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    Clinical Trial Results:
    A Comparative Study of Inhaled Ciclesonide Versus Placebo in Children with Asthma (RAINBOW)

    Summary
    EudraCT number
    		 2006-000803-40
    Trial protocol
    		 DE   ES   HU  
    Global end of trial date
    17 Aug 2007

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Jul 2016
    First version publication date
    22 Jul 2016
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    BY9010/M1-209
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00384189
    WHO universal trial number (UTN)
    		 U1111-1172-2297
    Sponsors
    Sponsor organisation name
    Takeda
    Sponsor organisation address
    One Takeda Parkway, Deerfield , IL, United States,
    Public contact
    Director, Clinical Science, Takeda, +1 877-825-3327, trialdisclosures@takeda.com
    Scientific contact
    Director, Clinical Science, Takeda, +1 877-825-3327, trialdisclosures@takeda.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    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
    17 Aug 2007
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Aug 2007
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Aug 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this study is to investigate the efficacy of inhaled ciclesonide at three different dose levels compared with placebo with respect to pulmonary function, asthma symptoms, and use of rescue medication in children aged 6-11 years with asthma. Treatment medication will be administered as follows: ciclesonide or placebo will be inhaled once daily in the evening. The study consists of a baseline period (2 to 4 weeks) and a treatment period (12 weeks). The study provides further data on safety and tolerability of ciclesonide.
    Protection of trial subjects
    All study participants were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Sep 2006
    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
    Bulgaria: 112
    Country: Number of subjects enrolled
    Germany: 53
    Country: Number of subjects enrolled
    Hungary: 152
    Country: Number of subjects enrolled
    Poland: 170
    Country: Number of subjects enrolled
    Romania: 60
    Country: Number of subjects enrolled
    Russian Federation: 189
    Country: Number of subjects enrolled
    South Africa: 112
    Country: Number of subjects enrolled
    Spain: 62
    Country: Number of subjects enrolled
    Ukraine: 170
    Worldwide total number of subjects
    1080
    EEA total number of subjects
    609
    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)
    1080
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants took part in the study at 110 investigative sites in Bulgaria, Germany, Hungary, Poland, Romania, Russia, South Africa, Spain, and Ukraine from 29 September 2006 to 17 August 2007.

    Pre-assignment
    Screening details
    		 Children with a diagnosis of asthma were enrolled equally in 1 of 4 treatment groups, once a day placebo, 40 µg, 80 µg or 160 µg ciclesonide.

    Period 1
    Period 1 title
    Randomized
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ciclesonide 40 µg
    Arm description
    		 Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Placebo-matching ciclesonide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour, liquid
    Routes of administration
    Inhalation use
    Dosage and administration details
    Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period.

    Investigational medicinal product name
    Ciclesonide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour, liquid
    Routes of administration
    Inhalation use
    Dosage and administration details
    Ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks.

    Investigational medicinal product name
    Salbutamol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Salbutamol 100 μg/puff was available to be used as rescue medication if needed.

    Arm title
    		 Ciclesonide 80 µg
    Arm description
    		 Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour, liquid
    Routes of administration
    Inhalation use
    Dosage and administration details
    Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period.

    Investigational medicinal product name
    Ciclesonide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour, liquid
    Routes of administration
    Inhalation use
    Dosage and administration details
    Ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks.

    Investigational medicinal product name
    Salbutamol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Salbutamol 100 μg/puff was available to be used as rescue medication if needed.

    Arm title
    		 Ciclesonide 160 µg
    Arm description
    		 Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour, liquid
    Routes of administration
    Inhalation use
    Dosage and administration details
    Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period.

    Investigational medicinal product name
    Ciclesonide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour, liquid
    Routes of administration
    Inhalation use
    Dosage and administration details
    Ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks.

    Investigational medicinal product name
    Salbutamol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Salbutamol 100 μg/puff was available to be used as rescue medication if needed.

    Arm title
    		 Placebo
    Arm description
    		 Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour, liquid
    Routes of administration
    Inhalation use
    Dosage and administration details
    Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period.

    Investigational medicinal product name
    Ciclesonide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour, liquid
    Routes of administration
    Inhalation use
    Dosage and administration details
    Ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks.

    Investigational medicinal product name
    Salbutamol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Salbutamol 100 μg/puff was available to be used as rescue medication if needed.

    Number of subjects in period 1
    		Ciclesonide 40 µg Ciclesonide 80 µg Ciclesonide 160 µg Placebo
    Started
    305
    312
    313
    150
    Completed
    304
    312
    311
    146
    Not completed
    1
    0
    2
    4
         Did Not Receive Treatment
    1
    -
    2
    4
    Period 2
    Period 2 title
    Randomized, Actual Treatment Received
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Ciclesonide 40 µg
    Arm description
    		 Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour, liquid
    Routes of administration
    Inhalation use
    Dosage and administration details
    Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period.

    Investigational medicinal product name
    Ciclesonide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour, liquid
    Routes of administration
    Inhalation use
    Dosage and administration details
    Ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks.

    Investigational medicinal product name
    Salbutamol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Salbutamol 100 μg/puff was available to be used as rescue medication if needed.

    Arm title
    		 Ciclesonide 80 µg
    Arm description
    		 Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour, liquid
    Routes of administration
    Inhalation use
    Dosage and administration details
    Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period.

    Investigational medicinal product name
    Ciclesonide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour, liquid
    Routes of administration
    Inhalation use
    Dosage and administration details
    Ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks.

    Investigational medicinal product name
    Salbutamol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Salbutamol 100 μg/puff was available to be used as rescue medication if needed.

    Arm title
    		 Ciclesonide 160 µg
    Arm description
    		 Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour, liquid
    Routes of administration
    Inhalation use
    Dosage and administration details
    Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period.

    Investigational medicinal product name
    Ciclesonide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour, liquid
    Routes of administration
    Inhalation use
    Dosage and administration details
    Ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks.

    Investigational medicinal product name
    Salbutamol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Salbutamol 100 μg/puff was available to be used as rescue medication if needed.

    Arm title
    		 Placebo
    Arm description
    		 Placebo-matching Ciclesonide ,inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour, liquid
    Routes of administration
    Inhalation use
    Dosage and administration details
    Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period.

    Investigational medicinal product name
    Ciclesonide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour, liquid
    Routes of administration
    Inhalation use
    Dosage and administration details
    Ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks.

    Investigational medicinal product name
    Salbutamol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Salbutamol 100 μg/puff was available to be used as rescue medication if needed.

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Seven participants in Period 1 were randomized but not treated. Baseline characteristics for these 7 participants are not being reported.
    Number of subjects in period 2 [2]
    		Ciclesonide 40 µg Ciclesonide 80 µg Ciclesonide 160 µg Placebo
    Started
    305
    312
    310
    146
    Completed
    255
    255
    255
    110
    Not completed
    50
    57
    55
    36
         Other Reason Not Specified
    50
    57
    55
    36
    Notes
    [2] - 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: Seven participants were randomized but did not receive treatment. These 7 participants are included in the worldwide number enrolled because they were randomized but baseline characteristics are not being reported for them.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Ciclesonide 40 µg
    Reporting group description
    		 Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.

    Reporting group title
    Ciclesonide 80 µg
    Reporting group description
    		 Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.

    Reporting group title
    Ciclesonide 160 µg
    Reporting group description
    		 Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo-matching Ciclesonide ,inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.

    Reporting group values
    		 Ciclesonide 40 µg Ciclesonide 80 µg Ciclesonide 160 µg Placebo Total
    Number of subjects
    		 305 312 310 146 1073
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 305 312 310 146 1073
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 8.4 ± 1.7 8.4 ± 1.6 8.7 ± 1.6 8.4 ± 1.7 -
    Gender, Male/Female
    Units: participants
        Female
    		 95 121 92 54 362
        Male
    		 210 191 218 92 711
    Race/Ethnicity, Customized
    Units: Subjects
        Caucasian
    		 276 279 277 133 965
        Non-Caucasian
    		 29 33 33 13 108
    Region of Enrollment
    Units: Subjects
        Bulgaria
    		 29 33 33 15 110
        Germany
    		 17 16 12 8 53
        Hungary
    		 42 45 43 22 152
        Poland
    		 49 48 49 23 169
        Romania
    		 15 16 21 8 60
        Russian Federation
    		 54 52 55 27 188
        South Africa
    		 32 34 32 13 111
        Spain
    		 18 18 17 8 61
        Ukraine
    		 49 50 48 22 169
    Inhaled Glucocorticosteroids (ICS) Pretreatment
    Units: Subjects
        Yes
    		 200 204 199 102 705
        No
    		 105 108 111 44 368
    Asthma Severity According to Global Initiative for Asthma (GINA)
    Units: Subjects
        Intermittent
    		 20 19 13 7 59
        Mild
    		 25 22 29 10 86
        Moderate
    		 112 110 104 50 376
        Severe
    		 148 161 164 79 552
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 134.6 ± 10.8 134.5 ± 11 135.9 ± 10.8 134.6 ± 11.1 -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 32.3 ± 9.1 31.9 ± 9.3 33.2 ± 9.5 32.7 ± 9.7 -
    Duration of Asthma
    Units: months
        arithmetic mean (standard deviation)
    		 44.3 ± 27.7 45.5 ± 27.8 45.5 ± 27.4 47.6 ± 28 -
    Inhaled glucocorticosteroids (ICS) Pretreatment Dose
    The number of participants who received ICS pretreatment is 200, 204, 199 and 102 in each treatment arm, respectively.
    Units: µg/day
        arithmetic mean (standard deviation)
    		 211.9 ± 181.9 228.8 ± 188.8 205 ± 177.1 224.6 ± 178.8 -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Ciclesonide 40 µg
    Reporting group description
    		 Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.

    Reporting group title
    Ciclesonide 80 µg
    Reporting group description
    		 Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.

    Reporting group title
    Ciclesonide 160 µg
    Reporting group description
    		 Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
    Reporting group title
    Ciclesonide 40 µg
    Reporting group description
    		 Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.

    Reporting group title
    Ciclesonide 80 µg
    Reporting group description
    		 Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.

    Reporting group title
    Ciclesonide 160 µg
    Reporting group description
    		 Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo-matching Ciclesonide ,inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.

    Subject analysis set title
    Ciclesonide 40 µg Intent-to-Treat (ITT)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All participants randomized to the Ciclesonide 40 µg who received at least one dose of study, regardless of dose, with data available for analysis.

    Subject analysis set title
    Ciclesonide 80 µg ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All participants randomized to the Ciclesonide 80 µg who received at least one dose of study, regardless of dose, with data available for analysis.

    Subject analysis set title
    Ciclesonide 160 µg ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All participants randomized to the Ciclesonide 160 µg who received at least one dose of study, regardless of dose, with data available for analysis.

    Subject analysis set title
    Placebo ITT
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All participants randomized to Placebo who received at least one dose of study, regardless of dose, with data available for analysis.

    Primary: Change from Baseline in Morning Peak Expiratory Flow (PEF)

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    End point title
    		 Change from Baseline in Morning Peak Expiratory Flow (PEF)
    End point description
    PEF is the maximum speed of expiration. A portable electronic PEF meter was used for the home PEF readings. The patients recorded PEF daily, in the morning immediately after getting up. Readings were done preferably at least 4 hours after use of rescue medication and before inhalation of the study medication. At each measurement, three readings were obtained in the standing position. All three values were recorded in the diary; the highest value was used for evaluation. The higher change from Baseline values are the best. Analysis of covariance (ANCOVA) model with the baseline value and age as covariates was used for analysis. Last observation carried forward.
    End point type
    Primary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Ciclesonide 40 µg Intent-to-Treat (ITT) Ciclesonide 80 µg ITT Ciclesonide 160 µg ITT Placebo ITT
    Number of subjects analysed
    304
    312
    311
    146
    Units: liters/minute
        least squares mean (standard error)
    15.23 ± 2.69
    14.79 ± 2.6
    17.37 ± 2.68
    5.4 ± 3.71
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Ciclesonide 40 µg Intent-to-Treat (ITT) v Placebo ITT
    Number of subjects included in analysis
    450
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0116 [1]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares Mean Difference
    Point estimate
    9.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.4
         upper limit
    		 18.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.3
    Notes
    [1] - Baseline value and age as covariates. One-sided p-value, significance level 2.5%.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Ciclesonide 80 µg ITT v Placebo ITT
    Number of subjects included in analysis
    458
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0148 [2]
    Method
    		 ANCOVA
    Parameter type
    		 Least Square Means Difference
    Point estimate
    9.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 17.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.3
    Notes
    [2] - Baseline value and age as covariates. One-sided p-value, significance level 2.5%.
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Ciclesonide 160 µg ITT v Placebo ITT
    Number of subjects included in analysis
    457
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0028 [3]
    Method
    		 ANCOVA
    Parameter type
    		 Least Squares Means Difference
    Point estimate
    12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.5
         upper limit
    		 20.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    4.3
    Notes
    [3] - Baseline value and age as covariates. One-sided p-value, significance level 2.5%.

    Secondary: Time to First Event of Lack of Efficacy (LOE) by Week 12

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    End point title
    		 Time to First Event of Lack of Efficacy (LOE) by Week 12
    End point description
    Kaplan Meier Estimates of the probability of not experiencing LOE by Week 12 was measured. LOE was reached if any of the following criteria occurred during the treatment period: • asthma exacerbation (a worsening of asthma symptoms requiring a change in medication; • nocturnal awakenings due to asthma on any 4 or more nights during any 7-consecutive-day period; • use of more than 8 puffs/day of salbutamol on any 4 or more days during any 7-consecutive-day period; • decrease in morning PEF to <80% of randomization value on any 4 consecutive days during the treatment period.
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Ciclesonide 40 µg Intent-to-Treat (ITT) Ciclesonide 80 µg ITT Ciclesonide 160 µg ITT Placebo ITT
    Number of subjects analysed
    304
    312
    311
    146
    Units: Percent
        number (not applicable)
    72.8
    74.5
    73.2
    66.9
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Ciclesonide 40 µg Intent-to-Treat (ITT) v Placebo ITT
    Number of subjects included in analysis
    450
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1362 [4]
    Method
    		 Logrank
    Confidence interval
    Notes
    [4] - Two-sided p-value, significance level 5%.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Ciclesonide 80 µg ITT v Placebo ITT
    Number of subjects included in analysis
    458
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0891 [5]
    Method
    		 Logrank
    Confidence interval
    Notes
    [5] - Two-sided p-value, significance level 5%.
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Ciclesonide 160 µg ITT v Placebo ITT
    Number of subjects included in analysis
    457
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1574 [6]
    Method
    		 Logrank
    Confidence interval
    Notes
    [6] - Two-sided p-value, significance level 5%.

    Secondary: Percentage of Days with Asthma Control Based on Symptoms, Use of Rescue Medication, Morning PEF and PEF Fluctuation

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    End point title
    		 Percentage of Days with Asthma Control Based on Symptoms, Use of Rescue Medication, Morning PEF and PEF Fluctuation
    End point description
    Control of asthma was evaluated on a daily basis (24 hours) using the following variables: asthma symptoms, use of rescue medication, morning (am) PEF and PEF fluctuation. The median percentage of days with asthma control is presented.
    End point type
    Secondary
    End point timeframe
    28 days prior to last visit (Up to 12 Weeks)
    End point values
    		 Ciclesonide 40 µg Intent-to-Treat (ITT) Ciclesonide 80 µg ITT Ciclesonide 160 µg ITT Placebo ITT
    Number of subjects analysed
    302
    311
    309
    144
    Units: percentage of days
        median (full range (min-max))
    7.14 (0 to 100)
    10.53 (0 to 100)
    6.67 (0 to 100)
    0 (0 to 100)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Ciclesonide 40 µg Intent-to-Treat (ITT) v Placebo ITT
    Number of subjects included in analysis
    446
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.001 [7]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [7] - One-sided p-value for superiority, significance level 2.5%.
    Statistical analysis title
    		 Statistical Analysis 2
    Comparison groups
    Ciclesonide 80 µg ITT v Placebo ITT
    Number of subjects included in analysis
    455
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0006 [8]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [8] - One-sided p-value for superiority, significance level 2.5%.
    Statistical analysis title
    		 Statistical Analysis 3
    Comparison groups
    Ciclesonide 160 µg ITT v Placebo ITT
    Number of subjects included in analysis
    453
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0002 [9]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [9] - One-sided p-value for superiority, significance level 2.5%.

    Secondary: Change from Baseline in Lung Function Variable Forced Expiratory Volume in One Second (FEV1)

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    End point title
    		 Change from Baseline in Lung Function Variable Forced Expiratory Volume in One Second (FEV1)
    End point description
    Spirometry was performed according to local standards. FEV1 is the maximal amount of air forcefully exhaled from the lungs in one second. Higher change numbers indicate better lung function.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Ciclesonide 40 µg Intent-to-Treat (ITT) Ciclesonide 80 µg ITT Ciclesonide 160 µg ITT Placebo ITT
    Number of subjects analysed
    270
    281
    270
    124
    Units: liters
        least squares mean (standard error)
    0.123 ± 0.015
    0.122 ± 0.015
    0.139 ± 0.015
    0.039 ± 0.022
    No statistical analyses for this end point

    Secondary: Change from Baseline in Lung Function Variable PEF by Spirometry

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    End point title
    		 Change from Baseline in Lung Function Variable PEF by Spirometry
    End point description
    Spirometry was performed according to local standards. PEF is the maximum speed of expiration. Analysis was ANCOVA with factors value at Baseline, treatment, age, sex, center pool, ICS pretreatment, spacer use and asthma severity. Higher change numbers indicate better lung function.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Ciclesonide 40 µg Intent-to-Treat (ITT) Ciclesonide 80 µg ITT Ciclesonide 160 µg ITT Placebo ITT
    Number of subjects analysed
    270 [10]
    281 [11]
    272 [12]
    124 [13]
    Units: liters/minute
        least squares mean (standard error)
    20.68 ± 2.61
    21.71 ± 2.51
    22.25 ± 2.61
    15.13 ± 3.69
    Notes
    [10] - Last observation carried forward (LOCF)
    [11] - LOCF
    [12] - LOCF
    [13] - LOCF
    No statistical analyses for this end point

    Secondary: Change from Baseline in Morning PEF from Diary

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    End point title
    		 Change from Baseline in Morning PEF from Diary
    End point description
    PEF is the maximum speed of expiration. A portable electronic PEF meter was used for the home PEF readings. The patients recorded PEF daily, in the morning immediately after getting up. Readings were done preferably at least 4 hours after use of rescue medication and before inhalation of the study medication. At each measurement, three readings were obtained in the standing position. All three values were recorded in the diary; the highest value was used for evaluation. The higher change from Baseline values are the best. Analysis of covariance (ANCOVA) model with the Baseline value and age as covariates was used for analysis.
    End point type
    Secondary
    End point timeframe
    Baseline and Weeks 1 thru 12
    End point values
    		 Ciclesonide 40 µg Intent-to-Treat (ITT) Ciclesonide 80 µg ITT Ciclesonide 160 µg ITT Placebo ITT
    Number of subjects analysed
    304
    312
    311
    146
    Units: liters/minute
    least squares mean (standard error)
        Change at Week 1 (n=303,311,310,146)
    11.61 ± 1.55
    9.2 ± 1.5
    11.54 ± 1.54
    4.54 ± 2.13
        Change at Week 2 (n=303,311,310,146)
    9.82 ± 1.89
    11.95 ± 1.83
    12.26 ± 1.89
    4.2 ± 2.61
        Change at Week 3 (n=304,312,310,146)
    11.36 ± 2.08
    11.11 ± 2.01
    13.15 ± 2.07
    6.74 ± 2.87
        Change at Week 4 (n=304,312,310,146)
    13.63 ± 2.18
    13.27 ± 2.12
    15.6 ± 2.18
    6.31 ± 3.02
        Change at Week 5
    14.86 ± 2.23
    13.33 ± 2.16
    15.39 ± 2.22
    9.67 ± 3.08
        Change at Week 6
    13.91 ± 2
    13.26 ± 2.23
    14.71 ± 2.29
    7.64 ± 3.18
        Change at Week 7
    14.57 ± 2.37
    15.05 ± 2.3
    14.14 ± 2.36
    6.21 ± 3.28
        Change at Week 8
    14.57 ± 2.39
    15.92 ± 2.31
    13.63 ± 2.38
    7.05 ± 3.3
        Change at Week 9
    15.26 ± 2.44
    16.02 ± 2.36
    13.23 ± 2.43
    7.88 ± 3.37
        Change at Week 10
    16.35 ± 2.48
    16.79 ± 2.4
    14.59 ± 2.47
    7.66 ± 3.43
        Change at Week 11
    16.12 ± 2.6
    15.97 ± 2.52
    16.24 ± 2.59
    6.8 ± 3.6
        Change at Week 12
    15.93 ± 2.72
    15.43 ± 2.64
    17.59 ± 2.71
    6.41 ± 3.76
    No statistical analyses for this end point

    Secondary: Change from Baseline in Evening PEF from Diary

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    End point title
    		 Change from Baseline in Evening PEF from Diary
    End point description
    PEF is the maximum speed of expiration. A portable electronic PEF meter was used for the home PEF readings. The patients recorded PEF daily, in the morning immediately after getting up. Readings were done preferably at least 4 hours after use of rescue medication and before inhalation of the study medication. At each measurement, three readings were obtained in the standing position. All three values were recorded in the diary; the highest value was used for evaluation. The higher change from Baseline values are the best. Analysis of covariance (ANCOVA) model with the Baseline value and age as covariates was used for analysis.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Ciclesonide 40 µg Intent-to-Treat (ITT) Ciclesonide 80 µg ITT Ciclesonide 160 µg ITT Placebo ITT
    Number of subjects analysed
    304 [14]
    312 [15]
    310 [16]
    146 [17]
    Units: liters/minute
        least squares mean (standard error)
    10.16 ± 2.54
    9.37 ± 2.46
    12.71 ± 2.53
    4.02 ± 3.52
    Notes
    [14] - LOCF
    [15] - LOCF
    [16] - LOCF
    [17] - LOCF
    No statistical analyses for this end point

    Secondary: Change from Baseline in Diurnal PEF Fluctuations

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    End point title
    		 Change from Baseline in Diurnal PEF Fluctuations
    End point description
    PEF is the maximum speed of expiration. A portable electronic PEF meter was used for the home PEF readings. The patients recorded PEF daily, in the morning immediately after getting up. Readings were done preferably at least 4 hours after use of rescue medication and before inhalation of the study medication. At each measurement, three readings were obtained in the standing position. All three values were recorded in the diary; the highest value was used for evaluation. A negative change from Baseline indicates improvement. Analysis of covariance (ANCOVA) model with the Baseline value and age as covariates was used for analysis.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Ciclesonide 40 µg Intent-to-Treat (ITT) Ciclesonide 80 µg ITT Ciclesonide 160 µg ITT Placebo ITT
    Number of subjects analysed
    303
    312
    310
    146
    Units: percent change
        arithmetic mean (standard deviation)
    -0.841 ± 9.942
    -1.209 ± 10.686
    -1.192 ± 11.29
    0.214 ± 9.453
    No statistical analyses for this end point

    Secondary: Change in Asthma Symptom Total Score

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    End point title
    		 Change in Asthma Symptom Total Score
    End point description
    Measurements of both nighttime and daytime asthma symptoms were assessed on a daily basis by the patient in the electronic diary, according to the following scales: Nighttime Asthma Score using a 5 point scale: 0=no asthma symptoms, slept through the night to 4=bad night, awake most of the night because of asthma. Daytime Asthma Score using a 5 point scale: 0=very well, no asthma symptoms to 4=asthma very bad, unable to carry out daily activities as usual. Total possible overall daily score range from 0 (best) to 4 (worst). A negative change from Baseline indicated improvement.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Ciclesonide 40 µg Intent-to-Treat (ITT) Ciclesonide 80 µg ITT Ciclesonide 160 µg ITT Placebo ITT
    Number of subjects analysed
    304 [18]
    312 [19]
    311 [20]
    146 [21]
    Units: score on a scale
    arithmetic mean (standard deviation)
        Asthma Total Symptom Score (n=304,312,310,146)
    -0.916 ± 1.265
    -0.983 ± 1.209
    -0.879 ± 1.27
    -0.572 ± 1.483
        Asthma Daytime Symptom Score (n=304,312,310,146)
    -0.529 ± 0.682
    -0.553 ± 0.721
    -0.517 ± 0.662
    -0.354 ± 0.801
        Asthma Nighttime Symptom Score
    -0.392 ± 0.775
    -0.435 ± 0.672
    -0.35 ± 0.791
    -0.233 ± 0.858
    Notes
    [18] - LOCF
    [19] - LOCF
    [20] - LOCF
    [21] - LOCF
    No statistical analyses for this end point

    Secondary: Change in Use of Rescue Medications

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    End point title
    		 Change in Use of Rescue Medications
    End point description
    The daily use of rescue medication (salbutamol) was recorded in the electronic diary in the morning and the evening. A negative change from Baseline indicates improvement.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Ciclesonide 40 µg Intent-to-Treat (ITT) Ciclesonide 80 µg ITT Ciclesonide 160 µg ITT Placebo ITT
    Number of subjects analysed
    304 [22]
    312 [23]
    311 [24]
    146 [25]
    Units: puffs/day
        arithmetic mean (standard deviation)
    -0.872 ± 1.634
    -0.999 ± 1.532
    -0.886 ± 1.771
    -0.527 ± 1.931
    Notes
    [22] - LOCF
    [23] - LOCF
    [24] - LOCF
    [25] - LOCF
    No statistical analyses for this end point

    Secondary: Percentage of Days with Asthma Control Based on Symptoms, Use of Rescue Medication and Morning PEF

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    End point title
    		 Percentage of Days with Asthma Control Based on Symptoms, Use of Rescue Medication and Morning PEF
    End point description
    Control of asthma was evaluated on a daily basis (24 hours) using the following variables: asthma symptoms, use of rescue medication, and morning (am) PEF . The median percentage of days with asthma control is presented.
    End point type
    Secondary
    End point timeframe
    28 days prior to last visit (Up to 12 Weeks)
    End point values
    		 Ciclesonide 40 µg Intent-to-Treat (ITT) Ciclesonide 80 µg ITT Ciclesonide 160 µg ITT Placebo ITT
    Number of subjects analysed
    302
    311
    309
    144
    Units: percentage of days
        median (full range (min-max))
    8.33 (0 to 100)
    13.64 (0 to 100)
    13.04 (0 to 100)
    0 (0 to 100)
    No statistical analyses for this end point

    Secondary: Change from Baseline in Pediatric Asthma Quality of Life Questionnaire Standard [PAQLQ(S)] Overall Score

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    End point title
    		 Change from Baseline in Pediatric Asthma Quality of Life Questionnaire Standard [PAQLQ(S)] Overall Score
    End point description
    PAQLQS is a disease specific instrument to assess the impact of asthma on the patient’s quality of life. The PAQLQS consists of 23 items in 3 domains evaluating activity limitations, symptoms and emotional function. Patients answered each question using a 7-point scale from 1= maximum impairment to 7=no impairment) about their experience during the previous week. Total possible score ranging from 23 (worst) to 161(best). Higher change from Baseline scores are the best. Analysis of covariance (ANCOVA) model with the baseline value and age as covariates was used for analysis.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Ciclesonide 40 µg Intent-to-Treat (ITT) Ciclesonide 80 µg ITT Ciclesonide 160 µg ITT Placebo ITT
    Number of subjects analysed
    167
    179
    171
    76
    Units: score on a scale
        least squares mean (standard error)
    0.78 ± 0.07
    0.71 ± 0.007
    0.72 ± 0.07
    0.43 ± 0.1
    No statistical analyses for this end point

    Secondary: Change from Baseline in Pediatric asthma Caregiver’s Quality of Life Questionnaire (PACQLQ) Overall

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    End point title
    		 Change from Baseline in Pediatric asthma Caregiver’s Quality of Life Questionnaire (PACQLQ) Overall
    End point description
    PACQLQ assesses the impact of the child’s asthma on the quality of life of the caregiver. The PACQLQ consists of 13 items in 2 domains evaluating activity limitations and emotional function. Caregivers answered each question using a 7-point scale from 1= maximum impairment to 7=no impairment about their experience during the previous week. Total possible score ranging from 13 (worst) to 91(best). Higher change from Baseline scores are the best. Analysis of covariance (ANCOVA) model with the baseline value and age as covariates was used for analysis.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Ciclesonide 40 µg Intent-to-Treat (ITT) Ciclesonide 80 µg ITT Ciclesonide 160 µg ITT Placebo ITT
    Number of subjects analysed
    169
    177
    172
    74
    Units: score on a scale
        least squares mean (standard error)
    0.82 ± 0.08
    0.88 ± 0.08
    0.84 ± 0.08
    0.71 ± 0.12
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    First dose of study drug to 30 days after last dose of study drug (Up to 20 Weeks)
    Adverse event reporting additional description
    At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.1
    Reporting groups
    Reporting group title
    Ciclesonide 40 µg
    Reporting group description
    		 Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI), once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.

    Reporting group title
    Ciclesonide 80 µg
    Reporting group description
    		 Placebo-matching ciclesonide, inhaled via a MDI, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.

    Reporting group title
    Ciclesonide 160 µg
    Reporting group description
    		 Placebo-matching ciclesonide, inhaled via a MDI, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo-matching Ciclesonide ,inhaled via a MDI, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.

    Serious adverse events
    		 Ciclesonide 40 µg Ciclesonide 80 µg Ciclesonide 160 µg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 305 (1.31%)
    5 / 312 (1.60%)
    2 / 310 (0.65%)
    1 / 146 (0.68%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Open wound
         subjects affected / exposed
    0 / 305 (0.00%)
    1 / 312 (0.32%)
    0 / 310 (0.00%)
    0 / 146 (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
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    0 / 305 (0.00%)
    0 / 312 (0.00%)
    0 / 310 (0.00%)
    1 / 146 (0.68%)
         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
    Nervous system disorders
    Tremor
         subjects affected / exposed
    0 / 305 (0.00%)
    0 / 312 (0.00%)
    0 / 310 (0.00%)
    1 / 146 (0.68%)
         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
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 305 (0.33%)
    2 / 312 (0.64%)
    1 / 310 (0.32%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Adenovirus infection
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 312 (0.00%)
    0 / 310 (0.00%)
    0 / 146 (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
    Appendicitis
         subjects affected / exposed
    0 / 305 (0.00%)
    1 / 312 (0.32%)
    0 / 310 (0.00%)
    0 / 146 (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 / 305 (0.00%)
    0 / 312 (0.00%)
    1 / 310 (0.32%)
    0 / 146 (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
    Otitis media
         subjects affected / exposed
    0 / 305 (0.00%)
    1 / 312 (0.32%)
    0 / 310 (0.00%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 305 (0.33%)
    1 / 312 (0.32%)
    0 / 310 (0.00%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    1 / 305 (0.33%)
    1 / 312 (0.32%)
    0 / 310 (0.00%)
    0 / 146 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis streptococcal
         subjects affected / exposed
    1 / 305 (0.33%)
    0 / 312 (0.00%)
    0 / 310 (0.00%)
    0 / 146 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Ciclesonide 40 µg Ciclesonide 80 µg Ciclesonide 160 µg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    49 / 305 (16.07%)
    45 / 312 (14.42%)
    45 / 310 (14.52%)
    14 / 146 (9.59%)
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    19 / 305 (6.23%)
    10 / 312 (3.21%)
    13 / 310 (4.19%)
    3 / 146 (2.05%)
         occurrences all number
    22
    10
    15
    3
    Pharyngitis
         subjects affected / exposed
    14 / 305 (4.59%)
    18 / 312 (5.77%)
    16 / 310 (5.16%)
    7 / 146 (4.79%)
         occurrences all number
    14
    19
    19
    8
    Upper respiratory tract infection
         subjects affected / exposed
    18 / 305 (5.90%)
    20 / 312 (6.41%)
    16 / 310 (5.16%)
    5 / 146 (3.42%)
         occurrences all number
    21
    21
    16
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Oct 2006
    • Mean PEF criterion regarding the minimum number of days with morning measurements defined. • Clarification of LOE criteria • Added calculation of PEF reversibility.

    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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