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    Clinical Trial Results:
    A multicenter, multi-national, randomized, double-blind, placebo-controlled, study to assess the efficacy and safety of ciclesonide metereddose inhaler at 80 μg bid (twice daily) or 40 μg bid for 12 weeks in patients aged 4 to <12 years with persistent asthma.

    Summary
    EudraCT number
    		 2006-004740-22
    Trial protocol
    		 HU  
    Global end of trial date
    22 Feb 2008

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Jun 2017
    First version publication date
    08 Jun 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EFC6695
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00392288
    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
    17 Mar 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Feb 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Feb 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary: To demonstrate the efficacy of ciclesonide, compared to placebo, at 80 μg bid or 40 μg bid for 12 weeks in patients aged 4 to <12 years with persistent asthma. Secondary: To assess the safety 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
    25 Oct 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
    United States: 180
    Country: Number of subjects enrolled
    Mexico: 67
    Country: Number of subjects enrolled
    Poland: 130
    Country: Number of subjects enrolled
    Russian Federation: 39
    Country: Number of subjects enrolled
    South Africa: 37
    Country: Number of subjects enrolled
    Hungary: 75
    Worldwide total number of subjects
    528
    EEA total number of subjects
    205
    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)
    528
    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
    		 Screening period 7-14 days, randomization with subsequent treatment period over 12 weeks

    Pre-assignment
    Screening details
    		 The number of subjects in section Participant Flow is related to the number of randomized subjects (= subject who were eligible for treatment period). This number is different to the number of subjects of the Intention to Treat (ITT) population in Outcome Measures. The statistical analyses of the Outcome Measures is related to the ITT population.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo metered dose inhaler (MDI)
    Arm description
    		 Placebo MDI over twelve weeks (ITT population)
    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

    Arm title
    		 Ciclesonide MDI 40 µg BID
    Arm description
    		 Ciclesonide MDI 40 µg BID over twelve weeks (ITT population)
    Arm type
    		 Experimental

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

    Arm title
    		 Ciclesonide MDI 80 µg BID
    Arm description
    		 Ciclesonide MDI 80 µg BID over twelve weeks (ITT population)
    Arm type
    		 Experimental

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

    Number of subjects in period 1
    		Placebo metered dose inhaler (MDI) Ciclesonide MDI 40 µg BID Ciclesonide MDI 80 µg BID
    Started
    175
    177
    176
    Completed
    143
    155
    159
    Not completed
    32
    22
    17
         Consent withdrawn by subject
    1
    -
    2
         Adverse event, non-fatal
    17
    7
    8
         Parent/legal guardian withdrawal
    1
    2
    1
         Unknown
    3
    4
    1
         Lost to follow-up
    1
    1
    1
         Lack of efficacy
    8
    5
    3
         Protocol deviation
    1
    3
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo metered dose inhaler (MDI)
    Reporting group description
    		 Placebo MDI over twelve weeks (ITT population)

    Reporting group title
    Ciclesonide MDI 40 µg BID
    Reporting group description
    		 Ciclesonide MDI 40 µg BID over twelve weeks (ITT population)

    Reporting group title
    Ciclesonide MDI 80 µg BID
    Reporting group description
    		 Ciclesonide MDI 80 µg BID over twelve weeks (ITT population)

    Reporting group values
    		 Placebo metered dose inhaler (MDI) Ciclesonide MDI 40 µg BID Ciclesonide MDI 80 µg BID Total
    Number of subjects
    		 175 177 176 528
    Age Categorical
    Units: Subjects
        Aged 6 to <12 years
    		 147 148 148 443
        Aged 4 to <6 years
    		 28 29 28 85
    Age continuous
    Age at last birthday
    Units: years
        median (full range (min-max))
    		 9 (4 to 11) 8 (4 to 11) 8 (4 to 11) -
    Gender, Male/Female
    Units: Subjects
        Female
    		 63 77 78 218
        Male
    		 112 100 98 310
    Time since first diagnosis of asthma
    Units: Months
        median (full range (min-max))
    		 35 (3 to 136) 35 (3 to 129) 47 (3 to 141) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo metered dose inhaler (MDI)
    Reporting group description
    		 Placebo MDI over twelve weeks (ITT population)

    Reporting group title
    Ciclesonide MDI 40 µg BID
    Reporting group description
    		 Ciclesonide MDI 40 µg BID over twelve weeks (ITT population)

    Reporting group title
    Ciclesonide MDI 80 µg BID
    Reporting group description
    		 Ciclesonide MDI 80 µg BID over twelve weeks (ITT population)

    Primary: Change from baseline in forced expiratory volume in one second (FEV1) at week 12.

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    End point title
    		 Change from baseline in forced expiratory volume in one second (FEV1) at week 12.
    End point description
    Change in FEV1 (Percent of predicted) from baseline to week 12. FEV1 was measured only in children between 6 to <12 years only. Least Squares Mean were adjusted for Baseline FEV1, age [yrs], pooled center, previous corticosteroid therapy and holding chamber.
    End point type
    Primary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Placebo metered dose inhaler (MDI) Ciclesonide MDI 40 µg BID Ciclesonide MDI 80 µg BID
    Number of subjects analysed
    136
    138
    146
    Units: Percent of predicted FEV1
        least squares mean (standard error)
    5.2 ( 1.06 )
    5.3 ( 1.06 )
    7.7 ( 1.06 )
    Statistical analysis title
    		 Comparison between ciclesonide and placebo
    Statistical analysis description
    This is an analysis of the change from baseline to week 12 or last visit. In this pairwise comparison Ciclesonide was compared with Placebo by testing the average effect of Ciclesonide 40 and Ciclesonide 80 versus Placebo. As statistical test a t-test was used to compare the corresponding least-square means of both treatment groups.
    Comparison groups
    Placebo metered dose inhaler (MDI) v Ciclesonide MDI 40 µg BID v Ciclesonide MDI 80 µg BID
    Number of subjects included in analysis
    420
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.2696 [1]
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
    Notes
    [1] - Due to usage of a-priori ordered hypotheses, adjustment of p-values is not necessary. The pre-specified significance level was 0.05. The tests were carried out two-sided.
    Statistical analysis title
    		 Comparison between ciclesonide 40 µg and placebo
    Statistical analysis description
    This is an analysis of the change from baseline to week 12 or last visit. As statistical test a t-test was used to compare the corresponding least-square means of Ciclesonide 40 versus Placebo.
    Comparison groups
    Placebo metered dose inhaler (MDI) v Ciclesonide MDI 40 µg BID v Ciclesonide MDI 80 µg BID
    Number of subjects included in analysis
    420
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.9146 [2]
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
    Notes
    [2] - Due to usage of a-priori ordered hypotheses, adjustment of p-values is not necessary. The pre-specified significance level was 0.05. The tests were carried out two-sided.
    Statistical analysis title
    		 Comparison between ciclesonide 80 µg and placebo
    Statistical analysis description
    This is an analysis of the change from baseline to week 12 or last visit. A t-test was used to compare the least-square means of Ciclesonide 80 versus Placebo.
    Comparison groups
    Placebo metered dose inhaler (MDI) v Ciclesonide MDI 80 µg BID
    Number of subjects included in analysis
    282
    Analysis specification
    Pre-specified
    Analysis type
    P-value
    		 = 0.0703 [3]
    Method
    		 ANCOVA
    Confidence interval
         level
    		 95%
    Notes
    [3] - Due to usage of a-priori ordered hypotheses, adjustment of p-values is not necessary. The pre-specified significance level was 0.05. The tests were carried out two-sided.

    Secondary: Change from baseline in total daily asthma symptom score at week 12.

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    End point title
    		 Change from baseline in total daily asthma symptom score at week 12.
    End point description
    Change in total daily asthma symptom score from baseline to week 12. 5-Point, ordinal scale specifying patient's experience of symptoms during day and night from 0 (no symptoms) to 4 (symptoms that prevent the patient from engaging in daily activities or sleep)
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Placebo metered dose inhaler (MDI) Ciclesonide MDI 40 µg BID Ciclesonide MDI 80 µg BID
    Number of subjects analysed
    161
    165
    170
    Units: Scores on a scale
        least squares mean (standard error)
    -0.96 ( 0.08 )
    -1.13 ( 0.08 )
    -0.99 ( 0.08 )
    No statistical analyses for this end point

    Secondary: Change from baseline in use of albuterol/salbutamol at week 12.

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    End point title
    		 Change from baseline in use of albuterol/salbutamol at week 12.
    End point description
    Change in albuterol/salbutamol use from baseline to week 12
    End point type
    Secondary
    End point timeframe
    Baseline and Week 12
    End point values
    		 Placebo metered dose inhaler (MDI) Ciclesonide MDI 40 µg BID Ciclesonide MDI 80 µg BID
    Number of subjects analysed
    162
    166
    172
    Units: Puffs per day
        least squares mean (standard error)
    -0.59 ( 0.08 )
    -0.87 ( 0.08 )
    -0.93 ( 0.08 )
    No statistical analyses for this end point

    Secondary: Change from baseline in morning PEF to Week 12

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    End point title
    		 Change from baseline in morning PEF to Week 12
    End point description
    Change in morning PEF from baseline to Week 12
    End point type
    Secondary
    End point timeframe
    Baseline and week 12
    End point values
    		 Placebo metered dose inhaler (MDI) Ciclesonide MDI 40 µg BID Ciclesonide MDI 80 µg BID
    Number of subjects analysed
    161
    165
    172
    Units: L/min
        least squares mean (standard error)
    9 ( 2.924 )
    16.36 ( 2.891 )
    23.55 ( 2.892 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the time the patient gave informed consent at the pre-screening visit (Visit 1) until 14 days after the last administration of study medication.
    Adverse event reporting additional description
    The numbers of subjects at risk are based on the Safety Population. It was based on all randomized patients receiving at least one dose of the double-blind study medication after randomization.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    Placebo metered dose inhaler (MDI)
    Reporting group description
    		 Placebo MDI over twelve weeks (ITT population)

    Reporting group title
    Ciclesonide MDI 40 µg BID
    Reporting group description
    		 Ciclesonide MDI 40 µg BID over twelve weeks (ITT population)

    Reporting group title
    Ciclesonide MDI 80 µg BID
    Reporting group description
    		 Ciclesonide MDI 80 µg BID over twelve weeks (ITT population)

    Serious adverse events
    		 Placebo metered dose inhaler (MDI) Ciclesonide MDI 40 µg BID Ciclesonide MDI 80 µg BID
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 172 (0.58%)
    1 / 174 (0.57%)
    4 / 175 (2.29%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    General disorders and administration site conditions
    Electric shock
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 172 (0.00%)
    0 / 174 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
    alternative dictionary used: MedDRA 11.0
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 172 (0.58%)
    0 / 174 (0.00%)
    2 / 175 (1.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Status asthmaticus
    alternative dictionary used: MedDRA 11.0
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 172 (0.00%)
    0 / 174 (0.00%)
    1 / 175 (0.57%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Forearm fracture
    alternative dictionary used: MedDRA 11.0
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 172 (0.00%)
    1 / 174 (0.57%)
    0 / 175 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo metered dose inhaler (MDI) Ciclesonide MDI 40 µg BID Ciclesonide MDI 80 µg BID
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    53 / 172 (30.81%)
    38 / 174 (21.84%)
    28 / 175 (16.00%)
    Nervous system disorders
    Headache
    alternative dictionary used: MedDRA 11.0
    alternative assessment type: Non-systematic
         subjects affected / exposed
    5 / 172 (2.91%)
    12 / 174 (6.90%)
    8 / 175 (4.57%)
         occurrences all number
    5
    18
    9
    Respiratory, thoracic and mediastinal disorders
    Asthma
    alternative dictionary used: MedDRA 11.0
    alternative assessment type: Non-systematic
         subjects affected / exposed
    18 / 172 (10.47%)
    10 / 174 (5.75%)
    3 / 175 (1.71%)
         occurrences all number
    18
    10
    3
    Infections and infestations
    Nasopharyngitis
    alternative dictionary used: MedDRA 11.0
    alternative assessment type: Non-systematic
         subjects affected / exposed
    9 / 172 (5.23%)
    8 / 174 (4.60%)
    7 / 175 (4.00%)
         occurrences all number
    11
    9
    7
    Upper respiratory tract infection
    alternative dictionary used: MedDRA 11.0
    alternative assessment type: Non-systematic
         subjects affected / exposed
    11 / 172 (6.40%)
    4 / 174 (2.30%)
    10 / 175 (5.71%)
         occurrences all number
    11
    5
    10
    Pharyngitis
    alternative dictionary used: MedDRA 11.0
    alternative assessment type: Non-systematic
         subjects affected / exposed
    17 / 172 (9.88%)
    7 / 174 (4.02%)
    4 / 175 (2.29%)
         occurrences all number
    19
    7
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Aug 2006
    Amendment 1: The stratification of the randomization was revised with respect to previous ICS use. Several parts of the instructions were clarified.
    12 Jan 2007
    Amendment 2: Criteria for worsening asthma were revised. The inclusion criteria for morning PEF, reversibility and daytime asthma symptom score were revised.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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