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    Clinical Trial Results:
    GR activity in induced sputum macrophages, and a change in inflammatory biomarkers 2-hours after a single dose of either Symbicort®/Budesonide/Formoterol or placebo in Chronic Obstructive Pulmonary Disease (COPD).

    Summary
    EudraCT number
    		 2010-020440-35
    Trial protocol
    		 GB  
    Global end of trial date
    30 Apr 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Jun 2020
    First version publication date
    19 Jun 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D589BC00004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01787097
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Imperial College London
    Sponsor organisation address
    South Kensington, London, United Kingdom, SW7 2AZ
    Public contact
    Omar Usmani, Imperial College London, o.usmani@imperial.ac.uk
    Scientific contact
    Omar Usmani, Imperial College London, o.usmani@imperial.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
    30 Apr 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Apr 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Apr 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The research question is whether inhaled drug treatments in combination (long-acting beta-2-agonists (LABA) together with inhaled corticosteroid (ICS)), that are routinely used for chronic obstructive pulmonary disease (COPD) patients can improve inflammation in the cells of the sputum/mucus from these patients compared to either drug component alone.
    Protection of trial subjects
    N/A
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jan 2013
    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: 31
    Worldwide total number of subjects
    31
    EEA total number of subjects
    31
    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)
    31
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited between January 2013 and April 2015. 1 participant withdrew before randomisation.

    Pre-assignment
    Screening details
    		 Patients with chronic obstructive pulmonary disease (COPD).

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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Formoterol 24ug
    Arm description
    		 Formoterol (FORM) total dose 24ug
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Formoterol (FORM) total dose 24ug
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Formoterol (FORM) total dose 24ug

    Arm title
    		 Symbicort® Total Dose 400ug/12ug
    Arm description
    		 Symbicort® Total Dose 400ug/12ug
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Symbicort® Total Dose 400ug/12ug
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Symbicort® Total Dose 400ug/12ug

    Arm title
    		 Symbicort® Total Dose 800ug/24ug
    Arm description
    		 Symbicort® Total Dose 800ug/24ug
    Arm type
    		 Experimental

    Investigational medicinal product name
    Symbicort® Total Dose 800ug/24ug
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Symbicort® Total Dose 800ug/24ug

    Arm title
    		 BUD Total Dose 800ug
    Arm description
    		 BUD Total Dose 800ug
    Arm type
    		 Active comparator

    Investigational medicinal product name
    BUD Total Dose 800ug
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    BUD Total Dose 800ug

    Number of subjects in period 1
    		Formoterol 24ug Symbicort® Total Dose 400ug/12ug Symbicort® Total Dose 800ug/24ug BUD Total Dose 800ug
    Started
    8
    7
    7
    9
    Completed
    7
    7
    7
    9
    Not completed
    1
    0
    0
    0
         Consent withdrawn by subject
    1
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups [1]
    Reporting group title
    Overall
    Reporting group description
    		 -

    Notes
    [1] - The number of subjects reported to be in the baseline period is not equal to the worldwide number of subjects enrolled in the trial. It is expected that these numbers will be the same.
    Justification: subject withdrew before randomization.
    Reporting group values
    		 Overall Total
    Number of subjects
    		 30 30
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 30 30
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 66 ± 6.4 -
    Gender categorical
    Units: Subjects
        Female
    		 20 20
        Male
    		 10 10
    Pre-bronchodilator FEV1 (% pred.)
    Units: % predicted
        median (inter-quartile range (Q1-Q3))
    		 62 (55 to 70) -
    Pre-bronchodilator FVC (% pred.)
    Units: % predicted
        median (inter-quartile range (Q1-Q3))
    		 93 (83 to 103) -
    GR activity
    Units: Relative to baseline (%)
        arithmetic mean (standard deviation)
    		 1 ± 0 -
    Sputum CXCL8
    Units: ng/mL
        median (inter-quartile range (Q1-Q3))
    		 2.3 (1.4 to 4) -

    End points

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    End points reporting groups
    Reporting group title
    Formoterol 24ug
    Reporting group description
    		 Formoterol (FORM) total dose 24ug

    Reporting group title
    Symbicort® Total Dose 400ug/12ug
    Reporting group description
    		 Symbicort® Total Dose 400ug/12ug

    Reporting group title
    Symbicort® Total Dose 800ug/24ug
    Reporting group description
    		 Symbicort® Total Dose 800ug/24ug

    Reporting group title
    BUD Total Dose 800ug
    Reporting group description
    		 BUD Total Dose 800ug

    Primary: GR-GRE Binding (Relative to Baseline)

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    End point title
    		 GR-GRE Binding (Relative to Baseline)
    End point description
    Enzyme immunosorbent assay system
    End point type
    Primary
    End point timeframe
    Screening visit and 2 hours post inhalation of treatment
    End point values
    		 Formoterol 24ug Symbicort® Total Dose 400ug/12ug Symbicort® Total Dose 800ug/24ug BUD Total Dose 800ug
    Number of subjects analysed
    5
    6
    6
    7
    Units: Fold activation
        arithmetic mean (standard error)
    1.1 ± .1
    1.8 ± .1
    2.3 ± .4
    2.1 ± .2
    Statistical analysis title
    		 GR-GRE Binding (Relative to Baseline)
    Statistical analysis description
    Statistical Analysis 1 for GR-GRE Binding (Relative to Baseline)
    Comparison groups
    Symbicort® Total Dose 400ug/12ug v Symbicort® Total Dose 800ug/24ug
    Number of subjects included in analysis
    12
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.003
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    4 months
    Adverse event reporting additional description
    All Adverse Events during the clinical investigation will be recorded and documented in the relevant section of the Case Report Form
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1.0
    Reporting groups
    Reporting group title
    Formoterol 24ug
    Reporting group description
    		 Formoterol (FORM) total dose 24ug

    Reporting group title
    Symbicort® Total Dose 400ug/12ug
    Reporting group description
    		 Symbicort® Total Dose 400ug/12ug

    Reporting group title
    Symbicort® Total Dose 800ug/24ug
    Reporting group description
    		 Symbicort® Total Dose 800ug/24ug

    Reporting group title
    BUD Total Dose 800ug
    Reporting group description
    		 BUD Total Dose 800ug

    Serious adverse events
    		 Formoterol 24ug Symbicort® Total Dose 400ug/12ug Symbicort® Total Dose 800ug/24ug BUD Total Dose 800ug
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Formoterol 24ug Symbicort® Total Dose 400ug/12ug Symbicort® Total Dose 800ug/24ug BUD Total Dose 800ug
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    0 / 30 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: There were no adverse events.

    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.
    Quality and quantity of sputum production varied between patients and between patient visits. Four patients withdrew consent prior to starting intervention. One patient discontinued- did not attend visit 2.
    For support, Contact us.
    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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