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    Clinical Trial Results:
    Small Particle Inhaled Steroids in Refractory Steroid-responsive Asthma

    Summary
    EudraCT number
    2010-018249-78
    Trial protocol
    GB  
    Global end of trial date
    23 Oct 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    14 Feb 2019
    First version publication date
    14 Feb 2019
    Other versions
    Summary report(s)
    A randomised controlled trial of small particle inhaled steroids in refractory eosinophilic asthma (SPIRA)

    Trial information

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    Trial identification
    Sponsor protocol code
    09115
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01171365
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    University of Nottingham
    Sponsor organisation address
    Jubilee Campus, Nottingham, United Kingdom, NG51PB
    Public contact
    Tim Harrison, University of Nottingham, 44 1158231714, tim.harrison@nottingham.ac.uk
    Scientific contact
    Tim Harrison, University of Nottingham, 44 8231714, tim.harrison@nottingham.ac.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    07 Oct 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Oct 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Oct 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    In patients with poorly controlled asthma with evidence of persistent eosinophilic inflammation can the addition of extra inhaled corticosteroid that targets the distal airways improve asthma control and reduce the eosinophilic airway inflammation? The primary endpoint will be the difference in sputum eosinophil count between active and placebo groups at 8 weeks.
    Protection of trial subjects
    N/A
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Dec 2010
    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 Kingdom: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    30
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Subjects with poorly controlled eosinophilic asthma

    Pre-assignment
    Screening details
    ATS criteria for severe asthma

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    active
    Arm description
    ciclesonide
    Arm type
    Experimental

    Investigational medicinal product name
    ciclesonide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour
    Routes of administration
    Auricular use
    Dosage and administration details
    640 mcg/day

    Arm title
    placebo
    Arm description
    -
    Arm type
    Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour
    Routes of administration
    Auricular use
    Dosage and administration details
    as active

    Number of subjects in period 1
    active placebo
    Started
    15
    15
    Completed
    15
    15

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    active
    Reporting group description
    ciclesonide

    Reporting group title
    placebo
    Reporting group description
    -

    Reporting group values
    active placebo Total
    Number of subjects
    15 15 30
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    0 15 15
        From 65-84 years
    15 0 15
        85 years and over
    0 0 0
    Gender categorical
    Units: Subjects
        Female
    7 7 14
        Male
    8 8 16
    Subject analysis sets

    Subject analysis set title
    Active
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    To compare high dose ciclesonide with placebo

    Subject analysis set title
    placebo
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    placebo control

    Subject analysis sets values
    Active placebo
    Number of subjects
    15
    15
    Age categorical
    Units: Subjects
        In utero
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
        Newborns (0-27 days)
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
        Children (2-11 years)
    0
    0
        Adolescents (12-17 years)
    0
    0
        Adults (18-64 years)
    15
    15
        From 65-84 years
    0
    0
        85 years and over
    0
    0
    Age continuous
    Units:
        
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    7
    7
        Male
    8
    8

    End points

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    End points reporting groups
    Reporting group title
    active
    Reporting group description
    ciclesonide

    Reporting group title
    placebo
    Reporting group description
    -

    Subject analysis set title
    Active
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    To compare high dose ciclesonide with placebo

    Subject analysis set title
    placebo
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    placebo control

    Primary: sputum eosinophils

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    End point title
    sputum eosinophils
    End point description
    End point type
    Primary
    End point timeframe
    week 8
    End point values
    active placebo Active placebo
    Number of subjects analysed
    15
    15
    15
    15
    Units: percent
    15
    15
    15
    15
    Statistical analysis title
    sputum cell counts
    Comparison groups
    placebo v Active
    Number of subjects included in analysis
    30
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.05
    Method
    t-test, 2-sided
    Parameter type
    Median difference (final values)
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    duration of study
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    SNOMED CT
    Dictionary version
    1
    Reporting groups
    Reporting group title
    active
    Reporting group description
    -

    Reporting group title
    placebo
    Reporting group description
    -

    Serious adverse events
    active placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 15 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    active placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
    3 / 15 (20.00%)
    Respiratory, thoracic and mediastinal disorders
    Wheezing
         subjects affected / exposed
    0 / 15 (0.00%)
    3 / 15 (20.00%)
         occurrences all number
    0
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    proxy measures of exacerbations
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