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    Clinical Trial Results:
    ACE inhibition and mechanisms of skeletal muscle weakness in COPD

    Summary
    EudraCT number
    		 2008-004431-38
    Trial protocol
    		 GB  
    Global end of trial date
    03 Dec 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 May 2020
    First version publication date
    20 May 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    P15099
    Additional study identifiers
    ISRCTN number
    		 ISRCTN05581879
    US NCT number
    		 NCT01014338
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Imperial College London
    Sponsor organisation address
    South Kensington Campus, London, United Kingdom, SW7 2AZ
    Public contact
    Dr Nicholas Hopkinson, Imperial College London, +44 020 73497775, n.hopkinson@ic.ac.uk
    Scientific contact
    Dr Nicholas Hopkinson, Imperial College London, +44 020 73497775, n.hopkinson@ic.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
    16 Dec 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Sep 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Dec 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To establish whether ACE inhibition can improve muscle strength in patients with COPD who have leg weakness. The effect of the study drug on the molecular pathways involved in muscle wasting will be determined in muscle biopsies taken before and after the study.
    Protection of trial subjects
    None
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Oct 2009
    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: 80
    Worldwide total number of subjects
    80
    EEA total number of subjects
    80
    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)
    0
    From 65 to 84 years
    80
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited in Royal Brompton Hospital, between October 2009 and December 2012

    Pre-assignment
    Screening details
    		 80 eligible participants with 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
    Yes

    Arm title
    		 ACE-inhibitor
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fosinopril sodium
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    10mg od

    Arm title
    		 Sugar Pill
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Sugar Pill
    Investigational medicinal product code
    Lactose
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    as another arm

    Number of subjects in period 1
    		ACE-inhibitor Sugar Pill
    Started
    39
    41
    Completed
    39
    41

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ACE-inhibitor
    Reporting group description
    		 -

    Reporting group title
    Sugar Pill
    Reporting group description
    		 -

    Reporting group values
    		 ACE-inhibitor Sugar Pill Total
    Number of subjects
    		 39 41 80
    Age categorical
    Units: Subjects
        From 65-84 years
    		 39 41 80
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 66.3 ± 8.2 64.6 ± 7.3 -
    Gender categorical
    Units: Subjects
        Female
    		 20 18 38
        Male
    		 19 23 42

    End points

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    End points reporting groups
    Reporting group title
    ACE-inhibitor
    Reporting group description
    		 -

    Reporting group title
    Sugar Pill
    Reporting group description
    		 -

    Primary: Change in Atrogin-1 Messenger RNA Expression

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    End point title
    		 Change in Atrogin-1 Messenger RNA Expression [1]
    End point description
    End point type
    Primary
    End point timeframe
    Baseline and 3 months
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: N/A
    End point values
    		 ACE-inhibitor Sugar Pill
    Number of subjects analysed
    31
    36
    Units: Arbitrary units
        arithmetic mean (confidence interval 95%)
    -0.18 (-0.41 to 0.04)
    -0.15 (-0.35 to 0.04)
    No statistical analyses for this end point

    Secondary: Quadriceps Endurance Assessed Non-volitionally

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    End point title
    		 Quadriceps Endurance Assessed Non-volitionally
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline and 3 months
    End point values
    		 ACE-inhibitor Sugar Pill
    Number of subjects analysed
    31
    36
    Units: seconds
        geometric mean (confidence interval 95%)
    5.1 (-4.3 to 14.5)
    4.6 (-5.8 to 15.1)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    3 months
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    ACE-inhibitor
    Reporting group description
    		 -

    Reporting group title
    Sugar Pill
    Reporting group description
    		 -

    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: N/A
    Serious adverse events
    		 ACE-inhibitor Sugar Pill
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 39 (0.00%)
    3 / 41 (7.32%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    0
    Nervous system disorders
    CVA
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute exacerbation of COPD
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Bladder cancer
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 41 (2.44%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 ACE-inhibitor Sugar Pill
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 39 (0.00%)
    0 / 41 (0.00%)

    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.
    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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