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    Clinical Trial Results:
    Can muscle dysfunction in COPD be altered by oxygenation in patients with intermittent hypoxia on exertion?

    Summary
    EudraCT number
    		 2011-003595-36
    Trial protocol
    		 GB  
    Global end of trial date
    15 Dec 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    04 Jan 2020
    First version publication date
    04 Jan 2020
    Other versions
    Summary report(s)
    		 Summary Results

    Trial information

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    Trial identification
    Sponsor protocol code
    ERN_11-0670
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01722370
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Birmingham
    Sponsor organisation address
    Edgbaston, Birmingham, United Kingdom,
    Public contact
    Alice Wood, University of Birmingham, +44 1214143344, a.m.wood@bham.ac.uk
    Scientific contact
    Alice Wood, University of Birmingham, +44 1214143344, a.m.wood@bham.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
    01 Dec 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    15 Dec 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Dec 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Our primary question is whether changes in muscle structure including gene expression occur during normal daily life in patients with COPD that can be corrected by giving oxygen. To do this we will compare the appearance of and genes expressed in muscle of patients after they have received oxygen and after they have been given air to use at home for 12 weeks.
    Protection of trial subjects
    Local anaesthetic was used for biopsies
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Jan 2012
    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: 25
    Worldwide total number of subjects
    25
    EEA total number of subjects
    25
    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)
    2
    From 65 to 84 years
    23
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 recruited between September 2012 and August 2014 in single site in England

    Pre-assignment
    Screening details
    		 32 subjects screened for inclusion of whom 25 recruited. All participants had completed pulmonary rehabilitation within 2 years prior to trial enrolment and demonstrated exercise induced desaturation to a nadir <88%.

    Period 1
    Period 1 title
    ambulatory oxygen
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Sealed envelope

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 ambulatory oxygen
    Arm description
    		 oxygen used on walking
    Arm type
    		 Experimental

    Investigational medicinal product name
    oxygen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour
    Routes of administration
    Inhalation use
    Dosage and administration details
    Oxygen 2l/min or as required to maintain saturations

    Arm title
    		 ambulatory air
    Arm description
    		 Air breathed from a cylinder blinded to look same as oxygen when walking
    Arm type
    		 Placebo

    Investigational medicinal product name
    medical air
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour
    Routes of administration
    Inhalation use
    Dosage and administration details
    Medical air given by cylinder used when walking

    Number of subjects in period 1
    		ambulatory oxygen ambulatory air
    Started
    13
    12
    Completed
    10
    7
    Not completed
    3
    5
         Physician decision
    1
    -
         Consent withdrawn by subject
    -
    4
         Lost to follow-up
    2
    1
    Period 2
    Period 2 title
    medical air
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Sealed envelope

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 ambulatory oxygen
    Arm description
    		 oxygen used on walking
    Arm type
    		 Experimental

    Investigational medicinal product name
    oxygen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour
    Routes of administration
    Inhalation use
    Dosage and administration details
    Oxygen 2l/min or as required to maintain saturations

    Arm title
    		 ambulatory air
    Arm description
    		 Air breathed from a cylinder blinded to look same as oxygen when walking
    Arm type
    		 Placebo

    Investigational medicinal product name
    medical air
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation vapour
    Routes of administration
    Inhalation use
    Dosage and administration details
    Medical air given by cylinder used when walking

    Number of subjects in period 2
    		ambulatory oxygen ambulatory air
    Started
    13
    12
    Completed
    10
    7
    Not completed
    3
    5
         Physician decision
    1
    -
         Consent withdrawn by subject
    -
    4
         Lost to follow-up
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ambulatory oxygen
    Reporting group description
    		 oxygen used on walking

    Reporting group title
    ambulatory air
    Reporting group description
    		 Air breathed from a cylinder blinded to look same as oxygen when walking

    Reporting group values
    		 ambulatory oxygen ambulatory air Total
    Number of subjects
    		 13 12 25
    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)
    		 1 1 2
        From 65-84 years
    		 12 11 23
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 67.35 ± 7.45 66.45 ± 6.52 -
    Gender categorical
    Units: Subjects
        Female
    		 7 6 13
        Male
    		 6 6 12

    End points

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    End points reporting groups
    Reporting group title
    ambulatory oxygen
    Reporting group description
    		 oxygen used on walking

    Reporting group title
    ambulatory air
    Reporting group description
    		 Air breathed from a cylinder blinded to look same as oxygen when walking
    Reporting group title
    ambulatory oxygen
    Reporting group description
    		 oxygen used on walking

    Reporting group title
    ambulatory air
    Reporting group description
    		 Air breathed from a cylinder blinded to look same as oxygen when walking

    Primary: Gene expression

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    End point title
    		 Gene expression
    End point description
    Not possible to give a single value as gene expression obtained for whole genome and analysed as gene set enrichment analyses, hence data inserted in this record entered as 1.0 to allow record completion. Data set can be found at https://www.ncbi.nlm.nih.gov/geo/query/acc.cgi?acc=GSE90154
    End point type
    Primary
    End point timeframe
    Compared between 12 weeks ambulatiory oxygen and 12 weeks air.
    End point values
    		 ambulatory oxygen ambulatory air ambulatory oxygen ambulatory air
    Number of subjects analysed
    10
    7
    10
    7
    Units: IU
        arithmetic mean (standard deviation)
    1.0 ± 1.0
    1.0 ± 1.0
    1.0 ± 1.0
    1.0 ± 1.0
    Statistical analysis title
    		 Comparison of gene expression oxygen v air
    Comparison groups
    ambulatory oxygen v ambulatory air
    Number of subjects included in analysis
    17
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.9 [2]
    Method
    		 Significance Analysis of Microarrays (SA
    Confidence interval
    Notes
    [1] - No significant differences in any individual gene .At a single gene level differential expression between ambulatory oxygen and air was not detectable.
    [2] - Many p values are obtained as this is genomewide, this is the average

    Secondary: Change in 6MWT distance

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    End point title
    		 Change in 6MWT distance
    End point description
    End point type
    Secondary
    End point timeframe
    Compared between 12 weeks intervention and 12 weeks air, reported as change between periods (only one arm as crossed over)
    End point values
    		 ambulatory oxygen ambulatory air ambulatory oxygen ambulatory air
    Number of subjects analysed
    10
    7
    10
    7
    Units: meters
        arithmetic mean (standard deviation)
    34.06 ± 125.33
    16.25 ± 99.25
    34.06 ± 125.33
    16.25 ± 99.25
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    12 weeks oxygen treatment, 12 weeks air
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    ambulatory oxygen
    Reporting group description
    		 oxygen used on walking

    Reporting group title
    ambulatory air
    Reporting group description
    		 Air breathed from a cylinder blinded to look same as oxygen when walking

    Serious adverse events
    		 ambulatory oxygen ambulatory air
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 25 (0.00%)
    0 / 25 (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: 1%
    Non-serious adverse events
    		 ambulatory oxygen ambulatory air
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 25 (4.00%)
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
    Additional description: Small nose bleed, self limiting
         subjects affected / exposed
    0 / 25 (0.00%)
    1 / 25 (4.00%)
         occurrences all number
    0
    1

    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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