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    Clinical Trial Results:
    Urine concentrations of vilanterol after inhaled administration of vilanterol/fluticasone furoate: Defining a urine threshold and decision limit for vilanterol in doping control analysis

    Summary
    EudraCT number
    		 2018-002529-48
    Trial protocol
    		 DK  
    Global end of trial date
    14 Dec 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Jan 2022
    First version publication date
    11 Jan 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    WADA2018vil
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Center for Aktiv Sundhed, Rigshospitalet
    Sponsor organisation address
    Rigshospitalet afsnit 7641, Blegdamsvej 9, 2100 København Ø, Copenhagen, Denmark,
    Public contact
    CFAS, Center for Aktiv Sundhed, Rigshospitalet, eriksorenhalvardhansen@gmail.com
    Scientific contact
    CFAS, Center for Aktiv Sundhed, Rigshospitalet, eriksorenhalvardhansen@gmail.com
    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
    14 Dec 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Dec 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Dec 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine urine concenctrations of vilanterol and its metabolites after therapeutic and supratherapeutic use.
    Protection of trial subjects
    The subjects had a bed to rest. No more measures were needed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jun 2020
    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
    Denmark: 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)
    25
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Eligibility criteria were physically active males or females (at least 5 hours physical activity weekly), aged 18-39 years. 42 individuals were screened and 25 included. 6 individuals dropped out during the study, resulting in 19 individuals completing all 4 trials.

    Period 1
    Period 1 title
    Trial 1 - 25 µg inhalation
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Trial 1 - 25 µg
    Arm description
    		 Due to the limits of reporting results, this "arm" represents the first trial of the four trials. The study only has 1 arm, which completes four trial periods.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Relvar ElliptaTM, 22/184 µg vilanterol/fluticasone furoate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    The study consisted of four trials. During trials 1 and 3, participants inhaled a single dose (25 µg; Trial 1) or four doses (100 µg; Trial 3). After the single-dose trials (Trial 1 and 3), participants received an inhaler for home administration of the study drug. Trials 2 and 4 were preceded by a repeated dosing regime of once-daily inhalation of 25 µg (7d25 µg; Trial 2) or 100 µg (7d100 µg; Trial 4) for 6 days. Trials were separated by at least a 1-week washout. Home administrations were monitored by staff via online video tools to maximize drug compliance and assess inhalation technique.

    Number of subjects in period 1
    		Trial 1 - 25 µg
    Started
    25
    Completed
    25
    Period 2
    Period 2 title
    Trial 2 - 7d 25 µg
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not Blinded

    Arms
    Arm title
    		 Trial 2 - 7d 25 µg
    Arm description
    		 Due to the limits of reporting results, this "arm" represents the second trial of the four trials. The study only has 1 arm, which completes four trial periods.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Relvar ElliptaTM, 22/184 µg vilanterol/fluticasone furoate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    The study consisted of four trials. During trials 1 and 3, participants inhaled a single dose (25 µg; Trial 1) or four doses (100 µg; Trial 3). After the single-dose trials (Trial 1 and 3), participants received an inhaler for home administration of the study drug. Trials 2 and 4 were preceded by a repeated dosing regime of once-daily inhalation of 25 µg (7d25 µg; Trial 2) or 100 µg (7d100 µg; Trial 4) for 6 days. Trials were separated by at least a 1-week washout. Home administrations were monitored by staff via online video tools to maximize drug compliance and assess inhalation technique.

    Number of subjects in period 2
    		Trial 2 - 7d 25 µg
    Started
    25
    Completed
    21
    Not completed
    4
         Consent withdrawn by subject
    3
         non-compliance
    1
    Period 3
    Period 3 title
    Trial 3 - 100 µg
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not blinded

    Arms
    Arm title
    		 Trial 3 - 100 µg
    Arm description
    		 Due to the limits of reporting results, this "arm" represents the third trial of the four trials. The study only has 1 arm, which completes four trial periods.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Relvar ElliptaTM, 22/184 µg vilanterol/fluticasone furoate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    The study consisted of four trials. During trials 1 and 3, participants inhaled a single dose (25 µg; Trial 1) or four doses (100 µg; Trial 3). After the single-dose trials (Trial 1 and 3), participants received an inhaler for home administration of the study drug. Trials 2 and 4 were preceded by a repeated dosing regime of once-daily inhalation of 25 µg (7d25 µg; Trial 2) or 100 µg (7d100 µg; Trial 4) for 6 days. Trials were separated by at least a 1-week washout. Home administrations were monitored by staff via online video tools to maximize drug compliance and assess inhalation technique.

    Number of subjects in period 3
    		Trial 3 - 100 µg
    Started
    21
    Completed
    20
    Not completed
    1
         Consent withdrawn by subject
    1
    Period 4
    Period 4 title
    Trial 4 - 7d 100 µg
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not blinded

    Arms
    Arm title
    		 Trial 4 - 7d 100 µg
    Arm description
    		 Due to the limits of reporting results, this "arm" represents the fourth trial of the four trials. The study only has 1 arm, which completes four trial periods.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Relvar ElliptaTM, 22/184 µg vilanterol/fluticasone furoate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    The study consisted of four trials. During trials 1 and 3, participants inhaled a single dose (25 µg; Trial 1) or four doses (100 µg; Trial 3). After the single-dose trials (Trial 1 and 3), participants received an inhaler for home administration of the study drug. Trials 2 and 4 were preceded by a repeated dosing regime of once-daily inhalation of 25 µg (7d25 µg; Trial 2) or 100 µg (7d100 µg; Trial 4) for 6 days. Trials were separated by at least a 1-week washout. Home administrations were monitored by staff via online video tools to maximize drug compliance and assess inhalation technique.

    Number of subjects in period 4
    		Trial 4 - 7d 100 µg
    Started
    20
    Completed
    19
    Not completed
    1
         Covid-19
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Trial 1 - 25 µg inhalation
    Reporting group description
    		 -

    Reporting group values
    		 Trial 1 - 25 µg inhalation Total
    Number of subjects
    		 25 25
    Age categorical
    Units: Subjects
        18-39
    		 25 25
    Gender categorical
    Units: Subjects
        Female
    		 9 9
        Male
    		 16 16

    End points

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    End points reporting groups
    Reporting group title
    Trial 1 - 25 µg
    Reporting group description
    		 Due to the limits of reporting results, this "arm" represents the first trial of the four trials. The study only has 1 arm, which completes four trial periods.
    Reporting group title
    Trial 2 - 7d 25 µg
    Reporting group description
    		 Due to the limits of reporting results, this "arm" represents the second trial of the four trials. The study only has 1 arm, which completes four trial periods.
    Reporting group title
    Trial 3 - 100 µg
    Reporting group description
    		 Due to the limits of reporting results, this "arm" represents the third trial of the four trials. The study only has 1 arm, which completes four trial periods.
    Reporting group title
    Trial 4 - 7d 100 µg
    Reporting group description
    		 Due to the limits of reporting results, this "arm" represents the fourth trial of the four trials. The study only has 1 arm, which completes four trial periods.

    Primary: Urine values of Vilanterol

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    End point title
    		 Urine values of Vilanterol [1]
    End point description
    The mean of maximum urine concentrations (Cmax) of parent vilanterol, with the min-max range, is presented here.
    End point type
    Primary
    End point timeframe
    Urine values was collected -1 to 72 hours after inhalation of vilanterol
    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: This study presents urine values of vilanterol and its metabolites after inhalation of relvar elipta. Only minor statistical analyses was made in the presentation of those values.
    End point values
    		 Trial 1 - 25 µg Trial 3 - 100 µg Trial 2 - 7d 25 µg Trial 4 - 7d 100 µg
    Number of subjects analysed
    25
    20
    21
    19
    Units: ng X mL
        arithmetic mean (full range (min-max))
    1.2 (0.2 to 4.1)
    6.2 (1.4 to 14.3)
    2.0 (0.3 to 4.8)
    22.4 (6.4 to 42.1)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    At the beginning of each trial day or by self-reporting.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Study dictionary
    Dictionary version
    1
    Frequency threshold for reporting non-serious adverse events: 5%
    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: I do not have access to records of non-serious adverse events. This will be typed in later.

    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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