130 mmol/L. Safety analysis set included all randomized participants who received at least 1 dose of trial medication.
    End point type
    Secondary
    End point timeframe
    Up to 12 months
    End point values
    		 Ciclesonide 100 µg Ciclesonide 200 µg Placebo
    Number of subjects analysed
    79
    76
    84
    Units: participants
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants with Adverse Events and Serious Adverse Events

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    End point title
    		 Number of Participants with Adverse Events and Serious Adverse Events
    End point description
    An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in congenital anomaly/birth defect or any other important medical condition considered serious based on medical and scientific judgement. Safety analysis set included all randomized participants who received at least 1 dose of trial medication.
    End point type
    Secondary
    End point timeframe
    Up to 12 months
    End point values
    		 Ciclesonide 100 µg Ciclesonide 200 µg Placebo
    Number of subjects analysed
    79
    76
    84
    Units: participants
        Adverse Events
    61
    64
    63
        Serious Adverse Events
    2
    2
    2
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 12 months
    Adverse event reporting additional description
    At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to treatment. All adverse events and serious adverse events were coded according to MedDRA versions 8.0, 8.1, 9.0 and 9.1.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    9.1
    Reporting groups
    Reporting group title
    Ciclesonide 100 µg
    Reporting group description
    		 Ciclesonide 100 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.

    Reporting group title
    Placebo
    Reporting group description
    		 Ciclesonide placebo-matching, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.

    Reporting group title
    Ciclesonide 200 µg
    Reporting group description
    		 Ciclesonide 200 µg, metered-dose inhaler, two puffs once daily, in the evening, for up to 12 months.

    Serious adverse events
    		 Ciclesonide 100 µg Placebo Ciclesonide 200 µg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 79 (2.53%)
    2 / 84 (2.38%)
    2 / 76 (2.63%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Surgical and medical procedures
    Myringoplasty
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 84 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 84 (1.19%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 84 (1.19%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 84 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epistaxis
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 84 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Arthritis bacterial
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 84 (1.19%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 84 (0.00%)
    1 / 76 (1.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lobar pneumonia
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 84 (0.00%)
    0 / 76 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Ciclesonide 100 µg Placebo Ciclesonide 200 µg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    56 / 79 (70.89%)
    56 / 84 (66.67%)
    55 / 76 (72.37%)
    Nervous system disorders
    Headache
    Additional description: non-serious
         subjects affected / exposed
    4 / 79 (5.06%)
    8 / 84 (9.52%)
    7 / 76 (9.21%)
         occurrences all number
    6
    10
    10
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    6 / 79 (7.59%)
    4 / 84 (4.76%)
    2 / 76 (2.63%)
         occurrences all number
    6
    5
    2
    Respiratory, thoracic and mediastinal disorders
    Asthma
    Additional description: non-serious
         subjects affected / exposed
    35 / 79 (44.30%)
    39 / 84 (46.43%)
    38 / 76 (50.00%)
         occurrences all number
    60
    82
    64
    Cough
         subjects affected / exposed
    6 / 79 (7.59%)
    6 / 84 (7.14%)
    4 / 76 (5.26%)
         occurrences all number
    8
    7
    10
    Rhinitis allergic
         subjects affected / exposed
    7 / 79 (8.86%)
    4 / 84 (4.76%)
    4 / 76 (5.26%)
         occurrences all number
    7
    6
    4
    Infections and infestations
    Ear infection
         subjects affected / exposed
    5 / 79 (6.33%)
    2 / 84 (2.38%)
    3 / 76 (3.95%)
         occurrences all number
    5
    2
    4
    Influenza
         subjects affected / exposed
    3 / 79 (3.80%)
    3 / 84 (3.57%)
    6 / 76 (7.89%)
         occurrences all number
    3
    3
    8
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 84 (1.19%)
    4 / 76 (5.26%)
         occurrences all number
    1
    1
    4
    Nasopharyngitis
         subjects affected / exposed
    13 / 79 (16.46%)
    14 / 84 (16.67%)
    9 / 76 (11.84%)
         occurrences all number
    20
    30
    18
    Pharyngitis
         subjects affected / exposed
    5 / 79 (6.33%)
    4 / 84 (4.76%)
    4 / 76 (5.26%)
         occurrences all number
    5
    5
    5
    Rhinitis
         subjects affected / exposed
    4 / 79 (5.06%)
    3 / 84 (3.57%)
    0 / 76 (0.00%)
         occurrences all number
    4
    5
    0
    Sinusitis
         subjects affected / exposed
    1 / 79 (1.27%)
    5 / 84 (5.95%)
    1 / 76 (1.32%)
         occurrences all number
    2
    7
    1
    Upper respiratory tract infection
         subjects affected / exposed
    18 / 79 (22.78%)
    16 / 84 (19.05%)
    19 / 76 (25.00%)
         occurrences all number
    28
    35
    31

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Sep 2004
    Amendment 1: • Addition of history of cataracts and/or glaucoma as an exclusion criterion due to the potential class effect of ocular disturbances with the long-term use of inhaled corticosteroid (ICS).
    01 Nov 2004
    Amendment 2: • Removal of the hyper-responsiveness test (challenge test) as a pre-randomisation requirement for study inclusion, • Dose for fluticasone propionate (FP) to be consistent with the marketed dosing of Flovent® and the standard in treatment (two puffs of 125 μg FP per day). • Inclusion of a guideline on inhalation technique for study medication that accommodated the full potential age range of participants enrolled in the trial. • Amendment of the paradigm for treatment of exacerbations to add a guideline on how to treat a participant who is getting better within 24 hours with regard to usage of FP. • Amendment of the study time table.
    08 Aug 2005
    Amendment 3:• Administrative change in personnel and contact information. • Changes referring to the use of intranasal medications for the treatment of rhinitis. • Exclusion criterion concerning use of topical steroids was originally implemented to limit any confounding variable. However, according to the literature available currently, no impact on growth or HPA axis has been demonstrated in many studies of topical nasal steroids.
    10 Mar 2006
    Amendment 4: Administrative changes to study personnel and contact information; submission to authorities; study protocol, documentation and archiving of data, and an increase in the number of study sites, reflecting the expansion of the trial to additional sites in countries other than Canada (Brazil and South Africa).
    22 Jun 2007
    Amendment 5: Administrative changes in the local sponsor and contact information reflecting a change in country of origin for study sites (from Canada, Brazil and South Africa to Canada, Hungary and South Africa). Change in study timelines.
    17 Jan 2008
    Amendment 6: Administrative changes to study timelines and local sponsor name and contact information.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

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